Supreme Court Rules that Government Regulators Can Sue Over Pay-for-Delay Agreements Between Brand and Generic Drug Manufacturers

George F. Indest III, Board Certified by The Florida Bar in Health Law

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

The U.S. Supreme Court ruled on June 17, 2013, that pay-for-delay agreements between brand name and generic drug manufacturers are subject to anti-trust scrutiny. These pay-for-delay agreements, or reverse payments, are usually a form of settlement between the two manufacturers in patent litigation. The Supreme Court decided that each instance must be considered on a case-by-case basis. This verdict rewrites the rules governing the release of generic drugs. It is likely to increase the number of generic drugs in the marketplace and reduce the price of generic drugs.

To read a previous blog on pay-for-delay agreements, click here.

What is a Pay-for-Delay Agreement?

Pay-for-delay agreements came as the result of the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. The Hatch-Waxman Act gives generic drug manufacturers an incentive to challenge brand name drug patents because the first generic drug manufacturer to received U.S. Food and Drug Administration (FDA) approval to launch a generic copy of a brand name drug can receive a 180-day marketing exclusivity period for the product. The FDA cannot approve any other generic applications for the same drug until the first-to-file generic manufacturer has sold its product for 180 days or has given up its exclusivity period. Click here to read the Hatch-Waxman Act.

Brand name manufacturers often challenge generic drug manufacturers who try to sell their product prior to patent expiration. This results in litigation to determine whether the generic manufacturer is violating the brand name manufacturer’s patents.

Instead of going to court over this, brand name manufacturers often choose to pay a settlement to the generic drug manufacturers for agreeing to delay the launch of its competing product.

Why the Supreme Court Overruled Court of Appeals Decision.

The 5-3 vote overruled the 11th Circuit Court of Appeals decision that said pharmaceutical companies can’t be sued unless the patent litigation is a sham or a generic drug maker agrees to delay introduction of a generic drug into the market even after the patent has expired.

A Med Page Today article lists the Supreme Court’s five reasons why the appellate court made a mistake in giving blanket immunity to pay-for-delay agreements from the decision written by Justice Stephen Breyer:

-  “A reverse payment, where large and unjustified, can bring with it the risk of significant anticompetitive effects.”

-  “One who makes such a payment may be unable to explain and to justify it.”

-  “Such a firm or individual may well possess market power derived from the patent.”

-  “A court, by examining the size of the payment, may well be able to assess its likely anticompetitive effects along with its potential justifications without litigating the validity of the patent.”

-  “Parties may well find ways to settle patent disputes without the use of reverse payments.”

Click here to read the entire Med Page Today article.

Pay-for-Delay Agreements Allegedly Cost Patients Millions of Dollars a Year.

According to Bloomberg, the high court’s decision may discourage brand name and generic pharmaceutical companies from reaching settlements. It’s been found that pay-for-delay agreements can delay a generic drug almost 17 months before it can be put on the market. In the meantime, patients must pay higher prices for the brand name version. This also impacts Medicare and Medicaid programs. The Federal Trade Commission (FTC) claims pay-for-delay agreements cost consumers $3.5 billion a year in the form of higher drug prices.

To read the Bloomberg article, click here.

The Case of the FTC v. Solvay Pharmaceuticals.

The Supreme Court case center around AndroGel, a treatment for low testosterone in men, made by Solvay Pharmaceuticals, Inc. The FTC sued Solvay and three generic drug companies. According to Bloomberg, the FTC said that a payment made by Solvay, the holder of a patent on AndroGel, to the generic drug manufacturers represented an unlawful restraint of trade because it was intended to keep cheaper, generic versions of AndroGel off the market until 2020.

FTC Enthusiastic About the Decision.

In a statement, the FTC Chairwoman said the Supreme Court’s decision is a “significant victory for American consumers, American taxpayers and free market.” She also stated, “The court made it clear that pay-for-delay agreements are subject to antitrust scrutiny.”

Click here to read the full statement from the FTC.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, 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.

Comments?

What do you think of the Supreme Court’s ruling? Do you agree or disagree? What effect do you think it will have on the pharmaceutical industry? Please leave any thoughtful comments below.

Sources:

Stohn, Greg. “Drugmakers Opened to ‘Pay for Delay’ Suits by High Court.” Bloomberg. (June 17, 2013). From:
http://www.bloomberg.com/news/2013-06-17/drugmakers-opened-to-pay-for-delay-suits-by-high-court.html

Frieden, Joyce. “Supreme Court Split on Pharma ‘Pay for Delay’ Deals.” Med Page Today. (June 17, 2013). From:
http://bit.ly/18SfhKb

Kaplan, Peter. “Statement of FTC Chairwoman Edith Ramirez of the U.S. Supreme Court’s Decision in FTC v. Actavis, Inc.” (June 17,2 013). From:
http://www.ftc.gov/opa/2013/06/actavis.shtm

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.

“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 © 1996-2012 The Health Law Firm. All rights reserved.

Drug Enforcement Administration Agents Raid Central Florida Pain Management Clinic

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

Drug Enforcement Administration (DEA) agents along with local police and sheriffs’ deputies raided a Longwood, Florida, pain management clinic on June 14, 2013. According to the Orlando Sentinel, agents searched for evidence at the clinic associated with multiple doctors. DEA agents stated the clinic was operating as a “pill mill” and allegedly diverting legal prescriptions for illegal purposes. No one was arrested during the raid. Longwood is a suburb of Orlando.

Investigation Spreads to South Florida.

According to WESH-TV, during the raid agents took everything from the clinic that could help them build a criminal prosecution. This included paper records, computer equipment and prescription drugs. DEA agents would not say how many people they were investigating, but they did say this raid was the result of a two-year long investigation.

In addition to the Longwood pain clinic, DEA agents said they are also searching locations in Brevard County, Florida, where associates of the Longwood clinic allegedly live.

To watch the WESH-TV report, click here.
Two Doctors Associated With the Longwood Clinic Allegedly “Blacklisted” by Pharmacy.

According to the Orlando Sentinel, two doctors associated with the Longwood clinic were allegedly “blacklisted” in 2011, by CVS Pharmacy. This means that CVS notified those physicians that the pharmacy chain would no longer fill prescriptions they wrote for certain drugs such as oxycodone, due to suspiciously high prescribing rates. To read a previous blog on the CVS blacklist, click here.

Click here to read the entire Orlando Sentinel article.

The Longwood pain clinic is currently closed. Whether this will be temporary or permanent is unknown at this time.

Different Clinic, Similar Storyline.

This raid on the Longwood clinic is just one of the many we’ve recently seen in Florida. DEA agents and local law enforcement officials are not slowing down in their fight against illegal pill mills, and illegal prescribing and dispensing practices. To read a blog on two Orlando-area pharmacists recently arrested on charges of alleged drug trafficking, click here. Even the biggest pharmacy chains are not immune to investigations. Walgreens just agreed to pay $80 million to settle a DEA investigation into the chain’s dispensing practices of prescription drugs. To read more, click here.

Contact Health Law Attorneys Experienced with DEA Cases and Licensing Actions.

The Health Law Firm represents physicians, pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH), and other law enforcement agencies.
If you are aware of an investigation of you or your practice, or if you have been contacted by the DEA or DOH, contact an experienced health law attorney immediately.

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

Comments?

What do you think about all of these raids on pharmacies and pain clinics? Please leave any thoughtful comments below.

Sources:

McDaniel, Dave. “Agents Raid Longwood Pain Clinic.” WESH-TV. (June 14, 2013). From:
http://www.wesh.com/news/central-florida/seminole-county/agents-raid-longwood-pain-clinic/-/17597106/20572512/-/item/0/-/afpnwwz/-/index.html

Pavuk, Amy. “Agents Raid Longwood Pain Clinic.” Orlando Sentinel. (June 14, 2013). From:
http://www.orlandosentinel.com/news/local/breakingnews/os-professional-pain-care-raid-20130614,0,3826330.story#tugs_story_display

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.

“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 © 1996-2012 The Health Law Firm. All rights reserved.

Texas Oncologist Accused of Poisoning Coworker/Boyfriend’s Coffee

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

A Houston, Texas, doctor is accused of spiking her co-worker’s coffee with a toxic chemical. Both the female doctor and the male co-worker she allegedly tried to poison worked as oncologists at The University of Texas M.D. Anderson Cancer Center. It’s reported the two were also dating at the time of the incident. The female oncologist was allegedly arrested on May 29, 2013, and charged with aggravated assault, according to ABC News.

Click here to read the ABC News article.

I’d like to point out that these are just allegations made against the female oncologist at this point in time and have not been proven by the state. “All persons are innocent until proven guilty in a court of law.” (Cops.)

Do You Take Your Coffee With or Without Antifreeze?

According to Associated Press, January 27, 2013, is when the alleged poisoning actually occurred. The female oncologist allegedly put ethylene glycol in her coworker/boyfriend’s coffee. When he mentioned it was too sweet, she said it was because she added Splenda to it. The female oncologist allegedly made him finish the cup and made him a second glass. It’s reported the second glass contained more of the chemical.

Currently, there is no reported comment from the maker of Splenda regarding the alleged incident.

Victim Left Severely Sick After Alleged Poisoning.

Four hours later, the man allegedly experienced slurred speech, blurred vision and loss of motor skills. At the emergency department he was found to have central nervous system depression, cardiopulmonary complications and renal failure. A test allegedly found crystals consistent with ethylene glycol poisoning, according to ABC News.

Ethylene glycol is present in all M.D. Anderson laboratories, according to the Associated Press. Therefore, the oncologist allegedly had access to the chemical.

Female Oncologist Not Currently Working.

According to the Associated Press, the oncologist accused of doing the poisoning is on paid administrative leave from M.D. Anderson. She has since bonded out of jail, but was ordered to surrender her passport.

To read the entire Associated Press article, click here.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), Department of Health (DOH) and other law enforcement agencies. Its 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.

Comments?

What do you think of this story? Please leave any thoughtful comments below.

Sources:

Shaw, Alexis. “Houston Oncologist Allegedly Poisoned Boyfriend’s Coffee with Antifreeze Chemicals.” ABC News. (June 8, 2013). From:
http://abcnews.go.com/US/texas-doctor-accused-lacing-boyfriends-coffee-poison/story?id=19356031#.UbdoB9jgXwk

Associated Press. “Houston Doctor Charged with Poisoning Her Lover.” Associated Press. (June 9, 2013). From:
http://www.chron.com/default/article/Houston-doctor-charged-with-poisoning-her-lover-4589978.php

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.

“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 © 1996-2012 The Health Law Firm. All rights reserved.

Health Care Professionals and Providers Beware: The Health Care Fraud Prevention and Enforcement Action Team (HEAT) Is Catching Fire

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

In May 2009, the Department of Health and Humans Services (HHS) and the Department of Justice (DOJ) created the Health Care Fraud Prevention and Enforcement Action Team (HEAT). HEAT’s mission is to focus its efforts on preventing and deterring fraud and to enforce current anti-fraud laws around the country. To date, almost 1,400 individuals have been charged in connection with schemes involving more than $4.8 billion in fraudulent billings in these HEAT takedown operations.

To learn more about HEAT, click here to visit the website.

The Success of the HEAT Team.

According to the website, between 2008 and 2011, HEAT actions led to a seventy-five percent (75%) increase in individuals charged with criminal health care fraud. So far there have been six nationwide HEAT sting operations.

In 2011, HEAT agents led the largest-ever federal health care fraud takedown involving $530 million in fraudulent billing. To read more on this sting, click here.

On May 14, 2013, the DOJ announced that more than 400 law enforcement officials with HEAT spread out between eight cities including Miami and Tampa Bay to arrest 89 people accused of false billing. A majority of these arrests were allegedly of health care professionals. Click here to read a blog with more information on this takedown.

HEAT Captures One of Medicare’s Most-Wanted Fugitives.

On June 1, 2013, a former Los Angeles physical therapy clinic owner, and one of Medicare’s most-wanted fugitives, was arrested by HEAT agents at the Los Angeles International Airport on his return flight. According to a Los Angeles Times article, the clinic owner was an acupuncturist who billed Medicare for $2.1 million in false claims and was paid about $1.2 million. To read more from the Los Angeles Times, click here.

Expanding the Medicare Fraud Strike Force Efforts.

HEAT is a multi-agency team of federal, state and local investigators who combat Medicare fraud through the use of Medicare data analysis techniques and an increased focus on community policing.

The Affordable Care Act has given HEAT additional tools to preserve Medicare by expanding the team’s authority to suspend Medicare payments and reimbursements when fraud is suspected.

To better combat fraud, the government has established HEAT in a number of cities, such as Los Angeles, Miami, Tampa Bay, Houston, Dallas, Chicago, Brooklyn, Baton Rouge and Detroit.

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 health care providers in 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.

Comments?

Have you heard of HEAT? Do you think the team’s efforts are curbing Medicare fraud around the country? Please leave any thoughtful comments below.

Sources:

Department of Justice. “Medicare Fraud Strike Force Charges 89 Individuals for Approximately $223 Million in False Billing.” Department of Justice. (May 14, 2013). From:
http://www.justice.gov/opa/pr/2013/May/13-crm-553.html

Terhune, Chad. “One of Medicare’s Most-Wanted Fugitives is Arrested in L.A.” Los Angeles Times. (June 3, 2013). From:
http://www.latimes.com/business/money/la-fi-mo-medicare-most-wanted-fugitive-arrest-20130603,0,7474342.story

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.

“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 © 1996-2012 The Health Law Firm. All rights reserved.

Department of Justice Seeks up to $600 Million in Whistleblower Case Against Halifax Health in Daytona Beach, Florida

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

The U.S. Department of Justice (DOJ) is asking for between $350 million and $600 million in damages and penalties from Halifax Health Medical Center in Daytona Beach, according to The Daytona Beach News-Journal. A Halifax employee filed the whistleblower lawsuit in 2009, accusing the hospital of illegal kickbacks to doctors, improper admissions and unnecessary spinal surgeries. The DOJ joined the case in 2011. Click here to read a previous blog on the DOJ joining the lawsuit.

If the government wins this case, it would amount to the largest whistleblower case of its kind in the nation.

Claims Against Halifax.

Halifax is accused of overbilling Medicare by inappropriately admitting patients and having financial arrangements with some of its doctors that violated a federal anti-kickback law.

The federal Stark Law prohibits Medicare and Medicaid payments for hospital services that are prescribed by doctors who have profit-sharing agreements with the hospital. The law was made to ensure that referrals are made for medical reasons only, without financial motives. However, according to the lawsuit, Halifax had agreements with its doctors that gave them a financial incentive to generate hospital revenues.

The whistleblower was recently interviewed in an Orlando Sentinel article. She claims neurosurgeons at Halifax allegedly received illegal kickbacks tied to their performance. The whistleblower claims a similar pattern existed with six of the hospital’s oncologists. The suit also alleges one surgeon performed spinal fusion surgeries that were not medically necessary.

To read more from the whistleblower in an Orlando Sentinel article, click here.

Halifax Denies All Claims.

Halifax denies all of the DOJ’s allegations. The hospital has filed two motions to dismiss the case. However, both have been denied. According to The Daytona Beach News-Journal, the case is set for trial in November 2013. Click here to read the entire article from The Daytona Beach News-Journal.

Whistleblowers Who Report Fraud and False Claims Against the Government Stand to Receive Large Rewards.

Since the Halifax whistleblower filed her action under a federal law, she is entitled to recoup fifteen percent (15%) to twenty-five percent (25%) of the damages. Similarly, individuals working in the health care industry, whether for hospitals, nursing homes, medical groups, home health agencies or others, often become aware of questionable activities. Often they are even asked to participate in it. In many cases the activity may amount to fraud on the government.

In a two-part blog, I explain types of false claims, the reward programs for coming forward with a false claim, who can file a whistleblower/qui tam lawsuit and what is needed to be a successful whistleblower. Click here for part one, and click here for part two.

Contact Health Law Attorneys Experienced with Medicaid and Medicare Qui Tam or Whistleblower Cases.

In addition to our other experience in Medicare, Medicaid and Tricare cases, attorneys with The Health Law Firm also represent health care professionals and health facilities in qui tam or whistleblower cases. We have developed relationships with recognized experts in health care accounting, health care financing, utilization review, medical review, filling, coding, and other services that assist us in such matters.

To learn more on our experience with Medicaid and Medicare quit tam or whistleblower cases, visit our website.

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

Comments?

What do you think of this qui tam/whistleblower lawsuit? Please leave any thoughtful comments below.

Sources:

Swisher, Skyler. “Justice Department Seeks up to $600 Million in Lawsuit Against Halifax.” The Daytona Beach News Journal. (June 3, 2013). From:
http://www.news-journalonline.com/article/20130603/NEWS/306039975/1040?p=1&tc=pg

Jameson, Marni. “Halifax Hospial Whistleblower at Forefront of $200M Alleged Fraud.” Orlando Sentinel. (April 15, 2013). From:
http://articles.orlandosentinel.com/2013-04-15/news/os-halifax-hospital-whistleblower-20130415_1_marlan-wilbanks-illegal-kickbacks-halifax-health
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.

 

 

“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 © 1996-2012 The Health Law Firm. All rights reserved.

The Affordable Care Act Offers the Government New Tools to Fight Healthcare Fraud

By Catherine T. Hollis, J.D., The Health Law Firm

In 2013, the government reported recovery of a record-breaking $10.7 billion in healthcare fraud in the past three years, according to the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Justice (DOJ). The HHS credits the Affordable Care Act’s tough stance on fraud for improving the efforts to fight Medicare fraud.

The increase in fraud recovery is attributed in part to the Act’s proactive approach to preventing fraud. The Act contains several initiatives that address Medicare fraud, resulting in increased fraud-fighting tools available to the government. The joint effort between the HHS, the DOJ and the Health Care Fraud Prevention and Enforcement Action Team has been a primary driving force in seeking out fraud and securing recoveries. The HHS and DOJ’s website highlights some of the Act’s “powerful steps” toward fighting fraud, waste and abuse. Click here to read more from www.stopmedicarefraud.gov.

Tougher Punishment.

The Act increases federal sentencing guidelines for healthcare fraud by twenty percent (20%) to fifty percent (50%) for crimes that involve more than $1 million in losses. The Act also establishes penalties for obstructing a fraud investigation or an audit.

Stricter Screening for Enrollment and Revalidation.

According to the HHS, the new screening procedures include licensure checks and site visits for all providers and suppliers. In addition, the Act imposes higher scrutiny on providers and suppliers who may pose a higher risk of fraud or abuse. High risk providers and suppliers can be subject to unscheduled site visits and fingerprint-based criminal background checks.

The Center for Medicare & Medicaid Services (CMS) has started to revalidate the enrollment of all 1.5 million existing Medicare providers and suppliers, using the new screening requirements set forth by the Act. Thousands of enrollments have already been deactivated or revoked as the result of this effort. There is a blog on our website about the devastating and far reaching effects of being excluded from the Medicare program. Click here to read that blog.

New Detection Technology.

CMS is using the Fraud Prevention System to screen all fee-for-service Medicare claims. This system uses advanced predictive technology, similar to that used by credit card companies, to analyze claims prior to payment. It also scans for suspicious billing patterns. Claims identified by the Fraud Prevention System as suspect are reviewed by CMS for possible fraud.

Increased Resources.

The Act provides an additional $350 million over ten years (2011 through 2020) through the Health Care Fraud and Abuse Control Account.

These steps represent a more proactive approach to Medicare fraud. The government is focusing on preventing fraud before it happens, rather than paying fraudulent claims and seeking reimbursement after the fact. The tools contained in the Act, as implemented by CMS and HHS, further the goal of the Act to reduce fraud, waste and abuse in the Medicare system. To read a summary of the anti-fraud provisions in the Affordable Care Act, click here.

Anti-Fraud Provisions At Work.

On May 14, 2013, the HHS and DOJ announced the arrest of 89 people, including doctors, nurses and other medical professionals, in eight cities. These people are allegedly charged in separate Medicare fraud schemes. According to the DOJ, the scans involve approximately $223 million in false billing. Click here to read a blog on these arrests. To read more blogs on Medicare and Medicaid fraud, visit our website.

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 healthcare providers in 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.

Comments?

Do you think the Affordable Care Act will help cut down on healthcare fraud? Why or why not? Please leave any thoughtful comments below.

Sources:

Sjoerdsma, Donald. “The Affordable Care Act Bolstered, Didn’t Drive Medicare Anti-Fraud Efforts.” The Medicare Newsgroup. (March 22, 2013). From:
http://medicarenewsgroup.com/context/understanding-medicare-blog/understanding-medicare-blog/2013/03/22/the-affordable-care-act-bolstered-didn-t-drive-medicare-anti-fraud-efforts
“The Affordable Care Act and Fighting Fraud.” U.S. Department of Health & Human Services and U.S. Department of Justice. From:
http://www.stopmedicarefraud.gov/aboutfraud/aca-fraud/index.html

 

Health Benefits ABCs. “Summary of Anti-Fraud Provisions in the Affordable Care Act.” U.S. Administration on Aging, Department of Health and Human Services. From:
http://www.smpresource.org/Content/NavigationMenu/ConsumerProtection/HealthCareReform/Anti-Fraud_Provisions_in_Health_Care_Reform.docx

“New Tools to Fight Fraud, Strengthen Federal and Private Health Programs, and Protect Consumer and Taxpayer Dollars.” U.S. Department of Health & Human Services. (March 15, 2011). From:
http://www.healthcare.gov/news/factsheets/2011/03/fraud03152011a.html
About the Author: Catherine T. Hollis is an attorney with 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 Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

 

“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 © 1996-2012 The Health Law Firm. All rights reserved.

Internal Revenue Service Decides Electronic Health Record Incentive Payments are Taxable

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

The Internal Revenue Service (IRS) has taken the position that electronic health record (EHR) incentive payments are taxable. Previously it was not specified how EHR incentive payments were to be treated or reported to the IRS. On January 14, 2013, the IRS issued guidance on this issue in a memorandum from the Office of Chief Counsel. This memorandum lists tax issues facing those who have received or who will receive EHR incentive payments. It also states the IRS’s position on those issues.

IRS Considered Three Different Issues and Gave its Stance on Each Issue.

In its memorandum, the Office of Chief Counsel considered the following three issues:

1. Whether recipients must include in gross income electronic health record
incentive payments paid by the Centers for Medicare and Medicaid Services
(CMS) pursuant to the American Recovery and Reinvestment Act (ARRA).

2. Whether CMS has a reporting requirement with regard to payments made under the EHR Incentive Program.

3. Whether the reporting requirement is altered if the payment is assigned to a third party.

The Summary of the Office of Chief Counsel’s Position on Each of the Issues.

1. The recipients must include the incentive payments in gross income unless they receive the payments as a conduit or an agent of another and are thus unable to keep the payments.

2. CMS has a reporting requirement under section 6041 of the Internal Revenue Code with respect to the eligible providers.

3. In the event of an assignment by the eligible providers to a third party, CMS would be obligated to report a payment to the eligible provider, even if the payment is assigned to a third party. The eligible provider would then likely bear a reporting obligation with respect to the assignment to a third party. CMS would not have a reporting obligation with respect to the third-party assignee unless CMS exercised managerial oversight with respect to, or had a significant economic interest in, the assignment.

Click here to read the entire memorandum.

Health Care Professionals Be Aware.

According to the IRS, taxpayers cannot avoid tax by turning over income to someone else. For example, a doctor earns an EHR incentive payment and turns it over to his/her practice. That doctor may still have to include the EHR payment on his/her personal tax return. The IRS allows an exception. If the doctor received the payment as an agent of the group practice, the doctor does not have to report it on his/her personal tax return.

Health care professionals and providers who have or will receive EHR incentive payments should plan to deal with the tax consequences of those incentives.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely represents physicians and medical groups on EHR problems. It also represents pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH) and other law enforcement agencies. Its 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.

Comments?

As a health care professional, do you think electronic health record (EHR) incentive payments should be taxable? Please leave any thoughtful comments below.

Sources:

Goldberg, Alan. “Healthcare Reimbursement List.” American Health Lawyers Association. (April 26, 2013).

Montemurro, Michael. “Electronic Health Records Incentive Payments, POSTS-145204-12.” Internal Revenue Service. (January 14, 2013). From:
http://www.thehealthlawfirm.com/uploads/1307005.pdf

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.

 

“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 © 1996-2012 The Health Law Firm. All rights reserved.

Healthcare Providers Service Organization (HPSO) Attorneys, Lawyers and Defense Council in Florida

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

Often we learn after the fact that a health professional such as a mental health counselor, psychologist, or pharmacist has received Healthcare Providers Service Organization (HPSO) insurance, has had a legal problem, and has not been able to locate an attorney or law firm that accepts this type of insurance. We have offices in Florida and Colorado, but we have attorneys licensed in Florida, Colorado, Louisiana, the District of Columbia, Virginia and other states.

Additionally, we can provide legal advice and representation in license investigations and administrative proceedings in many other states.

If you have HPSO Insurance, do not go without an attorney or with a lawyer that has little or no experience where you need it. Contact us, and we will help you.

Don’t Worry About Legal Bills While Your Case is Going On.

Call us first. We can assist you in determining if your legal problem is covered by your insurance, and we can help you file a claim to have your legal defense expenses and costs covered. In most cases, we will accept the assignment of your insurance so that you do not have to worry about legal bills while your case is going on.

Contact Experienced Health Law Attorneys That Will Work with Insurance Companies.

The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH) and other law enforcement agencies. Its attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

In cases in which the health care professional has professional liability insurance or general liability insurance which provides coverage for such matters, we will seek to obtain coverage by your insurance company and will attempt to have your legal fees and expenses covered by your insurance company. We will agree to take an assignment of your insurance policy proceeds in order to be able to submit our bills directly to your insurance company, if your insurance company will allow this. Many of these insurers will pay our firm to represent you in the legal defense of an investigation or complaint against your professional (nursing, medical, dental, psychology, mental health counselor) license or for an administrative hearing involving professional discipline.

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

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.

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 © 1996-2012 The Health Law Firm. All rights reserved.

Strike Force Busts 89 People, Mostly Health Care Professionals, in Nationwide Crackdown on Medicare Fraud

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

In a nationwide takedown nearly 100 people, including doctors, nurses and other medical professionals, in eight cities were all allegedly charged in separate Medicare fraud schemes. These individual scams involved approximately $223 million in false billing, according to the Department of Justice (DOJ) and the Department of Health and Humans Services (DHHS). On May 14, 2013, more than 400 law enforcement officials with the Medicare Fraud Strike Force spread out between Miami, Detroit, Los Angeles, New York, New Orleans, Houston, Chicago and Tampa to make the arrests of these 89 people, according to the DOJ.

Click here to read the press release from the DOJ.

Medicare Schemes Could Not Have Happened Without the Help of Health Professionals.

According to an article in Reuters, one out of every four defendants in this crackdown was some type of health professional. Authorities say most of these allegedly complex scams could not have happened without the participation of a doctor signing off on a bogus service, or a nurse filling out false paperwork.

Click here to read the entire article from Reuters.

Florida Health Professionals Involved.

According to the DOJ, in Miami, a total of 25 people, including two nurses and a paramedic, were allegedly part of numerous Medicare scams, totaling about $44 million in false claims. In one case involving a home health agency, defendants allegedly bribed Medicare beneficiaries for their Medicare information, which was used to bill for home health services that were never rendered or not medically necessary. The DOJ believes the lead defendant spent a majority of the money from the scam on luxury cars.

Phony Health Care Clinics Set Up.

In Tampa, nine individuals were charged in a variety of schemes, ranging from pharmacy fraud to health-care related money laundering. According to the DOJ, in one case four individuals allegedly established four health care clinics. The individuals allegedly used these clinics to steal more than $2.5 million from Medicare for surgical procedures that were never performed.

This Marks the Sixth Time the Medicare Fraud Strike Force Has Executed a Nationwide Crackdown.

This crackdown marks the sixth time the Medicare Fraud Strike Force has taken nationwide action against Medicare fraud. To date, the Medicare Fraud Strike Force is credited with making more than 1,500 arrests on charges related to $5 billion in allegedly false Medicare claims since 2007. According to the DOJ, it’s believed Medicare fraud costs the program between $60 billion and $90 billion each year.

Medicare operates under a pay-and-chase system, but according to the Washington Post, authorities are beginning to use new technology that flags suspicious claims before Medicare makes a payment. To read the entire Washington Post article, click here.

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 health care providers in 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.

Comments?

What do you think of these nationwide crackdowns on Medicare fraud? Do you think they work as a deterrent for others committing health care fraud? Please leave any thoughtful comments below.

Sources:

Department of Justice. “Medicare Strike Force Charges 89 Individuals for Approximately $223 Million in False Billing.” Department of Justice. (May 14, 2013). From:
http://www.justice.gov/opa/pr/2013/May/13-crm-553.html

Kennedy, Kelli. “Doctors and Nurses Among Nearly 100 Charged in $223 Million Medicare Fraud Busts in 8 Cities.” Washington Post. (May 14, 2013). From:
http://www.washingtonpost.com/politics/health_care/doctors-nurses-among-nearly-100-charged-in-223-million-medicare-fraud-busts-in-8-cities/2013/05/14/fbb0de3a-bcbc-11e2-b537-ab47f0325f7c_story.html

Morgan, David. “U.S. Charges 89 People in $223 Million Medicare Fraud Scheme.” Reuters. (May 14, 2013). From:
http://www.reuters.com/article/2013/05/14/usa-healthcare-fraud-idUSL2N0DV3GZ20130514

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.

 

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 © 1996-2012 The Health Law Firm. All rights reserved.

Two Separate Lawsuits Against Novartis Pharmaceuticals Corporation Allege Illegal Kickbacks and False Claims

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

Novartis Pharmaceuticals Corporation (NPC) is currently fielding two different lawsuits, filed just days apart from each other, by the U.S. Department of Justice (DOJ). The first lawsuit was filed on April 23, 2013, alleging the company gave illegal kickbacks to pharmacists. A second lawsuit was filed on April 26, 2013, alleging illegal kickbacks were paid by NPC to health care providers. According to the DOJ, the government’s complaint seeks damages and civil penalties under the False Claims Act, and under the common law for paying kickbacks to doctors to induce them to prescribe NPC products that were reimbursed by federal health care programs.

Click here to read the entire press release from the DOJ.

NPC Accused of Treating Health Care Professionals to Expensive Dinners, Product Discounts and Fishing Trips.

Both lawsuits allege NPC violated the Anti-Kickback Statute. In the April 23, 2013, complaint against NPC the lawsuit alleges the company gave kickbacks, in the form of rebates and discounts to pharmacies in exchange for the pharmacies’ cooperation in switching patients from competitors’ drugs to NPC products.

The April 26, 2013, lawsuit accuses NPC of paying doctors to speak about certain drugs at events that were allegedly social occasions. Many of the programs were allegedly held in circumstances in which it would be impossible to have a presentation. According to the DOJ, this included fishing trips off the Florida coast and meetings in Hooters restaurants. NPC is also accused of treating health care professionals to expensive dinners. The payments and dinners were apparently kickbacks to the doctors for writing prescriptions for NPC drugs.

Florida Doctors Involved.

The lawsuit alleges at least six Florida doctors of participating in the bogus conferences and taking thousands of dollars in kickbacks, according to the Tampa Bay Times. The doctors are not named or charged in the civil lawsuit.

To read the allegations listed in the lawsuit against Florida doctors, click here for the Tampa Bay Times article.

NPC Denies All Claims.

In a press release, NPC disputes all of the government’s allegations. The pharmaceutical company states that discounts and rebates by pharmaceutical companies are a customary and legal procedure, as recognized by the government. It also addresses the physician speaker programs by saying the programs are also acceptable practices designed to inform physicians about the uses of different types of medicines. Click here to read the entire press release from NPC.

The Law Against Using Bribes in Exchange for Selling a Drug or Service.

For years drug companies have paid doctors to speak about new drugs at educational conferences with other health care professionals. The practice is legal, but considered questionable.

Under the Anti-Kickback Statute, it’s a felony for health care professionals to accept bribes in exchange for recommending a drug or service covered by Medicare, Medicaid, TRICARE or the Department of Veterans Affairs health care program.

Whistleblowers Who Report Fraud and False Claims Against the Government Stand to Receive Large Rewards.

The original complaint against NPC was allegedly filed under the qui tam, or whistleblower, provisions of the False Claims Act by a former sales representative.

Individuals working in the health care industry, whether for hospitals, pharmacies, nursing homes, medical groups, home health agencies or others, often become aware of questionable activities. Often they are even asked to participate in it. In many cases the activity may amount to fraud on the government.

In a two-part blog series on whistleblower/qui tam lawsuits I explain types of false claims, the reward programs for coming forward with a false claim, who can file a whistleblower/qui tam lawsuit, and more. Click here to read the first part of this blog, and click here for the second part.

Contact Health Law Attorneys Experienced with Qui Tam or Whistleblower Cases.

Attorneys with The Health Law Firm represent plaintiffs, patients, health care professionals and health facilities in qui tam or whistleblower cases. We have developed relationships with recognized experts in health care accounting, health care financing, utilization review, medical review, filling, coding, and other services that assist us in such matters.

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

Comments?

What do you think of these lawsuits? Please leave any thoughtful comments below.

Sources:

Masow, Julie. “Novartis Pharmaceuticals Corporation Disputes Allegations in Two US Government Lawsuits and Looks Forward to a Fair Discussion of the Facts.” Novartis Pharmaceuticals. (April 26, 2013). From:
http://www.pharma.us.novartis.com/newsroom/pressreleases/137176.shtml

Davis, Brittany Alana. “Lawsuit: Pharmaceutical Company Gave Kickbacks to Florida Doctors.” Tampa Bay Times. (May 3, 2013). From:
http://www.tampabay.com/news/courts/lawsuit-pharmaceutical-company-gave-kickbacks-to-florida-doctors/2119133

Department of Justice. “United States Files Complaint Against Novartis Pharmaceuticals Corp. for Allegedly Paying Kickbacks to Doctors in Exchange for Prescribing Its Drugs.” Department of Justice. (April 26, 2013). From:
http://www.justice.gov/opa/pr/2013/April/13-civ-481.html
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.

 

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 © 1996-2012 The Health Law Firm. All rights reserved.