Archive for June, 2011

CMS Quarterly Provider Update

Thursday, June 30th, 2011

The CMS Quarterly Provider Update has been updated to include recently published instructions and regulations for the dates 6/14/11-6/30/11.

To view the page, go here.

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Category Health | Tags: Tags: , ,

340B Compliance–Who is the Authorizing Official?

Thursday, June 23rd, 2011

When completing the 340B registration forms, a healthcare organization will need to determine who its authorizing official is.  An authorizing official is one who signs the Registration Form.  Sounds easy, right?  It can be, but with certain entities, the answer may not be so obvious.  If OPA (Office of Pharmacy Affairs) determines that the signor is NOT an acceptable authorizing official, then the forms will not be processed.  This can be important for two reasons:

1.  There are quarterly deadlines for applying for 340B eligibility.  If a deadline is missed, then an organization may have to wait several months for acceptance into the program.

2.  Money.  The longer it takes the paperwork to be processed, the longer it takes the organization to become eligible for discounted pharmaceuticals.

For access to the OPA’s website and 340B registration forms, go here.

Who is the Authorizing Official?

Well, it depends on the type of healthcare organization that is applying.  Here’s a (non-exhaustive) list that is based on OPA’s website:

  • For STD and TB applicants, the Authorizing Official is the director of the State or City health department administering the respective STD or TB grant in your geographic area.
  • For Family Planning (FP) applicants, the Authorizing Official is a responsible representative of the funded grantee.
  • For hospitals, the Authorizing Official must be a senior managing official who can sign on behalf of an organization such as the CEO or CFO.
  • For Contract Pharmacies, the form must be signed by a responsible representative of each organization and submitted to OPA.  For the covered entity, the responsible representative may be the President, Chief Executive Officer, Chief Operating Officer, Chief Financial Officer, or Program Director.  For the pharmacy, the responsible representative may be the Owner, the President, Chief Executive Officer, Chief Operative Officer, or Chief Financial Officer.

(Disclaimer: This post is not intended as legal advice nor does it create an attorney-client relationship.  If you have questions regarding 340B compliance, please consult an attorney.)

Corona and Crawford

Friday, June 17th, 2011

…no, not THAT kind of Corona.  But since you’re here, you might as well read on.

On June 9, 2011, the Florida Supreme Court issued an important ruling on a defendant’s 6th Amendment Confrontation Clause protections.  The case is Corona v. State (SC06-1054) and the full opinion can be read here.

This case is important for three reasons:

1.  It holds that a discovery deposition is not the equivalent of a prior opportunity for cross-examination.

2.  It gives some guidance on how to properly preserve a Crawford issue or objection.

3.  It has a good analysis on the corpus delicti rule.

If any of these three points are of interest, check out the opinion.

Kidnapping in Florida: Awareness of the Victim’s Presence

Thursday, June 16th, 2011

On May 26, 2011, the Florida Supreme Court issued an opinion in Delgado v. State (SC09-2030). This case revolves around Rogelio Delgado and perhaps the unintended consequences that can follow from stealing a vehicle.

In this case, Mr. Delgado was convicted of burglary, grand theft of motor vehicle, and kidnapping from actions stemming from a 2006 incident.  The owners of an automobile parked the truck at a furniture store, leaving a two year old child unattended and fast asleep in a car seat located in the the back seat. (The truck had an extended-cab.)  While the owners were in the store, the truck was left running and the keys in the ignition.  During this time, Delgado and a co-defendant jumped into the vehicle and drove away.  The owners, upon realizing the truck had been stolen, called 911, and within 20-30 minutes, the truck was located.  The engine was left running, the doors unlocked, and the child unharmed. However, the front-seat area of the truck had been ransacked, the radio had been removed and several items had been taken or damaged.  Although there were no eyewitnesses to the auto theft, the defendant’s actions were caught on surveillance video, and they were subsequently apprehended.

Delgado went to trial where he was found guilty of his charges.  He was sentenced to 30 years prison for the burglary, time-served on the theft charge, and mandatory life in prison for the kidnapping as a PRR offender.

On appeal, Delgado argued the State did not present sufficient evidence to get a conviction on the kidnapping charge.  He lost at the DCA level, however, when his case was reviewed by the Florida Supreme Court, they agreed with Delgado. End result: kidnapping conviction vacated due to to insufficient evidence.

The important issue was whether a defendant commits the crime of kidnapping with the intent to commit or facilitate an underlying felony where the evidence produced at trial fails to establish that he or she had knowledge of the victim‟s presence before or during the execution of that underlying felony. (Or in other words, did the State prove Delgado knew the child was in the back seat before or during the execution of the auto theft?)

In this particular case, the detective’s testimony on which the State relied demonstrated that it was difficult to see the child unless, once inside the vehicle, one were to look into the backseat or move the front seat forward. The Supreme Court stated:

There is simply no evidence in the record that the child awoke, cried, or kicked the front seat of the vehicle’s interior, thereby alerting Delgado to her presence, before or during the auto theft.

In its holding, the Supreme Court said:

…because the State failed to produce sufficient evidence demonstrating Delgado’s awareness of the child before or during his execution of the underlying felony of auto theft, the statutory requirements under section 787.01(1)(a)2. were not met.

It is important to note that this case does not say that the State can NEVER prove awareness of the victim’s presence in a kidnapping case.  In this case, the circumstances were not enough.  However, in a child kidnapping case, judges will want to uphold the conviction if they legally can.  In fact, there were three judges who dissented in this ruling, meaning Delgado came down to a close 4-3 decision. If the circumstances are right, convictions can still be obtained.

Does Padilla apply retroactively in post-conviction proceedings?

Wednesday, June 15th, 2011

The Florida 2nd DCA has recently decided the case of Barrios-Cruz v. State (2D10-4774).  This case is important for Florida defense attorneys because it deals with failing to advise clients of possible consequences of entering a plea, primarily in the context of deportation consequences.  The way in which these claims arise in Florida is in a 3.850 post-conviction ineffective assistance of counsel claim (i.e., I would not have pled to the charges had my attorney advised me that I could possibly get deported.)

The fear among many jurists is that if Padilla is held to be retroactive in post-conviction matters, the floodgates would be opened, and many pre-Padilla pleas would come back before the courts.

The 2nd DCA held that Padilla should not be applied retroactively in post-conviction proceedings.  This holding is in line with the 3rd DCA, but does conflict with other courts.  Because courts are split on this issue, and because the decision carries with it significant implications for the treatment of pleas entered pre-Padilla, the 2nd DCA certified the following question of great importance to the Florida Supreme Court:


The legal test the 2nd DCA used in determining Padilla is not retroactive is the Witt standard, to which there are three elements.  Under Witt, a change of law will not be applied retroactively unless the change:

1.  emanates from [the Supreme Court of Florida] or the United States Supreme Court,

2.  is constitutional in nature, and

3.  constitutes a development of fundamental significance.

Because Padilla is a United States Supreme Court decision that is constitutional in nature, the first two elements of this analysis are satisfied. Accordingly, the question becomes whether Padilla represents a development of fundamental significance.  In the end, the 2nd DCA said,

While we recognize that Padilla represents an important development enumerating both a new right for defendants and a new duty for counsel, we do not find that it rises to the level of those rare “fundamental and constitutional law changes which cast serious doubt on the veracity or integrity of the original trial proceeding.”

Although this is the current state of the law in Florida, it remains to be seen what action, if any, the Florida Supreme Court will take.



Compliance Officers Are Funny People!

Tuesday, June 14th, 2011

A Wall Street Journal article today called, “If You Think Accountants are Hilarious, Try These Guys”, discusses America’s search for the funniest compliance officer.  As a partner in a law firm that practices healthcare compliance, I found this article wonderful!  Imagine my delight to also find the article located on the front page!

Congratulations are in order for Michael Shaw, from GlaxoSmithCline, the funniest compliance officer in America!  Next year’s profession appears to be lawyers…should be exciting!

Here’s a video that was attached to the WSJ article, which shows some of the stand-up routines!  Enjoy!

Impermissible Sentencing Factors

Tuesday, June 14th, 2011

A recent case in the Florida 2nd DCA has been decided and discusses some important aspects of Florida sentencing law, namely, what a judge is NOT allowed to consider when imposing sentence.  The case is Smith v. State (2D10-10), and to read the full opinion, go here.

After a jury trial, the Defendant was found guilty of Driving on Suspended License, Habitual Traffic Offender, a third-degree felony.  Before announcing the Defendant’s sentence, the judge stated:

All right. I’ve heard enough. I’m going to speak a little bit out loud. I’ve talked a little bit about this record. You do not have a very good record.

The good thing is I do believe you’re trying to do something but I think you’re kind of on the edge. That means you’re trying to do something but if you can still get away with some little things I think you do.

And I actually believe that you use Ms. Chandler . . . as a person to hide behind or to help with some of the issues that you have.

But what I didn’t hear is pretty much most things, you didn’t do the Burglary. Well, the Grand Theft really wasn’t you. The Driving While License [Revoked] is because of all the cops in Dade County. And I haven’t really heard you accept responsibility for anything.

And I’m not real convinced, as well as you’re [sic] fiancée’s story as to what occurred because I do believe that when you look at what is in the report—and I guess the officer could have lied here about it—but I do look at the fact that if there was something so bad and that you had to drive, you don’t then get back in the car and drive and actually get lost, according to her calling people, how do I get to the police, how do I get there and then drive.

There was no testimony that when she got there and bailed you out that now she either had a remarkable healing on the highway or it still wasn’t a problem until she got here. Then she had a remarkable healing here and then still drove to Miami and wasn’t . . . or to Arcadia and drove to Sebring, not real convinced of that story. It appears that the jury was not as well. I do believe that you use her as a way to hide some of your actions.

Now, I do believe you’ve been trying to [sic]. I do believe some instances you have. But, you know, to be driving again in ’08 and pick up Driving While License Suspended, pick up another one here with all these traffic summons and traffic fines still outstanding.

The Court then sentenced Defendant to 3 years prison.

On appeal, the Court found three factors the judge relied on to be impermissible when imposing sentence:

1.  Court cannot rely on defendant’s assertions of his innocence

2.  Court cannot rely on defendant’s refusal to admit guilt

3.  Court cannot consider the truthfulness of defendant’s testimony

In the end, the 2nd DCA found these considerations were a denial of due process resulting in fundamental error.  The case was reversed and remanded for sentencing before a different judge.


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Category Criminal | Tags: Tags: , ,

Exploitation of an Elderly Person

Monday, June 13th, 2011

The Florida Second DCA released an opinion last week dealing with the criminal charge of Exploitation of an Elderly Person.  The case name is Guarscio v. State (2D08-5000) and the full opinion can be read here.

In this matter, the Court found the state’s evidence insufficient to prove Exploitation of an Elderly Person.  This case represents some of the dangers a person accepts when becoming a health care surrogate or power of attorney.  If it is discovered that the elderly person’s finances are in disarray, it is quite possible the state will look to the surrogate/power of attorney for responsibility.  In the Guarscio case, the Court found that although “the refinancings were not a good idea…that is a far cry from proof that they were accomplished by Guarscio’s deception or intimidation of her grandmother.”

This case is a good case for Florida defense attorneys because it makes the State prove its allegations, and not rely on inferences or sympathy.


Thursday, June 9th, 2011

Physician-owned distributorships (POD’s), are rapidly growing across the country, and already exist in at least 20 states.  However, there are growing concerns over their legality, primarily in the context of anti-kickback regulations.  Just this month, Sen. Orrin Hatch, Ranking Member of the Senate Finance Committee, has called for an investigation into the structure of POD’s and their potential adverse impact on the Medicare program and its beneficiaries.

What Are POD’s and How Do They Work?

POD’s are business arrangements involving physician ownership of medical device companies.  At its most basic level, medical device companies are formed by physician-owners.  These physician-owners then have control over medical devices they implant in patients, and are given a share of the profits generated by the sale of the medical devices.  To put it more simply, Surgeon A is a physician-owner of a medical device company.  When patients come to Surgeon A, he implants the medical device in the patient during surgery.  Surgeon A profits from the sale and utilization of the medical device.

POD’s have been popular among surgeons and we are now seeing more orthopedic POD’s in the context of joint-replacement devices.

Potential Legal Problems with POD’s

There are several different concerns over the legality of POD’s.  One such concern is whether physician-owners are performing medically unnecessary procedures in order to profit off the sale of the medical device.  There are some statistics to back up this claim.  An article in the Wall Street Journal (“Senators Request Probe of Surgeons”, June 9, 2011) maintains that the spread of POD’s has coincided with an explosion in spinal fusion surgery.  A 2010 study in the Journal of of the American Medical Association found that complex spinal fusions increased 15-times among Medicare patients with spinal stenosis between 2002 and 2007.  According to a Wall Street Journal analysis, spinal infusion went from costing Medicare $343 million in 1997 to costing $2.4 billion in 2008.

Another legal concern involves the ant-kickback statute.  Some have argued POD’s may violate anti-kickback statutes and other federal fraud and abuse laws by creating financial incentives for physician investors to use devices that steer business back to themselves.  Unfortunately, there has been no clear guidance by the OIG on this topic.  While the OIG has acknowledged the risks of abuse POD’s pose, the lack of any specific rules from the government appears to be contributing to the potential for abuse and has allowed these entities to flourish.

Attention on this matter has made it up to Congress, where five senators have called for an investigation.  The five senators requesting an investigation are: Sen. Orrin Hatch (R-Utah), Senate Finance Committee Chairman Max Baucus (D-Mont.) and Sens. Herb Kohl (D-Wis.), Charles Grassley (R-Iowa) and Bob Corker (R-Tenn.). The senators have requested the Inspector General submit an initial report on his findings by Aug. 1

With all the uncertainty and potential liability, POD’s will continue to be a hot-topic in the area of healthcare compliance until the legality question is answered.




Thursday, June 9th, 2011

Failure to pay taxes in Florida can result in criminal charges.  The applicable statute is Fla. Stat. 212.15 and can be read in full here.

The penalties for violating this law can vary, depending on the total amount of stolen revenue.  Here is the portion of the statute which discusses penalties:

(2) Any person who, with intent to unlawfully deprive or defraud the state of its moneys or the use or benefit thereof, fails to remit taxes collected under this chapter is guilty of theft of state funds, punishable as follows:

(a) If the total amount of stolen revenue is less than $300, the offense is a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083. Upon a second conviction, the offender is guilty of a misdemeanor of the first degree, punishable as provided in s. 775.082 or s.775.083. Upon a third or subsequent conviction, the offender is guilty of a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

(b) If the total amount of stolen revenue is $300 or more, but less than $20,000, the offense is a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

(c) If the total amount of stolen revenue is $20,000 or more, but less than $100,000, the offense is a felony of the second degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

(d) If the total amount of stolen revenue is $100,000 or more, the offense is a felony of the first degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

The statute of limitations also vary depending on whether the charge is classified as a misdemeanor or felony.

(3)  Prosecution of a misdemeanor under this section shall commence no later than 2 years from the date of the offense. Prosecution of a felony under this section shall commence no later than 5 years from the date of the offense.

If you have been charged with failing to pay taxes in Florida, please consult a qualified attorney.  (Disclaimer: This post does not constitute legal advice nor does it create an attorney-client relationship.)