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New FDA Draft Guidance Regarding Financial Disclosures by Clinical Investigators Print E-mail
Written by   
Wednesday, 03 August 2011 13:21

New recommendations recently released by the FDA demonstrate the changing environment for conflicts of interest management and emphasize the need for pharmaceutical companies, medical device manufacturers and health care providers to ensure they have internal processes that adequately anticipate and meet the baseline requirements.

Read the full article here. | Source:

Last Updated on Wednesday, 03 August 2011 13:36
Best Hospitals in Florida 2011 Print E-mail
Written by U.S. News & World Report   
Wednesday, 27 July 2011 16:55

 Click on hot links to view.

Jacksonville     Lakeland (Polk County)

Miami-Fort Lauderdale

Sarasota-Bradenton      Orlando

Palm Bay-Melbourne (Brevard County)

Tampa-St. Petersburg          

SOURCE:  U.S. News & World Report      
Last Updated on Wednesday, 27 July 2011 17:02
Groupon & Other Daily Deal Sites: Old Regs, New Problems Print E-mail
Written by Jeffrey Segal, MD, JD & Michael J.Sacopulos, JD   
Tuesday, 19 July 2011 16:44

Last week, I receive a Groupon alert for a local restaurant I like. For those of you living under a rock, Groupon is a social networking group discount program.

Here's how it works. A local merchant, like a restaurant or hair salon, offers a discount - often 50% off or more. This gets a lot of attention. But, the discount isn't activated until a critical mass of Groupon subscribers 'tip" the deal. Enough people must commit to "paying" for the discount. That's how Groupon gets paid.

For the restaurant, the deal was $60 off. But, you had to pay Groupon $30 for the $60 off coupon. If you're good at math, you recognize the deal is really $30 off - still a nice discount. The deal didn't activate until it tipped with 20 people. Over 1,100 people ultimately took advantage of the deal. You now see the power of a rip-roaring discount. The restaurant will have to deliver. For all I know, they might "eat it" on this deal. But, if the restaurant's goal was to turn-on a large number of people to their restaurant to try it out - and potentially become repeat customers, this Groupon deal might be a smashing success.

Onward to healthcare. Some physicians and dentists have jumped in - offering Groupon discounts to subscribers for services. Their goal is the same as the restaurants. Think of the discount as a loss leader. Introduce the patient to the office. If they are happy with the service and care provided, perhaps they will become loyal, long-term paying patients.

Some doctors are already reporting eye-popping results. Over nine hundred new patients for a cosmetic procedure in California. Over a hundred new patients for dental work. Are these doctors losing money on the heavily discounted procedures? Difficult to tell. Will these people become long-term patients? Who knows?

Here's what we do know. Most medical and dental licensing boards have updated long-established policies that might create headaches for doctors embracing Groupon and other online daily deal discount websites as a marketing tool. A scant few are tackling the issues. Most are sitting on the sidelines. More on that in a minute.

Most licensing boards, if not all, have strict policies prohibiting fee-splitting. Fee splitting occurs when a patient is "induced' to visit a provider and the doctor "kicks back" a referral fee to the referrer. There are safe harbors which don't trigger enforcement of fee-splitting penalties - such as when a doctor refers to another doctor in his multi-specialty practice - and they are both employees in the same facility. If they split profits at the end of the year, then, in a sense, the referral has generated extra fees split by all. Fortunately, as a safe harbor, this does not trigger any action.

But, if two unrelated doctors have a handshake agreement whereby referrals will be paid a cool $300 for every surgery - that's likely against the law - and probably violates licensing board fee-splitting policies.

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Daily Deal Sites:  Headache or Goldmine?  (Continued from Top) 

On its face, doctors who sponsor Groupon discount deals are cutting Groupon in on their professional fees for the referrals And, since there is no safe harbor for Groupon deals, a doctor could be on the wrong side of a Board investigation.

In the earlier example, it's easy to see how a doctor abuses the trust of his patient by getting paid for referring to a surgeon and receiving cash for the referral. The cash taints the doctor's judgment - and it puts the doctor's financial interest above the patient's interest. But, do payments to Groupon promote that same type of abuse? Doubtful.

With Groupon, the prospective patient is being given information and a discount. The patient is free to make their own decision as to whether or not to accept the advertised discount. There is no pre-existing doctor-patient relationship whereby misplaced trust can result in a bad outcome. The Groupon model is consumer directed healthcare in action. 

The federal government has laws on its books which also prevent "kickbacks." The Office of Inspector General for U.S. Dept. Health and Human Services ("OIG") issued an Advisory Opinion on an analogous program - pay per lead - or pay per call program. There, OIG concluded that a pay per lead program did indeed violate the plain language of the Anti-Kickback Statute. And, such a program did not qualify for any statutory safe harbor. That said, OIG concluded they would not enforce the statute against participants in those programs, because such programs did not promote the type of abuse the statute was meant to curtail.

While this decision is helpful in giving a doctor comfort, a doctor making a decision whether or not to participate in Groupon must also pay attention to policies of their state professional licensing board. And, as noted, most licensing boards have explicit prohibitions against "fee splitting."

The Oregon Board of Chiropractic Examiners ("OBCE") appears to be the first out of the gate to tackle the issue. At a recent meeting, they formed a committee to draft language bringing their fee-splitting policy into the Internet age. Such language, if adopted, would narrowly allow doctor participation in Groupon like programs without opening the floodgates for other practices which abuse the doctor-patient relationship for personal financial gain.

It is unlikely professional licensing boards would take a strong stand against individual doctors for promoting Groupon deals. After all, the model voluntarily pushes down the cost of healthcare. But, Board investigations are often complaint-driven. So, if patients complain to the Board for any number of reasons, an investigation might broaden to include allegations of fee-splitting. Doctors who want to test the waters with social networking group discount programs would be well advised to proactively lobby their licensing bodies to update their decades-old fee-splitting policies. If a Board takes action against a doctor for fee-splitting, you can be sure that any assessed penalty would not be at a Groupon discount rate.

Jeffrey Segal, MD, JD, is founder and CEO of Medical Justice Services.  Mike Sacopulos, JD, is general counsel for the organization.  Run by physicians for physicians, Medical Justice is a membership-based organization that offers services and proprietary methods to protect physicians' most valuable assets - their practice and reputation. The company offers proactive services to deter frivolous medical malpractice lawsuits, prevent Internet defamation and provide strategies for successful counterclaim prosecution. Medical Justice works as a supplement to conventional professional liability insurance.

Last Updated on Wednesday, 27 July 2011 16:46
Florida's Healthcare Workers Command High Wages Despite Declining Reimbursements, Sagging Economy Print E-mail
Written by Jeffrey Herschler   
Thursday, 07 July 2011 09:42

According to the Florida Agency for Workforce Innovation, Florida's healthcare workers are outperforming many of their peers in other industries.  And this feat is achieved despite reimbursement reductions and a weak economy.

For example, physicians and surgeons boast a mean yearly wage of $107,540 for entry level and $235,710 for experienced practitioners.   Pediatricians don't do badly either, earning $89,550 to $200,970.  Meanwhile Registered Nurses are making $46,400 to $71,380.  Pharmacists gross $88,450 to $117,150 while an OBGYN's mean annual wage is $225,620. A typical Radiation Therapist's yearly salary is $55,720 to $89,040.  One hot emerging category is Physician Assistant. They earn $64,150 to $100,960.   Surprising many is the fact that Podiatrists gross $73,770 to $171,400.

Healthcare workers' outperformance is apparent at the national level as well.  According to (citing On Numbers analysis of federal compensation data for 801 occupations), the eight highest paying jobs in America are in the healthcare field.  See article:  Highest Paying Jobs in America

Not all healthcare jobs are high paying however. The Florida Agency for Workforce Innovation reports that Emergency Medical Technicians and Paramedics earn $23,010 to $36,950 while a Home Health Aid's annual salary comes in just a bit above the minimum wage at $18,090 to $26,940. has published a photo gallery illustrating several healthcare vocations and their average incomes.  Click here to view. 

Mr. Herschler is the Editor and Publisher of FHIweekly and 

Last Updated on Thursday, 14 July 2011 09:02
Law Firm Unveils Recommendations for Health Providers in Response to Controversial Draft ACO Regulations Print E-mail
Written by FHI Staff Writer   
Wednesday, 15 June 2011 00:00

McDermott Will & Emery recently released a detailed white paper entitled:

"The Controversial Draft Medicare ACO Regulations: Analysis, Comments, and Recommended Action." 

McDermott health lawyers have prepared this publication to help make sense of the proposed ACO regulations, and provide specific action steps.

ACOs, which create incentives for health care providers to work together to treat individual patients across multiple care settings, are at the core of the federal health care reform legislation enacted last year.  On April 7th, the Centers for Medicare and Medicaid Services (CMS) finally published 400+ pages of draft ACO regulations that many in the health care industry view as excessively burdensome and biased against providers. On May 17th, the Center for Medicare and Medicaid Innovation announced a parallel track ACO initiative called 'Pioneer ACO' that may have been intended to overcome such objections and stimulate interest in ACO participation.

"Reaction to the proposed rules issued by CMS to implement the Medicare Shared Savings Program ("MSSP") has reportedly been harsh and critical," observed Gary Scott Davis, a partner at McDermott Will & Emery who focuses his practice on managed care, hospital-physician alignment and health system strategic transactions, restructurings and reorganizations.  "While it remains to be seen how the Federal Government will ultimately implement ACOs, providers today are looking for much-needed guidance as they consider ACO participation," added Davis.  "Regardless of whether a hospital, health system, physician group or other provider presently intends to participate in the MSSP, understanding the regulations are important to any ACO formation, whether with Medicare or a private insurer. We believe that ultimately many of the concepts being vetted and developed - metrics and mechanics to measure and assess quality as a means for reimbursement -- will end up being incorporated into private market ACOs." 

Private sector efforts toward accountable care are well under way, and will continue whether or not the final regulations are implemented.  "The private sector will not wait for the government to figure this out," adds Davis. "There is a major paradigm shift already under way that is making the need for accountable care ever more urgent.  And, because there are elements in the proposed regulations that provide important  foundational concepts for achieving accountable care in the private sector, our white paper should prove uniquely valuable. This document should be particularly helpful to industry participants seeking to accomplish two critical goals of accountable care:  tying quality to payment and capturing and using the critical data needed to get paid on this basis."

Last Updated on Wednesday, 29 June 2011 16:56
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