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Florida Legislation Regarding Pain Management Clinics Print E-mail
Written by Troy A. Kishbaugh & Sarah L. Mancebo   
Monday, 19 March 2012 08:02

The Florida Legislature passed House Bill 7095 in 2011 to address the problem of prescription drug abuse in Florida.  Florida is known as a primary source of prescription drugs across the country.  According to the Drug Enforcement Administration (“DEA”), 49 of the top 50 practitioners dispensing oxycodone in the United States between certain periods in 2008 and 2009, were located in the State of Florida. 

The Florida Legislature responded to this statewide crisis by enacting laws that regulate prescription drugs. The law now regulates all entities in the supply chain for prescription drugs, including wholesale distributors, pain-management clinics, pharmacies, pharmacists and practitioners (physicians, dentists, veterinarians, osteopathic physicians, naturopathic physicians, and podiatrists). These new laws also impose criminal violations. House Bill 7095 became effective July 1, 2011. Below are some of the important amendments from the legislation.

In 2009 and 2010, the Legislature began regulating pain-management clinics and physicians who practice in them. On October 1, 2010, the Florida Statutes began to require "pain-management clinics" to register with the Florida Department of Health ("DOH") as a pain-management clinic. The following year, in 2011, the Legislature amended the definition of a pain-management clinic to require registration for all publicly or privately owned pain-management clinics that (i) advertise in any medium for any type of pain-management services, or (ii) where in any month a majority of patients are prescribed opioids, benzodiazepines, barbiturates, or carisoprodol for the treatment of chronic nonmalignant pain, unless certain exceptions apply.

Since 1986, practitioners who dispense "medicinal drugs for human consumption for fee or remuneration of any kind . . . ." have been required to register with his/her professional licensing board (e.g., Board of Medicine) as a dispensing practitioner. But now, as of January 1, 2012, physicians who prescribe any controlled substance for the treatment of chronic nonmalignant pain must also register with their respective boards to designate themselves as "controlled substance prescribing practitioners" on their practitioner profiles. Also, prescriptions for controlled substances must now be written on standardized counterfeit-proof prescription pads produced from a vendor approved by the DOH or electronically prescribed as set forth in the Florida Statutes.

Physicians are also prohibited from dispensing Schedule II and Schedule III controlled substances, unless certain exceptions apply that are set forth in the Florida Statutes. The dispensing of these drugs illegally is a third degree felony and grounds for licensure discipline including, restriction, suspension, revocation, probation, fines, letters of reprimand, remedial education, or corrective action. If Schedule II and III controlled substances were in a physician's possession that were acquired for dispensing when House Bill 7095 became effective, the physician was required to (i) return all Schedule II and III controlled substances under each physician's DEA number to the wholesale distributor from which the controlled substance was purchased, or (ii) give the undispensed controlled substances to law enforcement.

By enactment of these laws, among others, the Florida Legislature is very serious about enforcing the new regulations regarding prescription drug abuse in the state. It is crucial for physicians to ensure they are complying with these laws.

For more information about these prescription drug abuse laws, please contact Troy A. Kishbaugh and Sarah L. Mancebo with GrayRobinson's Health Law Team.
Last Updated on Monday, 26 March 2012 19:02
FDA Schedules Public Hearing to Evaluate Potential New Drug Approval Paradigm Print E-mail
Written by   
Friday, 16 March 2012 08:42

On March 22 and 23, 2012, the U.S. Food and Drug Administration (FDA) will hold a public hearing on a potential new paradigm that would enable the agency to approve drugs that would otherwise require a prescription for nonprescription use under conditions of safe use. In this newsletter, we provide a summary of the proposed paradigm and address some of its implications.

Read the full article here.
Last Updated on Friday, 16 March 2012 08:47
Do Not Let Another April 15th Be Rainy for You: Four Tax-Saving Ideas You Can Do Now Print E-mail
Written by David B. Mandell, JD, MBA, Jason M. O'Dell, MS, CWM & Carole Foos, CPA   
Thursday, 15 March 2012 00:00

It is estimated that 40-50% of physicians' working hours go toward federal and state taxes. Therefore, implementing strategies that reduce tax liabilities is critical. This article addresses several plans for this purpose.

Use the Right Practice Entity, Payment Structure and Benefit Plans

The right analysis and implementation requires consideration of the structure of the legal entity to maximize tax and benefits leverage, as well as the potential advantages of a multi-entity structure. Additionally, managing salary and bonus payments, distributions, and partnership flow-throughs for maximum retirement benefits, while minimizing income, social security, and self-employment taxes is crucial.

Use Investment Managers Who Manage with Taxes in Mind

According to mutual fund tracker Lipper, "Over the past 20 years, the average investor in a taxable stock mutual fund gave up the equivalent of 17% to 44% of their returns to taxes." Losing one-sixth to almost one-half of returns to taxes can be devastating to a retirement plan, yet many physician investors opt for these accounts. Additionally, the taxes on the transactions within the mutual fund, even though the fund value declines, can be significant. Working with an investment firm that designs a tax-efficient portfolio can maximize the leverage of different tax environments, offset tax losses and gains, and implement other tax minimization techniques.

Gain Tax-Deferral and Asset Protection through Cash Value Life Insurance

While stock mutual funds can create high tax bills, similar funds within a cash value life insurance policy will generate NO income taxes because the growth of policy cash balances is not taxable. Another advantage is that nearly every state protects the cash values from creditors, though the total shielded amount varies greatly between states.

Consider Charitable Giving, Including Conservation Easements

There are many ways to make tax-beneficial charitable gifts while also benefiting one's family. The most common tool for achieving this "win-win" is the Charitable Remainder Trust (CRT). A CRT is an irrevocable trust that makes annual or more frequent payments to you (or to you and a family member), typically, until death. The remainder of the trust then passes to a qualified charity of your choice.

Another effective tax-planning tool in this arena is the conservation easement. Donors may take a deduction for a "qualified conservation contribution" to a qualifying organization. In effect, a taxpayer can donate land for preservation and take a charitable deduction for the value of the land at its "highest and best" use after a valid qualified appraisal. The taxpayer can acquire a membership interest in an LLC that owns property eligible for a conservation easement and then take part in the contribution of the easement and the tax benefits surrounding such a transaction.


To minimize tax burdens, an advisory team that addresses tax planning and asset protection is critical. Several options have been discussed here, and additional techniques are available for larger practices with revenues over three million dollars. The authors welcome your questions and can be contacted at (877) 656-4362 or through the website

David B. Mandell and Jason O'Dell are principals of the financial consulting firm OJM Group, LLC where Carole Foos works as a CPA and tax consultant.

Please click HERE to read important disclosures.
Last Updated on Saturday, 24 March 2012 16:34
UnitedHealth Takes a Bold Step Forward in Payment Reform Print E-mail
Written by Bernd Wollschlaeger, MD, FAAFP, FASAM   
Monday, 05 March 2012 10:48

Recently, the Wall Street Journal published an interesting article titled "New Way to Pay Doctors: UnitedHealth, Nation's Largest Insurer, Is Latest to Announce Fee Overhaul."

According to the article, "Under the new plan the carrier is rolling out, part of medical providers' compensation could be tied to goals such as avoiding hospital readmissions and ensuring patients get recommended screenings. UnitedHealth has been trying such efforts on a more limited scale, but now the company says it plans to roll out new contracts nationwide that could include financial rewards for care the company considers high-quality and efficient, and in some cases potentially withhold expected increases if certain standards aren't met."

Under an aggressive projection, costs could amount to as much as $3.27 per member a month by 2015, with savings as high as $7.80, the documents said. Using a less-aggressive scenario, the company said, the costs could amount to 46 cents, and the savings to $1.35, per member a month.

Much of the cost under both projections wouldn't be locked in, since it would be tied to bonuses that providers would get only if they hit certain goals; indeed, those payments may be calculated as a share of the overall savings achieved. According to the released information pieces of the new payments may be in lieu of increases to traditional fees.  Driving the payment reform is the growing realization that the current health-care payment system, with its fees for each service, is flawed. The current system entices quantity but no quality and a value-based reimbursement system would stir healthcare towards prevention, quality and outcome oriented care. Donald Berwick, former administrator of the Centers for Medicare and Medicaid Services, said the initiative "looks promising," but it would be important for the incentives to be strongly enough tied to quality and patient-satisfaction measures, in addition to efficiency goals, to ensure there's no "skimping on care".

In a description of some of its pilot programs, the carrier mentioned potential bonuses of $1 to $3 per member a month for primary-care physicians. For a different provider setup, called accountable care organizations, the document said the bonuses could amount to $1 to $5 per member a month. Accountable care organizations can be built around hospitals or doctor groups, and they generally involve a provider taking overall responsibility for a group of patients.

UnitedHealth also said it could offer "clinical integration" fees for providers that make changes aimed at better tracking patients' conditions and coordinating their care. This would include the model known as "patient-centered medical homes," which are typically set up by primary-care doctors, but the fees could also be available to other providers making similar efforts.

In my opinion physicians can and should play a proactive role in the payment reform initiative. We have to reorganize our practices, implement efficiency measurements and form groups organized along the Patient-Centered Medical Home concept. We cannot expect that insurance companies will provide us with the panacea for our economic woes. Now is the time to act!

Dr. Wollschlaeger is a frequent contributor to FHIweekly and Specialty Focus.  You can read more of his articles by visiting
Last Updated on Saturday, 24 March 2012 16:35
Noncompetes Are Once Again Relevant For Recruited Doctors Print E-mail
Written by Jeffrey L Cohen, J.D.   
Friday, 24 February 2012 11:52

When the Stark II (Phase III) regulations were released in August, 2007, they clarified that when a hospital recruits a physician to a medical practice, the employment agreement between the medical practice and the newly recruited physician may contain practice restrictions as long as they do not "unreasonably restrict" the recruited physician's ability to practice medicine within the recruiting hospital's service area. This stymied many medical practices which were reluctant to hire a new physician without a noncompete and nonsolicitation provision. A 2011 CMS Advisory Opinion (No. CMS-AO-2011-01) changed this.

The Advisory Opinion involved a pediatric orthopedist who was recruited by a hospital to a medical practice. The medical practice wanted to hire the new doctor, but was not willing to do so without a noncompetition provision and other restrictive covenants. The practice asked CMS for guidance because the Stark regs suggested that perhaps a noncompete could not be contained in the employment agreement of a physician recruited by a hospital to join a local medical practice. In fact, a prior version of the Stark regs was clear that noncompetes were not permitted in the employment agreements of physicians recruited by hospitals.

Hospital recruitment transactions involve bringing a physician into a new area and funding the start up period (usually a year). The nice thing for a medical practice is that the dollars given by the hospital to the practice (the difference between salary and benefits and collections) can run into the hundreds of thousands of dollars! The down side was that the medical practice could not tie the recruited physician's hands with a noncompete or other similar restriction. The Advisory Opinion is, however, a game changer because it allowed the medical practice to impose a noncompete on the recruited physician.

As mentioned, the practice would not hire the recruited physician without the noncompete. The noncompete had a 25 mile radius, and the Opinion cited the following relevant facts: 

1. The recruited doctor would remain on one of five hospitals within the 25 mile zone;
2. The recruiting hospital's service area extended beyond the 25 mile zone, in which there were at least three other hospitals within a one hour driving range;
3. The noncompete complied with applicable state law.

Based on these facts, the OIG permitted a one year noncompete because it did not "unreasonably restrict" the doctor's ability to practice in the recruiting hospital's service area. Certainly, many other medical practices can be sure to follow suit.

Physicians interested in nocompetes must be familiar with state law. Getting to the bone of the issue, noncompetes are enforceable in Florida if:

Click HERE to read the rest of the story. 

With almost 25 years of healthcare law experience following his experience as legal counsel for the Florida Medical Association, Mr. Cohen is board certified by The Florida Bar as a specialist in healthcare law. With a background and expertise in transactional healthcare and corporate matters, particularly as they relate to physicians, Mr. Cohen's practice involves him in regulatory, contract, corporate, compliance and other healthcare law related matters. As Founder of the Florida Healthcare Law Firm, Mr. Cohen can be reached at 888-455-7702 or online at
Last Updated on Monday, 05 March 2012 11:00
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