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Compliance Update
Counterfeit Proof Prescription Pads Required for Health Care Practitioners in Florida Print E-mail
Written by   
Wednesday, 10 August 2011 10:14

Under House Bill 7095, also known as the "Pill Mill Bill", counterfeit-proof prescription pads must be used by health care practitioners for prescribing controlled substances listed in Section 893.03 of the Florida Statutes.  The law became effective on July 1, 2011.  However, Surgeon General, Dr. Frank Farmer issued a supplemental order on July 6, 2011, suspending the requirement for health care practitioners to use counterfeit-proof prescription pads for 60 days. 

The Florida Department of Health received many phone calls from both patients and practitioners stating that pharmacies were not filling prescriptions for controlled substances because the prescriptions were not written on the required counterfeit-proof prescription pads. 

"Once we began learning of the unintended consequences to law-abiding doctors and patients with legitimate health care needs, we knew we needed to take action to prevent substantial injury or harm to patients," said Dr. Farmer. "Issuing the supplemental order provides practitioners the time needed to order the necessary prescription pads to ensure public safety over the long term."

"As a licensed practitioner myself, I understand the complexities of running a medical practice," stated Dr. Farmer. "But in the interest of public health and safety to stop the abuse of prescription drugs, I urge all of Florida's licensed health care practitioners to visit DOH's website and order the counterfeit-proof prescription pads."

Dr. Farmer had declared that a "state of emergency" existed due to the prescription drug crisis in Florida.  House Bill 7095 was designed to stop Florida's prescription drug trafficking by cracking down on "pill mills, which are illegal clinics that prescribe painkillers without any medical justification.  Requiring counterfeit-proof prescription pads is one of the ways House Bill 7095 seeks to reduce drug trafficking.  The law additionally, requires reporting of narcotics prescriptions to a state database in seven days instead of fifteen days.  Florida is joining several others states, such as California and New Jersey, by requiring approved counterfeit-proof prescription pads.     

The Florida Department of Health website contains additional information, including answers to frequently asked questions regarding the prescription pads and an approved vendor list.

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Last Updated on Wednesday, 17 August 2011 12:58
Haven't Thought Much About Compliance Lately? The Government Has. Print E-mail
Written by Albert R. Meyer   
Thursday, 14 July 2011 08:55

       It is estimated that health care fraud is a $60 billion a year business fueled by illegal conduct such submitting false claims and paying kickbacks to physicians and suppliers. Until recently, if large health care organizations were the targets of fraud investigations, these companies, as their penance, typically wrote a big check to the government and continued business as usual. Things have changed.

While indicting and convicting health care executives is not a new practice, officials at the Department of Health and Human Services ("DHHS") and the Department of Justice ("DOJ") are said to be frustrated with the frequent occurrence of repeat violations and they are ramping up their strategy. Lately there have been aggressive new initiatives rolling out to combat rampant health care fraud and the government is increasingly bringing criminal charges against executives even if they were not complicit in the fraud scheme, but could have stopped it if they had known. 

                                                  Read On 

Albert R. Meyer, J.D., MHA, is an attorney with the Florida Healthcare Law Firm in Delray Beach, Florida. Mr. Meyer has nearly 20 years experience representing varying types of healthcare professionals and entities ranging from large nationwide group practices to managed care organizations.

Last Updated on Saturday, 05 October 2013 08:58
Physicians Need to Pay Attention to Fraud and Abuse Risks Print E-mail
Written by Todd Rodriguez   
Thursday, 09 June 2011 09:32

We spend a great deal of time on this blog recounting stories of physicians and other providers who have run afoul of the various federal and state abuse laws applicable to the practice of medicine.  However, in my travels in working with physicians and group practices, it is apparent that many physicians still lack a basic understanding of the complex legal and regulatory framework within which they practice every day.  Many physicians operate under the mistaken belief that their greatest area of legal exposure is professional (malpractice) liability.  But, unlike fraud and abuse exposure, most physicians carry significant insurance against catastrophic malpractice claims.  Too few physicians appreciate the fact that running afoul of Medicare billing and coding requirements or entering into an arrangement which is a violation of the federal Stark or anti-kickback statutes could result in significant overpayments which must be refunded to the Medicare program or even worse, massive civil money penalties or false claims liability.

Following a recent study in which the Centers for Medicare and Medicaid services (CMS) determined that residents were getting inadequate training on fraud and abuse laws, the Office of Inspector General (OIG) recently published a document entitled "A Roadmap for New Physicians: Avoiding Medicare and Medicaid Fraud and Abuse".  The document serves as a good primer on the various fraud and abuse laws which apply to medical practice under the Medicare program. Physicians are well-advised to not only review the document themselves but to have key office personnel including administrators, office managers and key billing personnel review the document as part of their regular compliance training.  Although this basic document cannot take the place of competent legal counsel, it will give physicians and their employees a fundamental understanding of the regulatory framework that applies to their daily practice and enough knowledge to know when to get health care legal counsel involved.

ABOUT THE AUTHOR:  Mr. Rodriguez is an attorney for Fox Rothschild, LLP.  He is Co-Chair of the firm's Health Law Practice.  To learn more click here:  Todd Rodriguez Bio & Contact Info

Last Updated on Tuesday, 21 June 2011 17:10
D.C./M.D. Arrangements Share Legal Issues Nationwide Print E-mail
Written by Jeffrey L. Cohen   
Thursday, 09 June 2011 08:53

Chiropractors and medical doctors (or D.O.s) have had a long and somewhat complex relationship. Though they approach healthcare issues differently, there are many instances where they share care or even work together. Such "M.D./D.C." relationships are legally complex, but often prove to be rewarding in many respects. Properly constructing the arrangements is critical, especially since government regulators and payers tend to view such arrangements with skepticism, alleging that the true reason for the combination is for chiropractors to avoid coverage restrictions.

The core legal issues the parties need to be aware of include:

Corporate practice prohibitions. Most states prohibit (or regulate) who can own a medical practice or a chiropractic practice. So called "corporate practice restrictions" for instance often prohibit a medical doctor and a chiropractor from jointly owning a clinical practice. Additionally, many states do not permit a chiropractor employing a medical doctor and vice versa. That leaves essentially two models for consideration-a direct employment model and a management type of model.

Legal structure. Getting this right is important, especially with respect to self referral restrictions. If federal patients dollars are involved (e.g. Medicare), some very complex and powerful federal laws (e.g. Stark and the Anti Kickback Statute) come into play. And many states have their own self referral restrictions. Single legal entity? Multiple legal entity? It depends on things like the payer mix, state regulation, and the type of services provided.

In office ancillary services (IOAS) or "group practice" concerns. This is closely related to self referral regulations. Both states and the federal government regulate such conduct. For instance, under applicable federal law, "designated health services" (which include physical therapy and diagnostic imaging) must be provided in the very same office where patient care is provided. Moreover, a physician (but not a chiropractor) must be physically present in the office when the DHS services are provided to patients. Additionally, to comply with the IOAS provision, the practice has to ensure that the physicians in the practice spend, on average, 75% of their total professional time working through the combined practice. MD/DC practices which don't require an M.D. often can find adhering to state and federal requirements difficult because of applicable supervision requirements.

Fee splitting. Many practices want to simply divide up income on a percentage basis, but this raises fee splitting (and kickback) issues.

These unique combined practices have to be careful to guard against the already tainted regulatory assumptions about them. Yet, there are many things conservative professionals can do to thwart successful investigations, like-

·Rules and regulations to address common risks like "patient channeling" allegations (for which many physicians have been criminally convicted);

·A compliance audit to ensure that what they are doing or planning to do complies with applicable state and federal law; and

·An annual audit to ensure continued compliance (including in areas like coding and proper documentation).

Mixed practices like M.D./D.C. relationships are not new, but the full spectrum of regulatory compliance is essential to ensure long term viability. It simply isn't sufficient to focus on one or more aspects. Getting the entity and form of compensation right is just one part of a legally complex business arrangement; and to serve physicians well requires all facets of the arrangement to be viewed and cleared.

With over 20 years of healthcare law experience following his position as legal counsel for the Florida Medical Association, Mr. Cohen is board certified by The Florida Bar as a specialist in healthcare law. His practice immerses him in regulatory, contract, corporate, compliance and employment related matters.  Mr. Cohen is the founder of The Florida Healthcare Law Firm. | 888-455-7702

Last Updated on Thursday, 09 June 2011 08:56
7 Essential Elements for Compliance Print E-mail
Written by Todd Demel, MBA   
Thursday, 26 May 2011 16:55

Establishment of Compliance Standards and Procedures:

Develop and distribute written standards of conduct, policies and procedures.


Designation of a Compliance Officer or Committee:

Specific individual(s) in high level positions within the organization should be assigned overall responsibility for compliance development, implementation, oversight, and enforcement.


Employee Education and Compliance Training:

Effectively communicate standards and procedures to all employees through development and implementation of ongoing program


Ongoing Monitoring and Reporting Systems:

Use audits and/ or evaluation techniques to monitor compliance and assist in the reduction of identified problem areas.


Corrective Actions:

Once an offense is detected, the organization should take all reasonable steps to respond appropriately.


Disciplinary Actions:

Compliance standards should be consistently enforced by the organization, including the use of appropriate disciplinary mechanisms.


Lines of Communication:

Mechanisms should be in place for raising questions or alerting the company of potential violations. Employees should be allowed to make complaints anonymously and confidentially as well as being assured of non-retaliation for complaints raised in good faith.  

Source:  MF Healthcare Solutions:  Developing a Compliance Plan


Last Updated on Wednesday, 29 June 2011 16:59
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