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Compliance Update
The IOM Report on Reform of the 510(k) Device Clearance Process and Beyond Print E-mail
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Wednesday, 31 August 2011 17:39

In the second step of the Food and Drug Administration's (FDA) initiative to assess and reform the 510(k) clearance process for Class II medical devices, the Institute of Medicine released its commissioned report on July 29, 2011, recommending that the FDA replace the 510(k) clearance process with a new regulatory framework.  The IOM report should be noted by stakeholders for the significance of this recommendation and the extent to which it may impact the direction and scope of upcoming FDA changes to the medical device clearance process. 
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CMS' 2012 OPPS Proposed Rule Further Revises Physician Supervision Requirements Print E-mail
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Tuesday, 16 August 2011 00:00

The U.S. Centers for Medicare & Medicaid Services (CMS) intends to further revise its physician supervision policy by proposing the federal Advisory Panel on Ambulatory Payment Classification Groups serve as the independent review body to evaluate and recommend physician supervision levels to CMS, and by defining personal supervision and general supervision for all hospital outpatient therapeutic services.

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Last Updated on Wednesday, 17 August 2011 13:21
Counterfeit Proof Prescription Pads Required for Health Care Practitioners in Florida Print E-mail
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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. 

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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
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