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Compliance Update
OCR launches Phase 2 HIPAA Audits Print E-mail
Written by The Health Law Offices of Anthony C. Vitale   
Monday, 28 March 2016 00:00

The U.S. Department of Health and Human Services Office of Civil Rights has launched Phase 2 of its long-awaited HIPAA Audit Program. OCR has already begun sending out address verification letters, which will be followed by a questionnaire.
 
The new round of privacy and security audits will focus on the business associates of healthcare providers, insurers and other HIPAA-covered entities to meet selected standards and implementation specifications of the Privacy, Security and Breach Notification Rules.

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Informed Consent for Termination of Pregnancy Now Requires a 24-Hour Waiting Period Print E-mail
Written by Sarah Warden, Esq., Florida Health Law Center   
Sunday, 27 March 2016 00:00

On June 10, 2015, after heated debate, Governor Rick Scott signed into law House Bill 633, instituting a 24-hour waiting period before a physician can terminate a pregnancy prior to viability or the third trimester.  The controversial new law was in effect for a single day before a state court in Leon County granted a temporary injunction enjoining its enforcement.   But as of February 26, 2016, the law is being enforced again after a Florida appellate court vacated the injunction.  Physicians must now be aware of and follow the law’s new conditions for voluntary and informed consent to termination of a pregnancy. 

Since 2011, Florida has required that physicians follow a strict protocol set forth in Florida Statute § 390.0111(3) before terminating a pregnancy, including the requirement that the gestational age of the fetus be verified by an ultrasound and that the pregnant woman be offered the opportunity to view the live ultrasound images and hear an explanation of the images.  The bill amended that protocol to further require that the performing or referring physician verbally inform the pregnant woman of statutorily required information “while physically present in the same room” with the patient at least 24 hours before the procedure is performed.  As such, physicians cannot satisfy this requirement using telemedicine.  Physicians should be mindful that the law requires a full 24-hour waiting period, not merely that the procedure be performed on the next day. 

A narrow exception to the 24-hour delay period was created for documented victims of sexual abuse.  Under the new law, if a patient provides the performing physician with a copy of a restraining order, police report, medical record, or other documentation that evidences she is terminating a pregnancy due to rape, incest, domestic violence, or human trafficking, the 24-hour waiting period does not apply.

While doctors that offer termination of pregnancy services may view the 24-hour delay and the added visit as burdens for their patients and their office, they must comply with the law or face discipline and fines imposed by the applicable licensing board.  As a best practice, physicians should meticulously document in the patient’s record the information necessary to show that voluntary and informed written consent was obtained.  Substantial compliance with the statutory requirements of voluntary and informed consent, or a reasonable belief by the physician that complying with those requirements would threaten the life or health of the patient, are statutory defenses to an action brought for failure to obtain the requisite consent.  Further, doctors that offer termination of pregnancy services in Florida should consult with a qualified attorney to ensure their compliance with the laws governing termination of pregnancy.

Sarah Warden is an attorney with Florida Health Law Center.  Ms. Warden represents healthcare providers, including hospital systems, physician groups, and physicians in managed care arbitrations and transactions, employment agreements, and regulatory compliance matters involving anti-kickback and self-referral laws, Medicare and Medicaid, HIPAA, and the Affordable Care Act.  Ms. Warden can be reached at swarden@flhealthlaw.com.

Last Updated on Thursday, 31 March 2016 11:08
 
CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016 Print E-mail
Written by Deborah Dowell, MD, MPH; Tamara M. Haegerich, PhD; Roger Chou, MD | JAMA   
Thursday, 17 March 2016 00:00

The guideline is intended to improve communication about benefits and risks of opioids for chronic pain, improve safety and effectiveness of pain treatment, and reduce risks associated with long-term opioid therapy.
 
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Last Updated on Friday, 18 March 2016 17:47
 
Lessons learned from whistleblower FCA case against cancer treatment company Print E-mail
Written by The Health Law Offices of Anthony C. Vitale   
Tuesday, 15 March 2016 18:23

Earlier this month, the U.S. Department of Justice announced that 21st Century Oncology and its wholly owned subsidiary, South Florida Radiation Oncology LLC, agreed to settle False Claims Act allegations relating to billing for procedures that were medically unnecessary. Specifically, the Fort Myers, Florida-based company was alleged to have billed for performing the Gamma function - a medical procedure designed to measure the exit dose of radiation from a patient after receiving radiation treatment.
 
The government alleged that the procedure served no medically appropriate purpose; that they were conducted by those who were not trained to interpret and use the results; that in some instances the results were not even reviewed until a week or more after the last day of a patient's treatment; and, in other cases, they billed for the procedure even if the results were not available due to imaging equipment failures.

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Last Updated on Monday, 04 April 2016 11:56
 
Board Revises Florida's Telemedicine Practice Rule for Physicians Print E-mail
Written by Florida Healthcare Law Firm Blog   
Monday, 29 February 2016 00:00

Effective March 7, 2016, the Board of Medicine's revised Telemedicine Rule, Rule 64B8-9.0141, F.A.C., goes into effect. The amended rule reads...

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