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Compliance Update
What You Should Know About OCR's HIPAA Privacy Audits Print E-mail
Written by Vitale Health Law   
Tuesday, 19 December 2017 19:27
Have you received a request from HHS Office for Civil Rights (OCR) asking that you provide the name of your privacy official along with any additional criteria? If you have, then you likely are aware that you may be the focus of a HIPAA privacy audit.

Last Updated on Tuesday, 19 December 2017 19:31
Compliant STEM Cell Therapy & HCT/Ps: Beginner's Guide Print E-mail
Written by Susan St. John | Florida Healthcare Law Firm   
Tuesday, 21 November 2017 00:00
Many practitioners or establishments looking to enhance their practice and offer more treatment options to their patients are considering HCT/P and Stem Cell Therapy in addition to other traditional treatment options. However, before embarking on offering HCT/P or STEM Cell Therapy, a practitioner or establishment needs to carefully consider protocol and procedure for offering HCT/Ps or STEM Cell Therapy.

Last Updated on Friday, 24 November 2017 18:21
Billing Under Another Provider's Number Can Land Physicians in Hot Water Print E-mail
Written by Emma Cecil | Mutual Matters   
Thursday, 09 November 2017 00:00
An Oklahoma physician agreed on August 28, 2017 to pay the government $580,000 to resolve allegations that he violated the False Claims Act by submitting claims to the Medicare program for services he did not provide or supervise. According to the government, the physician allowed a company that employed him and in which he had an ownership interest, to use his national provider identification (NPI) numbers to bill Medicare for physical therapy evaluation and management services that he did not provide or supervise. The government further alleged that after he separated from the company and deactivated his NPIs associated with the company, he reactivated those NPIs so that the company could use them to bill Medicare for services he neither performed nor supervised.

Last Updated on Friday, 10 November 2017 18:43
Protecting Your License Against Adverse Action Print E-mail
Written by Susan St. John | Florida Healthcare Law Firm   
Monday, 16 October 2017 00:00
If you have ever been the recipient of a Florida state agency's (i.e. Department of Health, AHCA, etc.) notice regarding an adverse action, such as a Notice of Intent to Deny, licensure application, renewal or change of ownership, you probably received an Election of Rights form along with the agency's notice. The Election of Rights form must be completed and returned to the agency within 21 days of receiving the agency's notice. In completing the Election of Rights form, you are given three options to choose from in deciding how you want to respond to the agency's notice.

Last Updated on Friday, 24 November 2017 18:17
Clinical Research & Healthcare Regulatory Compliance Print E-mail
Written by Jeffrey L. Cohen   
Monday, 21 August 2017 00:00

Doctors often consider the idea of clinical research to be an easy "add on" to their practices. The usual idea is "I already have the patients. This'll be easy." But that's not the case when you start to look at the healthcare regulatory compliance issues!

Pharmaceutical companies ("Sponsors") are often looking for resources for clinical research. They usually turn to clinical research organizations (CROs) to find research centers (Sites) and to manage some of the healthcare regulatory compliance issues in a way that creates enough distance between the Sponsor and the Site in hopes that the metrics from the patients enrolled in the study will provide clarity regarding the efficacy of a tested drug.

Medical practices that think it'll be easy to become a Site will be very surprised by some of the key challenges, which include...

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