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Doctor, patient frustration over pain med access leads to pharmacy rule change Print E-mail
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Tuesday, 24 November 2015 00:00

The Florida Board of Pharmacy recently approved a rule change designed to help patients get the pain medications they need.
The rule, which grew out of claims from frustrated patients and their physicians, is aimed at training pharmacists to change the way they look at prescribing controlled substances - from one of finding reasons to reject prescriptions, to one of making sure patients get the medications they need.
The board, in writing its rule, said "pharmacists should not fear disciplinary action from the board, or other state regulatory or enforcement agencies, for dispensing controlled substances for a legitimate medical purpose in the usual course of professional practice."

However, pharmacists still must take proper steps to determine that the prescription was issued for a legitimate medical purpose. One way would be to access the Prescription Drug Monitoring Program's database.
If a pharmacist believes that a prescriber is involved in the diversion of controlled substances, he or she has the obligation to report the prescriber to the Florida Department of Health.

The rule change comes in response to growing complaints from patients, doctors and pharmacists after a federal crackdown on so-called "pill mills"...
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Last Updated on Wednesday, 25 November 2015 17:48
HHS Office of Inspector General Calls for Increased Oversight and Enforcement of HIPAA Print E-mail
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Thursday, 12 November 2015 00:00

On September 29, 2015, the U.S. Department of Health & Human Services Office of the Inspector General (OIG), Office of Evaluation and Inspections, released two studies calling on the HHS Office for Civil Rights (OCR) to strengthen its efforts in both general enforcement of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Standards and enforcement of security breach reporting requirements. OIG commissioned both studies out of concern for the increased risk of an invasion of privacy and exposure to fraud, identity theft, and other harm that patients face in an ever-expanding digital health environment.

In its response to OIG, OCR generally concurred with the OIG's recommended improvements to its HIPAA investigation and enforcement practices and stated that OCR will launch its delayed its phase 2 audits (Phase 2 Audits) of compliance with the HIPAA Privacy, Security and Breach Notification Standards in early 2016. The anticipated launch of the Phase 2 Audits, as well as OCR's public statements that it intends to step up its enforcement activities, should be an impetus for covered entities and business associates to assess their privacy, security and breach notification practices for compliance with the HIPAA standards and to mitigate the risks, threats and vulnerabilities to protected health information (PHI) that lead to breaches. OCR's responses to the studies are consistent with its prior statements over the past couple of years that enforcement is a high priority.
Last Updated on Friday, 13 November 2015 16:36
Huge Stark Law Hospital Settlements and Physician Culpability - The New Normal Post- Tuomey? Print E-mail
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Thursday, 01 October 2015 00:00

After the federal government's victory against Tuomey Hospital, we have seen an increasing number of large False Claims Act (FCA) settlements with hospitals involving Stark Law allegations. Relators are even citing, as evidence of ongoing recklessness, that hospital executives have been e-mailing articles about the Tuomey case to their staff. Given the Stark Law's intricate requirements, it is unsurprising that many hospitals are presented with Stark Law compliance questions. However, the U.S. Department of Justice (DOJ) has not shown much leniency in its treatment of these cases, as shown by two recent settlements.
First, there is the settlement with Columbus Regional Healthcare System (Columbus) and Dr. Andrew Pippas to resolve two separate qui tams filed by a former Columbus executive, Richard Barker, in the Middle District of Georgia. Mr. Barker alleged both billing and Stark Law misconduct in his complaints. While the first complaint largely focused on allegations of improper evaluation and management upcoding and intensity-modulated radiation therapy billing, it also included some cursory allegations of improper physician financial relationships. The government declined to intervene in this case in 2013. In 2014, Mr. Barker filed a second qui tam alleging compensation to Dr. Pippas in excess of fair market value, determined in a manner that took into account the volume or value of his referrals, and paid pursuant to an employment agreement that would not have been commercially reasonable but for Dr. Pippas' referrals to Columbus. On September 4, Columbus entered into a FCA settlement to pay up to $35 million to resolve both cases.
The Columbus settlement contains several noteworthy characteristics...

Last Updated on Wednesday, 21 October 2015 14:53
OIG opinion: Free home health visits are not kickbacks Print E-mail
Written by The Health Law Offices of Anthony C. Vitale   
Tuesday, 22 September 2015 00:00

The U.S. Department of Health and Human Services Office of Inspector General recently issued  an opinion that a home healthcare provider's policy to offer free introductory visits to patients who have already chosen it as their provider does not violate the federal anti-kickback statute.

In its request for an advisory opinion, the home healthcare provider stated that patients who choose their services do so without any involvement from the home healthcare provider and with no remuneration to referral sources. Generally, patients are provided with a list of potential home healthcare agencies by their physician, hospital discharge planner or case manager.

Last Updated on Friday, 25 September 2015 19:20
FL ALFs Latest Target of Medicaid Fraud Investigators Print E-mail
Written by Health Law Offices of Anthony Vitale   
Thursday, 17 September 2015 00:00

Assisted Living Facilities (ALFs), and the patient placement agencies with which they work, have become the latest target of Florida's Medicaid Fraud Control Unit (MFCU) investigators.

Recently, these agencies have been conducting interviews with ALF owners, managers and marketing personnel at facilities where they suspect possible kickbacks in violations of the Florida Patient Brokering Statute and Florida Medicaid Provider Fraud StatuteFlorida Statute 409.20(2)(a)(5), punishable by five years or more in prison.

It is a violation to...

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Last Updated on Friday, 18 September 2015 16:43
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