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Compliance Update
With the New Year Comes Greater HIPAA Oversight Print E-mail
Written by The Health Law Offices of Anthony C. Vitale   
Wednesday, 09 December 2015 09:33

HIPAA-regulated entities can expect 2016 to be the year of increased oversight. That's when the Health and Human Services Department's Office for Civil Rights (OCR) begins Phase II of its audit program.

The program is expected to focus on common areas of noncompliance and will include HIPAA-covered entities as well as business associates. Phase 2 "will test the efficacy of the combination of desk reviews of policies as well as on-site reviews."

OCR is responsible for overseeing covered entities' compliance with the Privacy Rule, which provides federal safeguards to maintain the privacy of individuals' protected health information. To that end, OCR has indicated that it will select 350 covered entities and 50 business associates during the next three years to conduct audits.

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Last Updated on Saturday, 26 December 2015 11:55
 
OIG's 2016 Work Plan: Mixed Results for 2015 and New Data Mining and Policy Efforts in 2016 Print E-mail
Written by MWE.com   
Thursday, 26 November 2015 00:00

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) annual release of a new Work Plan both summarizes the results achieved last year and highlights new areas for examination in the next. This year's Work Plan reported rising audit results but declining investigative results, in contrast to previous years.

In examining the new topics added to the Work Plan, two themes emerge. First, many of the new payment audits reflect OIG's use of data mining to identify providers or suppliers who could potentially be considered "outliers" from the average use of a particular code or procedure. Data mining will also play a significant role in connection with the second theme-a notable increase in OIG's review of significant, and some controversial, policy issues concerning changes in the country's health care delivery system, operation of HHS programs and the effectiveness of HHS agency oversight of those changes and programs.

Based on how OIG identified new study topics, the main takeaway from the Work Plan is "know your data." Whether the issue is Medicare claims or data reporting obligations, the OIG increasingly turns to data analytics to both generate audit or investigative leads or to study HHS program effectiveness.

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Last Updated on Friday, 27 November 2015 18:05
 
Doctor, patient frustration over pain med access leads to pharmacy rule change Print E-mail
Written by www.VitaleHealthLaw.com   
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
Written by MWE.com   
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
Written by MWE.com   
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
 
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