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Compliance Update
HIPAA Enforcement Tops $28M in 2018 Print E-mail
Written by Vitale Health Law   
Monday, 25 February 2019 00:00
If it seems as if HIPAA violations were in the news more often than ever last year, that may be because 2018 saw an all-time record year in HIPAA enforcement activity. There 
 were 10 cases settled and one judgement secured by the Office of Civil Rights (OCR) of the U.S. Department of Health and Human Services totaling $28.7 million. That figure surpassed the previous record of $23.5 million from 2016 by 22 percent. The biggest chunk of that was $16 million, which came from a settlement with Anthem for one of the most extensive data breaches in U.S. history. Amounts paid by others ranged from $100,000 by Filefax in January 2018 to a $4.3 million judgment in June against the University of Texas MD Anderson Cancer Center

Last Updated on Tuesday, 26 February 2019 18:05
HHS Proposes Changes to Drug Rebate Safe Harbors Print E-mail
Written by Vitale Health Law   
Tuesday, 12 February 2019 00:00
The U.S. Department of Health & Human Services (HHS) has issued a proposed rule that would amend the safe harbor regulation for certain drug rebates that manufacturers pay to pharmacy benefit managers (PBMs) Medicare Part D, and Medicaid managed care organizations (MCOs). Published in the Federal Register on February 6, the proposal is designed to address criticism that these rebates have contributed to the skyrocketing costs of prescription drugs.

"The prominence of rebate arrangements in the prescription drug supply chain has been cited as a potential barrier to lowering drug costs," HHS notes in its proposed rule.
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Last Updated on Wednesday, 13 February 2019 08:50
What Would You Do? Print E-mail
Written by John Couris   
Thursday, 31 January 2019 00:00
As the new legislative session begins here in Florida, politicians from across the state once again consider whether the Certificate of Need (CON) program-the regulatory process designed to limit health care costs and promote planning for new health care services and facilities-is best kept on the books h­­ere in the Sunshine State. Those who know me, have followed me on social media or read my blog posts over the past several years, are familiar with my belief that repealing CON is not good for our consumers, our community or our state. They have read my detailed arguments outlining that the elimination of CON could trigger a chain reaction that would cause three problems for residents: an increase in health care costs, a decline in the quality of care and a decrease in access to care. They also know that my position on CON is deeply informed by my extensive research on quality, clinical outcomes, safety, access and cost. Based on this research, I believe there is no clear indication or definitive proof that a deregulated state drives lower costs, higher quality and greater access to care.

Last Updated on Friday, 01 February 2019 18:20
FDA plans overhaul of decades-old medical device system Print E-mail
Written by AP via STAT   
Tuesday, 27 November 2018 13:42
U.S. health officials said Monday they plan to overhaul the nation's decades-old system for approving most medical devices, which has long been criticized by experts for failing to catch problems with risky implants and medical  instruments. The Food and Drug Administration announced plans aimed at making sure new medical devices reflect up-to-date safety and effectiveness features. The system targeted by the actions generally allows manufacturers to launch new products based on similarities to decades-old products, not new clinical testing in patients.
The FDA's move came one day after the publication of a global investigation into medical device safety by more than 50 media organizations, including The Associated Press. Led by the International Consortium of Investigative Journalists, the group found that more than 1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices had been reported to the U.S. Food and Drug Administration over a 10-year period.
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Last Updated on Tuesday, 27 November 2018 13:44
Opioid Law Includes New Kickback Penalties for Drug Treatment Facilities/Labs Print E-mail
Written by Vitale Health Law   
Tuesday, 20 November 2018 18:22
Last month, President Trump signed into law a bill designed to address matters relating to opioid use and abuse. Dubbed the "Support Act" an acronym for Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment, it includes a broad assortment of provisions to address the nation's opioid crisis. One of the more significant provisions is Section 8122 known as Eliminating Kickbacks in Recovery Act of 2018 (EKRA). It creates an all-payor, anti-kickback prohibition that extends to arrangements with recovery homes, clinical labs, and clinical treatment facilities and comes with criminal penalties for taking or paying a kickback.
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Last Updated on Tuesday, 20 November 2018 18:26
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