Month:

October 2018

Compliance in Healthcare: Understanding Zone Program Integrity Contractor Investigations and Audits  

The Centers for Medicare and Medicaid Services (CMS) have a multitude of resources to detect and protect against fraud and abuse in claims. Particularly, CMS has at least six types of contractors that provide different roles in the prevention, detection, and reporting of fraud and abuse in healthcare. This list includes Recovery Auditors, which serve to reduce fraud and abuse by detecting and collecting overpayments from entities and Comprehensive Error Rate Testing (CERT) Contractors, which determine rates of improper payments by reviewing claims under Medicare Fee-For-Service (FFS). Another auditor that providers should be particularly mindful of are the Zone Program Integrity Contractors (ZPICs). This article is an overview ZPICS, its role in Medicare, and outlines the steps providers should take when faced with an audit by ZPICs.

Fifth Circuit Faced with Post-Marks Litigation: Do We Know What an “Automated Telephone Dialing System” is Anymore?

Will new litigation affect Beto O’Rourke’s campaign? With election polls opening up for early voting last week, a one week left of campaigning and the new Telephone Consumer Protection Act (the “TCPA”) litigation to defend, it is unlikely that Beto O’Rourke will be slowing down any time soon. O’Rourke has made it his mission to reach all voters, not just those residing in the three major cities: Austin, Houston and Dallas. New litigation filed October 19, 2018, raises the question whether “Beto for Texas” reached those voters in violation of the TCPA and the recent Marks v. Crunch decision. The litigation will address whether the 5th Circuit will implement Marks expansive definition of an “automated telephone dialing system.”

SCOTUS Overturns Stay, “Dark Money” Donors Will Be Partially Disclosed

On September 18, 2018, the United States Supreme Court overturned a stay blocking a District Court ruling requiring non-profits to disclose identity of all contributors who give more than $200 a year. Prior to the ruling, IRS designated 501(c)(4) social welfare organizations and 501(c)(6) organizations such as business leagues and boards of trade, who do not register as political committees with the Federal Election Commission (FEC), were required to disclose donors only when they contributed for specific political advertisements. While the ruling requires the FEC to give guidance, newly issued FEC rules limit the scope of the court’s intention. It is likely that the new ruling will allow some donors to remain undisclosed while requiring partial disclosure of donors who contribute towards certain, but not all, expenditures.

The Changing Face of Charity Care Determinations

Since the enactment of the Affordable Care Act, hospitals have faced strict and substantial regulations regarding the provision of financial assistance to patients in the form of “charity care.” An essential element in a hospital’s ability to maintain tax-exempt status and financial solvency, charity care has worked to serve uninsured and indigent patients while helping charitable hospitals serve their mission and retain the benefits that come with it. The state of Pennsylvania recently passed legislation requiring more explicit and affirmative acts to provide charity care to more eligible patients. The change is unprecedented, and other states look to be slowly responding in their own ways. Compliance with these changes is most beneficial with proactive measures and risk assessments even before change comes through the doors.

GDPR Enforcement Notice to AggregateIQ

On July 6, the Information Commissioner’s Office (ICO) issued their first Enforcement Notice to AggregateIQ (AIQ) under the General Data Protection Regulation (GDPR) and the United Kingdom’s Data Protection Act (DPA). The GDPR is a law regulating data protection and privacy as well as the export of personal data outside of the European Union (EU). It became enforceable on May 25, 2018. The DPA supplements the GDPR and regulates the processing of personal data. The ICO is a regulatory office in the UK which enforces regulations under the DPA and GDPR. AIQ is a Canadian digital advertising, web and software development company that was charged with violations regarding the use of data analytics in political campaigning. This article will address the AIQ enforcement notice and how companies ensure compliance with the GDPR to prevent receipt of an enforcement notice.

SEC Continues to Carve Out Regulatory Framework for Cryptocurrencies

On September 11, 2018, the Securities and Exchange Commission (SEC) announced two enforcement actions relating to failures to register by market intermediaries in connection with digital asset activities. Despite earlier suggestions that the Commodity Futures Trading Commission (CFTC) might be the primary self-regulatory organization (SRO) regulating this market, the main takeaway from these cases is that market intermediaries dealing in digital assets may also have registration and customer protection liabilities, and the failure to observe them can result in serious penalties.

You’ve Heard About the GDPR, but What About the CaCPA?

On June 28, 2018 California took a page out of the European Union’s (EU) book and signed the California Consumer Privacy Act (CaCPA) into law. The CaCPA is a landmark privacy bill that will come into effect on January 1st, 2020 and it is being closely compared to the General Data Protection Act (GDPR).

What does this mean for California businesses and residents? In short, more privacy and more control over data. Key aspects include allowing consumers to request what data an organization has collected about them, allowing consumers the right to fully erase data, protecting children’s data, and making verification processes more stringent for businesses.

Facial Recognition Technology: How Much Can State Law Protect Users?

Sei Unno Associate Editor Loyola University Chicago School of Law, JD 2019 Facial recognition has become mainstream, whether the laws are ready or not. Video games are using facial recognition to check the ages of their users and cars are being equipped with technology to identify drivers who are fatigued or distracted. In the U.S., states …
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Proposed Changes to the NIH Guidelines for Human Gene Transfer Experiments

The National Institute of Health (NIH) has submitted a proposal to amend the NIH Guidelinesfor research involving recombinant or synthetic nucleic acid molecules.  The proposed amendmentseeks to streamline the oversight for human gene transfer clinical research protocols and reduce duplicative reporting requirements already captured within existing regulatory framework.  The amendment specifically seeks to delete the NIH protocol registration submission and reporting requirements under Appendix M of the NIH Guidelines, and modify the roles and responsibilities of entities involved in human gene transfer or the Recombinant DNA Advisory Committee(RAC).

SEC’s Settlement to Prevent Future Market Disruption by Elon Musk and Tesla

On September 27, 2018, the Securities and Exchange Commission (“SEC”) filed a complaint, alleging Tesla CEO and Chairman, Elon Musk, committed stock market fraud by misleading investors. The matter was resolved through settlement and later approved by a judge. It is hoped that the settlement will prevent Tesla and Musk from causing future market disruption and harm to shareholders.