1st Talk Compliance features attorneys Sean McKenna, Lauren Nelson, and Vincent Aiello of Spencer Fane LLP, on the topic of Healthcare Assets: How to Preserve and Protect. We will discuss the interplay between enforcement and liability proceedings with asset protection, explore how government and private litigation matters can impact healthcare companies, clinicians, and executives, and provide tips and preventative strategies to preserve income and assets prior to such action to ensure business continuity and succession planning.
A Practical Approach to The Safe Harbor Law
1st Talk Compliance features guest Raymond Ribble, CEO and Founder at SPHER, Inc., on the topic of A Practical Approach to The Safe Harbor Law. Ray joins our host Catherine Short to discuss how HIPAA data breach penalties typically get measured in millions of dollars, even following an organization implementing NIST cybersecurity framework measures. However, with the new HIPAA Safe Harbor Law, signed in January 2021, HHS and OCR may consider some penalty mitigation. It is important to understand that the Safe Harbor Law, while offering substantial protection, does not provide a true safe harbor and only offers some protection. This episode will examine what the established security practices for healthcare are, and how to pivot your organization’s security profile to mitigate breach penalties if an event occurs.
DMEPOS – In Compliance with CMS
1st Talk Compliance features guest Rachel V. Rose, JD, MBA, principal with Rachel V. Rose – Attorney at Law, P.L.L.C., on the topic “DMEPOS – In Compliance with CMS.” Rachel joins our host Catherine Short to discuss special payment rules associated with durable medical equipment, prosthetics, orthotics and supplies. DMEPOS products must meet quality standards, suppliers need to be accepted by Medicare to participate, similar to providers, and are subject to fraud, waste, and abuse laws. This episode will provide an overview of participation and quality requirements, relay the latest compliance and requirements updates, and discuss the consequences of non-compliance, as well as submitting false and fraudulent claims.
Fraud, Healthcare, COVID-19, and the False Claims Act
Shauna Itri, Partner at Seeger Weiss LLP will be presenting for us today. A whistleblower or qui tam action can provide financial rewards to individuals who have information that a company/individual has committed fraud. The primary statutes under which this relief may be sought are the federal and state False Claims Acts (“FCAs”). In addition to the FCAs, there are other statutes which apply to tax fraud, securities fraud, and in California, fraud on private insurance companies. This practical Course will provide an overview of the False Claims Acts, the knowledge and skills to be able to recognize a potential whistleblower case, and understand the unique procedures utilized in filing whistleblower cases/tips. The second half of the Course will go into recent trends in cases brought (or could be brought) under the False Claims Act including cases involving mined data and potential fraud related to COVID-19.
New Stark Law and AKS Final Rules -Valuation Considerations
Catherine Short converses with Rachel V. Rose, JD, MBA, principal with Rachel V. Rose – Attorney at Law, P.L.L.C. and Don Barbo, Managing Director with VMG Health, on the topic of “New Stark Law and AKS Final Rules -Valuation Considerations.” On January 19, 2021, a new era was ushered in as the CMS Stark Law Final Rule and the HHS-OIG Anti-Kickback Statute Final Rule became effective. The impetus behind the new Final Rules is value-based care and care coordination. In light of the advent of Value-Based Arrangements, which include Value-Based Enterprises, as well as the continuing importance of fair-market value and commercial reasonableness, we will focus on these aspects of the respective Final Rules, which must be read in conjunction with each other.
Valuation Considerations in the Era of the New Stark Law and AKS Final Rules
Rachel V. Rose, JD, MBA, principal with Rachel V. Rose – Attorney at Law, P.L.L.C., Houston, TX and Don Barbo, Managing Director with VMG Health are presenting this timely webinar. On January 19, 2021, a new era was ushered in as the CMS Stark Law Final Rule and the HHS-OIG Anti-Kickback Statute Final Rule became effective. The impetus behind the new Final Rules is value-based care and care coordination. In light of the advent of Value-Based Arrangements, which include Value-Based Enterprises, as well as the continuing importance of fair-market value and commercial reasonableness, this presentation focuses on these aspects of the respective Final Rules, which must be read in conjunction with each other. Additionally, a portion of the presentation will be dedicated to the nuances of balance sheets, income statements, and valuations in relation to both the healthcare industry and the aforementioned laws.
Waivers and Discounts: What are They and When do They Apply?
C.Trey Scott, Coordinating Attorney at Kennedy, Attorneys & Counselors at Law leads this webinar. Waivers and discounts are normal business activities that occur throughout the US daily as a way to reward customers or to assist when an invoice or bill may too expensive. However, in a healthcare context, the normal rules for waivers and discounts don’t apply. This presentation will highlight what waivers and discounts are, how they work, and when they are problematic/illegal.
The New AKS and Stark Laws Final Rules – Key Take-Aways
Catherine Short converses with Rachel V. Rose, JD, MBA, principal with Rachel V. Rose – Attorney at Law, P.L.L.C., Houston, TX, on the topic of “The New AKS and Stark Laws Final Rules – Key Take-Aways.” On November 20, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a Final Rule related to the Medicare Physician Self-Referral Law (Stark Law). Nearly simultaneously, the Office of the Inspector General, Department of Health and Human Services (HHS-OIG), released a Final Rule, which amends various safe harbors to the Federal Anti-Kickback Statute (AKS). The changes appear to be based, in large part, on value-based healthcare delivery and payment systems. On this episode, we will highlight the key changes, along with the similarities and differences in the language between the two Final Rules, examine the new AKS safe harbors and Stark Law exceptions, compare and contrast critical items found in both Final Rules, and appreciate the risks of non-compliance.
Big Data & False Claims Act Risk Due to COVID-19
Stephen Bittinger, partner with K&L Gates in the firm’s Charleston office and a member of the health care/FDA practice group, is presenting with us on the brief history of use of big data in investigating and proving False Claims Act liability. He will offer an explanation of the government agencies and contractors involved in gathering health care data for investigation of fraud and abuse. We will look into the increased risk of fraud investigations due to regulatory changes implemented in response to COVID-19, and give practical ways to use data to reduce risk of investigation and liability.
The New AKS and Stark Laws Final Rules Key Take Aways
Rachel V. Rose, JD, MBA, principal with Rachel V. Rose – Attorney at Law, P.L.L.C., Houston, TX presents on these new updates. On November 20, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a Final Rule related to the Medicare Physician Self-Referral Law (Stark Law). Nearly simultaneously, the Office of the Inspector General, Department of Health and Human Services (HHS-OIG), released a Final Rule, which amends various safe harbors to the Federal Anti-Kickback Statute (AKS). The changes appear to be based, in large part, on value-based healthcare delivery and payment systems. The purpose of this presentation is to highlight the key changes, along with the similarities and differences in the language between the two Final Rules.
