Author: WadeEmmert

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Weighing the Pros and Cons of Synthetic Healthcare Data Use

Summary of article from Health IT Analytics, by Shania Kennedy:

Healthcare data, while valuable for improved outcomes, faces challenges including data quality, patient privacy, and HIPAA compliance. Synthetic data, artificially generated information that mimics real-world data (RWD), offers a promising solution by maintaining statistical properties of RWD without containing personally identifiable information. Synthetic data provides privacy preservation, prevents data re-identification, and supports algorithm training. However, it also presents challenges, including potential data quality issues, bias, and AI model collapse. While synthetic data generators need improvement and standardized quality assessment, they are being increasingly utilized for various healthcare projects.

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Health Law Highlights

Kickbacks and Medically Unnecessary Treatments: Five Major Qui Tam Settlements from May 2024

Summary of article from Kohn, Kohn & Colapinto LLP, by Geoff Schweller:

In May, the U.S. Department of Justice (DOJ) and U.S. Attorneys’ Offices announced several substantial settlements under the False Claims Act (FCA), resolving qui tam whistleblower lawsuits related to healthcare fraud. The settlements involved cases of kickbacks, billing for unnecessary treatments, and non-compliance with Medicare rules. Prominent cases included a $27 million settlement with Daniel Hurt for alleged Medicare fraud, a $24.3 million settlement with Cape Cod Hospital for non-compliance with Medicare rules, and a $12 million settlement with Innovasis Inc. for alleged kickbacks to surgeons. Other notable settlements involved RiverSpring and Elara Caring, which settled for $10.1 million and $4.2 million respectively. These settlements underscore the importance of whistleblowers in combating healthcare fraud, and highlight the significant financial burden and potential harm caused by fraudulent practices.

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Health Law Highlights

AI in the Health Insurance Industry: An Explainer and Research Roundup

Summary of article from The Journalist’s Response, by Rachel Layne:

As artificial intelligence (AI) becomes increasingly prevalent in health insurance, U.S. states are seeking to regulate its use due to concerns of racial bias and flawed coverage determinations. Major health insurers like Humana, Cigna, and UnitedHealth face lawsuits over alleged improper use of AI in coverage decisions. Various state and federal initiatives aim to increase transparency around AI systems’ creation, data inputs, and decision-making algorithms. The National Conference of State Legislatures reports that at least 40 states have introduced or passed AI-regulating legislation in 2024, with many states modeling their regulations on guidance from the National Association of Insurance Commissioners. However, the varying rules across states could pose challenges for insurers.

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Health Law Highlights

3 Ways AI Can Improve Revenue-Cycle Management

Summary of article from American Hospital Association:

The integration of artificial intelligence (AI) and automation can enhance revenue-cycle management (RCM) in healthcare, reducing costs and boosting efficiency. AI applications in RCM include automated coding and billing, predictive analytics for denial management, revenue forecasting, patient payment optimization, data security, and operational efficiency. Case studies demonstrate that AI can lead to significant improvements in RCM, such as reducing denials, increasing productivity, and improving financial outcomes. However, the adoption of AI also carries risks, requiring careful data structuring to prevent bias and validation of AI outputs. The adoption of AI in healthcare is expected to grow in the coming years, with initial focus on simpler tasks and gradually expanding to more complex aspects of RCM.

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Health Law Highlights

Privacy Abuses Will Meet ‘Full Force of the Law’ From New Texas Unit, Attorney General Says

Summary of article from The Record, by Joe Warminsky:

Texas Attorney General Ken Paxton has announced the formation of a new data-privacy team within the consumer protection unit of his office. The team will enforce Texas privacy laws, focusing on data privacy and security, identity theft, data brokers, biometric information, consumer protection, and federal laws covering children’s privacy (COPPA) and healthcare information (HIPAA). The Texas Data Privacy and Security Act, a consumer-friendly law, will come into effect on July 1. Paxton has stated that companies exploiting consumer data will face legal consequences. This move is in line with several states, like Vermont, implementing broad privacy laws as federal regulation remains in limbo.

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Health Law Highlights

Lessons Learned From Walmart, Amazon, and Walgreens: Healthcare’s Retail Reset

Summary of article from D Magazine, by Will Maddox:

Walmart, Amazon, and other major corporations have struggled to make a profitable venture into primary care, often citing high operating costs and reimbursement challenges. Retail healthcare has proven complex due to the transient nature of providers in these settings and the difficulty in maintaining long-term patient relationships. Further, the current fee-for-service model in healthcare is unsustainable. The ongoing shortage of physicians is a significant challenge. A new payment model could alleviate the shortage and better meet the growing demand for primary care.

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Health Law Highlights

Now is Not the Time to Relax: Record Settlements in Stark Law and False Claims Cases

Summary of article from Lathrop GPM, by Jesse A. Berg:

In May 2024, the University of Pittsburgh Medical Center (UPMC) settled a False Claims Act case for $38 million, marking one of the largest settlements in U.S. history for alleged Stark Law violations. The case emphasizes the importance of fair market value compensation in hospital-physician financial arrangements and debunked the idea that a Department of Justice (DOJ) decision not to intervene in an FCA case means the issue is resolved. The case underscores the need for healthcare organizations to ensure their physician compensation practices can withstand increased regulatory scrutiny and comply with Stark Law principles.

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Health Law Highlights

Employers Must Keep Reproductive Health Information About Their Plan Participants Private Under New HIPAA Privacy Rule

Summary of article from Akerman LLP, by Beth Alcalde, Elizabeth Hodge:

The newly updated HIPAA Privacy Rule, effective June 25, 2024, provides enhanced protection for reproductive health care records, preventing their disclosure to state law enforcement agencies except under certain conditions. The definition of “reproductive health care” is broad, encompassing a wide range of male and female health services. There are strict restrictions on using such information for investigations, and health plan administrators and associated businesses have direct responsibility for compliance. Upon receiving a request for such information, a signed written attestation is required from the requester stating the intended use or disclosure is not for a prohibited purpose. Revisions to the Notice of Privacy Practices (NOPP) must be in place by February 16, 2026, and legal challenges to the Final Rule are expected.

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Pharmacy Owner Sentenced for Paying Illegal Kickbacks and Engaging in a Money Laundering Conspiracy

Summary of press release from United States Department of Justice:

A Texas pharmacy owner was sentenced today to four years and four months in prison and ordered to pay over $59 million in restitution for paying illegal kickbacks and engaging in a money laundering conspiracy. According to court documents and evidence presented at trial, Richard Hall, 53, of Fort Worth, worked with others to create and market expensive compounded medications, which are intended to be custom-tailored to individual patient needs. Hall paid marketers to recruit area doctors to write prescriptions for these expensive compounded medications, including by creating so-called “investment opportunities” so that doctors who wrote prescriptions to the pharmacy could profit from the pharmacy operations. Hall paid illegal kickbacks to these marketers and engaged in a conspiracy to launder the unlawful proceeds. A federal jury in the Northern District of Texas convicted Hall in July 2023 of four counts of paying and receiving unlawful kickbacks and one count of conspiring to launder money.

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Health Law Highlights

How Generative AI Will Change Jobs In Healthcare

Summary of article by Bernard Marr:

Generative AI is poised to revolutionize healthcare by assisting in diagnosis and treatment, personalizing care, and accelerating research and development. It can analyze complex datasets, like medical images, and provide personalized treatment programs, while AI chatbots can offer specialized advice and patient monitoring. It can also expedite drug discovery by generating genetic codes and simulating human physiological responses. However, ethical implications concerning data privacy, bias, and AI accountability must be addressed. Professionals will need to understand these issues, ensure secure data handling, and comprehend when human intervention is necessary.