Billing & Coding
Summary of article from VMG Health, by Frank Cohen:
In the evolving healthcare landscape, advanced analytics, including predictive analytics, AI, and machine learning, are transforming billing and coding processes by enhancing accuracy and efficiency, thereby mitigating audit risks. These technologies analyze vast amounts of data to predict potential audit triggers, automate coding, and reduce human error. Case studies demonstrate significant benefits, such as reduced audit rates and cost savings. Implementing these technologies requires a cultural shift towards data-driven decision-making and thorough staff training. As these tools advance, they will become essential for healthcare organizations aiming to improve financial stability and compliance.
Fraud & Abuse
Summary of article from Bass, Berry & Sims PLC, by Latazia Carter, Scott Gallisdorfer:
In Q2 2024, the Department of Justice announced significant False Claims Act settlements, highlighting ongoing enforcement in areas such as unlawful kickbacks, improper billing, and subcontracting violations. Notable settlements included a $27.9 million agreement with a laboratory owner for fraudulent cancer genomic tests and a $12 million settlement with Innovasis Inc. for paying kickbacks to spine surgeons. Cape Cod Hospital and a chronic disease management provider, facing Medicare billing violations, each entered into Corporate Integrity Agreements (CIAs) and paid $24.3 million and $14.9 million, respectively. Additionally, CityMD resolved COVID-19 testing fraud allegations with a $12 million settlement, and Sikorsky Services Inc. and Derco Aerospace Inc. paid $70 million for unlawful subcontracting practices in Navy procurement. These cases underscore the importance of compliance for entities engaged in government contracts and healthcare services.
No Surprise Act
Summary of article from Proskauer Rose LLP, by D. Austin Rettew, Vinay Kohli:
Two district courts have issued conflicting rulings on the enforceability of arbitration awards under the No Surprises Act (NSA), highlighting ongoing challenges in its implementation. The NSA, enacted in 2020, aims to protect patients from unexpected medical bills by capping out-of-network charges at median in-network rates and establishing a mandatory dispute resolution process. The New Jersey District Court ruled that the Federal Arbitration Act (FAA) applies to enforce NSA awards, while the Texas District Court concluded that the FAA does not provide such a mechanism. The Texas ruling is being appealed, and additional NSA-related regulations and legal challenges are pending. Health care providers should seek expert legal advice to navigate this complex and evolving regulatory landscape.
Patents
Summary of article from Foley & Lardner LLP, by Nikhil T. Pradhan:
The analysis of patent portfolios for nine AI drug discovery companies reveals a predominant focus on conventional pharmaceutical technologies over AI/machine learning (ML) innovations, though AI/ML filings are increasing. Companies’ patent strategies generally align with their commercial targets, though AI/ML patents often lack specific target details, suggesting broad applicability. Comparisons with the overall patent landscape show these companies have fewer filings than established “big pharma,” indicating potential opportunities for strategic patent development. The findings suggest that AI drug discovery firms could enhance their competitive edge by expanding patent protections across various drug and target classes, leveraging both conventional and AI/ML technologies. This strategic expansion could be crucial given the impending patent cliff and the rapid evolution of the biotech/pharma sector.
Pharmacy
Summary of article from Woods Rogers, by Justin Lugar:
The Department of Justice (DOJ) announced a $408 million settlement with Rite Aid and its affiliates over allegations of violating the Controlled Substances Act (CSA) and the False Claims Act (FCA) by filling unnecessary opioid prescriptions. This settlement underscores the DOJ’s commitment to enforcing pharmacists’ responsibilities to ensure prescriptions are issued for legitimate medical purposes. Recent enforcement actions, including significant penalties against various pharmacies and individuals, highlight the increasing scrutiny and accountability faced by pharmacists and pharmacies. The DOJ, alongside the DEA, is utilizing predictive analytics and state monitoring programs to intensify these actions. Pharmacies must now be more vigilant in adhering to CSA regulations to avoid severe penalties and legal consequences.
Qui Tam
Summary of article from Arnall Golden Gregory LLP, by Kara Gordon Silverman:
The integration of AI and data mining in False Claims Act (FCA) litigation presents both opportunities and challenges, enabling whistleblowers to analyze vast datasets and detect potential fraud without insider knowledge. However, these technologies must navigate legal hurdles such as the public disclosure bar and the requirement for specificity in allegations as per Rule 9(b) of the Federal Rules of Civil Procedure. Despite these challenges, professional whistleblowers, exemplified by entities like Integra Med Analytics, continue to leverage AI-driven data to bring FCA cases, sometimes securing significant settlements. This trend necessitates vigilant defense strategies to scrutinize the standing and validity of such claims. The ongoing evolution underscores the need for balancing technological advancements with legal safeguards to ensure fair and substantiated whistleblowing.
Regulatory Compliance
Summary of article from ArentFox Schiff, by Douglas a. Grimm, Lowell C. Brown, David S. Greenberg, Pascal Naples:
The Supreme Court’s decision in Loper Bright Enterprises v. Raimondo overturns the Chevron deference, requiring courts to independently interpret ambiguous statutory provisions rather than deferring to federal agencies. This shift, particularly impacting the health care industry, reinstates the more limited Skidmore deference, where courts only defer to agency interpretations found persuasive. Additionally, the decision in Corner Post v. Federal Reserve extends the statute of limitations for challenging agency actions, potentially increasing litigation against agency regulations. Health care organizations may face greater regulatory uncertainty and variability across jurisdictions as courts independently interpret complex statutes and regulations. Consequently, HHS may adopt more cautious regulatory approaches and increased reliance on guidance over formal rulemaking.
Ransomware
Summary of article from King & Spalding, by Elizabeth Kimball Key:
On July 1, 2024, the HHS Office of Civil Rights (OCR) announced that Heritage Valley Health System agreed to pay $950,000 to settle alleged HIPAA violations following a 2017 ransomware attack. The settlement includes a corrective action plan (CAP) to address compliance gaps, marking the third HIPAA enforcement action involving ransomware. The OCR’s investigation revealed several potential HIPAA violations, including inadequate risk analysis, lack of a contingency plan, and insufficient access controls for electronic protected health information (ePHI). As part of the CAP, Heritage Valley will conduct a comprehensive risk analysis, implement a risk management plan, update its policies and procedures, and train its workforce on HIPAA compliance. OCR highlighted a significant increase in ransomware-related breaches, underscoring its enforcement priority.
Telehealth
Summary of article from Womble Bond Dickinson, by Melissa Ratliff:
Telehealth, which has evolved significantly over centuries, has revolutionized modern healthcare by providing patients with remote access to medical services. However, this advancement brings complex legal challenges, including state-specific licensure requirements, standards of care, privacy and confidentiality under HIPAA, informed consent, online prescribing regulations, reimbursement and billing policies, and technology platform compliance. Healthcare providers must navigate these issues to ensure legal and ethical telehealth practices. Understanding these legal nuances is essential for maintaining compliance and delivering quality care.