Author: WadeEmmert

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HHS Releases Final Part Two Guidance to Help People with Medicare Prescription Drug Coverage Manage Prescription Drug Costs

Summary of article from CMS Press Release:

The Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS), has released the final part two guidance for the Medicare Prescription Payment Plan under the Inflation Reduction Act. This plan, effective in 2025, allows Medicare beneficiaries to spread their prescription drug costs over the calendar year, rather than paying upfront at the pharmacy. Additionally, annual out-of-pocket prescription drug costs will be capped at $2,000, providing significant financial relief. The guidance also includes educational outreach efforts to ensure beneficiaries are informed about this new option. This initiative is part of broader measures to reduce prescription drug costs, including capping monthly insulin costs at $35 and providing free ACIP-recommended vaccines. The final part two guidance updates and finalizes the draft released in February 2024, and CMS has provided model materials for Part D plans to communicate these changes to enrollees.

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Health Law Highlights

HHS Aligns AI, Tech Strategy Under its Policy Agency

Summary of article from GovCIO, by Silvia Oakland:

The Department of Health and Human Services (HHS) has restructured its technology and data strategy responsibilities, consolidating them under its policy office. This reorganization primarily affects the Office of National Coordinator for Health IT (ONC), now renamed the Assistant Secretary for Technology Policy and ONC (ASTP/ONC). A new Office of the Chief Technology Officer will be established, encompassing the Office of the Chief AI Officer, Office of the Chief Data Officer, and a new Office of Digital Services. This digital services team will oversee HHS-wide digital strategy and ethics in technology initiatives. The 405(d) cybersecurity program will transition to the Administration for Strategic Preparedness and Response (ASPR) to enhance healthcare cybersecurity. HHS Secretary Xavier Becerra emphasized the growing importance of cybersecurity, data, and AI in healthcare. Additionally, ONC has updated the Trusted Exchange Framework and Common Agreement (TEFCA) to improve the nationwide exchange of electronic health information.

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Health Law Highlights

A Lifecycle Management Approach Toward Delivering Safe, Effective AI-Enabled Health Care

Summary of blog post from FDA, by Troy Tazbaz:

AI’s continuous learning and adaptability pose risks, such as exacerbating biases, which can harm patients and underrepresented populations. Lifecycle Management (LCM), integral to reliable software since the 1960s, can address these challenges through structured frameworks. The AI Lifecycle (AILC) concept maps traditional Software Development Lifecycles to AI-specific phases, emphasizing systematic methods for data and model evaluation. This AILC model serves as a guide for assessing standards, tools, metrics, and best practices, promoting quality, interoperability, and ethical practices. The health care community is encouraged to engage with and refine these concepts to ensure AI’s safe and effective integration into health care. Feedback and involvement are welcomed to support the development of high-quality AI models.

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Health Law Highlights

Medicaid Overpayment Audits: What Medical Providers Need to Know

Summary of article from Nelson Mullins, by Gabriel Imperato, Hannah Kays, Melissa Scott:

Medicaid overpayment audits ensure program integrity but can be challenging for medical providers. Auditors review medical records and billing documents, typically involving notification, document submission, preliminary findings, appeals, and final determination. Common audit triggers include high claim volumes, unusual billing patterns, frequent adjustments, specific service types, and high rates of new patient claims. Providers can mitigate risks by maintaining accurate documentation, conducting regular internal audits, training staff, implementing compliance programs, and staying updated on regulations. Legal strategies include timely responses, thorough documentation reviews, expert consultations, and utilizing the appeal process to address discrepancies. Engaging knowledgeable healthcare attorneys can help protect practices and efficiently resolve disputes. Understanding the audit process and adhering to best practices can aid providers in managing Medicaid audits effectively.

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Health Law Highlights

Microsoft, Mass General Developing AI Models for Radiology

Summary of article from Fierce Healthcare, by Heather Landi:

Microsoft is collaborating with Mass General Brigham and the University of Wisconsin-Madison to enhance AI in medical imaging. The partnership aims to develop, test, and validate AI algorithms to improve the accuracy and consistency of medical image analysis. These AI models will be integrated into clinical workflows via Microsoft’s Azure AI platform and Nuance’s PowerScribe radiology reporting platform. The collaboration seeks to assist radiologists and clinicians in interpreting medical images, generating reports, classifying diseases, and analyzing structured data. This initiative addresses the healthcare industry’s challenges of physician burnout and staffing shortages by leveraging generative AI to enhance workflow efficiencies. Key leaders from the partner organizations emphasize the potential of generative AI to transform clinical care and improve patient outcomes. Additionally, Microsoft is working with Nvidia to advance generative AI and cloud computing in healthcare and life sciences.

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Health Law Highlights

Healthcare Organizations at Risk of Data Breach Due to Insecure File Sharing Practices

Summary of article from HIT Consultant, by Fred Pennic:

A resent report highlights significant vulnerabilities in healthcare organizations’ data security practices, particularly concerning insecure file sharing. Key findings reveal that 25% of publicly shared files and 68% of externally shared private files contain Personally Identifiable Information (PII), while 77% of internally shared private files also include PII. Additionally, many organizations fail to update or remove access permissions, increasing security risks. The consequences of these practices include rising data breaches, substantial financial impacts from ransomware attacks, and potential compliance violations with HIPAA and GDPR regulations. The report also notes the risk to financial data, such as credit card information, stored in insecure files. To mitigate these risks, healthcare organizations must adopt robust data loss prevention (DLP) solutions and data security tools to ensure proper handling and sharing of sensitive information. Metomic emphasizes the need for these tools to prevent data leaks and protect both patient information and organizational integrity.

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Health Law Highlights

Pharmacy Association and 40 Providers Sue Change Healthcare Over Cyberattack

Summary of article from The HIPAA Journal, by Steve Adler:

The National Community Pharmacists Association (NCPA) and over 40 healthcare providers from 22 states are suing Change Healthcare, Optum, and UnitedHealth Group following a February 2024 ransomware attack. This Blackcat ransomware incident resulted in significant disruptions, as Change Healthcare’s critical systems were taken offline, affecting claims processing and revenue management for numerous providers nationwide. The plaintiffs argue that the defendants failed to implement adequate security measures and did not provide timely guidance or support, exacerbating financial hardships for healthcare providers. The lawsuit, which spans 140 pages, includes claims of negligence, breach of contract, and violations of various state consumer protection laws. It seeks permanent injunctive relief, enhanced security measures, and various forms of damages.

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Health Law Highlights

6 Steps to Release a Medical IoT Device

Summary of article from Edge Industry Review, by Gilad David Maayan:

Releasing a medical IoT device involves a detailed process to ensure its effectiveness, compliance, and market viability. The first step is conducting market research to assess demand, compare with competitors, and evaluate market size and acceptance, guiding stakeholders on investment decisions. Regulatory planning is crucial, requiring familiarity with laws like the EU MDR and FDA regulations to define the device’s use and ensure compliance.

Design controls must be documented throughout development, adhering to standards such as ISO 13485 to maintain product quality. Establishing a tailored Quality Management System (QMS) addresses design, risk, and supply chain management, ensuring compliance with relevant standards. Clinical evaluation demonstrates the device’s safety and efficacy through trials or literature review, summarizing risks and benefits.

Postmarket surveillance is essential for ongoing monitoring of the device’s performance, ensuring long-term safety and effectiveness, and complying with stringent regulations. Edge computing enhances medical IoT devices by enabling local data processing, which speeds up analysis and response times, reduces reliance on internet connectivity, and ensures functionality in remote areas. Key considerations include hardware capabilities, data security, interoperability, and processing speed, all vital for timely healthcare decisions.

The Internet of Medical Things (IoMT) is transforming healthcare by providing personalized, detailed treatment outside hospitals. Despite the complexity of development and regulatory approval, these devices offer significant potential for improved patient outcomes and profitability.

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Health Law Highlights

Vanishing Texas Companies Linked to Millions in Fraudulent Medicare Billings

Summary of article from MSN, by Brian New:

CBS News Texas’ investigation into alleged Medicare fraud uncovered over $200 million in fraudulent activities linked to several companies, prompting numerous viewers to report their own experiences with Medicare fraud. A subsequent report identified 11 additional Texas-based medical supply companies potentially involved in fraudulent practices. Many of these companies, such as Lone Star Medlab Laboratories and Peak Health Diagnostics, were found to have vacated their offices and disconnected their contact numbers. Aids for Recovery faced numerous complaints for fraudulent billing and had abandoned their office, leaving behind unopened Medicare correspondence. The Centers for Medicare & Medicaid Services (CMS) confirmed ongoing investigations into these companies, suspected of nearly $3 billion in fraudulent catheter billing.

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Health Law Highlights

Balancing Act: Industry Concerns Over CISA’s Proposed Cyber Incident Reporting Rule

Summary of article from Bradley Arant Boult Cummings LLP, by Sinan Pismisoglu, Eric Setterlund:

The proposed cyber incident reporting rule by the Cybersecurity and Infrastructure Security Agency (CISA) aims to enhance national cyber defenses but has raised concerns about its broad scope and potential overreporting, which could overwhelm CISA with low-value data. Industry groups, particularly in manufacturing and healthcare, worry about the rule’s impact, citing increased compliance burdens and potential disruptions. Recommendations to address these issues include narrowing the rule’s scope, harmonizing reporting mechanisms, providing support to smaller entities, and tailoring requirements to specific industry needs. The debate highlights the need for a balanced approach that strengthens cybersecurity while ensuring practical compliance for businesses. Collaboration between CISA and industry stakeholders is essential to refine the rule and achieve this balance.