Maria Perez
Maria is an experienced writer, providing content for Healthcare Industry News since 2021. Working as a senior writer, Maria focuses on news reporting, making the complex healthcare topic comprehensible for readers. Maria’s expertise and dedication to delivering accurate stories make him a trusted source on our site.
by Maria Perez | Mar 5, 2024 | Digital Health
Haemonetics has announced its acquisition of Attune Medical for $160 million, a strategic move aimed at improving its portfolio with innovative solutions that enhance patient safety during cardiac ablation procedures. This move shows Haemonetics’ proactive approach to strengthening its presence in critical medical procedures, particularly in the area of cardiac ablation. Attune Medical, a Chicago-based company renowned for its innovative ensoETM proactive esophageal cooling device, stands as a pivotal addition to Haemonetics’ diverse portfolio. The acquisition is structured as an upfront cash payment of $160 million, with additional contingent considerations tied to sales growth and specific milestones, as outlined in the agreement between the two companies.
Radiofrequency ablation, an important procedure in treating conditions like atrial fibrillation, involves the creation of controlled scars in the heart tissue to rectify irregular heartbeats. The procedure poses inherent risks, particularly the potential for thermal injury to the esophagus due to its proximity to the heart. Attune’s ensoETM device addresses this challenge by offering a sophisticated temperature management system designed to cool the esophagus during ablation procedures, mitigating the risk of injury and enhancing patient safety. This innovative solution has garnered acclaim, culminating in the FDA’s de novo authorization for ensoETM in September 2023, outlining its efficacy and safety profile.
The acquisition of Attune Medical comes due to Haemonetics’ mission of advancing patient care and Attune’s innovative technology. Stewart Strong, Haemonetics’ global hospital president, has highlighted the synergies between the acquisition and the company’s existing portfolio, particularly in the electrophysiology (EP) and interventional cardiology markets. This partnership is strengthened by Attune’s revenue growth, which doubled to approximately $22 million in 2023, reflecting its market potential and attractiveness as an acquisition target. Haemonetics anticipates immediate effects on its revenue and earnings growth upon completing the acquisition, further solidifying its position as a leader in healthcare technology solutions.
The financial intricacies of the acquisition are outlined in the agreement between Haemonetics and Attune Medical. The $160 million upfront cash payment signifies Haemonetics’ commitment to acquiring Attune’s innovative technology and expertise. The inclusion of contingent considerations tied to sales growth and specific milestones outlines the shared vision between the two companies and their commitment to mutual success. Haemonetics plans to fund the acquisition through a combination of cash on hand and a revolving credit facility draw, highlighting strategic approach to capital allocation.
With the completion of the acquisition expected in the first quarter of Haemonetics’ fiscal year 2025, the company is poised to leverage synergies between the two entities quickly. This strategic move reinforces Haemonetics’ commitment to innovation and outlines its dedication to shaping the future of healthcare through strategic partnerships and investments. By integrating Attune Medical’s pioneering technology into its portfolio, Haemonetics aims to enhance patient outcomes, drive operational efficiencies, and unlock new growth opportunities in the rapidly evolving healthcare landscape. The acquisition of Attune Medical represents a strategic win-win for both companies, paving the way for continued innovation and advancement in healthcare technology.
by Maria Perez | Mar 4, 2024 | Healthcare Industry News
The Medical Group Management Association (MGMA) has urged the Department of Health and Human Services (HHS) to utilize every available means to mitigate the impacts of the Change Healthcare cyberattack on medical groups in a letter to HHS Secretary Xavier Becerra. With over 60,000 members representing more than 15,000 group medical practices and over 350,000 physicians, MGMA emphasized the widespread repercussions of the cyber event affecting physician practices nationwide.
The letter from the MGMA urgently emphasized the need for an immediate reestablishment of all Change Healthcare operations, recognizing the healthcare system’s uncertain state following the cyberattack. MGMA provided detailed insights into the challenges faced by medical groups during the past week, shedding light on the distressing consequences reported by its extensive membership. Among these challenges, medical groups encountered substantial disruptions in billing and cash flow, impacting both electronic claims processing and the timely handling of statements. The difficulties extended to obtaining electronic remittance advice from health plans, forcing groups to resort to manual processes. The rejection of prior authorization submissions and the inability to perform eligibility checks for patients further compounded regulatory burdens, presenting a direct threat to patient care. Pharmacies grappled with disruptions, leaving patients with obstacles like self-payment or forgoing important medications due to unverified insurance information. The absence of connectivity to critical data infrastructure needed for success in value-based care arrangements also poses considerable challenges for medical groups striving to maintain service continuity.
In urging the HHS to act decisively, MGMA called upon the authority of HHS to provide comprehensive guidance, financial resources, and enforcement discretion. Emphasizing the urgency of avoiding additional complications for physician practices, MGMA highlighted the important timing of financial support, particularly for those without reserves. The letter acknowledged the diligent efforts of physician groups in implementing workarounds but stressed that existing financial constraints, including ongoing Medicare reimbursement cuts, high inflation, and staffing shortages, could weaken their ability to operate effectively. MGMA emphasized the need for collaboration with HHS to address the ongoing challenges presented by the cyberattack on Change Healthcare. MGMA expressed its anticipation of working closely with HHS to safeguard the operational effectiveness of medical groups as the impact of the cyberattack persists, actively participating in mitigating attempts to weaken the nation’s health system.
by Maria Perez | Feb 27, 2024 | Healthcare Industry News
The U.S. Department of Health & Human Services Office for Civil Rights (OCR) has advanced transparency and accountability in the healthcare sector by issuing two Reports to Congress focused on HIPAA compliance and enforcement, specifically involving the HIPAA Privacy, Security, and Breach Notification Rule Compliance, along with Breaches of Unsecured Protected Health Information. Mandated by the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009, these annual reports provide regulated entities, including health care providers, health plans, and healthcare clearinghouses, with valuable insights to guide their HIPAA compliance efforts. The reports detail OCR’s actions in investigating complaints, breach reports, and compliance reviews related to potential violations of the HIPAA Rules.
The 2022 Report on HIPAA Privacy, Security, and Breach Notification Rule Compliance discloses key information, including the staggering number of 30,435 new complaints received by OCR, demonstrating the heightened awareness and vigilance in reporting potential violations. OCR successfully resolved 32,250 complaints, emphasizing the commitment to addressing reported issues promptly. The report highlights the resolution of 17 complaint investigations with Resolution Agreements and Corrective Action Plans (RA/CAPs), resulting in monetary settlements totaling $802,500, and one complaint investigation that led to a civil money penalty of $100,000. The report also found that OCR conducted 846 compliance reviews, with corrective actions or civil money penalties imposed in 80% of cases, totaling 674 investigations. Three compliance reviews were successfully resolved with RA/CAPs and monetary payments amounting to $2,425,640.
The 2022 Report on Breaches of Unsecured Protected Health Information also covers incidents reported to the Secretary of HHS throughout the calendar year, highlighting trends and vulnerabilities. Hacking/IT incidents remained the largest breach category, comprising 77% of reported breaches and impacting a large number of individuals. OCR also noted the consistent prevalence of network servers as the primary location for breaches involving 500 or more individuals, constituting 58% of the reported large breaches. This comprehensive report emphasizes the persistent cybersecurity challenges faced by the healthcare sector and emphasizes the urgent and ongoing need for regulated entities to elevate their compliance with HIPAA Security Rule requirements. Areas such as risk analysis, information system activity review, audit controls, response and reporting mechanisms, as well as person or entity authentication are key in this aspect, offering valuable insights for entities to strengthen their defenses and proactively address potential security threats.
These reports provide valuable objectives for the healthcare industry, emphasizing the importance of maintaining robust HIPAA compliance efforts. OCR Director Melanie Fontes Rainer stressed their importance, stating “OCR’s Reports to Congress provide useful information for everyone on trends in HIPAA complaints and breach reporting,” said OCR Director Melanie Fontes Rainer. “Our health care systems should take note of these trends and address potential HIPAA compliance issues before they experience a breach or receive notice of an OCR investigation. My staff and I stand ready to continue to work with Congress and the health care industry to drive compliance and protect against security threats.”
by Maria Perez | Feb 19, 2024 | Healthcare Industry News
The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), has reached a settlement with Montefiore Medical Center, a non-profit hospital system in New York City, concerning multiple potential violations of the HIPAA Security Rule. The $4.75 million settlement arises from data security breaches at Montefiore, leading to an employee stealing and selling patients’ protected health information over a six-month period.
In a statement, OCR Director Melanie Fontes Rainer emphasized the increasing risk of cyber-attacks from malicious insiders, “Unfortunately, we are living in a time where cyber-attacks from malicious insiders are not uncommon. Now more than ever, the risks to patient protected health information cannot be overlooked and must be addressed swiftly and diligently,” said OCR Director Melanie Fontes Rainer. “This investigation and settlement with Montefiore are an example of how the health care sector can be severely targeted by cyber criminals and thieves—even within their own walls. The settlement aligns with HHS’ broader cybersecurity strategy for the health care sector, reflecting the department’s commitment to enhancing cybersecurity measures across the industry. HHS Deputy Secretary Andrea Palm stressed the importance of maintaining patient trust in securing medical records, stating “Cyber-attacks that are carried out by insiders are one of the many ways that can lead to a security breach, leaving patients vulnerable,” said HHS Deputy Secretary Andrea Palm. “Our priority is and always has been improving the quality of health care patients receive. Part of this health care is establishing a trust that medical records will not be exposed. HHS will continue to remind health care systems of their responsibility as providers, which is to have policies and procedures in place to keep patients’ medical information secure.”
The investigation originated in May 2015 when the New York Police Department alerted Montefiore Medical Center to evidence of the theft of a specific patient’s medical information. Subsequent internal investigations revealed that an employee had stolen electronic protected health information from 12,517 patients two years earlier, selling the data to an identity theft ring. Montefiore Medical Center reported the breach to OCR, prompting an investigation that uncovered multiple potential violations of the HIPAA Security Rule. These included failures in risk analysis, monitoring of health information systems, and the implementation of policies and procedures for recording and examining activity in systems containing protected health information. Montefiore Medical Center, lacking these safeguards, was unable to prevent or detect the cyberattack until years later.
Under the settlement terms, Montefiore Medical Center will pay $4,750,000 to OCR and implement a corrective action plan addressing various measures to protect and secure the security of protected health information. These actions involve conducting a comprehensive assessment of security risks and vulnerabilities, developing a written risk management plan, implementing mechanisms to record and examine activity in information systems, reviewing and revising policies to comply with HIPAA rules, and providing workforce training on HIPAA policies and procedures. OCR will closely monitor Montefiore Medical Center for two years to ensure compliance with these measures.
In OCR’s breach reports, the alarming increase in affected individuals—134 million in 2023 compared to 55 million in 2022—emphasizes the urgency for health care providers, health plans, clearinghouses, and business associates covered by HIPAA to implement safeguards against cyber threats. OCR recommends measures such as reviewing vendor and contractor relationships, integrating risk analysis and management into business processes, ensuring audit controls and regular reviews of information system activity, implementing multi-factor authentication, encrypting protected health information, incorporating lessons learned from previous incidents, and providing ongoing training to reinforce workforce members’ roles in protecting privacy and security. These proactive steps aim to mitigate or prevent cyber threats, safeguarding patient information as digital healthcare evolves.
by Maria Perez | Feb 15, 2024 | Telehealth News
The COVID-19 pandemic provoked a swift adoption of telemedicine in primary care settings. Amid this transition, the extent to which depression screening occurred during telehealth encounters remained poorly understood. To address this gap, researchers at the University of California, San Francisco (UCSF), conducted a meticulous study, the findings of which were published in JAMA Network Open. This study aimed to investigate depression screening probabilities across various visit types and patient demographics during the initial stages of the pandemic. Drawing from electronic health record (EHR) data, the researchers focused on adult depression screening in six UCSF primary care practices spanning from June 2020 to September 2021.
The study used an in-depth approach to define and assess depression screening. Depression screening was operationally defined as the completion of the Patient Health Questionnaire 2 (PHQ-2) during eligible visits, a validated tool commonly used in primary care settings. To ensure accuracy and consistency, visits were categorized into three modalities: in-person, video, or telephone encounters, based on billing information extracted from the electronic health records (EHR). This categorization allowed for a nuanced examination of depression screening rates across different modes of healthcare delivery. Leveraging the vast repository of EHR data, the study had an extensive sample size, comprising 57,301 eligible visits and 37,250 unique patients. This large dataset provided a strong foundation for a detailed analysis of depression screening rates across diverse visit types and patient demographics.
Upon scrutinizing the study’s findings, disparities in depression screening rates between various visit types emerged. Notably, patients undergoing video and telephone visits exhibited markedly lower odds of depression screening compared to those in in-person encounters. Adjusted odds ratios of 0.28 and 0.24 were observed for video and telephone visits, respectively, outlining the challenges inherent in integrating depression screening into telehealth amidst the demand imposed by the pandemic’s onset. The abrupt transition to telemedicine, coupled with the urgent need to adapt to remote care delivery, may have contributed to disparities in depression screening rates across different visit modalities.
The study unveiled disparities in depression screening rates based on patient demographics, shedding light on potential barriers to equitable access to mental healthcare. Patients preferring Chinese, Spanish, or other non-English languages, as well as older adults above 75 years and Medicaid beneficiaries, experienced diminished odds of screening. This outlines the importance of considering linguistic and socioeconomic factors when designing and implementing depression screening protocols within telehealth settings. Addressing these disparities is necessary to ensure equitable access to mental healthcare for all patient populations, particularly with the evolving nature of telemedicine.
Looking closer into the study’s implications, the authors emphasized the need for a recalibration of telemedicine practices to ensure equitable access to depression screening. They advocated for the seamless incorporation of screening into telehealth visits, outlining the importance of innovative solutions that alleviate burdens on support staff, such as pre-visit distribution of PHQ-9s through patient portals. Proactive measures are necessary to mitigate the resurgence of disparities along racial, ethnic, linguistic, and age lines, which persisted even in the telemedicine landscape. The study’s findings show the urgent need for healthcare professionals to increase efforts in integrating depression screening into telehealth visits, particularly as telemedicine continues to grow post-pandemic.
