The Centers for Medicare and Medicaid Services are modifying prior authorization requirements in a recently proposed rule to shorten the time it takes payers to accept requests, and they are introducing HL7 FHIR standards to facilitate an electronic procedure.

CMS is recommending that certain payers, including Medicare Advantage companies, use electronic prior authorization and deliver judgments for expedited requests within 72 hours and non-urgent requests within seven days.

In order to facilitate electronic prior authorization, the Advancing Interoperability and Improving Prior Authorization Proposed Rule, published on December 6, would mandate the adoption of a Health Level 7 (HL7) FHIR standard API. According to CMS, some payers would have to send decisions within 72 hours to seven days, which is twice as quickly as the current Medicare Advantage response time limit, and provide a specific reason when rejecting requests. They would also have to publicly report some pre-approval metrics and make decisions based on the level of urgency.

Under the Medicare Promoting Interoperability Program and for clinicians eligible for the merit-based Incentive Payment System (MIPS) under the Promoting Interoperability performance category, the proposed regulation would include a new Electronic Prior Authorization metric.

When a patient switches payers or has concurrent coverage, the rule also proposes to require some payers to enforce benchmarks that would enable data exchange from one payer to another. This is expected to make sure that complete patient records are accessible throughout patient transitions between payers.

In order to promote alignment between different coverage types, these proposed requirements would typically apply to Medicare Advantage organisations, state Medicaid and Children’s Health Insurance Program (CHIP) organisations, Medicaid managed treatment plans, CHIP managed care entities, as well as Qualified Health Plan (QHP) issuers on the Federally Facilitated Exchanges (FFEs). According to the CMS, over a ten-year period, these policies’ implemented efficiencies are expected to save hospitals and medical practises more than $15 billion.

The rule includes policies that would require payers to build and maintain a Provider Access FHIR API, which would facilitate information exchange from payers to in-network suppliers with whom the patient has a treatment relationship, as well as policies that would expand the existing Patient Access API to include data about prior authorization decisions, enable providers access to their patients’ data, and create spatial patient records.

The proposed rule also includes five requests for information on standards for social risk factor data, electronic behavioural health information sharing among behavioural health providers, bettering the sharing of medical records among some providers in the Medicare fee-for-service programme, developing the Trusted Exchange Framework as well as the Common Agreement (TEFCA), and the potential benefits of interoperability for enhancing maternal health outcomes.

According to CMS, the proposed rule is in line with the agency’s ongoing efforts to improve patient access to treatment, lessen the administrative load on doctors so they can concentrate on providing direct care, and enhance interoperability throughout the healthcare system. The earlier interoperability and prior authorisation draught rule, announced in December 2020, is withdrawn and replaced.

Numerous hospital and physician associations, as well as the insurance industry association AHIP, have endorsed the proposed regulation. They were especially pleased that it would cover Medicare Advantage plans. President and CEO of AHIP, Matt Eyles, said they commend CMS for prioritising patients with a proposed rule that makes it simple for them to exchange their data with organisations of their choice. In order to ensure that patients receive prompt, evidence-based care that enhances value and lessens administrative hassles for everyone, AHIP’s Fast PATH demonstration demonstrated the importance of electronic systems for prior authorization.

Eyles asserted that there is a hole in the country’s privacy framework for the sharing of private health information with organisations not subject to HIPAA regulations.

They earnestly urge CMS to collaborate with Congress to close this gap, Eyles stated.

The deployment of cutting-edge technologies, according to Premier, is required to close any loopholes in the proposed rule regarding payer openness to pre-approval denials and clearances. The healthcare provider said that it would keep working with Congress to advance the Improving Seniors’ Timely Access to Care Act’s broad measures that would fix these gaps.

The Improving Seniors’ Timely Access to Care Act would formalise protections by adding them to the law, according to the American Hospital Association. According to Ashley Thompson, senior vice president of the AHA’s public policy analysis and development division, the AHA applauds CMS for taking significant action to remove unjustified obstacles to patient treatment by simplifying the prior authorization procedure for some health insurance plans. Hospitals and health systems are especially grateful that CMS complied with the AHA’s request to include Medicare Advantage plans in these standards. Prior authorization is frequently employed in a way that burdens healthcare professionals, puts patients at risk for unsafe delays in care, and raises unnecessary expenditures for the healthcare system.

Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association (MGMA), stated that the fact that CMS complied with their request to include Medicare Advantage plans in the scope of this proposed rule gives the MGMA Medical Group Management Association hope. A startlingly high proportion of medical groups report submitting pre-authorization requests on paper forms, via phone, or via various exclusive online payer portals. The burdensome processes for fulfilling these demands, along with the rising volume, are unsustainable. If properly implemented, an electronic prior authorization procedure might reduce the administrative load on practises and free up funds for patient care.

According to Dr. Tochi Iroku-Malize, president of the American Academy of Family Physicians, the average doctor spends too much time collecting prior authorizations, taking time away from patients and potentially resulting in dangerous care delays.

The Improving Seniors’ Timely Access to Medical Act, which the AAFP also urged the Senate to rapidly enact, will shield Medicare Advantage beneficiaries from what the group called needless care delays and lessen the load on physicians.

Mary Beth Donahue, president and chief executive officer of the Better Medicare Alliance, stated, while they continue to evaluate the proposed rule in greater detail, they believe it enhances their goals of protecting prior authorization’s essential role in coordinating secure, efficacious, and high-value care while also building on the work of the Medicare Advantage community and simplifying this clinical platform to better serve its 30 million diverse enrollees. Notably, the proposed regulation addresses recent concerns raised by a few congressmen regarding the budgetary effects of the Improving Seniors’ Timely Access to Care Act, which has the support of the BMA and has already been passed by the U.S. House of Representatives with a vote of all members present.

The Interoperability and Patient Access final rule, which CMS announced in March 2020, has been expanded upon. To facilitate the electronic sharing of data and expedite previous authorizations, CMS published a proposed interoperability regulation in December 2020. Through an HHS rider on the CMS proposed rule, the Office of the National Coordinator for Health IT sought to set specific requirements.

To the dismay of provider organisations like the AHA, the proposed rule at the time did not cover Medicare Advantage plans.

CMS Administrator Chiquita Brooks-LaSure stated that CMS is committed to enhancing access to high-quality care and making it simpler for doctors to offer such care. The prior permission and integration proposals they are announcing would optimise the prior approval process and encourage health care data sharing to improve the care experience for patients, caregivers, and providers – helping them to address preventable disruptions in patient care and accomplish better health outcomes for all.

HeartVista, a pioneer and leader in automated MRI solutions, announced that it has changed its name to Vista.ai as the company broadens its sights to simplify and enhance MRI exams for anatomies beyond the heart. A major academic medical center has already begun a clinical study to evaluate the software for use with the prostate, and Vista.ai plans to launch a similar study for musculoskeletal scans in the near future.

Vista.ai’s One Click MRI AI-driven software-only solution makes it easier to acquire high quality MRI images by automating the exam workflow. The company initially targeted cardiac MRI (CMR) as it is increasingly considered the gold-standard cardiac diagnosticⁱ, yet the heart is a notoriously difficult and time-consuming anatomy to scan. Today, specially-trained CMR technologists need to perform an exam, and in the U.S., there is only one such technologist for every 20 MRI machinesⁱⁱ. One Click MRI’s benefits include simple, streamlined workflows and improved image consistency, so any MRI technologist can complete a cardiac scan in a regular mixed-use MRI time slot.

Vista.ai is demonstrating One Click MRI this week at Booth 5143 in the AI Showcase during RSNA exhibit hours. In addition, Raymond Y. Kwong, MD, MPH, FACC, FSCMR Director of cardiac magnetic resonance imaging at Brigham and Women’s Hospital and Professor of medicine at Harvard Medical School, will share case studies and research findings using the software in his clinical cardiac MRI practice.

Vista.ai developed One Click MRI using sophisticated and versatile AI-based algorithms that would be scalable to other types of MRI scans. The company chose the prostate and spine as its next candidates because of known challenges with those exams and the number of people who could benefit. In the U.S., more than 10 million people receive prostate and spine MRI scans annually, 25% of the total MRI volume.ⁱⁱⁱ

“Given the complexity of manual CMR, and the millions of patients who could benefit from the exam, it was clear that applying our automation technology to the heart would create enormous value in the market. Despite the evidence-backed advantages of MRI for diagnosing a myriad of heart conditions, only 2% of scans today are CMRs^iv yet 700,000 people are dying of heart disease each year in the U.S.^v,” said Itamar Kandel, Vista.ai’s CEO. “But we always knew it was just the beginning. Once we had the most complex anatomy tested, validated, adopted and endorsed by several elite medical institutions, we planned to roll out to other anatomies that would share in the benefits we have shown for numerous heart diseases.”

Each year clinicians in the U.S. conduct almost 40 million exams^vi on the approximately 12,000 MRI machines installed in the country.^vii But MRI scanners are only beneficial if trained healthcare professionals are available to run the exam, which is an escalating concern. In 2019, the U.S. had 20,000 fewer healthcare professionals than necessary to meet the needs of Americans^viii, a situation that only worsened during the COVID-19 pandemic.

“Radiologist and technologist burnout is at a breaking point, which has only worsened since the pandemic given the exodus of medical professionals, backlog of imaging cases and increasing incidence of COVID-related illnesses, such as myocarditis and pericarditis,” said Dr. Scott Flamm, Section Head of Cardiovascular Imaging at The Cleveland Clinic Foundation. “To address the staffing shortages – particularly for challenging, time-consuming procedures like CMR – we are in earnest need of automation technologies like Vista.ai’s One Click MRI to ensure patients anywhere can receive the quickest possible diagnosis and treatment.”

Heart Test Laboratories, Inc. a medical technology company focused on saving lives by making an ECG (also known as an EKG) a far more valuable screening tool through the use of Artificial Intelligence (AI)  announced that it has entered into a multi-year collaboration agreement with Rutgers University (Rutgers), one of America’s leading public research universities.

HeartSciences and Rutgers will collaborate to develop AI-based ECG algorithms, which are expected to accelerate HeartSciences’ product development pipeline and further expand the clinical value of an ECG for low-cost detection of heart disease. Partho P. Sengupta, MD, MBBS, FACC, Professor and the Chief of Division of Cardiology at Rutgers Robert Wood Johnson Medical School and the Robert Wood Johnson University Hospital, will serve as Rutgers’ Principal Investigator. These collaboration efforts will be focused on leveraging the extensive clinical data compiled at Rutgers. The collaboration agreement follows HeartSciences’ recent participation and demonstration of the MyoVista® at the Inauguration Ceremony of the Center for Innovation at the Rutgers and Robert Wood Johnson University Hospital in September 2022. The new collaborative relationship will operate out of the new Rutgers Robert Wood Johnson, Center for Innovation.

Dr. Sengupta stated, “We look forward to strengthening our existing relationship with HeartSciences for innovating in the important area of leveraging AI to expand the clinical capabilities of an ECG. AI is playing an important role in developing and advancing innovations in cardiology and has demonstrated significant potential for enhancing electrocardiography to improve heart disease detection, while reducing overall healthcare costs.”

Andrew Simpson, CEO of HeartSciences, stated, “We are excited and honored to enter a collaboration with Dr. Sengupta and Rutgers University. Dr. Sengupta is a globally respected figure in the field of cardiology, including the application of technology to accelerate innovation in the field of cardiology.  We have worked with Dr. Sengupta and his team in the past, with multiple published studies using MyoVista technology. This collaboration formalizes a multi-year arrangement with Rutgers, which we believe will significantly accelerate our product development pipeline of new ECG algorithms for front-line physicians and other healthcare providers.  There are millions of ECGs conducted every week and this collaboration reaffirms HeartSciences’ position at the leading edge of bringing new clinical capabilities to the ECG.”

Konica Minolta Healthcare Americas, Inc. announced the introduction of the company’s acclaimed KDR® Primary U-arm Digital Radiography (DR) and mKDR Xpress™ Mobile X-ray systems in select Latin America countries.* Chosen by numerous healthcare facilities throughout North America, the KDR Primary and mKDR Xpress will complement Konica Minolta’s existing portfolio of CR systems, DR retrofit solutions and PACS throughout the region. Additionally, both systems are designed for future integration of Dynamic Digital Radiography (DDR), Konica Minolta’s evolution in radiography that enables clinicians to observe anatomical motion over time, enhancing diagnostic capabilities and providing clinicians with a way to visualize anatomy like never before.

“As a leading provider of DR systems in North America, Konica Minolta is pleased to bring our advanced DR systems to Latin America,” says Bruce Ashby, Vice President of Sales for DR Solutions at Konica Minolta Healthcare. “Our solutions are backed by exceptional sales, service and applications teams who are dedicated to assuring our customers’ success. Introducing the KDR Primary U-arm and the mKDR Xpress are just the first steps toward bringing some of the most innovative imaging solutions available today to the Latin American region.”

The KDR Primary system is a cost-effective solution to facilitate the transition from film or CR to DR and improve the quality of care by streamlining workflows and improving clinical productivity. It is an advanced digital X-ray system with a small footprint, making it ideal for nearly any clinical site – hospitals, clinics, urgent care centers, orthopedics and general practices – to provide high-quality, general radiography services in exams rooms with less space. A full range of motion enables all imaging views with the KDR Primary system, making it a versatile imaging solution for patients who are standing, sitting, laying down or in a wheelchair. It includes an integral 17” x 17” detector that captures high-resolution digital images in seconds.

The mKDR Xpress delivers exceptional imaging performance in a small footprint at the bedside or in the ER, OR, CCU or ICU. With a slim design and collapsible column to facilitate its use in tight spaces, the mKDR Xpress can be more easily moved wherever it’s needed. On-board charging for two detectors and front and back storage for detectors and accessories help technologists meet the most demanding mobile X-ray imaging needs. An industry-unique, tube-mounted graphical user interface and image preview function help ensure clear images are visible quickly, improving efficiency when time matters.

“Digitizing radiography delivers numerous benefits to the provider and the patient, including faster workflow for shorter exam times and the ability to capture higher quality images with a lower dose,” says Ernesto Marquez, VP & General Manager, Latin America Region for Konica Minolta. “After our initial launch in Mexico, we will introduce the KDR Primary and mKDR Xpress to other markets and countries pending regulatory approvals. We look forward to helping our customers in Latin America realize the benefit of digital technologies and will continue to deliver the service and support that healthcare organizations need throughout their transformation to a digital imaging environment.”

*The KDR Primary and mKDR Xpress are cleared for commercial use in several Latin America countries and pending clearance in others.

Circuit Clinical—one of the nation’s fastest growing integrated research organizations—has expanded their presence in the Hudson Valley region through a partnership with Middletown Medical, a top tier, multi-specialty physician group, increasing access to clinical research as a care option to an additional 100,000 patients that Middletown Medical serves. This partnership will bring trials to a more diverse patient population—comprised of approximately 50% non-white individuals.

The breadth of Middletown Medical’s primary and specialty care, combined with Circuit’s commitment to improving patient access and inclusion in clinical trials, will bring new care opportunities to Middletown’s patients through the provider relationships they already trust – further positioning the region as a destination for medical research and advancements. This partnership will initially include 11 Principal Investigators, participating in specialties such as, but not limited to, cardiology, rheumatology, neurology, gastroenterology, and family medicine.

“Patient care is a top priority for Middletown Medical and we are committed to providing any and all opportunities to our physicians and the communities they serve,” said Dr Rajan Gulati, President of Middletown Medical.

Middletown Medical and Circuit Clinical are committed to reducing the burden on patients who opt in for research participation. Along with localizing patient care within the Middletown Medical physicians’ offices, Circuit’s approach to transforming the patient journey includes hybrid care options through telemedicine, fully decentralized trial solutions, as well as trialjourney.com—an award-winning patient experience platform for finding trials and leaving site ratings and reviews to improve the experience of participating in clinical trials. This variety of care options can help eliminate traditional care obstacles that have created a burden for patients to participate in clinical research. Furthermore, patient participation in research will serve to benefit both individuals and communities, including offering extra care visits without co-pays, strengthening the patient-provider relationship, and often leading to improved health outcomes through a better and more personal care experience.

This collaboration was made possible through strategic partnerships with Labcorp—a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions—as well as Medidata—a Dassault Systems company that is powering smarter treatments and healthier people with the world’s most trusted platform for clinical development, commercial, and real-world data.

“We are beyond excited to expand our national research network through amazing partnerships like this one with Middletown Medical,” said Irfan Khan, MD, CEO of Circuit Clinical. “Together we can empower patients to engage with clinical trials as a care option. The combined efforts of Circuit Clinical and our strategic partners, Labcorp and Medidata, allow us to make partnerships like this with Middletown Medical not only a reality, but as optimal and innovative as possible.

Roche Pharma India  launched a new mobile app, The Blue Tree 2.0, for patients who are part of Roche’s Blue Tree patient support programme in India.

“The app aims to improve both the patient and healthcare professional’s experience by speeding up programme enrollment, providing easy access and advance notifications to avail multiple support services,” the company said in a statement.

Roche said the mobile app will increase the scale and reach of the programme to patients, particularly to those who are in remote locations, and will allow the support programme journey to be managed directly from their phones.

Through the Blue Tree programme patients can enroll for the programme, place request for free drug assistance, ensure doorstep delivery services of drugs and also allow advance notifications to patients on their upcoming infusion schedules.

Commenting on the launch, V Simpson Emmanuel, managing director and CEO, Roche Pharma India, said, “The launch of the app signals Roche’s goal to leverage digital platforms and mobile applications that put effective and scalable solutions, including patient support programmes at patients’ fingertips.”

To make the treatment journey a truly integrated experience for patients, Roche has partnered with Tata 1MG that overall manages The Blue Tree program and the last mile deliveries are managed by Vardhaman and IMS.