While patient communication requires HIPAA adherence, so does any discussion between other parties. Essentially, any time PHI is discussed, a degree of confidentiality must be involved. For example, the Health Insurance Portability and Accountability Act (HIPAA) requires that sensitive patient data be protected when shared or discussed among:
Healthcare Providers and Patients
Any time a caregiver, staff member, doctor, nurse, or any other employee communicates with a patient, resident, or client, outside of face-to-face meetings, it must be done securely in a way that meets HIPAA standards.
Healthcare Professionals Among Themselves
HIPAA compliance must be met when healthcare professionals discuss PHI within their department or collaborate with external departments.
Healthcare Providers and Insurance Companies
Insurance providers require patient details and sensitive PHI. Still, anything that makes information vulnerable to interception must be fully compliant with HIPAA standards.
Healthcare Organizations and Third-Party Associates
Third parties that need to handle PHI (e.g., IT consultants, collections agencies, or other vendors) must do so in a way that protects patient data. To safeguard communication, healthcare organizations should ask outside associates, vendors, or agencies to sign a business associate agreement (BAA) and/or Data Processing Agreement (DPA). This is a formal agreement to comply with HIPAA standards and ensure accountability.
Healthcare Organizations and Public Health Authorities
Some diseases or conditions require healthcare professionals to report to public health authorities (e.g. COVID-19 information during the pandemic). This communication requires stringent security measures and protection of PHI.
Why HIPAA Compliance Matters
In healthcare, effective communication is essential for providing high-quality care. However, without HIPAA compliance, the risk of data breaches increases. Implementing secure, HIPAA-compliant communication systems ensures the protection of Personal Health Information (PHI) while improving overall operational efficiency.
Key Benefits of HIPAA-Compliant Communication
Protects Patient Privacy and Data Security
HIPAA-compliant platforms use advanced encryption and access controls to prevent unauthorized access. This protects patient information, including medical histories, diagnoses, and test results.
Enhances Communication Efficiency
Secure messaging platforms streamline communication between patients, caregivers, and healthcare providers. These tools eliminate inefficient methods like phone calls and ensure real-time communication.
Strengthens Collaborative Care
Providing high-quality healthcare often involves a team of professionals working together. Whether it is a hospital placing a patient in rehabilitation or home care, coordinating with intake team, care team and providers,collaboration is key. HIPAA-compliant communication tools allow these professionals to securely share critical patient information, ensuring everyone has the details they need to deliver cohesive, well-informed care.
Reduces Legal and Financial Risks
Compliance with HIPAA regulations minimizes the risk of violations, protecting organizations from hefty fines and legal repercussions.
Maintains Patient Trust
Patients are more likely to engage openly with healthcare providers when they feel confident that their sensitive information is protected.
How to Ensure HIPAA Compliance in Communication
To comply with HIPAA regulations, healthcare organizations should adopt the following secure communication methods:
Encrypted Emails
Ensure emails containing PHI are encrypted and, in some cases, require patient consent.
Secure Messaging Platforms
Use platforms specifically designed for HIPAA compliance for text-based communication.
HIPAA-Compliant Voice Calls and Telehealth
Ensure voice and video communication channels are encrypted and secure.
Patient Portals
Provide secure portals with two-factor authentication for patients to access their medical information.
Secure File Sharing
Use encrypted systems for sharing patient documents and medical records.
Implementing HIPAA-Compliant Communication Platforms
Adopting a HIPAA-compliant communication platform requires a thorough evaluation of existing systems and policies. Organizations should consider the following steps:
Conduct a Communication Audit
Identify all channels currently used for healthcare communication and assess their compliance.
Choose a Secure Platform
Select an all-in-one communication solution designed to meet HIPAA standards.
Establish Access Controls
Implement role-based access to ensure only authorized personnel can view PHI.
Provide Staff Training
Educate employees on the importance of HIPAA compliance and how to use secure communication tools.
Monitor and Evaluate
Regularly assess communication practices to identify and address vulnerabilities.
Final Thoughts
HIPAA-compliant communication is not just a legal obligation—it’s a commitment to patient privacy, security, and high-quality care. By implementing secure communication platforms, healthcare organizations can enhance efficiency, foster trust, and reduce the risk of data breaches. Investing in compliance is an investment in the long-term success and reputation of your organization.
# # #
Devin Paullin is an award-winning innovator and executive in Healthcare Technology, having developed successful products, solutions, and partnerships in Life Sciences, Post-Acute Care, SDOH, and Long-Term industries.
He is currently Chief Growth Officer for Skyscape which provides Buzz, an all-in-one, real-time HIPAA-compliant clinical collaboration and communication platform that enables the entire staff (admins, operations, clinicians, caregivers, partners, patients, and families) with the tools to communicate securely, easily, in groups or one to one, and affordable, by any mode they choose. Visit Buzz or contact them to learn more about Buzz by Skyscape today.
The Critical Importance of HIPAA Compliance in Home Healthcare Communication
The Rise of Messaging Apps and Healthcare Communication
Nearly 44% of the global population (3.5 billion people) rely on messaging apps to communicate. Unfortunately, available consumer SMS, text, and even “secure” messaging apps like WhatsApp, Apple Message, or Google Messages do not come with safety and security features specifically required to be compliant in the healthcare industry.
Still, consumer SMS apps are quite often used for healthcare communication in which Personal Health Information (PHI) is shared, and many individuals don’t understand the level of risk or that this is a violation of the law.
HIPAA Compliance in Communication Advantages
Group and Individual texting are a proven, timesaving, real-time communication tool in healthcare, and must be done through a HIPAA-compliant messaging platform. Secure platforms can improve privacy and security while maintaining compliance in such a sensitive industry.
There are many reasons why HIPAA compliance is vital for secure communication in home healthcare.
HIPAA Compliance in Communication - Not Just for Doctors and Nurses
HIPAA compliance is not just for medical clinics and hospitals. HIPAA compliance extends to all types of services that hold healthcare information. Physical Therapy, Personal Care, Home Health, Wellness, Behavioral Health, Assisted Living, and many more all fall under HIPAA. Most importantly, ALL providers, staff members (full or part-time), contractors, and third-party partners who come in contact with PHI are subject to HIPAA law, violations, and fines.
We're too Small for Violations to be Noticed, Though
Wrong. We regularly speak to many owners and staff members of large and small Home Health Care, Assisted Living, Hospice and Palliative, Mobile Imaging, PT and Rehabilitation, and Behavioral Health across the country. Many openly operate under the false assumption that their business is too small to be noticed by the U.S. Department of Health and Human Services (HHS) and the Office for Civil Rights (OCR), who is responsible for enforcing the HIPAA Privacy and Security Rules. That is not how it works.
Complaints logged by those within or close to your business alert the OCR to possible HIPAA violations. These can be from current and former staff, patients, clients, business partners, or anyone who claims to have witnessed a HIPAA breach. This can include disgruntled employees and whistleblowers. Even for companies that are HIPAA compliant, any breach is to be reported by an employee assigned as the security officer.
HIPAA Compliance in Home Healthcare by Type
HIPAA mandates compliance for all communications involving PHI. Some key examples include:
Provider-to-Patient Communication
Secure platforms are necessary when caregivers contact patients outside of in-person visits.
Provider-to-Provider Communication
Sharing PHI within or between departments must meet HIPAA standards.
Provider-to-Insurance Communication
Insurance companies require sensitive patient data, which must be securely transmitted.
Provider-to-Third-Party Communication
Any third-party associates handling PHI must have a signed Business Associate Agreement (BAA) and adhere to HIPAA regulations.
Provider-to-Public Health Authorities
Reporting communicable diseases or pandemics requires secure communication.
Consequence of HIPAA Violations
HIPAA violations can have severe consequences, including:
Financial Penalties
Fines range from $100 to $50,000 per violation, depending on the level of negligence.
Reputational Damage
Data breaches erode patient trust, leading to a damaged reputation.
Legal Consequences
In cases of willful neglect, organizations may face lawsuits or criminal charges.
Final Thoughts
Understanding and adhering to HIPAA regulations is crucial in home healthcare. Compliance not only safeguards sensitive information but also strengthens patient trust and ensures ethical operations.
# # #
Devin Paullin is an award-winning innovator and executive in Healthcare Technology, having developed successful products, solutions, and partnerships in Life Sciences, Post-Acute Care, SDOH, and Long-Term industries.
He is currently Chief Growth Officer for Skyscape which provides Buzz, an all-in-one, real-time HIPAA-compliant clinical collaboration and communication platform that enables the entire staff (admins, operations, clinicians, caregivers, partners, patients, and families) with the tools to communicate securely, easily, in groups or one to one, and affordable, by any mode they choose. Visit Buzz or contact them to learn more about Buzz by Skyscape today.
The UnitedHealth Group and Amedisys merger has been an ongoing story since the initial merger agreement was signed in June of 2023. The proposed merger came under scrutiny by the Federal Trade Commission (FTC) and the Department of Justice (DOJ). UnitedHealth Group and Amedisys are competitors in the home healthcare market and the merger would hurt patients.
“UnitedHealth’s plan to extinguish Amedisys as a competitor is the result of an intentional, sustained strategy of acquiring, rather than beating, competition.”
Department of Justice
DOJ Pushes Back
Late in 2024, the DOJ filed a lawsuit against the merger, claiming that both companies have acknowledged that their competition helps keep them honest and drive quality both in patient and employee care. The DOJ noted that the acquisition would be presumptively illegal in multiple markets. UHG, Amedisys, and Optum proposed selling off some of its care centers to address the concerns about competition.
Merger Deadline Reached
Under the initial merger agreement, UHG would pay $3.3 billion to acquire Amedisys, which would remain as a subsidiary of UHG. That agreement was set to be finalized on December 27, 2024. There has been no decision made on the DOJ lawsuit, so the merger could not be completed. UHG and Amedisys have mutually agreed to extend the merger and added a break fee of $275 million.
Indefinite Merger Extension Through 2025
The new agreement has an indefinite ending. According to the wording, the merger agreement will now expire either on December 31, 2025 or 10 days after a final court decision in the lawsuit, whichever comes first.
According to the new filing with the SEC, UnitedHealth and Amedisys will be divesting assets to secure the merger and satisfy the DOJ. If not, they will incur a break fee of up to $325 million. Both companies have an agreement with VitalCaring Group to acquire the necessary assets.
What If?
If…The Trump administration is less stringent in antitrust matters, as expected.
The lawsuits currently at the U.S. District Court and five states will likely fail.
If…the U.S. District Court for the District of Maryland either decides to block the merger permanently or does not reach a final order by the end of the year…
The merger agreement will expire.
If…UnitedHealth Group, Optum, and/or Amedisys fails to divest holdings…
The merger agreement will not satisfy the antitrust regulations and the failing party will pay hundreds of millions in damages, and the merger agreement will end.
This is an ongoing story and we will continue to report on updates as they occur. See our accompanying BREAKING NEWS story.
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Kristin Rowan has been working at Healthcare at Home: The Rowan Report since 2008. She has a master’s degree in business administration and marketing and runs Girard Marketing Group, a multi-faceted boutique marketing firm specializing in event planning, sales, and marketing strategy. She has recently taken on the role of Editor of The Rowan Report and will add her voice to current Home Care topics as well as marketing tips for home care agencies. Connect with Kristin directly kristin@girardmarketinggroup.com or www.girardmarketinggroup.com
This article provides updated information about a discrimination case filed against a home care agency by the EEOC. The Rowan Report published the initial press release and article last year.
by Elizabeth E. Hogue, Esq.
What to do When Patients Don't Want Caregivers of Certain Races or Nationalities
The Equal Employment Opportunity Commission (EEOC) sued ACARE HHC, Inc.; doing business as Four Seasons Licensed Home Health Care Agency in Brooklyn, New York. The EEOC claimed that the Agency removed home health aides from work assignments based on their race and national origin to accommodate clients’ preferences in violation of the Civil Rights Act of 1964 [EEOC v. ACARE HHC d/b/a/ Four Seasons Licensed Home Health Care, 23-cv-5760 (U.S. District Court for the Eastern District of New York)].
This case recently settled, and Four Seasons will pay a whopping $400,000 in monetary relief to affected home health aides! The Agency must also update its internal policies and training processes related to requirements of the Civil Rights Act, stop assigning home health aides based on clients’ racial or nationality preferences, and provide semi-annual reports to the EEOC about any reports or complaints received about discrimination.
Aides Removed from Assignments
According to the EEOC, Four Seasons routinely responded to patients’ preferences by removing African American and Latino home health aides based on clients’ preferences regarding race and national origin. Aides removed from their assignments would be transferred to new assignments, if available, or, if no other assignments were available, would lose their employment altogether. The lawsuit asked for both compensatory and punitive damages, and for an injunction to prevent future discrimination based on race and national origin. The EEOC says that “Making work assignment decisions based on an employee’s race or national origin is against the law, including when these decisions are grounded in preferences of the employer’s clients.”
As many providers know, patients’ preferences for certain types of caregivers are common. Experienced managers have been asked by patients not to provide caregivers who are, for example, “foreign.” Such requests should generally be rejected, especially when they involve discrimination based upon race, national origin, religion, or any other basis commonly used to treat groups of people differently. Legally and ethically, providers should not engage in such practices.
Exception to the Rule
There is one exception to this general rule that occurs when patients ask for caregivers of the same sex as the patient based upon concerns about bodily privacy. It is then acceptable to assign only same-sex caregivers to patients who have made such requests.
Risk Management
In addition to concerns about discrimination, providers must also be concerned about risk management when they honor such requests. Especially in view of increasing staff shortages, limitations on available caregivers may mean that patients’ needs cannot be met by staff members who are acceptable to patients. In view of staffing shortages, the fewer caregivers who are permitted to care for certain patients, the more likely it is that patients’ needs will go unmet. Unmet patient needs are, in turn, likely to significantly enhance the risk associated with providing care to patients.
Preferences at Home
Perhaps the pressure to honor patients’ requests is at its greatest when patients receive services at home. Patients who will accept any caregiver assigned to them in institutional settings somehow feel that they have the right to decide who may provide services in their homes. On the contrary, with the exception noted above, staff assignments should be made without regard to client preferences for services rendered at home, just as assignments are made in institutional settings.
Agency Response
How should managers respond when patients tell them not to assign any “foreign” nurses to them? First, they should explain that the organization does not discriminate and that to avoid assignments based on cultural or racial background may constitute unlawful discrimination. Then staff should explain that if limitations on caregivers were acceptable, the provider may be unable to render services to the patient at all because they may not have enough staff. The bottom line is that staff will be assigned without regard to patient preferences in order to prevent discrimination and to help ensure quality of care.
Patients’ requests and managers’ responses must be specifically documented in patients’ charts. Documentation that says patients expressed preferences for certain caregivers or rejected certain types of caregivers is too general. Specific requests and responses of management must be documented.
Monitoring the Patient
After patients have expressed what may amount to prejudice against certain groups of caregivers, managers must follow up and monitor for inappropriate behavior by patients directed at caregivers who are not preferred. Managers should be alert to the potential for this problem and should follow up with patients and caregivers to help ensure that caregivers are receiving the respect they deserve. Follow-up activities and on-going monitoring should also be specifically documented.
From the EEOC
“Employers cannot make job assignment decisions based on a client’s preference for a worker of a particular race or national origin. It is imperative for employers to have policies, training and other safeguards in place that help prevent a client’s prejudices from influencing their employment decisions.”
-EEOC Representative
Final Thoughts
Caregivers are a scarce commodity. Providers cannot afford to lose or alienate a single caregiver based upon discrimination or inappropriate behavior by patients.
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Elizabeth Hogue is an attorney in private practice with extensive experience in health care. She represents clients across the U.S., including professional associations, managed care providers, hospitals, long-term care facilities, home health agencies, durable medical equipment companies, and hospices.
On March 28, CMS issued a new proposed rule to update Medicare hospice payments. Here’s what we know.
The new proposed rule:
Would change the existing hospice wage index
Clarifies current policy related to the hospice “eletion statement” and the “ntoice of election”
Adds clarifying language around hospice certification
Includes a request for information to get comments on implementing a separate payment mechanism for high-intensity palliative care services
Proposes that Hospice Quality Reporting Program (HQRP) measures be collected through the Hospice Outcomes and Patient Evaluation (HOPE), adding two new measures
Also proposes changes to the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Hospice Survey
The new proposed rule includes a net 2.6% increase in payments over FY 2024. This includes a 3% market-based update, and a 0.4% cut for productivity. Submitting quality data is a requirement of the net pay. Hospices that do not submit quality data will be penalized 4%, netting a 1.4% decrease in payments. The propsed rule for 2025 is .5% lower than the 2024 hospice payment increase.
The National Hospice and Palliative Care Organization (NHPCO) says the rate increase is good, but not high enough. NHPCO COO and Interim CEO, Ben Marcantonio said, “To continue providing the high level of care our patients and their families deserve, hospices require a payment rate that accurately reflects the current economic challenges. We know that hospice care has demonstrated $3.5 billion in annual savings for Medicare, which underscores the critical importance of investing in hospice to ensure continued beneficiary access to quality end-of-life care.”
Palliative Care
CMS is interested in feedback and proposals from hospice agencies for providing complex palliative treatments and high-intensity hospice care when that care negatively impacts hospices financially. CMS aims to care for high-cost patients through palliative care rather than acute care. The NHPCO agrees with the CMS proposal to fund palliative care separately from standard hospice or acute care. CMS will take feedback and proposals through May 28, 2024. Comments can be submitted electronically at http://www.regulations.gov, by following the “Submit a Comment” instructions. Comments can also be sent by regular or express mail. Addresses can be found in the full proposed rule. Follow the search instructions at http://www.regulations.gov to see all submitted comments.
Kristin Rowan has been working at Healthcare at Home: The Rowan Report since 2008. She has a master’s degree in business administration and marketing and runs Girard Marketing Group, a multi-faceted boutique marketing firm specializing in event planning, sales, and marketing strategy. She has recently taken on the role of Editor of The Rowan Report and will add her voice to current Home Care topics as well as marketing tips for home care agencies. Connect with Kristin directly kristin@girardmarketinggroup.com or www.girardmarketinggroup.com
by Bryan Robinson, PH.D. Contributor author of Chained to the Desk in a Hybrid World: A Guide to Balance
April is National Stress Awareness Month with the goal of raising awareness of the impacts of stress. According to the American Psychiatric Association, 26% of respondents anticipate they will be more stressed in 2023 and their mental health will be worse. Two out of five adults ranked their mental health from “fair” to “poor.” When you have fewer stressors, you have increased emotional stability, better moods and overall superior health. This month is a time to pay special attention to how you can remain stress-free throughout your workday, and you can do that in very simple ways. You don’t have to quit your day job or even work fewer hours. You can continue your daily work routines while practicing stress reducers at the same time. The one thing you must do is have a stress awareness plan that you can practice at work.
A Stress Awareness Plan Keeps Job Stress At Bay
My 2023 New Years Resolution was to do one kind thing each day for someone—especially strangers. It has heightened my awareness of how important and easy it is to be kind to others without taking extra time. Plus, how simple it is to practice and how good it makes me feel (and hopefully the other person) in just minutes. A work stress awareness plan has the same effect. Here’s how it works. Simply choose one thing to commit to each day that you can accomplish in three to five minutes to mitigate stress during your workday.
A max of five minutes of chill a day can have mental and physical benefits to keep you engaged, calm and energized on the job. These short work breaks lead to higher job engagement and performance as well as better sleep, increased immunity, lower blood pressure, improved digestion and increased emotional well-being. In fact, research from scientists at North Carolina State University shows the value of what I call Microchillers or taking what the researchers call Microbreaks throughout the workday. These short breaks—I recommend five minutes or less—are effective energy management strategies as simple as stretching, walking up and down stairs, gazing out a window at nature, snacking or having a five minute mindful meditation.
Viventium Releases its 2024 Caregiver Onboarding Experience Report, Demonstrating a Need to Raise the Bar for Onboarding in the Post-Acute Care Industry
BERKELEY HEIGHTS, N.J., April 02, 2024 (GLOBE NEWSWIRE) — Viventium, the leading SaaS-based human capital management platform serving the post-acute care industry, released its 2024 Caregiver Onboarding Experience Report, a comprehensive research study analyzing survey responses from 175 post-acute care administrators and 220 caregivers. The report finds a shockingly low bar for what passes as a “good” onboarding experience in home-based and facility/community-based care, with strong indications that raising that bar could correlate to higher retention rates.
“Staffing shortages and high turnover rates within post-acute care are recurring issues in need of solutions,” said Navin Gupta, Viventium CEO. “Our research illuminates a crucial pathway towards addressing these persistent challenges, and it begins with onboarding.”
Findings point to post-acute care managers and administrators having a major impact on the steps their organization can take to better engage, motivate, and retain its caregiving staff.
“The study significantly advances our knowledge of what it takes to recruit and retain caregivers in today’s highly competitive workforce market. The onboarding process is fully within the control of the employer, and the study shows that doing it right pays dividends. Most notably, many of the elements of successful onboarding are simple improvements in the process that bring a real return on investment. I would encourage all of home care to learn from this study.”
About Viventium
Viventium provides a SaaS-based human capital management solution that is focused on the post-acute care industry. The company’s mission is to enrich the lives of caregivers through technology so they love going to work every day. By providing specialized software and expert guidance, Viventium helps its clients throughout the lifecycle of each caregiver. The company has clients in all 50 states and supports over 420,000 client employees each year.
Average 2023 hourly rate for home health aide increased 5.2%
Hourly per visit nurse rate decreased 1.6% with facility prices mixed
Washington and New Hampshire most expensive states for home health aides
illumifin’s comprehensive study provides insight which empowers consumers, insurers, and providers by benchmarking the prices of senior care.
WOODBURY, Minn., March 27, 2024 /PRNewswire/ — illumifin, the leading insurance administration and claims solution provider for long term care (LTC) insurance, has just released its 2023 Cost of Care study and comprehensive analysis. Now in its tenth year, this longitudinal study includes national, state and regional costs of various care services, spanning skilled nursing, adult day care, home health care and assisted living facilities.
illumifin’s Cost of Care study gathers tens of thousands of data points from care providers nationwide, with results normalized by the company’s in-house actuarial and data science teams. Insurers and financial services providers rely on this data for both forecasting and stakeholder education as well as informing customers and agents about national and regional cost variations. In addition, care providers benefit from understanding the market rates for services in their area. These insights are also accessible via illumifin’s What Care Costs website, which offers interactive maps and projection tools to sort, rank and evaluate average costs of LTC services across the US.
illumifin’s study found that the average hourly rate for a home health aide in 2023 was $30.62, an increase of 5.2 percent over the prior year. Meanwhile, the average per-visit rate for a registered nurse in 2023 was $147.72, a decrease of 1.6 percent over the prior year, potentially reflecting rates beginning to normalize post pandemic.
The research also shows facility prices were mixed. The average assisted living facility rates increased between 0.6 and 3.8 percent in 2023 depending on room type, reversing course from the pandemic where assisted living facility rates had been trending downward. However, skilled nursing facility rates experienced a small decrease in 2023 between 0.4 and 1.0 percent.
The most expensive states for home health aides were Washington and New Hampshire, whereas Mississippi and Louisiana were the least expensive. Meanwhile, the most expensive assisted living rates were found in New Hampshire and New Jersey, while the lowest assisted living prices were found in Alabama and Oklahoma.
“We are proud to leverage our 30 years of experience in senior care to provide actionable data for insurers, consumers, providers and financial institutions,” said Peter Goldstein, illumifin’s President and CEO. “Our focus remains on customer centric initiatives which assist in managing risk and planning for the future. Our Cost of Care survey has proven valuable to not only to our business partners but providing valuable knowledge to consumers and their families as they navigate the maze of service types when making care decisions.”
The study, interactive tool and data are available for use by insurers, providers and financial services firms. For more information regarding illumifin’s Cost of Care Study, please contact Jennifer Frost via email at jenniferfrost@illumifin.com.
About illumifin illumifin provides third party administration and technology services to individual and group insurers. The company, launched in 2021, blends insurance industry knowledge, technology leadership and operational execution to prepare insurers for the digital future. illumifin is a diverse, passionate and empowered team of insurance specialists committed to the growth and success of its customers. With illumifin, there’s a brighter future. Visit www.illumifin.com.
Contact: Chris Tofalli Chris Tofalli Public Relations, LLC 914-834-4334
NEW REPORT FINDS THAT DIGITAL DIABETES MANAGEMENT TOOLS FAIL TO DELIVER MEANINGFUL HEALTH BENEFITS TO PATIENTS WHILE INCREASING SPENDING
Independent evaluation from Peterson Health Technology Institute recommends new directions for digital diabetes solutions
NEW YORK — Peterson Health Technology Institute (PHTI), an independent organization that evaluates healthcare technologies to improve health and lower costs, today released a new evaluation of digital diabetes management tools. These solutions are used by millions of Americans and have been funded by $58 billion of investment and mergers and acquisitions, yet the evidence shows that the technologies do not deliver meaningful clinical benefits, and result in increased healthcare spending.
The analysis, conducted by a team of health technology assessment experts and informed by clinical advisors, evaluated eight widely used digital tools that people with Type 2 diabetes use to track and manage blood glucose using a noncontinuous glucometer.
The report found that people who use these tools achieve only small reductions in hemoglobin A1c (HbA1c) compared to those who do not, and these reductions are not sufficient or sustained enough to change the trajectory of their health, care, or long-term prognosis, including cardiovascular risks. The solutions also result in increased overall healthcare costs. One promising solution, Virta, supports nutritional ketosis to achieve diabetes remission in patients who follow the rigorous diet modifications.
“When these digital diabetes management tools launched more than a decade ago, they promised to improve health outcomes for people with diabetes and deliver savings to payers. Based on the scientific evidence, these solutions have fallen short, and it is time to move toward the next generation of innovation,” said Caroline Pearson, executive director of PHTI. “Patients with diabetes invest time, energy, and resources in these tools, and they deserve to experience meaningful, positive benefits for their health. The healthcare sector as a whole needs transparent, accurate information about the clinical and economic impact of these digital tools that are taking up precious healthcare dollars.”
PHTI’s rigorous analysis incorporated an evidence-based assessment framework and review of more than 1,100 articles, including 120 submitted to PHTI by companies evaluated in the report. PHTI’s ratings are at the category level, including remote patient monitoring solutions that support providers, and behavior and lifestyle modification solutions that engage users to improve their diet, exercise, and self-management.
HbA1c is the standard form of measurement of glycemic control in diabetics. The studies show that these digital tools deliver small reductions in HbA1c of 0.23 to 0.60 percentage points compared to usual care. These results are generally below industry standards for Minimal Clinically Important Difference (MCID) of 0.50 percentage points. Further, the evidence indicates that this small improvement is not durable because the reduction is not sustained over time.
Additionally, PHTI’s analysis did not find evidence to demonstrate that digital diabetes management tools improve other health factors, including weight loss, body mass index, blood pressure, cholesterol, or other common conditions impacting people with diabetes. The analysis also concluded that, despite the disproportionate impact of diabetes on low-income and racially and ethnically diverse communities, these tools are not currently being deployed in ways that improve health equity.
PHTI’s evaluation further determined that these tools increase net healthcare spending. This is due to the fact that price for the solutions exceeds the associated healthcare cost savings, because the minimal clinical benefit does not enable the patient to avoid other care or treatments. For patients using tools in the remote patient monitoring category, annual spending is projected to increase by $2,002 for commercial insurance patients, by $1,011 for Medicare patients, and by $723 for Medicaid patients, as a result of higher provider payments. For patients using tools in the behavior and lifestyle modification category, annual spending is estimated to increase by $484 for commercial insurance patients, by $513 for Medicare patients, and by $574 for Medicaid patients. For all payers, the increased spending associated with virtual diabetes solutions has a significant impact on total spending given how many people are eligible to use the solutions, including 4.3% of those with commercial insurance, 17.0% of those with Medicare, and 4.8% of those with Medicaid.
In addition to its scientific literature review, PHTI proactively engaged the companies included in the report and provided an opportunity for them to share data and product information. Companies in PHTI’s evaluation include DarioHealth, Glooko, Omada, Perry Health, Teladoc (Livongo), Verily (Onduo), Vida, and Virta. The evaluation considered evidence about which populations stand to benefit the most from using the technology, as well as the durability of clinical impacts given the importance of sustained glucose control to achieve health benefits. The economic analysis modeled expected healthcare savings resulting from improved glycemic control for patients using digital diabetes management solutions who are enrolled in Medicare, Medicaid, and commercial insurance.
PHTI identified two potential bright spots for digital diabetes management tools. Initial data showed that Virta users are much more likely to achieve clinically meaningful benefits in glycemic control, including diabetes remission and the ability to reduce or eliminate their diabetes medications, if they can maintain the rigorous dietary requirements of the intervention. The other area of greater potential is among patients with higher starting HbA1c levels who are newly starting insulin. By engaging these patients at an early critical transition point in their care, digital solutions could have more impact by helping establish good self-management habits among these higher-risk patients.
In the United States, about one in seven adults—more than 38 million living in the U.S.—has Type 2 diabetes, which is the eighth leading cause of death. At over $400 billion of total healthcare spending annually, diabetes is the most expensive chronic condition to treat and manage. Given the critical role of patient self-management, investment in digital health tools has surged in recent years.
Throughout the assessment process, PHTI worked with a range of independent evaluation partners, clinical advisors, patients with Type 2 diabetes, and other stakeholders. Report contributors and reviewers included:
Curta: assessed the clinical and economic impact of these technologies using the published ICER-PHTI Assessment Framework for Digital Health Technologies, including the systematic literature review and budget impact assessment
Charm Economics: identified what technologies cost to deliver, how they work, and their impact on patients and purchasers
Institute for Clinical and Economic Review (ICER): co-developed the ICER-PHTI Assessment Framework for Digital Health Technologies, and was consulted to review its implementation in this report
Ami Bhatt, MD, chief innovation officer of the American College of Cardiology
Richard Milani, MD, chief clinical innovation officer, Sutter Health; former innovation lead at Ochner Health System
Karen Rheuban, MD, co-founder and director of the University of Virginia Center for Telehealth
“Managing diabetes is complex and essential to future cardiovascular health. Patients will gain agency and drive better clinical benefit if they direct their time and effort towards effective interventions rather than tools that provide marginal or no benefit,” said report contributor Ami Bhatt, MD, chief innovation officer of the American College of Cardiology.
“New diabetes technologies need to be easier to use, by the people who need them most, at lower cost than standard care, and provide real health benefits,” said report contributor Richard Milani, MD, chief clinical innovation officer at Sutter Health. “This evaluation suggests there is room for new innovations that deliver for patients and address worrying increases in healthcare spending.”
The PHTI report provides recommendations and best practices for innovators, providers, and payers. The next generation of diabetes management solutions should aim for clinically meaningful improvements in glycemic control, potentially integrating continuous glucose monitors and new GLP-1 obesity medications. Solutions should also generate sufficient evidence to support broader adoption, and they should prioritize access for populations who need them most. Providers of diabetes care should have clarity about the performance of these digital solutions when recommending them to their patients. Payers, including health plans and employers, should adapt their contracting approach to require transparency about the solution’s usage and benefits within their covered population and to include financial performance guarantees tied to clinical outcomes.
“PHTI is filling an important role in delivering actionable and market-facing information to digital health purchasers about what solutions will make a meaningful impact on health outcomes for members, making them worth investment,” said Peter Long, PhD, executive vice president, Strategy and Health Solutions at Blue Shield of California and a PHTI Advisory Board member. “Having an organization like PHTI cut through the noise of digital health options helps payers make faster and more effective decisions for members so that we can focus on the big work of transforming the healthcare system.”
PHTI has announced that future assessment areas include virtual physical therapy, blood pressure monitoring, and mental health tools.
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About the Peterson Health Technology Institute
The Peterson Health Technology Institute (PHTI) provides independent evaluations of innovative healthcare technologies to improve health and lower costs. Through its rigorous, evidence-based research, PHTI analyzes the clinical benefits and economic impact of digital health solutions, as well as their effects on health equity, privacy, and security. These evaluations inform decisions for providers, patients, payers, and investors, accelerating the adoption of high-value technology in healthcare. PHTI was founded in 2023 by the Peterson Center on Healthcare. For more information, please visit PHTI.com.
Primary caregivers – often patients’ family members – are crucial players in home care. Without them, it can be impossible to provide home care services and to keep patients in their homes. If patients cannot care for themselves, reliable caregivers are an essential prerequisite for the provision of all types of home care.
Caregivers have a very “hard row to hoe” because caregiving is physically, emotionally, intellectually, and spiritually demanding. Is it possible that enhanced assistance for caregivers can positively impact quality of care? Intuitively, the answer to this question seems to be “yes.” What additional assistance may be helpful and can providers offer it?
Here are some initial ideas for helpful assistance:
Caregiver support groups
More intensive education about patients’ clinical conditions, with an emphasis on signs and symptoms of changes in patients’ conditions and what to do about them
Assistance from volunteers, especially for patients who are chronically ill
The next question is whether providers can offer additional assistance, such as the activities described above. This issue has been addressed by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services, the primary enforcer of fraud and abuse prohibitions. The OIG has clearly stated that providers may not give patients or potential patients free items or services that cost more than $15.00 at a time or more than $75.00 in aggregate per calendar year.
In Advisory Opinion No. 18-05; issued on June 18, 2018; the OIG also addressed the circumstances under which providers can establish “caregiver centers” that provide or arrange for free or reduced-cost support services to caregivers in local communities. The provider that requested this Advisory Opinion recognized the difficulties faced by primary caregivers and, consequently, established a caregiver Center.
The Center is staffed primarily by volunteers. Private donations fund the Center and none of its costs are shifted to any federal health care program.
The Center either directly or, in collaboration with local nonprofit organizations, provides free and fee-based services to caregivers. Free services include, but are not limited to, access to a resource library, various educational sessions, a short-term equipment lending program, and free on-site respite care during events sponsored by the Center and attended by caregivers. The Center offers or partners with other providers in the community to offer stress reduction workshops, low-cost ride-share programs, and additional respite care.
The provider does not specifically market the Center’s services, but information is available on its website, social media pages, and in brochures. These sources make it clear that every caregiver is eligible to use the Center’s services, regardless of healthcare provider or payor.
Center staff members do not market, promote, or make referrals for any medical items or services that are reimbursable by federal care programs and do not provide any items or services that are reimbursable by federal health care programs. Referrals for services include a comprehensive list of local service providers offering requested services, without recommending any provider over another.
In response to this request, the OIG first stated that the key question is whether these services are likely to influence caregivers to select the provider or items or services reimbursable by the Medicare or State health care programs in the future. The OIG then acknowledged that the services provided have intangible, psychological value to caregivers. Some of the services relieve caregivers of expenses they might otherwise have incurred. The OIG also noted that many of the support services take place on the provider’s premises, which might encourage selection of the provider for future services. The OIG also acknowledged that this arrangement does not fit into any safe harbor or exception under the federal anti-kickback statute.
Nonetheless, the OIG said that it would not impose sanctions on the provider because:
The services offered at the Center primarily benefit caregivers, not patients.
The Center’s services are available to all caregivers.
The provider does not actively market the Center and its services.
The Center is unlikely to increase costs to federal health care programs.
Caregivers have a tough job and need the support of home care providers. Based on this Advisory Opinion, the OIG has provided guidance about how home care providers of all types can expand their support for caregivers.
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