M&A: Commure Acquires Augmedix
Artificial Intelligence Acquisition Creates Large AI Software Provider by Tanay Tandon, CEO, Commure Today I’m excited to share that Commure is signing to acquire Augmedix (NASDAQ: AUGX) and take the company private. Combined, we believe we’re creating one of the largest, most comprehensive,...The Future of Care at Home
Admin by Kristin Rowan, Editor Home Nurses are joining unions. The advent and unionization of Hospital-at-Home (H@H) is changing the care at home landscape. Large hospital systems across the country have engaged in H@H studies and launched H@H programs, providing...Telehealth and AI in Home Care: An Interview with Dr. Pamela Ograbisz
Artificial Intelligence by Kristin Rowan, Editor Telehealth’s evolution includes the dramatic shift to at-home and hybrid healthcare models post COVID-19 as well telehealth’s role in program management and staffing. From telehealth’s earliest models to today’s...Little Clinical, Cost Benefit to Diabetes Tech
AdminCONTACT: Shannon Bishop-Green, SBishopGreen@
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.
Category-level ratings are available here.
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.
# # #
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.
MedPAC Recommends More Pay Cuts
CMSBy Kristin Rowan, Editor
In December, 2023, The Medicare Payment Advisory Committee (MedPAC) recommended a 22% payment reduction for hospice providers. This week, they’ve recommended additional cuts once again.
MedPAC has just released the March, 2024 Medicare Payment Policy Report, issued to Congress. The initial statement from MedPAC recognized the long-lasting impact of the COVID-19 pandemic on healthcare providers and the record inflation rates. The commission admits that the pandemic has caused burnout and personal risk to clinicians and other health care workers. The commission also admits that the effects of COVID-19, PHE-related policy changes, and emergency funding made it difficult to interpret the indicators of adequacy in Medicare’s payment rates.
The commission openly states that the fundamental problem with FFS Medicare payments is that providers are paid more when they deliver more services, whether or not those services provide value. The call for additional payment reforms to force providers to coordinate care over time and across care settings and to eliminate what may be necessary services that MedPAC doesn’t deem valuable.
Home Health Agencies
The commission reports the Medicare margins for HHAs at 22.2 percent in 2022. The commission calculates these margins excluding some fixed costs. The margins, according to the commission, indicate that FFS Medicare payments exceed the costs of care. This should incentivize HHAs to take on additional beneficiaries, as the margins are calculating using only costs that diminish by volume.
The commission notes a drop in HHA use in 2022 and lists possible causes including:
- The number of FFS Medicare beneficiaries is lower due to the increased enrollment in Medicare Advantage
- Lower use of inpatient hospital care among FFS beneficiaries
- Hospitalized FFS beneficiaries were less likely to be discharged to home health care (no reason for this was given)
- More FFA beneficiaries are using SNFs after hospitalization (no reason for this was given)
- The staffing shortages reported by HHAs limit the volume of services they can provide
The commission implies that the staffing shortages are not a factor in the decline in HHA usage. The Department of Commerce’s employment data indicates staffing levels that are currently higher than pre-pandemic levels. Even though the data includes HHAs, hospice, private duty, pediatric agencies, and other home care providers, the commission still contends that Medicare HHAs comprise a significant enough share of this group to conclude there is no staffing shortage nationwide.
The commission also reports that the decrease in the number of HHAs nationwide is not a factor in the decline of HHA usage, because most beneficiaries still live in an area with at least on HHA. The commission recognizes that the number of employees and contract laborers is not used to calculate access to care, even though it is a factor. They also admit that an HHA does not need to serve an entire area to be counted as serving the area, and that the capacity to serve additional beneficiaries is not considered.
The report recognizes that preventable readmissions to hospitals is lower among for-profit and free-standing HHAs than for hospital-based care. However, the commission dismisses this data in favor of the all-cause measure of hospitalization, which is much higher for HHAs. This measure covers 60 days and includes all hospitalizations for any cause and includes community-admitted and home health admitted patients. Essentially, MedPAC is assigning a 14.2 percent hospitalization rate to all home health patients, regardless of the cause of hospitalization, whether or not it is deemed preventable, and whether or not it is in any way related to the initial 30-day-period of post acute care.
The average cost of a 30-day period increased by 4 percent in 2022, due to a higher cost per visit. The HHAs are combatting this by reducing the number of in-person visits per 30-day period. Since MedPAC did not track telehealth visits, there is no data on the overall cost per visit, regardless of whether it was in person or remote. HHAs are working within the PDGM model for reimbursement by lowering their overall costs per 30-day period through telehealth visits, remote patient monitoring, and other technologies implemented to increase efficiency in HHAs. MedPAC wants to penalize this by reducing payment rates. This will only serve to push HHAs to further decrease the number of visits, which will impact quality of care, satisfactions rates, and rehospitalization rates.
The commission concludes that because the payments exceed the costs, the benefits of home health care are devalued as a substitute for more costly care options. MedPAC argues that the overpayment since 2000 creates higher expenditures for beneficiaries, but fails to provide data to this effect.
As noted by NAHC, there are flaws in MedPACs calculations as well as in the foundation of their position:
- Exclusions such as taxes, telehealth, and marketing in cost calculations incorrectly inflate the margins
- MedPAC relies heavily on the CMS calculations for budget-neutrality, which NAHC has already refuted as incorrect, bordering illegal formulas
- The data used in these calculations omitted all HHAs that are hospital-based.
NAHC, along with other agencies, will continue to advocate on behalf of HHAs, hospice providers, and other home-based care agencies in front of Congress to ensure these disastrous cuts will not become permanent inclusions in Medicare policy. We will continue to bring you updates as this issue continues to unfold.
# # #
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
©2024 by The Rowan Report, Peoria, AZ. All rights reserved. This article originally appeared in Healthcare at Home: The Rowan Report.homecaretechreport.com One copy may be printed for personal use: further reproduction by permission only.
President Biden’s Proposed Budget has Indications for Medicare and Medicaid
Regulatory From the NAHC Newsdesk, March 12, 2024 On Monday, March 11th, President Biden released a $7.26 trillion proposed budget for fiscal year (FY) 2025, which begins October 1st, 2024. While the White House budget is simply a request and Congress has final say on government...Family Caregiver Tax Credit Bill
CMSBy Kristin Rowan, Editor
Republican and Democratic leaders joined forces to introduce the Credit for Caring Act (S. 3702, H.R. 7165) in support of family caregivers across the country. Family caregivers are those who are caring for a family member but are not nurses or employees of any home care agency. They are not eligible for Medicare or Medicaid payments, nor is there an employer paying them for the endless hours of support they provide. Family caregivers are often under a lot of emotional and financial stress. Some have full-time jobs in addition to the care provide. Others are caring for more than one family member, sometimes in different homes.
The Credit for Caring Act, a bipartisan effort to recognize the personal cost to family caregivers with a $5,000 federal tax credit for eligible working family caregivers. As is generally the case with government intercession, the “eligible” part will exclude many family caregivers. From Congress.gov:
“This bill allows an eligible caregiver a tax credit of up to $5,000 for 30% of the cost of long-term care expenses that exceed $2,000 in a taxable year. The bill defines eligible caregiver as an individual who has earned income for the taxable year in excess of $7,500 and pays or incurs expenses for providing care to a spouse or other dependent relative with long-term care needs.”
The bill also includes the caveat that eligible caregivers must incur qualified expenses, limited to goods, services, and supports. The language excludes the time and energy a family caregiver expends, essentially limiting the tax credit to repayment of money paid out of pocket for care that should have been covered by Medicare, Medicaid, or private health insurance, but isn’t. The cost of a direct care giver is included in eligible expenses, but doesn’t consider the family caregiver to be one.
As I break down the math in my head, I come up with this:
A tax credit of $5,000 is received if the caregiver has spent $16,600 in the previous year (5,000/.3). This leaves a total out of pocket amount of $11,100. Supportive home care services average $30/hour. $16,660 is equivalent to 555 hours of non-medical home care. That’s roughly 10 hours per week or 1-1/2 hours per day. This doesn’t include the costs for DME, doctor visits, lost wages from time off work, medication, or any of the other eligible expenses included in the bill.
This is getting us one step closer to paying for supportive in-home care and palliative care services, but I don’t think it goes far enough. An under-served, under-paid population who makes $7,500 per year cannot afford $16,000 in out-of-pocket expenses in order to qualify for the maximum tax credit. Once this bill is (hopefully) passed, we should move on to including additional services in the Medicare/Medicaid reimbursement model. The Rowan Report joins NAHC in its support of the Credit for Caring Act and urges you to reach out to your representatives to urge them to support the passing of the bill.
# # #
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
©2024 by The Rowan Report, Peoria, AZ. All rights reserved. This article originally appeared in Healthcare at Home: The Rowan Report.homecaretechreport.com One copy may be printed for personal use: further reproduction by permission only. editor@homecaretechreport.com
Read the article and statement from NAHC here
Read the full text of the bills: H.R. 3321 and S. 3702
Find your Senator here
Find your Representative here
Why Every Provider Must Establish and Maintain a Fraud and Abuse Compliance Program
Adminby Elizabeth E Hogue, Esq.
Providers may have heard or read about the importance of Fraud and Abuse Compliance Plans in their organizations. Despite the wealth of available information about Compliance Plans, many providers continue to express uncertainty about their value. Here are some of the questions providers commonly ask about Compliance Plans:
Why should we have a Fraud and Abuse Compliance Plan?
First, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services has clearly stated that, consistent with the Affordable Care Act (ACA) as described below, all providers are now expected to have current Compliance Plans that are fully implemented.
As a practical matter, when providers establish and maintain Compliance Plans, it clearly discourages regulators from pursuing allegations of fraud and abuse violations.
Technically speaking, the Federal Sentencing Guidelines make it clear that establishment and implementation of Compliance Plans is considered to be a mitigating factor. That is, if accusations of criminal conduct are made, the consequences may be substantially less severe because of a properly implemented Compliance Plan.
In addition, providers with Compliance Plans are more likely to avoid fraud and abuse. This is because Plans routinely establish an obligation on the part of every employee to report possible instances of fraud and abuse, and Plans include training for all employees.
Compliance Plans may help to prevent qui tam or so-called “whistleblower” lawsuits by private individuals, rather than by government enforcers, who believe that they have identified instances of fraud and abuse. There are significant incentives to bring these legal actions since whistleblowers receive a share of monies recovered because of their efforts. Some whistleblowers have received millions of dollars. Compliance Plans make it clear that employees have an obligation to bring any potential fraud and abuse issues to the attention of their employers first. Compliance Plans provide a clear path to resolve fraud and abuse issues internally.
In addition, the federal Affordable Care Act (ACA) requires providers to have Compliance Plans. In short, it’s the law!
Finally, the Deficit Reduction Act (DRA) requires providers who receive more than $5 million in monies from state Medicaid Programs per year to implement policies and procedures, provide education to employees, and put information in their employee handbooks about fraud and abuse compliance. These requirements can be met through implementation of Fraud and Abuse Compliance Plans.
We don’t receive reimbursement from the Medicare or Medicaid Programs. Do we still need a Compliance Plan?
Statutes and regulations governing fraud and abuse also apply to providers who receive payments from any federal and state healthcare programs, including Medicaid, Medicaid waiver and other federal and state health care programs, such as TriCare and the VA. Many private insurers have followed the federal government’s lead in terms of fraud and abuse enforcement. Therefore, providers that don’t receive reimbursement from the Medicare Program must have compliance plans, too.
We hear that the OIG of the U.S. Department for Health and Human Services has provided guidance for various segments of the healthcare industry regarding Compliance Plans.
- Specifically, the OIG has already published guidance for clinical laboratories, hospitals, home health agencies, hospices, physicians’ practices, third-party billing companies, and home medical equipment companies. Should we just use the model guidance that is applicable to us?
The answer is, “No!” Guidance from the OIG is not a model Compliance Plan. Guidance from the OIG consists of general guidelines and does not constitute valid Compliance Plans. In addition, the OIG has made it clear that Plans must be customized for each organization.
We have read that, before implementing Compliance Plans, providers must conduct expensive internal audits that can take many months to complete. Is this true?
While beginning the compliance process with an extensive internal audit is certainly one way to proceed, it is not the only viable way to work toward compliance. It is equally valid to begin with Compliance Plans that are customized for the organization and include training for all employees about fraud and abuse, and Compliance Plans. Then all staff members can subsequently participate in internal compliance activities, including audits, with a process in place to handle any issues that arise as a result of the audits.
We have all sorts of policies and procedures in our organization. Why do we need something else called a Compliance Plan?
Compliance Plans are specific types of documents that routinely address fraud and abuse issues that providers do not usually cover in internal policies and procedures. In addition, providers may not gain benefits under the Federal Sentencing Guidelines described in paragraph one (1) above if there is no formal document called a Compliance Plan.
We just spent a lot of money to become accredited or reaccredited. Doesn’t certification mean that we are in compliance?
On the contrary, Compliance Plans appropriately address potential fraud and abuse issues. They also include mechanisms for helping to ensure compliance, such as processes for identification and correction of potential problems that are not addressed during the certification process. In other words, organizations may be accredited, but fail to meet applicable compliance standards for fraud and abuse.
Will the fact that our organization has a Compliance Plan make any difference regarding the outcome of fraud and abuse investigations and the imposition of Corporate Integrity Agreements (CIA’s)?
Yes, it may make a considerable difference, based on statements from the OIG. If providers have Compliance Plans in place during investigations that are current and fully implemented, the OIG may be less aggressive in pursuing potential violations. Enforcers are likely to ask for information about Compliance Plans and related policies and procedures. Enforcers are now also likely to ask providers to show them how much money they have spent on fraud and abuse compliance activities!
When the OIG discovers problems with fraud and abuse in organizations, providers are usually asked to develop and implement a Corporate Integrity Agreement (CIA). The OIG often requires CIA’s to include a process for stringent monitoring by the OIG on a continuous basis. These monitoring activities can be extremely burdensome to providers in terms of both time and money. Providers with valid Compliance Plans may not be asked to develop and implement CIA’s.
Now is the time for all providers to recognize and act upon the need to establish and maintain Compliance Plans. “Working on it” is no longer good enough.
©2024 Elizabeth E. Hogue, Esq. All rights reserved.
No portion of this material may be reproduced in any form without the advance written permission of the author.
Call to Action: Advocacy Is Everyone’s Responsibility
CMS by Tim Rowan, Editor Emeritus T he battle for stable Home Health reimbursement rates continues full speed ahead on Capitol Hill, but the advocacy organizations engaged on the front lines of that battle are losing ground. The Partnership for Quality Home Healthcare and...
