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Friday, April 2, 2021

B of A Acquires Healthcare Payment System Axia Technologies

 Acquisition Enhances the Bank’s Ability to Serve Healthcare Clients with a Comprehensive Range of Payment Solutions

Bank of America today announced that it has acquired Axia Technologies, Inc. ("AxiaMed"), an industry-leading health care payment and technology company focused on facilitating secure patient payments.

The acquisition will deepen and expand Bank of America’s payment offerings for healthcare clients and will further accelerate the bank’s ability to serve this key vertical. It is part of a broader initiative to integrate merchant services onto its proprietary platform following the dissolution of its merchant services joint venture last year. Terms of the acquisition were not disclosed.

"We are adding a talented team that brings great domain expertise and technology, and we’re excited to have them join Bank of America," said Mark Monaco, head of enterprise payments at Bank of America. "We have a shared vision of providing clients with the best technology to meet their payment needs. Working together, we can leverage our joint expertise and capabilities to deliver a comprehensive range of payment and settlement solutions to our healthcare clients and their patients."

Established in 2015, AxiaMed provides a gateway and terminal software solution, powering many healthcare providers to offer end-to-end, omni-channel patient payment solutions. Its integrated offerings help the financial performance of healthcare providers by expanding the payment options available to patients and streamlining administrative workflows.

Bank of America has been developing its proprietary merchant services solutions over the past year that will better serve the payment needs of clients across all business lines. The platform leverages innovations such as real-time payments and best-in-class digital capabilities to provide essential functions such as merchant acquiring, payments processing and settlement, along with value-added services such as analytics and security solutions.

https://finance.yahoo.com/news/bank-america-acquires-axia-technologies-130000677.html

FDA extends review of Abbvie's sNDA for Rinvoq in atopic dermatitis

 

  • The FDA is extending the PDUFA data for Abbvie's (NYSE:ABBV) sNDA for the JAK inhibitor Rinvoq (upadacitinib) in moderate to severe atopic dermatitis by three months to Q3 2021.
  • AbbVie previously disclosed it received an information request from the FDA for an updated assessment of the benefit-risk profile for the drug in this indication and it responded.
  • Last month, Abbvie said the FDA was extending the PDUFA data for another Rinvoq sNDA in psoriatic arthritis to late Q2.

Personalized Care Act Empowers Individuals Instead of Bureaucrats

 Every time I take my children to the doctor, I’m reminded of the ridiculous restrictions around health savings accounts (HSAs). With four kids, I quickly run out of money in my HSA if any of them need non-routine care. It doesn’t need to be this way.

Created in 2003, HSAs allow people to save money on a pre-tax basis to use for medical expenses. Unlike flexible spending accounts (FSAs), which expire at the end of the year, funds in HSAs rollover year to year. In theory, this would allow families to save money in low-expense years to use in high-expense years. HSAs could have revolutionized health care financing in the U.S., but the current restrictions stifle the impact of the accounts.

Sen. Ted Cruz (R-TX) and Rep. Chip Roy (R-TX) have introduced the Personalized Care Act of 2021, which would remedy many of these limitations and help HSAs live up to their promise.

To start with, only people covered by specific high deductible insurance plans are currently eligible for HSAs. So, while I get frustrated by a lack of money in my HSA, I have friends who can’t even use one at all. That’s much worse. And there is no rational reason for this limitation.

Rather than trying to micromanage our health care from Washington, D.C., lawmakers need to empower people to manage their own affairs. The Personalized Care Act would be a step in the right direction as it would expand HSA eligibility to include individuals covered under any health plan or health insurance. Moreover, allowable expenses would be expanded to include the fees for coverage under these plans, such as insurance premiums.

Expanded HSAs would drive cost-containment and innovation—the one-two punch we need to improve health care affordability. For example, recent years have seen a growth of health care plans like direct primary care (DPC) practices that don’t rely on typical health insurance. With DPC, patients pay a flat monthly or yearly membership fee that covers primary care needs and preventative services. This makes health care costs more predictable and transparent. It also improves efficiency by removing the middleman (insurance companies). By allowing HSA funds to pay DPC membership fees, more people will be able to take advantage of these options.

Consolidation in the healthcare industry has accelerated in recent years. By 2018, around half of all physicians and 72 percent of hospitals were affiliated with hospital systems. This trend, driven in large part by government policies, is likely to continue—especially in the wake of COVID. Direct primary care can reduce the power of regional health care monopolies by giving consumers more alternatives.

Of course, expanded uses aren’t very useful if contribution limits are unreasonably low. Current limits are $3,600 for individuals and $7,200 for families. With four kids, these limits pretty much guarantee there will be eligible expenses I won’t be able to cover with my HSA. Sometimes this means paying more out of pocket, other times it means delaying care. And it typically means no rolling over funds for future expenses.

Fortunately, the Personalized Care Act recognizes these limits are too low. The legislation would increase contribution limits to $10,800 for individuals and $29,500 for families. While I’d recommend an allowance for additional dependents, these contribution limit increases would be a tremendous improvement.

Expanding HSA access could have another important impact: reduced reliance on employer-sponsored health insurance. Current tax rules give preferential treatment to employer-based plans, which has led to nearly 90 percent of Americans with private health insurance receiving it through their employers. With people changing jobs more often than in the past and with technology fueling the growth of independent contractors, employment-based health insurance is becoming less attractive. As HSA usage expands, more insurance options will become available outside of the workplace. This will provide the flexibility modern life demands.

With some sensible reforms like the ones proposed in the Personalized Care Act, HSAs could bring an entirely new patient-centered focus to health care financing. This would give individuals greater autonomy over their health care spending and lessen the control of insurance and government bureaucrats. The ability to rollover funds for future expenses would give people the incentive to shop around for non-emergency care. Over time, this would force providers to be more transparent in their pricing. Bit by bit, expanded HSAs would bring market forces to bear in the health care sector.

For families like mine, the bill would give us peace of mind knowing we’re building a cushion to help deal with unexpected medical expenses. This cushion will enable more people to make healthcare decisions based on medical—not just financial—concerns.

The Personalized Care Act won’t solve every problem we face when it comes to health care access. But it would go a long way toward putting individuals in the driver’s seat when it comes to their health care. And that’s a change that’s long overdue.

Colleen Hroncich is a visiting fellow with the Independent Women’s Forum.

https://www.realclearhealth.com/articles/2021/04/01/personalized_care_act_empowers_individuals_instead_of_bureaucrats_111184.html

Conservatives have healthcare ideas too

 Democrats are pushing ahead with their healthcare agenda. In the last few weeks, progressive lawmakers have introduced a new Medicare for All bill, proposed legislation that would implement a public option, and poured billions of dollars into expanding Obamacare subsidies.

The press is wondering how Republicans will respond. Last month, POLITICO asserted that there was "a big fat question mark about what vision of health care Republicans will offer to voters as the country emerges from the pandemic."

But there are plenty of ideas from the right for healthcare reform. An array of conservative activists, lawmakers, and free-market thinkers have been advancing a vision for healthcare policy that would reduce costs and expand consumer choice. Republicans would be wise to start talking about them.

Take a recent collection of ideas from Americans for Prosperity that they've branded the "personal option," in opposition to President Biden's public option. AFP's agenda focuses on tax breaks, cutting regulations, and boosting access to more flexible insurance options.

For example, the personal option envisions a significant expansion of health savings accounts, or HSAs. These accounts offer patients a tax-advantaged way to save for medical expenses. Beneficiaries can set aside up to $3,600 for individuals and $7,200 for families tax-free each year. Individuals keep that money forever—regardless of changes to their employment or insurance plan.

HSAs are particularly appealing to young Americans. More than 75% of eligible millennials have one, according to a 2018 report. In total, Americans currently contribute to more than 30 million HSAs, according to new data from HSA services firm Devenir.

Unfortunately, existing regulations prevent many people from opening HSAs. Only consumers with high deductible insurance plans are eligible to do so. It's illegal for Medicare beneficiaries to deposit money in the accounts. These types of rules prevent 90% of Americans from contributing to an HSA, according to AFP senior health policy fellow Dean Clancy.

Removing those restrictions could help reduce patients' healthcare costs. In a 2015 study, the National Bureau of Economic Research found that among a group of 13 million individuals, HSAs reduced overall healthcare spending by 15% annually.

Health reimbursement arrangements, or HRAs, offer similar value. They allow employers to set aside funds for workers to spend on health insurance. As a result, employees aren't bound to a single plan offered by their employer. They instead use that money in whichever way they choose.

In 2019, former President Trump implemented a rule that expanded HRAs. His administration projected that more than 11 million Americans would be enrolled in an HRA by 2029. That estimate included 800,000 previously uninsured people.

Since then, Republican lawmakers have proposed legislation that would codify that rule into law. The personal option urges Congress to continue pushing that bill forward.

The Health Policy Consensus Group has been advancing ideas similar to the personal option as part of its Health Care Choices 20/20 plan for years. It's also called on lawmakers to reform existing healthcare delivery models by rolling back regulations on telehealth.

Pre-pandemic, most physicians weren't allowed to provide telehealth services to patients living in another state. Lawmakers temporarily removed those restrictions during the pandemic. Those changes should be made permanent.

After all, receiving care virtually isn't just convenient for patients. It can generate significant healthcare savings—up to $121 per visit, according to a study published in the American Journal of Emergency MedicineOver 80% of patients plan to utilize telemedicine after the pandemic, according to a recent poll.

These health policy proposals have one thing in common—they give patients greater control over their health care.

(They have another thing in common, too—they overlap with the "Pipes Plan," which I've articulated in several of my recent books.)

In contrast, Democrats are trying to take that choice away. Reps. Pramila Jayapal, D-Wash., and Debbie Dingell, D-Mich., have attracted 113 cosponsors of their new Medicare for All bill, which would ban private insurance and put every American on a government health plan. President Biden's public option would do the same, albeit on a slower scale.

Our country's leaders need to expand Americans' affordable healthcare options—not limit them. Thinkers on the right have loads of ideas for doing so.

https://www.forbes.com/sites/sallypipes/2021/03/29/conservatives-have-healthcare-ideas-too/

WHO warns of fake Pfizer, BioNTech COVID shot in Americas

 

Suspected fake Pfizer and BioNTech's COVID-19 vaccines discovered in Mexico last month have now been confirmed as falsified by the World Health Organisation.

In an alert, the WHO warned that the falsified BNT162b2 COVID-19 vaccine may still be in circulation in the Americas. The vaccines – which were supplied and administered to patients outside authorised vaccination programmes – are being laboratory tested to see what they contain.

According to the agency, Pfizer and BioNTech have confirmed they did not manufacture the product, that the batch number and expiry dates are falsified, and the glass vials and label are different from genuine BNT162b2 vials. Details of the fake are included below:

Click image to expand

"Falsified COVID-19 vaccines pose a serious risk to global public health and place an additional burden on vulnerable populations and health systems," said the WHO in its alert. "It is important to identify and remove these from circulation."

It advises that all medical products must be obtained from authorised/licensed suppliers, and the products’ authenticity and physical condition should be carefully checked.

SecuringIndustry.com asked BioNTech for information on the measures it takes to protect its vaccine from falsification and other security threats like diversion or theft, and the guidance it gives to those administering them, but the company declined to comment.

Houston Methodist among largest providers of monoclonal antibody treatment for COVID-19

 Houston Methodist has been a leader in successfully treating high-risk patients with monoclonal antibodies (mAB) for mild to moderate Covid-19 infection. Among the nation's largest providers of mAB therapy, Houston Methodist has infused nearly 4,000 patients since the FDA's Emergency Use Authorization (EUA) was issued. The hospital system was able to quickly ramp up its program once the EUA was granted by leveraging a number of resources through interdisciplinary collaboration.

As more hospitals begin to ramp up for treating Covid-19 with mAB therapy, Houston Methodist's example serves as a valuable model for other medical systems to establish or expand mAB treatment programs and improve patient access to this critical therapy. A commentary outlining the challenges, resources used and benchmarks of success published online March 29 in the New England Journal of Medicine Catalyst.

Houston Methodist drew upon its experience with clinical trials on other Covid-19 therapies and forged early partnerships with industry through the Houston Methodist Research Institute to conduct mAB clinical trials beginning early on in the pandemic. Doing so helped the hospital system overcome a number of obstacles to rapidly establish and scale up treatment clinics to bring mAB therapy to thousands of patients. Challenges included designing clinics using existing resources to separate Covid-19 positive patients from other hospitalized patients, establishing a referral stream that could treat large patient volumes and maintaining a sufficient drug supply to treat all patients.

Highlights included establishing six clinics in less than six weeks across the greater Houston area throughout Houston Methodist's system of hospitals; having an average of 1.2 days from referral to treatment; infusing more than 2,500 patients; and avoiding nearly 250 Covid-19-related hospitalizations. Some of these numbers have increased since the initial study period published in NEJM. Another mark of success, some patients have traveled as many as eight hours to receive mAB therapy at Houston Methodist. This also suggests a need for other healthcare systems to create or expand mAB infusion clinics to improve availability for those unable to travel.

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The commentary authors reflect the breadth of specialties involved in creating Houston Methodist's successful mAB treatment infrastructure and include Nursing Director Jennifer R. Berry, D.N.P., R.N.; Director of System Clinical Pharmacy Services Michael G. Liebl Pharm.D.; System Director of Research Operations Pauline H. Todd, M.B.A., B.S.N., R.N.; and Chief Nursing Officer Vicki Brownewell, M.S., R.N.

To read the study, titled "Rapid Operationalization of Covid-19 Monoclonal Antibody Infusion Clinics," visit https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0040.

Citation: Rapid Operationalization of Covid-19 Monoclonal Antibody Infusion Clinics. New England Journal of Medicine. (online March 29, 2021) Jennifer R. Berry, Michael G. Liebl, Pauline H. Todd and Vicki Brownewell; DOI: https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0040

https://www.eurekalert.org/pub_releases/2021-03/hm-hma033121.php

'COVID-19 patients can be categorized into three groups'

 In a new study, researchers identify three clinical COVID-19 phenotypes, reflecting patient populations with different comorbidities, complications and clinical outcomes. The three phenotypes are described in a paper published this week in the open-access journal PLOS ONE 1st authors Elizabeth Lusczek and Nicholas Ingraham of University of Minnesota Medical School, US, and colleagues.

COVID-19 has infected more than 18 million people and led to more than 700,000 deaths around the world. Emergency department presentation varies widely, suggesting that distinct clinical phenotypes exist and, importantly, that these distinct phenotypic presentations may respond differently to treatment.

In the new study, researchers analyzed electronic health records (EHRs) from 14 hospitals in the midwestern United States and from 60 primary care clinics in the state of Minnesota. Data were available for 7,538 patients with PCR-confirmed COVID-19 between March 7 and August 25, 2020; 1,022 of these patients required hospital admission and were included in the study. Data on each patient included comorbidities, medications, lab values, clinic visits, hospital admission information, and patient demographics.

Most patients included in the study (613 patients, or 60 percent) presented with what the researchers dubbed "phenotype II." 236 patients (23.1 percent) presented with "phenotype I," or the "Adverse phenotype," which was associated with the worst clinical outcomes; these patients had the highest level of hematologic, renal and cardiac comorbidities (all p<0.001) and were more likely to be non-White and non-English speaking. 173 patients (16.9 percent) presented with "phenotype III," or the "Favorable phenotype," which was associated with the best clinical outcomes; surprisingly, despite having the lowest complication rate and mortality, patients in this group had the highest rate of respiratory comorbidities (p=0.002) as well as a 10 percent greater risk of hospital readmission compared to the other phenotypes. Overall, phenotypes I and II were associated with 7.30-fold (95% CI 3.11-17.17, p<0.001) and 2.57-fold (95% CI 1.10-6.00, p=0.03) increases in hazard of death relative to phenotype III.

The authors conclude that phenotype-specific medical care could improve COVID-19 outcomes, and suggest that future research is needed to determine the utility of these findings in clinical practice.

The authors add: "Patients do not suffer from COVID-19 in a uniform matter. By identifying similarly affected groups, we not only improve our understanding of the disease process, but this enables us to precisely target future interventions to the highest risk patients."

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Citation: Lusczek ER, Ingraham NE, Karam BS, Proper J, Siegel L, Helgeson ES, et al. (2021) Characterizing COVID-19 clinical phenotypes and associated comorbidities and complication profiles. PLoS ONE 16(3): e0248956. https://doi.org/10.1371/journal.pone.0248956

Funding: 1. NIH National Heart, Lung, and Blood Institute T32HL07741 (NEI) 2. This research was supported by the Agency for Healthcare Research and Quality (AHRQ) and Patient-Centered Outcomes Research Institute (PCORI), grant K12HS026379 (CJT) and the National Institutes of Health's National Center for Advancing Translational Sciences, grant UL1TR002494. 3. NIH National Heart, Lung, and Blood Institute T32HL129956 (JP, LS) The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing Interests: The authors have declared that no competing interests exist.

This URL provides access to the freely available article in PLOS ONE: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0248956

https://www.eurekalert.org/pub_releases/2021-04/p-cpc040221.php