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Saturday, September 12, 2020

Home BP Monitoring Can Make Inroads During the Pandemic


The rapid expansion of telemedicine due to COVID-19 presents an opportunity for home blood pressure (BP) monitoring to stake a place as a component of routine clinical practice — provided that policymakers recognize the changes needed to facilitate greater access to healthcare, according to a discussion by hypertension experts.

There is increasing recognition of the importance of out-of-office confirmation of BP elevation even when white coat hypertension isn’t strongly suspected, said J. Brian Byrd, MD, of University of Michigan Medical School in Ann Arbor.

It may be the right time to push for home BP measurement — a more practical alternative to ambulatory monitoring — as a standard part of patient care, several suggested during a session of the virtual Hypertension conference, hosted by the American Heart Association (AHA).

In-office screening for hypertension in adults with confirmation outside of the clinical setting was tentatively given a grade A recommendation by the U.S. Preventive Services Task Force in June. Around the same time, a joint policy statement from the AHA and American Medical Association affirmed that self-measured blood pressure at home is a validated, cost-effective addition to office monitoring.

“The pre-COVID status quo of the cost of care for hypertension is not sustainable. Increased utilization of telehealth has the potential to reduce the economic burden from costly hospital care attributed to poor hypertension control,” said Gbenga Ogedegbe, MD, MPH, of NYU Grossman School of Medicine in New York City.

With people avoiding doctor’s offices due to SARS-CoV-2 exposure risk, non-urgent care virtual visits exploded with an increase of 4,345% from March to April this year at NYU, he said.

Patients Can Do a Better Job Themselves

Switching from office to home BP reading could be an improvement given the unreliability of the former, some suggested.

“Patients can do as good a job or an even better job than what happens in the office setting” provided that they use a validated, calibrated device and are properly educated on how to use it, Byrd said.

Both home and 24-hour ambulatory BP monitoring are more reproducible than office BP, according to Steven Yarows, MD, of IHA Chelsea Primary Care in Michigan.

Yarows detailed the workflow of starting home BP monitoring with a patient:

  • Provider recommends a validated automatic upper arm monitor and suggests the correct sized cuff (usually a size large in the U.S.). The medical assistant teaches patient how to use the monitor or arranges for an educational nurse visit at another time (billable for $11 once).
  • Patient is then told the frequency and times of measurement. “I personally ask for breakfast and dinner readings for 1 month when starting or changing medication,” Yarows said.
  • After a month of data has been recorded on a spreadsheet, the patient is given an action plan (billable at $16 per month until BP is under control).


Home BP readings should be accompanied by regular clinician contact, Ogedegbe emphasized. His group found that tailored feedback on home BP was shown to push systolic BP lower at 12 months among low-income stroke survivors in New York City in a randomized study.

Hurdles to Wider Adoption

Yet there are “still many rivers to cross” when it comes to making home BP telemonitoring part of routine practice, Ogedegbe said.

Reimbursement is one of the most prominent and lamented barriers.

On the upside, new CPT codes for self-measured BP were introduced January 2020.

However, coverage of home monitoring variable among payers, Ogedegbe noted. He added that CMS still has no national coverage determination addressing this practice despite recently finalizing one for the use of ambulatory BP monitoring.

“We should advocate for coverage for home BP devices from Medicare too — affordability should not be a barrier,” commented Ian Kronish, MD, MPH, of New York-Presbyterian/Columbia University Irving Medical Center in New York City, during the virtual chat.

“Completely agree! Devices should be covered period,” wrote Stephen Juraschek, MD, PhD, of Beth Israel Deaconess Medical Center in Boston.

“It seems so obvious that it would be cost-effective to pay for these device [sic],” Byrd added.

Another obstacle for home monitoring is the assurance of patient confidentiality without making data transfer cumbersome.

“Currently, privacy and security concerns prohibit automatic input of data from home BP monitors directly into most EMRs via web-based interfaces. This is a major barrier preventing the full realization of the potential for [home BP telemonitoring] as an effective tool for the management of hypertension,” according to Ogedegbe.

“In a busy practice, it is prohibitive to have to log into a separate cloud-based vault to extract home BP data,” he continued.

The preponderance of non-validated automated oscillometric devices on the market is all the more reason for caution, suggested James Sharman, PhD, of the University of Tasmania, Australia.

FDA and other regulators allow BP devices to be cleared for sale without validation according to rigorous scientific standards, so validated and non-validated BP devices can be sold next to one another, indistinguishable by appearance alone.

“Non-validated BP devices are less accurate and may lead to suboptimal care,” Sharman emphasized.

His group recently reported that among BP devices available for online purchase in Australia, 18% of upper arm cuff devices met international validation standards (versus 8% of wrist cuff devices and zero of the wristband wearables that dominate the marketplace). E-commerce retailers such as Amazon and eBay supplied 92% of BP devices available online but only 5.5% turned out to be validated.

Sharman and several discussants recommended that consumers check the validity of BP devices on www.validatebp.org. Other resources include the general registries STRIDE BP and Medaval.

Finally, existing socioeconomic disparities in healthcare may be exacerbated by the increased use of telemedicine during and after COVID-19, Ogedegbe warned.

At least one in every four people in the U.S. may not have digital literacy skills or access to Internet to engage in video chat, he said.

https://www.medpagetoday.com/meetingcoverage/ash/88589

NYU Langone Health creates template for remote COVID-19 care delivery

NYU Langone Health and NYU Long Island School of Medicine released a new template on Sept. 10 to assist providers with assessing and triaging patients who may have COVID-19.

Four details:

1. Researchers published the template and their report in Medicina; the New York City-based health system clinicians created a decision-tree diagram to help practitioners classify the seriousness of the patient’s infection.

2. During the telemedicine exam, the researchers instruct the clinician to observe the patient’s breath to identify whether they are having trouble breathing, which could be a warning sign of a serious COVID-19 infection.

3. Respiratory issues can be determined virtually by looking, listening and counting a patient’s respiratory rate and respiratory efforts.

4. The researchers also advise clinicians to instruct patients to use a flashlight so the clinician can get a virtual view of their throat.

Click here to view the full report.

https://www.beckershospitalreview.com/telehealth/nyu-langone-health-creates-template-for-remote-covid-19-care-delivery-4-details.html

What coronavirus recovery centers have learned from treating ‘long-haulers’

Several health systems in the New York and New Jersey have established care centers for COVID-19 patients who recover from the disease but continue to experience symptoms, and they have discovered that these patients require ongoing, multispecialty care, according to MedPage Today.

Health systems, including Mount Sinai Health System in New York City and Edison, N.J.-based Hackensack Meridian Health, opened COVID-19 recovery centers for patients facing long-term complications from the disease, dubbed “long-haulers.” These patients continue to experience symptoms, including fatigue, shortness of breath and joint pain, in the months after they recover from the virus.

Patients at Hackensack Meridian Health’s COVID Recovery Center receive personalized care treatment plans from primary care physicians and are connected with specialists, including pulmonologists, cardiologists and neurologists, program chair Laurie Jacobs, MD, told MedPage Today.

Zijian Chen, MD, who oversees Mount Sinai’s COVID-19 recovery program also told the publication that post-COVID-19 recovery, patients require care from several specialists. “Right now, we have almost every medical specialty working with the program,” he said.

Patients often come in with lung injury issues and require rehabilitation to “regain lung elasticity,” Jeffrey Fine, MD, who provides care at Rusk Rehabilitation at NYU Langone Health in New York City, told MedPage Today. They also come in with neurologic issues, such as cognitive impairment or neuropathy.

“They may not require a formal cardiac or pulmonary rehab, but they still need to work on focus, attention and reconditioning,” Dr. Fine said.

Patients coming into these recovery centers are not necessarily those who have been hospitalized after contracting COVID-19. Some never went to a hospital, while others had long hospital stays and inpatient rehabilitation, MedPage Today reported.

The centers also offer mental healthcare services, to help patients cope with the mental toll of the illness and its long-lasting ramifications.

https://www.beckershospitalreview.com/public-health/what-coronavirus-recovery-centers-have-learned-from-treating-long-haulers.html

12% of docs eye leaving medicine and 7 other COVID-19 linked trends

About 54 percent of U.S. physicians said they have treated COVID-19 patients in person, and another 26 percent report treating coronavirus patients over the phone or via video, according to a new Medscape report.

The survey polled 7,414 physicians from eight countries, including 5,005 physicians from the U.S. The survey was conducted between June 9 and July 20.

Eight findings from U.S. physicians’ survey responses:

1. Emergency medicine physicians (94 percent) and nephrologists (89 percent) are the top two specialists treating COVID-19 patients in person.

2. Twenty-three percent of physicians report lacking appropriate personal protective equipment when treating COVID-19 patients.

3. Around 5 percent of physicians said they have been diagnosed with COVID-19.

4. Sixty-two percent of physicians said their income decreased since the beginning of the pandemic, with 33 percent reporting their income decreased by 11 percent to 25 percent.

5. Approximately 64 percent of physicians report higher burnout since the pandemic started.

6. Forty-six percent said they are lonelier due to stay-at-home and social distancing guidelines.

7. About 25 percent of physicians are planning to retire earlier than planned as a result of their experiences treating COVID-19, and 12 percent are considering leaving medicine.

8. Forty-three percent of physicians said their workplace offers activities to help clinicians with stress and grief.

https://www.beckershospitalreview.com/hospital-physician-relationships/12-of-physicians-are-considering-leaving-medicine-and-7-other-findings-about-the-us-physician-covid-19-experience.html

Gilead nears $20B-plus deal to buy Immunomedics

Gilead Sciences (NASDAQ:GILD) is close to a deal to buy Immunomedics (NASDAQ:IMMU) and its prized Trodelvy breast cancer drug for more than $20B, with an announcement expected by Monday or sooner, WSJ reports.

The acquisition would come at a hefty premium, even after a recent surge in its stock has lifted Immunomedics’ market value to ~$10B.

In April, Trodelvy was approved in the U.S. to treat triple-negative breast cancer, an aggressive form of the disease that has spread to other parts of the body.

Trodelvy has shown signs of success in treating lung and other cancers too, and Immunomedics is expected to present data on the drug’s performance against bladder cancer at a medical conference this coming week.

https://seekingalpha.com/news/3613491-gilead-nears-20b-plus-deal-to-buy-immunomedics-wsj

Antibody therapy developer AbCellera hires banks for U.S. IPO

Canadian antibody therapy developer AbCellera Biologics Inc, which has been participating in efforts to develop a treatment for the novel coronavirus, has hired investment banks for a U.S. initial public offering (IPO) which could come later this year, according to people familiar with the matter.

The planned listing would come amid strong demand for new biotechnology stocks, with almost half of the U.S. IPOs in 2020 coming from the healthcare sector, according to data from IPOScoop.

AbCellera has hired Credit Suisse Group AG CSGN.S, Stifel Financial Corp SF.N and SVB Leerink as the lead underwriters of its upcoming IPO, the sources said, requesting anonymity because the arrangement is confidential.

The company could look to raise between $200 million and $300 million in the IPO, the sources said, cautioning that the plans are subject to change and market conditions.

AbCellera is planning to submit a filing with U.S. regulators for the IPO in the coming weeks, one of the sources said.

Vancouver-based AbCellera uses high-throughput microfluidics, data science and machine learning to develop antibodies that can be deployed to prevent and treat disease.

The company has been working with Eli Lilly and Co LLY.N this year to develop antibody therapies to tackle COVID-19.

AbCellera’s investors include billionaire Peter Thiel, the Bill & Melinda Gates Foundation and healthcare-focused buyout firm OrbiMed Advisors LLC.

AbCellera is at least the fourth Thiel-backed startup to make preparations to go public in recent weeks, the others being Palantir Technologies, Asana and Compass Pathways Plc.

https://www.reuters.com/article/us-abcellera-ipo/antibody-therapy-developer-abcellera-hires-banks-for-u-s-ipo-idUSKBN2622PH

Pfizer, BioNTech propose expanding COVID-19 vaccine trial to 44,000 volunteers

Pfizer Inc and BioNTech SE on Saturday proposed to the U.S Food and Drug Administration (FDA) to expand their Phase 3 pivotal COVID-19 vaccine trial to about 44,000 participants while increasing the diversity of the trial population.

The initial target figure for the trial was up to 30,000 participants, which the companies said they expect to reach by next week.

The proposed expansion would also allow the companies to enroll people as young as 16 and people with chronic, stable HIV, hepatitis C and hepatitis B, they added.

Drugmakers racing to develop a safe and effective coronavirus vaccine pledged in July to ensure their larger clinical trials would include diverse sets of volunteers.

“Diversity in clinical trials is a priority for Pfizer and is critical given that COVID-19 disproportionately impacts communities of color in the U.S.,” Pfizer’s Chief Business Officer John Young said in a U.S. congressional hearing in July.

If the study is successful, the companies could submit the vaccine for regulatory approval as early as October, putting them on track to supply up to 100 million doses by the end of 2020 and 1.3 billion by the end of 2021.

“As stated previously, based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October,” the companies added in the joint statement on Saturday.

The vaccine candidate utilizes chemical messenger RNA to mimic the surface of the coronavirus and teach the immune system to recognize and neutralize it. Although the technology has been around for years, there has never been an approved messenger RNA (mRNA)vaccine.

https://www.reuters.com/article/us-health-coronavirus-pfizer-biontech/pfizer-biontech-propose-expanding-covid-19-vaccine-trial-to-44000-volunteers-idUSKBN2630QH