Long-term care facilities: CVS, Walgreens partnership slows COVID-19 vax

 The effort to vaccinate long-term care facility residents against COVID-19 has been slowed by the federal program that sends retail pharmacists into nursing homes, reports Kaiser Health News. 

The federal partnership consists of Walgreens and CVS pharmacy teams vaccinating nursing home residents and staff. As of Jan. 14, the partnership was allocated more than 4.7 million Pfizer-BioNTech and Moderna vaccine doses. Since the program rolled out in some states Dec. 21, only a quarter of those doses have been administered, according to the CDC.

Some nursing home directors and health officials say the partnership is slowing the vaccination process by imposing paperwork and cumbersome corporate policies on inadequately staffed facilities. They argue that nursing homes are unique medical facilities that would be better served by medical workers who already understand how they operate.

The partnership "has been a fiasco," said Thomas Dobbs, MD, Mississippi's state health officer, according to KHN. The state has 90,000 vaccine doses for nursing homes, but had administered only 5 percent of the shots as of Jan. 14, according to Dr. Dobbs. Pharmacy officials told him they're struggling to find enough people to staff the program.

Nursing homes have resources that could've helped the effort but often aren't utilized. Most centers already work with pharmacists who understand the needs of nursing homes and administer medications and yearly vaccinations. The pharmacists know the patients' medical histories and are familiar with nursing homes, said Linda Taetz, senior vice president and chief compliance officer for Palm Desert, Calif.-based Mariner Health Central.

"It's not that they aren't capable," Ms. Taetz said of the retail pharmacists. "They just aren't embedded in our buildings."

CVS and Walgreens said they're set to finish administering the first doses by Jan. 25, as planned.

https://www.beckershospitalreview.com/pharmacy/a-fiasco-long-term-care-facilities-say-cvs-walgreens-partnership-slowing-covid-19-vaccinations.html

Ex-Merck employee arrested, charged with stealing trade secrets

 Shafat Quadri, Merck's former director of medical and scientific affairs, was arrested Jan. 13 and charged with one count of theft of trade secrets and one count of unauthorized transmission of trade secrets, according to the U.S. District Court in New Jersey.

The court's press release refers to Mr. Quadri's employer as "Company 1," saying it is a New Jersey-based drugmaker and one of the largest in the world. It says Mr. Quadri worked as the company's director of medical and scientific affairs since 2015; his LinkedIn profile shows he was employed in that position at Merck during the same period. 

Mr. Quadri remained at Merck through Sept. 30, 2019. In October 2019, Merck notified the FBI of "suspicious activity" by Mr. Quadri, according to the press release.

The drugmaker reported that it conducted an internal investigation, which showed that Mr. Quadri copied and removed thousands of files housing Merck's proprietary information. The investigation also found that he used unauthorized USB devices and personal email accounts to copy and retain the information. 

Mr. Quadri made his first appearance before the district court via videoconference before being released on $100,000 unsecured bond. He faces a maximum prison sentence of 10 years and a fine up to $250,000, or twice the gross pecuniary gain or loss.

https://www.beckershospitalreview.com/pharmacy/former-merck-employee-arrested-charged-with-stealing-trade-secrets.html

What IT improvements are needed to expedite the COVID-19 vaccine rollout?

 The effort to achieve mass vaccination in the U.S. is said to have gotten off to a slower-than-predicted start, plagued by supply shortages, disorganization and inadequate IT systems.

Below, five CIOs from hospitals and health systems across the country share what IT infrastructure improvements they think are necessary to improve the efficiency of the vaccine rollout process.

Brian Herrick, MD, CIO, Cambridge (Mass.) Health Alliance: Improvements include a clinical tracking system, open access to scheduling, and ensuring that our process does not increase inequity.

These improvements require 1) analytics to identify the correct population at the correct time of the phased vaccine timeline, 2) the ability for patients who qualify for the vaccine to easily schedule themselves without needing to interact with a person at a time that works for them, 3) ensuring that patients are able to schedule and commit to the second dose at the correct interval, 4) automated reminders and an outreach system to ensure the maximum number of patients return for their second dose at the correct interval, and 5) automated education opportunities in all languages and multiple forms.

Michael Restuccia, senior vice president and CIO for corporate information services, Penn Medicine (Philadelphia): The vaccine rollout process is a classic case study for successful projects requiring "people, process and technology." In this equation, the technology infrastructure of an electronic health record and network connectivity seem to be sufficient at most health systems and communities to support the cause. As a result, the most crucial elements to enable success is the project leadership and teamwork amongst all segments of the healthcare delivery system (people and process).  

The efforts by many to coordinate the vaccine supply, timing, storage and manufacturing of the vaccine, along with patient scheduling, administration and tracking of the vaccine are critical to the process. A break in the chain of any one of the critical path segments will result in vaccine rollout delays, continued spread of the virus and overall dissatisfaction.

Zafar Chaudry, MD, senior vice president and CIO, Seattle Children's: At Seattle Children's we looked at initially supporting the workforce (employees and providers), then planning for community members, parents, caregivers and patients. 

The crucial IT components are: functionality to define phases, sub-phases and criteria to prioritize the list of individuals for vaccination management; functionality to provide the ability to self-serve and schedule an appointment for single or multiple doses of vaccine; the capability to manage the administration and tracking of vaccines; and functionality to run reports and export data to the state based on state reporting requirements.

We’ve built out two capabilities: a solution within our Epic EHR, and using MazikCare (built on Microsoft Dynamics 365 and utilizes its Health Accelerator) that enables an online portal for eligibility determination, real-time appointment scheduling with encrypted QR code touchless check-in, and second appointment reminders.

Mark Amey, CIO, Alameda Health System (Oakland, Calif.): Historically we have vaccinated our employees for the flu through our employee health department, utilizing an employee medical record system. However, like many others, we found it lacked important functionality such as scheduling and a robust portal to aid in the vaccination process. Thus, we are migrating some of these functions into our EMR, which is a growing trend among healthcare systems.

Vaccinating our patients especially in the emergency department and inpatient setting has the challenge of the patients' need to receive a second dose, possibly after they have been discharged from the hospital three to four weeks later. As patients move through services, departments, and potentially other organizations or care providers, the IT infrastructure needs to be able to communicate and support the vaccine type, dose timing and location of the patient.

Lastly, public health vaccine clinics require supporting such things as scheduling vs. walk-up clinics, tracking and reminders of follow-up appointments, gathering of appropriate demographics, and reporting. This all must be done in a very rapid manner. 

However, this does not begin to address the shortages of clinical staff to administer the vaccines or keeping abreast of ever-changing data requirements, priority groups to receive the vaccine, and guidance from the government. In short, I believe that the issues we’re facing across the country and certainly in California are less technology and much more operational, procedural, and people power.

Steve Garske, PhD, CIO, Children’s Hospital Los Angeles: At Children’s Hospital Los Angeles, efforts to design, build and implement a functional system with robust reporting over just a few weeks in order to quickly vaccinate staff were made possible by combining equal parts predictive readiness across the organization  — existing infrastructure and connections with the county, CDC, etc. — with technically savvy and nimble teams for IT informatics, integration, development, technical analytics and training, with robust support IT infrastructure, and tight coordination throughout, both with clinical staff and our quality partners. 

In the absence of some or any of these things, the most crucial element to maintain is a capable, committed technical team and strong leaders. These folks were able to take what we had, fill in the gaps, and make something truly inspiring happen in a very short period of time.

https://www.beckershospitalreview.com/data-analytics/what-it-improvements-are-needed-to-expedite-the-covid-19-vaccine-rollout-5-cios-weigh-in.html

China, Russia Target Hack of U.S. Vaccine Supply Chain

 National Counterintelligence and Security Center Chief William Evanina said several countries are targeting America’s coronavirus vaccine supply chain.

In an interview Tuesday, Evanina said Russia and China are engaging in cyber warfare against the U.S.

He believes the country’s adversaries are trying to get a peak at our systems through intelligence gathering operations.

This comes on the heels of a SolarWinds hack in which U.S. government agencies and private firms were the victims of a massive data breach.

“We’ve had too many wake up calls and I think right now, as we put into context our counterintelligence strategy in America, supply chain management is the second pillar,” Evanina explained. “And I think we have to find the right mechanism, the right modality, where we can have real life public and private partnership that’s beyond what we see now.”

Evanina has warned that cyber threats will only increase in the future as new technological developments, especially 5G, are within arm’s reach.

https://www.oann.com/report-china-russia-hacking-u-s-vaccine-supply-chain/

Texas Becomes First State To Administer 1M Vaccine Doses

 Texas became the first state to administer 1 million COVID-19 vaccine doses. Gov. Greg Abbott (R-Texas) announced the milestone on Thursday, saying the Lone Star State is leading the nation in its vaccine program.

Abbott said the state opened up vaccination hubs and expanded its vaccine eligibility.

“As you know, we’ve now opened up an additional category and that is anybody over the age of 65 or older, or people under the age of 65 who face or deal with certain chronic healthcare conditions that have been pre-identified,” Abbott announced.

Abbott pledged Texas would have no more lockdowns, blasting California for shutting down businesses which only resulted in a spike of COVID-19 cases.

https://www.oann.com/texas-becomes-first-state-to-administer-1m-vaccine-doses/

Pandemic propels health systems to mull insurer acquisitions, partnerships: JPM21

Nearly a year after the first confirmed case of COVID-19 in the U.S., some of the nation's largest health systems made a case for the need to accelerate toward value-based arrangements and potentially acquiring or partnering with health plans to become an integrated system.

Amid new records for deaths and cases from the novel coronavirus, executives gathered virtually for J.P. Morgan's 39th annual healthcare conference, which typically draws prominent healthcare leaders to San Francisco at the start of each year.

The pandemic has been a heavily discussed topic during the digital gathering. One theme has been health systems either acknowledging they are on the hunt for health insurer acquisitions and partnerships or advocating for such arrangements as result of the challenges.

Anu Singh, managing director and the leader of the mergers, acquisitions and partnerships practice at consultancy Kaufman Hall, said it's a natural migration for health systems, though it does come with some risk.

"If you want to move into the realm of being a population health manager, and take greater responsibility for your patient bases, you're going to have to be thinking about maintaining their health," Singh said. "And that's typically something that, at least traditionally and historically, has been driven a little bit more by the health plan."

For Utah's Intermountain Healthcare, the lessons of the pandemic are clear: The industry needs to move away from a system that rewards volume. Intermountain is a fully integrated system that manages both providers and an insurance unit.

"It is becoming increasingly apparent that systems that are well integrated, especially systems that understand how to take risks, have prospered in the face of the terrible burden, caring for people in the midst of the first pandemic in 100 years," Intermountain CEO Marc Harrison said Monday.

From his vantage point, Harrison said it has been interesting to watch the consternation around telehealth visits.

"Lots of folks who are really still caught in the volume-based system are actively switching patients back from tele- or distance to in-person visits so they can maximize revenue," he said. "I understand that. But that's a really great example of poorly aligned incentives."

Intermountain has managed to stay in the black as many other systems have struggled financially as a result of the pandemic driving down patient volumes. It reported net income of $167 million through the first nine months of 2020, compared with $919 million the year prior.

Another integrated system, Baylor Scott and White Health, the largest nonprofit system in Texas, said such diversification has helped buoy its finances as hospital and clinic operations bottomed out in the spring due to the virus.

Baylor Scott and White illustrated this point by showing how operating income for its clinical segment took a nosedive in the spring while operating income for its health plan remained relatively steady.

Retrieved from Baylor Scott and White Health on January 12, 2021

 

The theme of integrated health systems also seemed to be on the minds of investors. CommonSpirit Health executives were asked during their presentation if buying or creating a health plan was on their radar as the system has a sizable footprint of 140 hospitals across the country.

"I think this is a interesting question, one that of course we've discussed many times strategically," CFO Daniel Morissette said, noting the system does have a number of regional plans. "At this time, we have no plan of having a national CommonSpirit branded plan." However, Morissette said the system would consider a partnership opportunity.

On the other hand, Midwest-based Advocate Aurora Health said it is actively on the hunt for a potential insurer deal as part of its long-term strategy.

"We do believe that having health plan capability, not necessarily having our own, but partnering for health plan capability, is going to be critical to our success, and we are taking steps to do that," CEO Jim Skogsbergh said during the virtual conference.

Kaufman Hall said in its latest report that it expects more payer-provider partnerships as a result of the pandemic. "Limitations on fee-for-service payment structures exposed by the pandemic may increase the number of payer-provider partnerships around new payment and care delivery models," according to the report.

Singh of Kaufman Hall said it's not surprising that some may lean more toward a partnership due to the risks of starting a new venture, especially an insurance unit that can have "catastrophic loss". Systems with less experience of moving toward implementing value-based initiatives may be more vulnerable to such risk.

It's why he thinks partnerships may be a good fit, at least at first. Payers and providers can work together to improve the health of certain populations and then share in the cost savings.

https://www.healthcaredive.com/news/pandemic-propels-health-systems-to-mull-insurer-acquisitions-partnerships/593228/ 

Push for more 'underutilized' COVID-19 antibody drugs as pandemic worsens

 With two highly effective coronavirus vaccines now being distributed across the country, the U.S. government’s announcement Thursday to set aside $2.6 billion for purchasing an antibody drug for COVID-19 may have raised a few eyebrows. 

After all, the two currently authorized antibody drugs, from Regeneron and Eli Lilly, have not been widely used since the Food and Drug Administration cleared both in November. And the logistical issues that have hindered their launch haven’t been solved, either. 

But Operation Warp Speed officials, including top FDA drug evaluator Janet Woodcock, are campaigning hard to change that, arguing the drugs are being “underutilized” in the COVID-19 response. Study results have shown the treatments can keep some sick patients from needing hospital care, which could be a huge benefit for healthcare systems under greater and greater strain.  

“If we don't do this,” Woodcock said on a conference call with reporters Thursday, “then the likelihood is that we'll have even more overwhelmed hospitals and healthcare workers.”

Antibody drugs for COVID-19 gained notice when they were used to treat President Donald Trump and several other high-profile politicians in November. The treatments are made of synthetic antibodies that mimic the body's natural defenses. While clinical trials are still ongoing, the data so far indicate they’re particularly beneficial for certain patients with mild or moderate symptoms whose own immune systems aren’t mounting a strong defense. The U.S. government initially pre-purchased 300,000 doses of both Regeneron’s and Lilly’s drugs and has since expanded deals with each company.  

But the limitations of both drugs have become clear as they’ve been rolled out. The treatments must be infused in a healthcare setting, raising the risk that infected patients could endanger others at a hospital or clinic. They’ve only been authorized for those at high-risk of becoming hospitalized, a group the FDA has defined by age and certain underlying health conditions. And the drugs have to be given early in a person’s disease course, meaning fast testing and administration is needed to get the right patients treated at the right time. 

Other problems have emerged as well. Woodcock noted the clinical evidence supporting each drug is not yet conclusive. Providers have to cover the costs of infusions while the associated codes are being entered into government systems. With rising COVID-19 case counts and intensive care units filling up across the country, hospitals are having difficulties staffing administration sites with healthcare workers. And that, in turn, has made antibody treatment difficult to get. 

“Urging patients to go get treated when we couldn't tell them where, and where things weren't set up, was problematic,” Woodcock said. 

Early last year, antibody drugs were viewed as a potential “bridge” to vaccines. Now, the fear is an opportunity has been missed for antibody drugs to help mitigate the pandemic’s impact. Between 20% to 25% of the government stockpile has been given to patients, officials said Thursday. With the vaccine rollout stumbling, though, there’s still a chance for antibodies to play an important role.

“We are working very hard with the government to rectify the situation,” Regeneron chief scientific officer George Yancopoulos said at the J.P. Morgan Healthcare Conference this week. “Obviously, and unfortunately, millions will continue to be infected and at risk over the next many months, and perhaps years until vaccines can be used to help create widespread immunity.”

Lilly CEO David Ricks told CNBC this week that utilization numbers are “climbing” but vary widely “state to state.” He noted, for instance, that the drugs have been widely used in Alabama.

“Anecdotally, I would say, we truly believe they have helped us turn the tide on our COVID outbreak here in south central Kansas,” in October and November, said Wes Hoyt, chief of operations at the Hutchinson Regional Medical Center, on the conference call. 

In Michigan, the hospitalization rate two weeks after antibody treatment has been “pretty consistently around 5%,” compared to about 15% for high-risk patients given the placebo in clinical testing, said William Fales, medical director of the Michigan Department of Health and Human Services. Only about 10% of the 21,000 doses allocated to the state have been used, however.

But positive reports can only go so far in helping to boost use without improvements in access to the treatments. John Redd, the chief medical officer of the HHS Assistant Secretary for Preparedness and Responses office, said the government is focused on boosting supply, awareness and physical support to providers. The government has now secured options for up to 4.5 million antibody doses combined between Regeneron and Lilly. Some 660,000 had been allocated as of Wednesday, and states had delivered roughly 500,000 of those courses.

Government officials are also connecting with providers and local health departments and are ramping up an online treatment locator, into which all states will be required to input information. Reed said they’re sending emergency medical personnel from the National Disaster Medical System to help set up infusion centers in or around hospitals, citing efforts underway in California, Arizona and Nevada. 

Woodcock acknowledged, however, that even more has to be done. Hospitals stretched to the limit likely aren’t the best option for antibody treatment at this point, particularly given how fast a patient must be treated after symptoms start. Urgent care clinics and nursing homes, by contrast, may be better suited. 

“I think over the next coming weeks we'll hear about some additional experiments groups are doing to enable getting to people who are high-risk very fast,” Woodcock predicted.  “The bottleneck here in the funnel is administration, not availability of product."