Keith A. Reynolds

Health insurers are looking to the massive expansion of telehealth brought on by the COVID-19 pandemic in creating new plans for patients.

 from Kaiser Health News, some of the biggest names in health insurance are getting in on the action offering plans which see beneficiaries encouraged to choose an online doctor which acts as their first point of contact for most primary care and can make referrals for in-person care.

Many insurers offering these plans have hired outside firms to provide physicians who may hold licenses in several states and not located near the patients. Patient information is passed to the physicians through either the insurers internal EHR system or that of the third-party provider leading to questions of how health information could be passed from out of network hospitals or physicians, the report says.

Kaiser Health News likens the new programs to “HMO 2.0,” noting that skeptics have raised concerns about the need for primary care visits to be held in person due to the need to collect vital health information. Some insurers have provided patient with personal health devices to collect this information.

The latest insurer to step into the space is UnitedHealthcare. According to 

, the company is launching a new virtual first plan called NavigateNOW. The plan is touted as offering beneficiaries 24/7 access to care through Optum for a premium 15 percent cheaper than traditional benefit plans.

“Patients want more options for getting care that is convenient for them and their lives,” said Kristi Henderson, Optum senior vice president for virtual transformation, and CEO of Optum Virtual Care, which includes Optum’s national virtual-first medical group. “Our work with UnitedHealthcare is designed to help make it simpler for patients and members to interact with their care providers by bringing together our virtual resources and national clinical footprint to provide a more seamless, connected experience.”

None of these programs would be possible without the seismic shift in healthcare toward 

 36 percent of patients have accessed telehealth services during the past year, up from just 9 percent in 2020 and 7 percent in 2019. Usage is consistent across all generational groups, with the highest usage among members of Generation Y and Pre-Boomers. The top reasons for telehealth utilization are convenience (57 percent), ability to receive care quickly (47 percent), and safety (36 percent).

While it has seen a boom, patients’ patience with telehealth seems to be waning as overall satisfaction with both direct-to-consumer and payer-sponsored telehealth services declined in 2021 from 2020. The most frequently cited barriers encountered by patients are limited services (24 percent), lack of awareness of costs (15 percent), confusing technology requirements (15 percent), and lack of information about providers (15 percent).

Overall satisfaction is 85 points lower (on a 1,000-point scale) among patients with the lowest self-reported health status than among patients who consider themselves to be in excellent health. Similarly, healthier patients are more likely than less healthy patients to 

 provided during the visit, say they receive clear explanations, perceive that their visits are highly personalized, and obtain high-quality diagnoses.

This article was originally posted on Medical Economics®. 

Articles

UnitedHealthcare’s newly launched virtual first plan is one part of a push by the industry.

Insurers and virtual-first plans

The Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee voted unanimously yesterday to recommend booster shots of Moderna COVID-19 vaccine for many who’ve already received the initial doses.

the panel approved an emergency use authorization for the half-dose of the Moderna vaccine to be administered six months after the initial two-dose regimen for those considered at high risk of severe COVID-19 infection; the same groups eligible for the Pfizer booster shot

The committee also voted unanimously to recommend boosters of the Johnson and Johnson vaccine for all adults two months after the initial dose, according to the 

FDA officials have said they are considering regulatory changes to allow those patients who received the initial dose of the Johnson and Johnson vaccine to receive a Pfizer or Moderna booster dose. A timeline on such a move has yet to be established, the 

An official ruling from the agency is expected in the coming days.

 which the committee used to reach their determination show that, when administered six months after a second dose, the booster dose of the Moderna vaccine raise antibody titers 15 times a month after the additional shot and provides protection against the now-dominant Delta variation of the disease.

The documents also show that the booster shots appear safe, with the reactogenicity and adverse event profile similar to that seen after the second dose of the vaccine.

 found that a second dose of the Johnson and Johnson vaccine administered 56 days after the first provided 100 percent protection against severe or critical COVID-19, 75 percent protection against symptomatic COVID-19 globally, and 94 percent protection against symptomatic COVID-19 in the U.S. When the second shot is administered, it boosts antibody levels four to six times higher than what is observed after the initial dose.

When the booster shot was given six months after the initial dose antibody levels shot up nine-fold after a week and 12-fold after four weeks irrespective of the age of the patient.

The committee will reconvene on Nov. 30 to discuss the Merck investigational antiviral pill, molnupiravir, for the treatment of mild-to-moderate COVID-19 in adults.

, a planned interim analysis of a Phase 3 MOVe-OUT trial in 775 at risk, non-hospitalized adult patients with mild to moderate COVID-19 found that the antiviral reduced the risk of hospitalization or death by 50 percent. No patients who received the pill died after 29 days compared to eight who died after receiving a placebo.

The company plans to produce 10 million courses of treatment by the end of the year and previously entered into an agreement with the federal government to supply about 1.7 million courses of molnupiravir upon receiving an EUA or approval from the FDA. Merck has struck similar deals with other countries.

 the Centers for Disease Control and Prevention (CDC) recommended booster shots of the Pfizer COVID-19 vaccine Comirnaty for those over 65 and those at high risk of severe COVID-19 due to an underlying condition. CDC Director Rochelle Walensky went a step further and recommended the extra shots for those in high-risk occupations or institutions.

Specifically, the CDC recommends boosters for:

people 65 years and older and residents in long-term care settings should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,

people aged 50–64 years with underlying medical conditions should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,

people aged 18–49 years with underlying medical conditions may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks, and

people aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.

The advisory panel is also scheduled to discuss Merck antiviral pill late next month.

Moderna, Johnson and Johnson COVID-19 boosters recommended by FDA

To err is human. So the question is not whether a medical malpractice lawsuit will be filed against a physician, but when.

As physicians pick their way through this minefield, if they’re not careful, one lawsuit from one patient could define their entire career, and lead to a loss of revenue, increased insurance costs and a massive hit to a physician’s professional reputation.

Bob White, chief operating officer of malpractice insurer TDC Group, says that some specialists such as neurosurgeons or obstetricians can spend as much as 25% of their career with an open malpractice suit against them.

“The sheer psychological fatigue that that creates for them is no small distraction for folks who’ve gone through it,” he said.

There are actions physicians can take to reduce their exposure to litigation.

The standard defense to lawsuits for years has been to maintain proper documentation, which White says has been greatly helped by the widescale adoption of electronic health records, but there are still limitations.

“There’s a finite amount of time that someone has to document things and we try to be practical when we talk to doctors about how to document, especially when a patient or the patient’s family is having difficulty in accepting the outcome of treatment,” he says.

Matt Gracey, former CEO of medical malpractice insurer Danna-Gracey and managing director of risk management firm Risk Strategies, says any lawsuit filed can become a much greater headache for the physician if patient records are not accurate, clear and timely.

“The most important document they can have in their patient records is a consent for treatment,” he says. “Those consent forms spell out all the risks of any procedure that the doctor is going to perform on a patient.”

A physician’s legal representative can present proper consent forms to a jury and highlight that the patient agreed to the service after being informed of the possible complications, thereby easing the way to win in the courtroom.

Gracey says the complaints in many malpractice suits are often tied to a known complication of a treatment and that the public often mistakenly assumes that when these known complications arise it is the doctor’s fault.

“It’s that confusion that leads to many lawsuits, and that’s a fundamental part of risk management: to make (the risks) clear to patients in writing, and that’s what the consent form is about — that even if the doctor doesn’t make any mistakes there still can be bad outcomes,” he says.

Sean P. Byrne, JD, founder of Byrne Canaan Law in Richmond, Virginia, has defended physicians in medical malpractice cases for 20 years. He says that proper documentation is key because the cases he handles often take years to reach a courtroom, which can lead to failed memories. Juries view contemporaneous documentation as more reliable than eyewitnesses, Byrne says.

Although medical documentation can be onerous to deal with, it is the first thing a potential plaintiff will take to a lawyer when seeking to file a malpractice suit. Lawyers determine whether to file cases based on expert analysis of these records, he explained.

“It’s the chart that tells the story of the case,” Byrne says.

He notes that the opposing medical expert will be looking for what was documented to determine whether the physician provided good care; if the treatment wasn’t documented, it’s as though it wasn’t done.

Byrne says that physicians should avoid just using the checkboxes and autofill templates in electronic health records because those might not encompass all of the care given to a patient.

“What I really love is a patient-specific narrative that shows you gave thoughtful, individualized care to this patient; that part of the documentation is gold,” he says.

When documenting patient interactions, White suggests noting what the physician initially recommended as the optimum course of care if that differs from what the physician and patient agreed upon as the treatment plan.

He says that physicians often get into trouble when they only document the care plan they and the patient finally select. When outside experts such as a physician’s attorney examine such records, they can’t defend what the doctor initially recommended if that suggested optimum care and treatment were not documented.

Although documentation can serve as a good defense in a malpractice suit, Gracey says that maintaining a solid relationship with a patient and their family is a good preemptive move.

“What really stands out when you look at the data and surveys of patients is that very few doctors who have great relationships with their patients get sued, even when there are bad outcomes, and even when there’s malpractice, and that’s why the doctor-patient relationship needs to be on top of the list,” he says.

All of the staff should be instructed to emphasize good patient relationships from the moment the patient enters the office. Gracey says that patients already assume their physician is educated and skilled, but when they have a good relationship with the doctor and their staff, they believe the practice cares about them.

“Caring doctors get sued much, much less than doctors whose patients don’t get that warm and fuzzy, caring feeling from their doctors,” he says. “It’s a different take on risk management, which is mostly defensive. The offensive mode, (to avoid) being sued, is just to be really caring and have great relationships with patients and their families.”

The period between an adverse outcome and the filing of a malpractice suit can be fraught with anxiety for the physician.

Byrne says many defense attorneys used to tell their clients not to speak to the patient or their families at all after a poor outcome, but he now emphasizes listening to patients and their families after something goes awry during care. He tells clients to be candid and honest with the patient and stick to the facts without speculating, as speculation can erode any confidence the patient or family has in the physician.

“If there’s other information that needs to be gathered to have more answers, and you offered a follow-up, then do it,” he says. “Follow up and do it.”

Although any communication should be run past a defense attorney, White says that being open and available to the patient or their family can do wonders. He says that TDC Group tells doctors to sit down with the patient or family and discuss the adverse outcome.

“You explain that this is one of those kinds of complications that can occur in delivering treatment, and it’s not about a failure on the part of the patient’s ability to heal or anything else, this is one of the possible outcomes from this treatment,” he says.

Furthermore, White adds that physicians should explain that you will be available when needed, in case of questions and concerns.

“You want to help them get through this,” he says. “Be there for the patient.”

Gracey warns about apologizing when something goes wrong, as that can affect the physician’s liability in some states, though an apology often is exactly what the patient or their family are looking for after an adverse outcome.

“It’s really what patients and families want,” he says. “However, some risk managers and some states say that’s absolutely the wrong approach because they can use that in court against you.”

Gracey says that if the physician does communicate with the patient or their family after an adverse outcome, they should not admit guilt because their statements might be used in court against them.

It’s still unknown what impact the COVID-19 pandemic will have on medical malpractice litigation.

Byrne says it’s too early to tell as most medical malpractice claims take at least a year to mature. He believes there will be more cases in the COVID-19 era because early in the pandemic when resources were stretched many patients deferred routine care and preventive screenings.

White believes that the pandemic will not lead to a rise in COVID-19 medical malpractice cases against physicians.

He notes that the most common allegation against doctors is failure to diagnose or treat the patient in a timely manner. With COVID-19, physicians are unable to cure the patient, which eliminates part of the common complaint.

“With this pandemic, all they can do is treat the symptoms, they can’t cure the disease,” he says. “So the delay only matters if you fail to recognize and respond to the more dire symptoms, difficulty breathing, for example. That’s the only real potential that (plaintiffs) have.”

He says that of the 80,000 physicians the TDC Group insured in 2020, only 10 have pending claims related to the COVID-19 pandemic.

Many states, such as Florida, have granted certain immunities to physicians protecting them from lawsuits tied to the pandemic. Gracey points out that there are some federal protections as well.

“It’s too early to tell if the if the federal protections will be strong enough or not, but it certainly looks like some of the state-enacted protections will be strong,” he says.

Although he expects many lawsuits to be filed, Gracey believes that once many of these cases are thrown out due to legal protections, the increased filings will quickly taper off.

Byrne also notes that the public health emergency surrounding the pandemic may lead the public to better understand the difficulties of practicing medicine, which could lead to fewer cases being filed. He has tried a few cases during the pandemic, and although they have nothing to do with the pandemic, he’ll mention COVID-19 to the jury.

“In part to just say to jurors that if we’ve learned anything from COVID-19, we’ve learned how difficult the science of medicine is, how quickly things evolve and how so many very sad, difficult outcomes are really unpreventable despite the best efforts of great people,” he says.

This article was originally published in Medical Economics®. 

Preemptive actions can limit a physician’s exposure to litigation.

How to avoid medical malpractice suits

Because of the prevalence of apps and connected devices transferring health data, the Federal Trade Commission (FTC) is offering clarity on the Health Breach Notification Rule.

 from the agency, the rule ensures that entities not covered by the Health insurance Portability and Accountability Act (HIPAA) still face consequences when health data is compromised. It requires vendors of personal health records (PHR) and PHR-related entities must notify consumers and the FTC, and possibly the media, if unsecured identifiable health information is breached or face civil penalties. It also covers these entities’ service providers.

Simply put, the statement says those entities covered by the rule which have experienced breaches cannot hide this from the consumers who have trusted them with sensitive health information.

Issued more than a decade ago, the rule’s requirements with respect to health apps and connected devices are more important than ever with the explosion in their use. While the FTC has advised mobile health app to examine their obligations under the rule, the agency has never enforced it and many entities appear to misunderstand its requirements, according to the statement.

The statement goes on to explain that the rule is triggered when a vendor of PHR with individually identifiable health information created or received by a healthcare provider experiences a breach of security. These breaches are not limited to cybersecurity intrusions or nefarious actions. Incidents of unauthorized access, including sharing of covered information without the individual’s consent, triggers the notification obligation of the rule.

 of many healthcare organizations and saw an increase in attacks from bad actors.

This article was originally posted on Medical Economics®.

The agency wants to give clarity to the Health Breach Notification Rule.

FTC explains Health Breach Notification Rule

The financial outlook for hospitals is likely to remain bleak throughout 2021 as the COVID-19 pandemic continues to impact bottom lines across the country.

 prepared by Kaufman Hall and funded by the American Hospital Association, $54 billion in net incomes are projected to be lost by hospitals nationwide over the course of 2021 even with federal CARES Act funding being taken into account.

Specifically, the analysis projects that median hospital margins could be 11 percent below pre-pandemic levels by the end of the year, but warns that the recent increase in COVID-19 cases tied to the Delta variant was not a factor considered in the study.

The analysis, which is based on actual performance data from the first and second quarters of this year, found that more than one-third, 35 percent, of hospitals in the U.S. will maintain negative operating margins through the end of 2021. The authors also notes that the uncertain course of emerging COVID-19 variants in the U.S. this fall could lead to even more losses.

The actual performance results show that the percentage of hospitals with negative operating margins had decreased from the first to second quarters, the analysis see it improving to 35 percent in the third quarter and then stay flat in the fourth. It’s worth noting that the surge in cases tied to the Delta variant was also not included in this analysis, according to the report.

Contributing factors to the continued losses are:

More high acuity, inpatient cases which require longer stays than before the pandemic.

Increasing costs for labor, drugs, purchased services, personal protective equipment, and other supplies have led to higher expenses for hospitals.

Profitable outpatient visits have continued to grow from the depths of the early pandemic but are still below 2019 levels.

Kaufman Hall believe hospitals across the country will lose about $54 billion in net incomes.

Hospital losses expected to grow through 2021

Healthcare providers at the receiving end of a ransomware attack may have more lose more than access to their data.

, a new analysis found that ransomware attacks could lead to increased mortality rates. About one-in-four, or 22 percent of healthcare providers reported an increase in mortality rate tied to these attacks.

The report was prepared by the privacy, data protection, and information security research center Ponemon Institute and was commissioned by healthcare IT risk solution provider Censinet. The full report is entitled 

The Impact of Ransomware on Healthcare During COVID-19 and Beyond

 and is based on a survey of 597 IT and IT security professionals

The analysis also warns that the onset of the COVID-19 pandemic has only introduced new risk factors to these providers including remote work and the new systems to support it, staffing challenges, and increased care requirements.

“Our findings correlated increasing cyberattacks, especially ransomware, with negative effects on patient care, exacerbated by the impact of COVID on healthcare providers,” Larry Ponemon, chairman and founder of the Ponemon Institute, says in the release. “We also analyzed steps that (healthcare delivery organizations) are taking to protect patient safety, data, and care operations to determine what is working since so many respondents have been victims of more than one ransomware attack.”

The analysis also found that of the providers who had fallen victim to ransomware attacks 71 percent observed their patient had longer lengths of stay, 70 percent reported that delays in procedures and tests resulted in poor outcomes, and 65 percent reported increases in patients transferred or diverted to other facilities. A further 36 percent say they’ve seen an increase in medical procedure complications.

“The combination of data breaches, ransomware attacks, and COVID-19 has created the perfect cybersecurity storm and worst two years on record for IT and security leaders in healthcare,” Ed Gaudet, CEO and founder of Censinet, says in the release. “The Ponemon Research results are an urgent wake-up call for the healthcare industry to transform its cybersecurity and third-party risk programs or jeopardize patient lives.”

About a quarter of healthcare providers report increased mortality rates due to ransomware.