Donna Marbury

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In 1971, President Richard Nixon declared a war on cancer. Many oncologists and patients now reject the bellicose analogy but coming up to the 50th anniversary of Nixon’s statement, the progress that has been made against the second leading killer of Americans is notable.

Because of a combination of public health policies, medical advances, and social reforms, the overall, age-adjusted cancer death rate has been falling since 1991 when it peaked at 215 cancer deaths per 100,000 people. The death rate from cancer declined by 2.2% from 2016 to 2017, the largest single-year drop ever, according to the American Cancer Society’s Cancer Facts & Figures 2020 report.

Earlier diagnosis, more precise treatment, and reduced exposure to known carcinogens — principally cigarettes — have had a favorable effect on five-year survival rates, which now stand at 70% for Whites and 64% among Blacks, as well as on mortality rates.

Lung, colorectal, breast, and prostate cancer are among the most common types of cancer, so declines in their death rates account for much of the drop in the overall death rates. Here are mortality rate trends for those cancers as reported in cancer society’s 2020 report:

Lung cancer death rates declined by 51% from 1990 to 2017 among men and 26% from 2002 to 2017 among women.

Breast cancer death rates declined 40% from 1989 to 2017 among women.

Prostate cancer death rates declined 52% from 1993 to 2017 among men.

Colorectal cancer death rates declined 53% from 1980 to 2017 among men and by 57% from 1969 to 2017 among women.

The cancer society also noted a steep decline in melanoma deaths that it attributes to treatment advances. “The accelerated drops in lung cancer mortality as well as in melanoma that we’re seeing are likely due at least in part to advances in cancer treatment over the past decade, such as immunotherapy,” said William Cance, M.D., the chief medical and scientific officer for the American Cancer Society, in a statement. “They are a profound reminder of how rapidly this area of research is expanding, and now leading to real hope for cancer patients.”

It is important to understand the journey of cancer research and treatment that led to the 25-year decline in deaths, but also to set new goals to ensure treatment is more personalized and equitable in years to come.

“There are certain cancers that have very poor prognoses and high fatality rates. Some of these cancers could benefit from making preventive healthcare and better lifestyles become accessible to all,” notes Smita Bhatia, M.D., M.P.H., an investigator on the St. Baldrick’s Foundation–SU2C Pediatric Cancer Dream Team and director of the Institute for Cancer Outcomes and Survivorship at the University of Alabama, Birmingham. Others, such as pancreatic cancer, she says, require ongoing scientific discovery, and equal access of the scientific discovery to all, in order for death rates to continue to decline.

Maybe one of the more under-appreciated facts about cancer in the United States is huge growth in the number of Americans who have had cancer who are still living: cancer survivors. In an opinion article published in the

 in September, Richard Schilsky, M.D., chief medical officer and executive vice president of the American Society of Clinical Oncology (ASCO), and his coauthors noted that there were 3 million cancer survivors in the United States in 1970. Now there are almost 17 million. The country has a larger population, and the cancer incidence—the number of new cases diagnosed each year—has tripled from just over 600,000 in 1970 to a projected 1.8 million cases this year, Schilsky and his colleagues noted. Earlier detection because of screening and treatment advances factor into survivorship. In 1970, the five-year survival rate was 49%. Now it is about 70%.

“It was a very different landscape both in understanding risk factors for cancer, understanding cancer biology, and having a wide array of cancer-specific treatments,” Schilsky said in podcast that accompanied the article.

 article, Schilsky and his colleagues credit the 1971 National Cancer Act billed by Nixon as launching a war on cancer as catalyzing the progress in cancer treatment over the past 50 years. They credit the law with increasing funding for research and creating the network of comprehensive cancer centers, which, in turn, led to new treatment strategies (including palliative care), a better understanding of risk factors, and a national network of clinical trials.

In the podcast, Schilsky talked about risk factors “coming into much clearer focus” and efforts to mitigate those risks, including prophylactic breast surgery for women with the highly penetrant BRCA gene mutations, sunscreen to prevent skin cancer, programs to encourage Americans to quit smoking, and vaccination against the human papillomavirus to protect against cervical and anal cancer.

All of this occurred against the backdrop of recognizing that early detection of cancer is associated with better outcomes and that has led to the widespread implementation of cancer screening strategies, said Schilsky, who mentioned screening for cervical, colorectal, breast, and lung cancer specifically.

But cancer screening is controversial. Otis Brawley, M.D., a professor at Johns Hopkins University in Baltimore and a member of the 

® editorial advisory board, has been outspoken about what he sees as overscreening that leads to false positives, overtesting, and overtreatment. “Yes, we are still overscreening, but it is not as bad as it once was, especially in prostate cancer,” Brawley said in a recent interview with the 

A 2018 article posted on the National Cancer Institute’s website titled “Crunching Numbers: What Cancer Screening Statistics Really Tell Us” goes through some of the explanations and arguments for how screening may skew cancer mortality statistics, including lead-time and length bias. Moreover, any relative risk reduction seen in a cancer screening program that covers the general population is likely to translate into reductions in absolute risk that are quite small for the simple reason that for a general population the risk of developing cancer is small.

Although overall cancer mortality figures are encouraging, the disaggregated numbers paint a different picture. Survival rates are lower for Black patients (62%) than for White patients (68%) for every type of major cancer except for kidney and pancreatic cancer, for which they are roughly the same, according to Cancer Facts & Figures 2020.

The American Association for Cancer Research (AACR) published a 156-page report about disparities in September. “In recent years, some strides have been made in combating cancer health disparities, as illustrated by narrowing of racial and ethnic disparities in the overall cancer incidence and death rates,” the report notes. “However, progress has come too slowly, and the cost of all health disparities, including cancer and COVID-19 health disparities—in terms of premature deaths, lost productivity, and the impact on communities—remains monumental and must be addressed.” AACR recommendations for closing the disparity gap include increasing funding for efforts to close the gap and enrolling diverse populations in clinical trials.

Donna Marbury is a freelance writer in Columbus, Ohio.

Articles

Public health policies and treatment advances have made a difference. 

Headed in the Right Direction: Cancer Mortality is Going Down

Most providers absolutely dread prior authorization. It adds to administrative work and may seem to stand in the way of good patient care. But for payers, “prior auth” is among the sturdiest, sharpest tools in the managed care toolkit because it gives them a way to control costs and steer physicians toward cost-
effective choices.

Could electronic prior authorization (ePA) bring the two sides together?

“Prior authorization has not changed much in the last five years, but we have seen a shift in the method in which prior authorization requests are submitted,” says Caitlin Graham, vice president of Core Network, a division of CoverMyMeds, a healthcare technology company in Columbus, Ohio, owned by McKesson Corporation. Traditionally, the prior authorization process has been cumbersome, with providers and health plans exchanging phone calls and faxes, says Graham. It is a time-intensive process (Graham puts it rather mildly) that places a burden on pharmacists, providers, health plans and, most critically, the patient who is waiting. As ePA software becomes more accessible to providers, the hassle and wait time for prescriptions may be declining — assuming that providers are ready and willing to use the new technologies.

The COVID-19 pandemic caused many payers to suspend prior authorizations of diagnostic tests and services related to the virus. The disease has reinforced the need to minimize points of friction in the prior authorization process and take the patient out of the middle, says David Lassen, Pharm.D., chief clinical officer at Prime Therapeutics, a PBM headquartered in the suburban Twin Cities and owned by Blue Cross Blue Shield plans. “COVID-19 will likely have a transformative impact on the future as telehealth, and digital automation and tools continue to evolve to meet the rapid demand for greater efficiency and effectiveness in the process,” Lassen says.

Many large health plans have temporarily changed their policies, but the need for continued change and ePA adoption reaches beyond the current pandemic. The ePA software typically integrates directly into electronic health records (EHRs) to provide a near real-time approval for many prescription drugs. Some software providers offer portals and additional software integrations that work alongside EHR systems. As of April 2020, 14 states require ePAs and 16 states allow it. The remaining states have pending ePA legislation, according to Surescripts, an electronics prescription company.

“Just as COVID-19 has impacted nearly every aspect of healthcare, we have seen prior authorization requests drop at the same rate as overall prescriptions in the past few months,” Graham says. “We anticipate that prior authorization volume will return to expected levels as states continue to lift
stay-at-home orders and as people begin to visit their healthcare providers for acute care.”

As more software is developed to make prior authorization less of an administrative burden, providers still struggle with the increased work that goes into the process. The result can be congested workflows that may, ultimately, result in poorer patient care, says Ross Moore, MBA, general manager for revenue cycle at Olive, a healthcare artificial intelligence company in Columbus, Ohio.

At a large health system, it’s not uncommon to have a team of more than 50 people responsible for managing the prior authorization process, notes Moore. Even then, backlogs occur and have a domino effect that may delay patient care, hinder quality and reduce patient satisfaction, he says.

Physicians are not fans of prior authorization. In a 2019 survey of 1,000 practicing physicians conducted by the American Medical Association, more than 90% of respondents said prior authorization had a negative clinical impact and 28% said it led to a serious adverse event, such as death, hospitalization, disability or permanent bodily damage.

PBMs are increasing the number of drugs they are excluding from their national formularies — formularies that the PBMs’ clients don’t necessarily follow but do set a standard. Exclusions make prescribing difficult when providers aren’t able to get real-time prior authorization results, Lassen says. Often, patients are stuck with dealing with the prior authorization process and finding out which drugs are both covered and affordable. “Practitioners don’t have sufficient information available to them at the time of prescribing or point of care,” observes Lassen. They should, he says, be able to identify a drug’s formulary status, utilization management criteria, cost and alternative covered therapies. Because of that lack of information, patients typically find out at the pharmacy that the drug is not covered or requires a prior authorization. “Unfortunately, that puts the patient in the middle of the situation and needing to go back to the practitioner to seek a prior authorization request,” says Lassen.

Although nearly all pharmacies, payers and EHRs have access to ePA in one form or another, half of prior authorizations are still submitted via telephone or fax, according to 2018 payer data collected by CoverMyMeds.

“Although the industry has moved readily to ePAs, most prior authorizations are still not fully automated, but this is the goal,” Lassen says. “With the increased use of prior authorizations for specialty and high-cost medications, the volume of work has potentially become harder.”

One reason providers avoid starting prior authorization requests at the point of prescribing is because they don’t trust the plan formulary information supplied in their EHRs, Graham says. According to CoverMyMeds’ 2020 Medication Access Report, 60% of practitioners report that they only sometimes trust the insurance data available in the EHR and 19% reported they rarely or never trust this information.

Another issue that providers face in increasing ePA adoption is the multiple platforms within a healthcare setting and their interoperability. “As many software and EHR integrations take place, it can be harder for practitioners to work on multiple platforms unless there is full integration into the workflow,” notes Lassen.

Graham says CoverMyMeds works directly with system vendors to develop integrations, making access to its ePA software easier.

Streamlining the most common prior authorizations could lessen the technology and administrative burden. According to Moore at Olive, part of the service that his company provides is an upfront determination if prior authorization is required. The company then helps facilitate authorization requests, frequently checks their status and manages prior authorization denials by automatically making appeals for procedures that have already been pre-authorized but were denied. Moore says that making prior authorization systems more efficient helps to improve the overall satisfaction of patients.

Earlier this year, America’s Health Insurance Plans (AHIP), the trade association for the health insurance industry, launched the Fast Prior Authorization Technology Highway (Fast PATH) program to assist providers in adopting ePA. Fast PATH utilizes the technology of Surescripts, owned by CVS Health, Express Scripts, the National Association of Chain Drug Stores and the National Community Pharmacists Association. As AHIP pitched it in a press release, when medications are ordered through the EHR, Fast PATH gives prescribers immediate access to patients’ pharmacy benefits so they know whether the prior authorization is required and have information about alternatives. And if the doctor prescribes a medication that does require prior authorization, he or she can immediately submit the approval request through the EHR.

Lassen says his company is also jumping on the ePA bandwagon and investing in strategies and tools that will serve up information at the point of care, including real-time benefit check, alternative drugs, cost comparison and the ability to auto- approve prior authorizations. “Our objective is to limit any friction to our providers and members and ensure people get the medicine they need to live healthy lives,” Lassen says.

Moore says one of the obstacles to a more streamlined approach to prior authorizations is the lack of uniformity. “There must be greater collaboration between payers and providers to set universal guidelines on requirements, starting with the high-volume, low-complexity procedure types that consume the greatest administrative cost across the healthcare continuum,” says Moore.

But there are plenty of holdouts. Half of submissions are still done by phone or fax.

Electronic Prior Authorization is Catching on

Have pain? For many years, the answer has been to take a pill. But the opioid epidemic has shown the limitations - dangers - of sticking to just pharmacological approaches to one of the most common, fearsome health problems that people have, especially when the pain settles in as a chronic problem. Clinicians and entrepreneurs - and some patients - have a growing interest in nonpill approaches to pain treatment that use device technologies.    

Multiple virtual reality (VR) solutions now available have been effective in helping patients cope with acute pain. VR can be so absorbing that it takes people’s minds off their pain. For instance, VR applications can help women manage labor pains and even help with the sharp pain caused by removing a bandage. But chronic pain is complex and VR applications to help with it are still very much under development. 

“Acute pain has been proved many times over to be treated very well through VR via distraction therapy,” says Sandra Marshall, a senior associate at the consulting firm Booz Allen Hamilton, who focuses on VR and other augmented reality technologies. “I’ll be curious to see where chronic pain goes in the VR space. It’s a newer application for VR technology, and, as chronic pain manifests itself differently in everyone, what might work for one individual might not work for the next,” she says. 

Marshall says at-home mindfulness, meditation and breathing treatments coupled with VR in the office could help patients with pain. “There is a difference between a wellness app and a clinically prescribed pain management application. If people want to get a wellness app, they can easily get one and use that in the comfort of their home,” she says. “But if they want to use a clinical app specific to treating chronic pain, then it has to be prescribed and monitored by their doctor. Chronic pain therapy can be used both in a clinical setting and at home through a prescription service. That being said, acute pain management is more often used in just a clinical setting.”

For now, Marshall says, practitioners should implement VR in a pain management plan on a case-by-case basis. The devices are getting smaller, although most models are still about the size of a snorkeling mask, and they’re becoming more affordable. VR headsets on Amazon are priced as low as $35. Treating pain with VR “really has to be tailored to the patient, and we are still exploring what types of therapies we can offer in the form of VR treatment that will best help individuals suffering from chronic pain,” says Marshall. She also notes that gathering and analyzing data about chronic pain will help with the development of VR techniques.

Spinal cord stimulators are devices that involve placing electrodes between the spinal cord and the vertebrae in the epidural space. Why they relieve pain isn’t completely understood, but researchers believe that the electrical impulses modulate dysregulated pain pathways. The impulses may also dilate blood vessels, thereby relieving ischemic pain. In this country, the most common indication is for chronic pain after failed back surgery. In Europe, practitioners use spinal stimulators to treat peripheral vascular disease. Yet studies of the efficacy of spinal cord stimulators have produced mixed results. Calculations of how many patients suffer complications vary greatly, from small minority to as many as 40%. Lead migration, when the electrodes move out of place, is one of the most common complications.

Medtronic, Boston Scientific and other large medical device companies offer spinal stimulators. One of the newest is Abbott’s Proclaim XR recharge-free device, which the FDA approved in September 2019. A key selling point is that it works at low doses, so the battery can go without recharging for 10 years, according to Abbott.  

“Our device has a lot of unique aspects to it that are very patient centric,” notes Allen Burton, M.D., medical director for neuromodulation at Abbott. The stimulator works with Bluetooth and Apple iOS, allowing patients to fine-tune the settings within limits set by the physician. “The device controls patients’ pain and brings their symptoms down to a very tolerable level. The patient goes on about their life, and they don’t have to spend a lot of time making those subtle adjustments with the device,” he says.

Burton says the Proclaim XR is for patients with chronic pain who are stuck in a “chronic care cycle where they’re having a terrible quality of life and consuming lots of healthcare resources.” He adds, “We have studied and found that psychologically, it is very advantageous for chronically ill patients to get control of their chronic symptoms but not have constant reminders that they have a chronic illness. We’ve really taken time to engineer this in a very patient-centered way to achieve those goals.”

The vagus nerve, the longest cranial nerve, travels down the body from the brainstem to the pharynx, larynx, trachea, heart and the entire gastrointestinal tract. But it also has two branches that go out to the auricle, or the external part of the ear.

Transcutaneous auricular vagus nerve stimulators take advantage of this structure and the access it provides to the vagus nerve. They work by stimulating the vagus nerve with electrodes placed on the auricle. The first auricular nerve stimulator to get the go ahead from the FDA was approved for acupuncture-like treatment in 2014. 

The IB-Stim device is a version of a transcutaneous auricular vagus nerve stimulator for the treatment of pain from irritable bowel syndrome. The FDA approved it last year for use in patients 11 to 18 years old. Innovative Health Solutions, a device company headquartered in Versailles, Indiana, markets IB-Stim and a similar device, sold as NSS-2 Bridge, for treating the symptoms of opioid withdrawal. 

Katja K. Kovacic, M.D., a pediatric gastroenterologist at Children’s Hospital of Wisconsin in Milwaukee, says patients wear the IB-Stim device for five days straight, day and night, and then take it off for two days before seeing their doctor the following week for evaluation. She adds that depending on individual needs, a patient can use the device on this schedule for several months. Transcutaneous auricular vagus nerve stimulators are an attractive choice for younger people because many parents, as well as the patients themselves, don’t want to involve strong pain medications, observes Kovacic. Practitioners have so far treated more than 500 patients with the device, according to Kovacic.   

Donna Marbury is a writer in Columbus, Ohio. 

The opioid epidemic has led doctors and patients to look for other ways to control pain, and they’re turning to technology for answers.

New Tech Delivers Needed Options for Treating Pain

In the past five years, HHS’ Office of Civil Rights (OCR) has increased enforcement of Health Insurance Portability and Accountability Act (HIPAA) violations, according to the 

. In 2015, there were only six HIPAA penalties, compared with 11 in 2018. Not only have enforcements increased, but fines and settlement amounts are also on the rise. In 2018, more than $28 million in penalties was paid to OCR. The mean penalty amount for 2018 was $2.6 million. Anthem settled for $16 million for failure to respond to breaches that had occurred since 2015 and for lacking technical controls to prevent unauthorized electronic personal health information (PHI) access.

Because OCR enforcement continues to grow, costing healthcare organizations in both dollars and damage to their brands, it is important that health systems stay proactive when deploying technology that keeps PHI and other healthcare data safe. As the healthcare industry becomes more connected, through providers and payers, PHI and other data are transferred between more vendors, says Tim Eades, CEO of VArmour, an applications security company in Los Altos, California. “As health insurance carriers begin or mature within their ‘digital’ journey - think digital health ID cards held in digital wallets or mobile healthcare policy apps - the potential for PHI and personally identifiable information exposure increases,” Eades says.

But with interoperability, there’s a greater risk involved, with data becoming increasingly accessible, says Rich Temple, vice president and CIO of Deborah Heart and Lung Center in Brown Mills, New Jersey. “Ironically, the push for interoperability, and the goal to bring to a provider a patient’s entire medical history across many different arenas of care, poses some serious challenges in the HIPAA realm,” Temple says. “As the flow of PHI increases in the three V’s - volume, velocity and variety - more opportunities open up for that sacred information to be compromised, either by hackers or even by, ostensibly, well-meaning providers who may be using the patient’s data for use cases that go beyond what HIPAA allows.”

21st Century-Style Diabetes Disease Management: Coaches and Tech-Enabled

Ultimately, healthcare executives must stay on the hunt for technologies that can keep data protected, because threats from hackers continue to grow and be more sophisticated every day, says David Williams, general manager of the healthcare provider division of Conduent, a healthcare technology company in Florham Park, New Jersey. “Whether you’re talking about a national level or international level, the ability to hack healthcare data is fairly alarming.”

With the explosive growth of cloud-based technology, especially with many healthcare organizations using third- and fourth-party vendors, the fact that EHR systems are being moved to or connected with cloud-based platforms is a concern. Cloud-based applications can help with data security because the major providers have capabilities that can be used to enable strong security overall, says Eades. “However,” he adds, “if any system is brought from a non-cloud space to full cloud - lift and shift - or a fully on-premise platform is suddenly connected to the cloud, data security - and overall security - can be threatened if the naturally exponential relationships cloud introduced aren’t managed correctly.” 

Although cloud-service vendors can stay abreast of security issues, often faster than their clients, working with a third-party also has its risks, says Temple. “The challenge is that the healthcare organization is now dependent on yet another party, or business associate, to maintain HIPAA standards, and any breach on the part of the business associate will come back to bite the provider, even if the provider themselves didn’t do anything wrong,” Temple says. 

Being able to visualize or map data flow is critical to applying appropriate protection technologies, says Eades. “Healthcare platforms must have the means to map network and systems topologies against data flow. As in the EHR to cloud/cloud-connected example, it’s critical that hybrid cloud and multi-cloud environments are considered as well.”

Since 2009, more than 189 million healthcare records have been stolen or exposed in over 2,500 breaches, according to the 

. The number of breaches in the past decade amounts to nearly 60% of the U.S. population possibly being affected.  

As more connected devices become available for patients, Temple says, providers have to stay alert when they interact with a health system’s data network. Medical devices themselves, such as balloon pumps and patient monitors, and the growing array of healthcare devices classified as the “internet of things,” are alluring targets for criminals, notes Temple. Having technologies that are monitoring data and how it’s being used can be one of the best ways to catch a possible HIPAA violation early and take steps to fix it, Williams says. “Health systems should have technology to identify a threat, monitoring on a daily basis, if not hourly,” Williams adds. 

Building in redundancy is also important if a primary system gets compromised through a malware attack. “We go well beyond the standard anti-virus, anti-malware that most organizations have deployed. We have robust backup regimens so in the event of an attack, we are as well positioned as we possibly can be to recover a legitimate dataset,” Temple says. “We are continuing to enhance our security toolset to monitor packets crossing our firewall and our endpoint assets for irregular activity. We even have some redundancy in our monitoring to make sure we have that extra layer of protection.”

Although increased technological advances can keep healthcare organization in compliance with HIPAA, ultimately educating staff on data safety is a first barrier, says Temple. A 2019 analysis by Bloomberg Law found that the fifth most common cause of data breaches in healthcare is from staff having inappropriate access to team members’ or patients’ information. Though the intent of the staff’s inappropriate access wasn’t always clear, the analysis found that some employees had looked up patients’ or other staff members’ data out of goodwill, such as to send a sympathy card. However, many staff breaches are due to mistakes, carelessness, and ignorance of HIPAA laws, the Bloomberg analysis found. 

Because of the real risk in human error, Temple also suggests endpoint and perimeter protections that can monitor for unusual behavior on the network and alert key players to that behavior. “A big technology gap is the human beings who work at healthcare organizations,” says Temple, noting that bad actors gain access to systems through phishing emails. We constantly have to keep our people vigilant to not click or open things [when] they are not absolutely certain of the legitimacy of the source.”

Technology that provides encryption, two-factor authentication, secure messaging portals and automatic log offs can help when human error leaves PHI vulnerable, says Michelle Garvey Brennfleck, associate and healthcare attorney at Buchanan Ingersoll and Rooney, a Pittsburgh law firm and lobbying group.

 “Technology that is as close to fool-proof as possible may limit vulnerabilities and associated risk.” Brennfleck adds. “This is particularly important in the HIPAA space where one negligent or bad actor can create high dollar exposure.” 