Healthcare system costs continue to be in the centre of political debate, despite some irreconcilable differences over the Obama-era Affordable Care Act. The last news from the Capitol seemed to leave some hope for the near future, concerning at least some healthcare system related issues. Lawmakers in both chambers of Congress are working towards reaching a bipartisan agreement on lowering costs for people who are already insured.
According to CNN and the Associated Press, there has been shown a willingness to work together on a few health care issues that directly affect Americans.
After the Fourth of July recess, the Senate and House are making efforts to elaborate legislation that should put an end to surprise medical bills, restrain high drug prices, and set limits to prescription copays for people insured in Medicare.
A sign that things are going in the desired direction is the fact that the House recently voted in favor of making generic drugs more available for people, after bipartisan efforts in recent weeks concerning surprise billing and drug prices.
Previous efforts to prevent surprise medical bills
The stakes are high, since medical bills weigh heavily on American families: lowering prices and reducing unknown billing are of utmost importance. President Trump has spoken out since January against surprise medical bills that patients often cannot afford, calling upon administration officials HHS Secretary Alex Azar and Labor Secretary Alex Acosta to investigate how to prevent surprise medical bills.
Then, in March, a bipartisan Senate health care price transparency working group released draft legislation that it hopes will protect patients from surprise medical bills.
In a statement, the group of Senators said the draft bill was intended to jumpstart discussions in Congress about how to best stop the use of balanced billing to charge patients for emergency treatment or treatment provided by an out-of-network provider at an in-network facility.
Meanwhile, overbilling patients has not been without consequences for some companies. uBiome, for instance, suspended clinical operations în May, following an FBI investigation regarding their billing practices, following complaints from customers who allegedly have been billed multiple times for tests.
Where are we now with the new legislation?
More than three months later, we might be getting closer to a satisfactory form of the needed legislation. The Alexander-Murray discussion draft on surprise billing has elements of legislation presented to the House and Senate last week. The idea is basically one representatives have been working on for a while now, ensuring that patients who need out-of-network emergency care would only be responsible for their in-network costs. Even more important, any patient needing follow up services and further treatment would have to be informed beforehand if any of the medical care providers are not part of their insurance plan. Patients would then be able to make informed decisions about their care, and not be taken by surprise when the final bill is issued.
The draft legislation includes more options for paying the difference between what the patient pays, and what the provider bills. The provider will be paid the median in-network rate for the services rendered, and the insurer and provider can even have recourse to arbitration in case of need. The law would also impose a 30-day rule requirement for providers to send the bills, otherwise patients would not be required to pay them. Insurers would be obliged to keep their directories of in-network providers up-to-date.
The bipartisan legislation draft tackles the problem of overpriced generic drugs, by introducing “biosimilars”, less expensive versions of complex and high-priced biologic medications. The idea is to give people access to complete information concerning the whole range of drugs and their respective prices, impeding the ability of providers and insurers to make agreements such as banning gag clauses, to hide cost and quality information. Insurers and providers would be obliged to supply an estimated out-of-pocket cost for certain services, so patients can make truly educated decisions about the care they want or can afford to receive and pay for.
Medicare for All, a question of “whether” or “when”?
The legislation draft was presented only a day after the House Budget Committee hearing on establishing a single, government-run health insurance system in the US, such as Medicare for All.
Last month, experts from the Congressional Budget Office released a report, at the lawmakers’ request, about what Congress would be forced to take into account when elaborating a viable plan for Medicare for All: how it would be financed,how much patients would have to contribute out-of-pocket and the ratio at which providers would be reimbursed. The estimated costs for a 10 year period are of $32 trillion, a number which prompted insurers, doctors, hospitals and pharma industry representatives to strongly oppose any legislation.
Lawmakers at the hearing tried to strike political points during the debate. Republicans declared the system to be costly, and were against limiting choice for Americans, in a healthcare plan which would lengthen the waits for care. On the other side, Democrats reiterated the need to offer access to healthcare to the estimated 30 million people who are now uninsured, and focused on the ability for a government-run plan to lower administrative costs and be able to conclude better deals with providers.
House Democratic leaders have not yet embraced Medicare for All, but Budget Committee Chairman John Yarmuth, a Kentucky Democrat, feels things are going along in the right direction. “It is incumbent upon us to begin to work through the opportunities and tradeoffs involved in a single-payer system, as well as other ways to achieve universal coverage, many of which have been proposed by members of this committee,” he said. “I strongly believe it’s not a matter of if we will have universal coverage, but when. The CBO report and this hearing are designed to advance that timeline.”
The voters will have the last word on the matter in next year’s elections
Yarmuth’s optimism might be based on solid grounds. Partisan disagreements about Medicare for All could make things difficult; both parties want a good outcome in the 2020 elections. Lawmakers are afraid of the voters’ verdict next year if they cannot cut drug prices, as promised. Since President Donald Trump himself promised results which have not yet become true, he also is now politically exposed. July 7th, he promised an executive order that would allow the U.S. government to pay lower prices for prescription drugs thus making sure, according to him, that the U.S. would not pay more than the lowest price charged to other nations or companies.
While different parts of proposed legislation are currently in a half-dozen committees, both in the Senate and the House, all at various stages, the power to decide what will pass seems to lay with the Senate, since Republicans and Democrats have to work together to avoid gridlock on the Senate floor that could sidetrack passing any legislation.
It remains to be seen, however, whether the solution politicians choose will be revolutionary, or more on the cautious side. “The public demand for action is high on both sides of the aisle and I’m sure these guys are feeling it,” said John Rother of the National Coalition on Health Care, an umbrella group that represents a cross section of business and consumer organizations. “They have to do something, and the question is, is that something is going to be meaningful, or is it going to be window-dressing?”
I had the distinct pleasure working with family physician colleagues in Sweden recently. It was a similar experience to a trip I made to Britain about five years ago that I also wrote about. I got to spend some time watching one of my colleagues care for her patients in her surgery (they use the same description of a clinic as the British).
I got to spend some time watching one of my colleagues care for her patients in her surgery (they use the same description of a clinic as the British).
The infrastructure was very similar to what I saw in Britain. It was a spacious office that included a physical therapist, a counselor, and at least one chronic disease nurse. They also had a fitness center at the end of the building.
The waiting room is small, because patients don’t spend much time there. The family physicians’ offices large, much larger than the typical American office. It includes a desk and two chairs, and examination table, and other equipment such as a spirometer. The doctor stays in the same room all day and does not bounce from room to room.
There were no in MAs, no screenings, no PHQ-9 questionnaires, and often no vital signs were taken other than blood pressure in patients with pre-existing hypertension. They need fewer employees per physician. All of the patients I saw her care for were in their 80s who were there for their annual review. The interviews were in Swedish, but another Swedish physician was with me, and he was able to type out what they were saying on an iPad.
Just like in Britain, their EMR is so much easier to use than American EMRs, because they are not loaded down with all the American baggage. There are almost no buttons to click, no pop-ups, and no bill’s to fill out. After each visit, the family physician spent 30 to 60 seconds dictating a note, and that was it for her documentation. A secretary in her office typed out the note that was much shorter than an American Medicare-mandated bullet counting note bloat monstrosity. The purpose of the note was to serve as a brief reminder to the physician of what she did in the visit. That was it. The EMR included e-connections to the pharmacy. To the degree the doctor looked at the computer instead of the patient, it was almost entirely to click the prescription refill buttons after the doctor and patient it talked about the related conditions.
For further evidence that more prevention will not decrease health care costs, I found that this physician was more comfortable with higher blood pressures in her patients than American guidelines would tolerate. The other physician I was with confirmed that this is common practice. They are worried that falls will increase if the pressure gets too low. Also, there is essentially no primary prevention of cholesterol disease with statins and Sweden. The doctors said that if a patient had a really high family history of coronary disease or strokes and asked to be on a statin, they would probably prescribe it, but in general, statins are not prescribed until after someone has a heart attack, a coronary artery procedure, or a stroke.
When I talked to Swedes who were not in the health care system, they were generally very happy with their national system. There were some complaints about long waiting times for elective surgeries and a national shortage of nursing home beds. Others questioned if they were getting full value for their investment in taxes. I met several people who had spent some time in America, and they were the most vehement about how well the Swedish system cares for his people, in contrast to some horror stories they told about relatives back in the U.S.
There are many similarities in how Sweden and Britain finance their health care systems. One difference is that Sweden has a relatively small percentage of its doctors who are family physicians, which they are trying to increase. Britain has a looming shortage, but there are still many more there than in Sweden.
The biggest difference for me between the systems is that in Britain, the NHS is a national religion. It’s always in the news, and the general public thinks about it a lot. In Sweden, as another example of how prevention does not explain lower national health care costs, they only provide colonoscopy for cancer screening in Stockholm and Gothenburg. They want to expand the service to other regions, but it won’t happen soon. I saw no angst or protests about this fact.
I found the Swedish people to have a more passive acceptance than the British that the national health care system will take care of them. Someone in Stockholm is making rationing decisions, but I saw no evidence that those decisions are anywhere as public and transparent as they are in Britain. Both countries make difficult decisions to live within their means, but the Swedes just choose not to worry about it. That’s not a criticism by any means, just an observation of how they choose to spend their emotional energies. Instead of worrying about national or regional health care policy decisions, they prefer to spend their energy planning their next Fika (coffee break).
New findings suggest a simple blood test could one day offer a way to diagnose Alzheimer’s disease—and monitor patients’ response to treatment.
Researchers designed a new system called APEX (Amplified Plasmonic Exosome) to pick up the aggregated amyloid beta (Aβ), an early-stage molecular marker of Alzheimer’s.
The new technology is highly sensitive and provides an accurate diagnosis—comparable to brain positron emission tomography (PET) imaging—the current gold standard for Alzheimer’s disease. The cost is only about $30 per test, less than 1 percent of the cost of PET imaging.
The current design could test 60 samples simultaneously and produce results in less than one hour, researchers say. Because the APEX system uses native blood plasma without additional sample processing, it conducts direct measurement and is very simple to use in clinical settings.
Simple, safe, and affordable
In 2018, dementia affected 50 million people worldwide, and experts expect the number to rise to 82 million by 2030 and 152 million by 2050. Every year, over 9.9 million new cases of dementia are diagnosed worldwide.
Alzheimer’s disease is the most common cause of dementia, researchers say. Due to its complex and progressive nature, early detection and intervention can improve the success of disease modifying therapies.
Unfortunately, current diagnosis and monitoring—using clinical evaluation and neuropsychological assessments—are subjective and the disease tends to be detected only at a late stage. Other alternatives such as PET imaging and cerebrospinal fluid tests are either too expensive for wide clinical adoption or require invasive lumbar punctures.
Blood-based tests, on the other hand, have the advantage of being safe, affordable, and easy to administer. However, one key challenge for scientists is that blood has very low concentrations of Alzheimer’s disease molecules, and not all of these molecules are disease-reflective, making detection and diagnosis difficult.
The new system could be a big step forward in providing a solution to effectively “capture” and measure the most meaningful Alzheimer’s molecules in blood samples and amplify them for analysis, researchers say.
“There is currently no good blood-based method to effectively screen and monitor AD. New tests that are under investigation have either poor accuracy or low sensitivity,” says Shao Huilin, assistant professor from the Institute for Health Innovation & Technology (NUS iHealthtech) at the National University of Singapore.
“The APEX technology addresses both of these limitations and is therefore a very powerful and objective companion diagnostic system to complement existing clinical and neuropsychological tests for early detection and better management of AD.
“As blood tests are relatively easy to administer, APEX can be also used to monitor a patient’s response to treatment. Furthermore, this technology can be easily scaled up for large cohort clinical validations and drug evaluation.”
How the APEX system works
A key characteristic of Alzheimer’s disease is the buildup of amyloid beta (Aβ) proteins in the brain. These Aβ proteins clump up as aggregates and kill brain cells. Aβ proteins also release into and circulate through the bloodstream.
Researchers designed the APEX system to detect and analyze the earliest aggregated forms of Aβ proteins in blood samples, to allow detection of Alzheimer’s even before clinical symptoms appear and to accurately classify the disease stages.
“Traditional technologies measure all Aβ molecules found in the blood, regardless of their aggregation states, and thus show poor correlation to brain pathology. Our study found that the aggregated form of the protein could accurately reveal brain changes and reflect AD disease stages,” says Carine Lim, a doctoral student from NUS iHealthtech and NUS Biomedical Engineering, and co-first author of the study in Nature Communications.
The APEX technology is size-matched to distinguish this group of reflective Aβ proteins directly from blood samples. Each APEX chip is 3 cm by 3 cm—about a quarter the size of a credit card—and contains 60 neatly-arranged sensors, each to analyze one blood sample.
“Within each APEX sensor, there are millions of nanoholes to enable unique interactions with the aggregated Aβ. The APEX sensor recognizes the abnormal Aβ aggregates directly from a very small amount of blood, induces and amplifies a color change in the associated light signal,” says co-first author Zhang Yan, a doctoral student from NUS iHealthtech and NUS Biomedical Engineering.
APEX vs. PET
To determine the performance of the APEX system, Shao and her team conducted a clinical study involving 84 individuals, including patients diagnosed with Alzheimer’s or mild cognitive impairment, as well as a control group comprising healthy individuals and patients diagnosed with vascular dementia or neurovascular compromises. The researchers conducted PET imaging and blood sampling on all participants.
“The results of the APEX tests correlate extremely well with PET imaging results. The clinical study shows that the APEX system can accurately identify patients with AD and those with MCI; it also differentiates them from healthy individuals and patients suffering from other neurodegenerative diseases. In fact, this is the only blood test that shows such comparable results with PET imaging, the current gold standard for AD diagnosis,” Shao says.
Shao and her team are currently in discussions with industry partners to commercialize this technology. Researchers expect the device will reach market within the next five years.
In the next phase of research, the team hopes to use the technology to manage the disease and to evaluate therapeutics under development.
SugarBEAT, a non-invasive continuous glucose monitor (CGM) that can be worn around the arm, has been approved for sale in the European market. GlobalData, a leading data, and analytics company, predicts that the device is set to disrupt the wearable health tech market.
Renuka Sreeramoju, medical device analyst at GlobalData, said: “Due to its non-invasive nature and relatively low cost, SugarBEAT is expected to give tough competition to invasive CGM devices and attain a strong position in both diabetic (insulin and non-insulin dependent), pre-diabetic and wearable health tech markets in [the] future.”
What is SugarBEAT
SugarBEAT, which is manufactured by United Kingdom company Nemaura Medical, is a disposable adhesive patch worn on the arm. The patch draws interstitial fluid from the skin for glucose analysis by passing an imperceptible electric current through the skin.
Nemaura Medical said the adhesive patch system can be worn on non-continuous days, making it suitable for pre-diabetic and Type II diabetes patients, both of whom typically check their blood sugar levels periodically.
A press statement explained that the device is connected to a rechargeable transmitter and provides real-time, continuous glucose readings at five minute intervals — that is per hour — thereby creating an ambulatory glucose profile chart, where the trends, patterns and the extent of fluctuations and out of range glucose profiles can be observed.
The CGM device works with a smartphone app, which provides audible alerts or physical vibration of the Bluetooth-enabled mobile phone connected to SugarBEAT in instances where glucose levels are deemed to fall to dangerously low levels, until switched off by the user.
Sreeramoju said: “The high unmet need of standard finger stick testing and the painful insertion of CGM devices under the skin can be achieved by the availability of a Bluetooth-enabled smartphone CGM wearable device.”
Nemaura Medical plans to launch SugarBEAT in the United Kingdom and German markets in the third quarter of this year. The company says it is on track to submit an application to the U.S. Food and Drug Administration (FDA) mid this year.
Size of the CGM market
GlobalData estimtes that the glucose monitoring devices market in Europe will grow from $3.4 billion in 2018 to nearly $4.8 billion in 2025. In addition, GlobalData said the global and U.S. markets are set to grow 4.6 percent and 3.2 percent to reach US$16.3 billion and $5.6 billion, respectively, over the same period.
Due to its non-invasive nature, GlobalData projected that SugarBEAT was best placed to disrupt the multi-billion-dollar global diabetic and pre-diabetic markets.
Nemaura Medical Chief Executive Officer, Faz Chowdhury, described SugarBEAT, as the world’s first non-invasive, needle-free, continuous glucose monitor, which was painless and versatile in terms of wear time.
“Given these benefits, we look forward to aggressively entering both the multi-billion-dollar diabetic (insulin and non-insulin dependent) and pre-diabetic markets. In addition, we plan to target the wearable health tech market for health-conscious consumers, which is experiencing explosive growth,” Chowudhry said.
Nemaura Medical’s clinical studies took place over 225 patient days and included 75 participants with either Type I orType II diabetes. The studies generated over 12,000 paired data points, with blood samples taken via catheter every 15 minutes over a 12-hour period for three non-consecutive days for each patient, the company said in a statement.
Nemaura Medical added that no device-related adverse events were reported.
Other continuous glucose monitoring devices that are available on the market are Senseonics’ Eversense, Abbott’s FreeStyle Libre system, Medtronic’s Guardian Connect and Dexcom G6.
Abbott’s FreeStyle Libre 2 CGM and Dexcom’s next-generation integrated G7 CGM are lined up for market entry in future, the GlobalData statement said.
LifeScan has also announced plans to launch a CGM system at the beginning of next year in collaboration with Sanvita Medical, a subsidiary of Nova Biomedical.
A public cloud is a smart option for mid-sized organizations since they often run lean and may have a small or non-existent IT team. But in the rush to take advantage of the cloud, they tend to focus on overcoming networking issues and scaling capabilities first, with security as an afterthought. And when they do think about security, it is usually in terms of who on the team has access. It is often assumed that security is the cloud provider’s responsibility when in reality, it is a shared responsibility.
This creates a security gap that malicious actors are happy to flow through. Securing your data is critical, but it does not have to be complicated. Mid-sized businesses tend to put most of their security eggs in the network-based solutions basket. These solutions are focused on preventative measures, when zero-day attacks, by definition, take advantage of unknown vulnerabilities.
Another serious weak spot is the continued use of passwords or any other form of shared-secret scheme used to authenticate people. Lists of hacked passwords are for sale on the dark web, phishing remains a successful method of obtaining users’ passwords and password-cracking tools are getting better and better.
Topping the list of weak spots, though, is the notion that cybercrimals wouldn’t bother to breach you because your company is too small, unimportant or not valuable enough. Bigger is not always better to cybercriminals. Yes, bigger businesses tend to yield a bigger pay-off, but they also have stronger security programs than mid-sized companies. Attackers like low-hanging fruit just as much as the next guy.
Breaches Are Costly
Surviving a data breach can be much more difficult for mid-sized companies. According to the Ponemon Institute’s 2017 State of Cybersecurity in Small & Medium-Sized Businesses report, the average clean-up cost for mid-market companies after being hacked is more than $1 million. In addition to clean-up and containment costs, there may be fines, depending on the industry and jurisdiction the company falls within. A mid-sized business may not have the funds to survive a breach.
The most popular attack methods against smaller businesses, the Ponemon report found, are ransomware, malware, phishing/social engineering and web-based threats. While firewalls and malware detection software are available inexpensively, they cannot protect data once the network has been breached.
Encryption Is Not Just for Enterprises
Encryption is often regarded by mid-sized organizations as an expensive solution to a problem they don’t have. After all, who would want their data? However, medium-sized companies are being increasingly targeted by cybercriminals for data. One study found that 53 percent – just over half – of mid-market businesses suffered one or more breaches last year.
Data needs to be kept safe for the sake of compliance, too. Small companies with medical records, for instance, have private data that needs strong data protection that meets industry compliance regulations.
Mid-market companies tend to view encryption as complex and hard to implement, they tend to ignore it or discount it as a viable security method for mid-sized companies.
However, encryption is not as hard as it sounds. At its most basic, encryption is a cryptographic system to encode data and files in such a way that only authorized users/devices can access it and those who are not authorized cannot. However, data encrypted at the network, web server, application server, database, app system or hard
This is the case because it matters where data is encrypted or decrypted. If it happens in any part of the system—the hard disk drive, operating system, database, etc.—other than the business application using that data, significant residual risks remain despite the encryption. An attacker need only compromise a software layer above the encrypting layer to see unencrypted (plaintext) data.
The most logical place to protect sensitive data is the application layer—the highest layer in the technology stack—because it offers the attacker the smallest target. This also ensures that, once data leaves the application layer, it is protected no matter where it goes – and, conversely, it must come back to the application layer to be decrypted.
Criminals don’t want encrypted data because it is unreadable unless the person who accesses it has the appropriate key. Authentication is how you control access to those encryption keys.
Authentication is Essential
The idea behind authentication is to make sure that a person or technology trying to gain access to data is actually that person or technology. There are various kinds of authentication, such as two-factor authentication delivered via SMS, email or biometric verification. In the case of gaining access to encryption keys, authentication that requires tokens or biometrics is the strongest option.
To encourage organizations to adopt strong authentication, the FIDO Alliance has developed a specific protocol. By conforming to the latest FIDO Alliance standard, strong authentication leverages years of Public Key Infrastructure (PKI) cryptography expertise to verify the identity of users and devices to enable strict authorization and access to encrypted data and files.
The goal of the FIDO Alliance is to promote ubiquitous, phishing-resistant, strong authentication to protect internet users worldwide. The FIDO protocols and authenticators on which they are based:
Require the customer, in the case of a purchase, to prove their presence in front of the computer originating the purchase—with possession of the FIDO authenticator.
Cannot be used for phishing attacks. Attackers cannot compromise the protocol’s cryptographic messages and use them to masquerade as the legitimate customer.
Protect users’ privacy. Even with a stolen or lost authenticator, attackers cannot learn a customer’s identity and use it to compromise the customer’s account.
Require a hardware-based authenticator, which is not susceptible to attacks from the internet like file-based credentials are.
Strengthen Your Data Security
Recent statistics reveal that mid-sized businesses are targets for cybercrime just like their larger counterparts. With valuable data and smaller IT security teams, mid-market companies need encryption as part of their security strategy. The cost to clean up a breach keeps rising, and some businesses can’t survive that financial hit. Use the information above to implement strong encryption and authentication so that when a breach eventually occurs, you can rest easy knowing that any stolen data is useless to attackers.