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CMS seeks to expand provider access to claims data through pilot program

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The Centers for Medicare and Medicaid have launched a new program meant to give providers more access to claims data as an effort to drive better clinician practices.

The pilot – dubbed Data at the Point of Care (DPC) – is part of the agency’s MyHealthEData initiative which is meant to enable the free flow of patient data. It builds on the organization’s launch of Blue Button 2.0 last year, which created the technical ability for beneficiaries to securely link their Medicare data to apps and tools created by developers.

DPC would essentially use the standardized FHIR-based API to link claims data into a physician’s workflow, allowing providers to get a more holistic and complete picture into an individual’s health status.

Participants will have the ability to request a Medicare beneficiary claims data from CMS to better understand their medical history and previous treatment patterns from other providers. That additional insight could lead to fewer unnecessary testing and procedures, more informed clinician decision making and ultimately lower downstream costs.

CMS touts the new program as helping to unlock the silos that exist between clinical data locked in EHRs and other healthcare systems, allowing for a much more useful and extensive health record.

The organization is looking for volunteers for the program which is slated to begin its roll out later in the fall.

Alongside the announcement about the DPC program, a group of 20 technology companies, healthcare providers and health plans including Apple, Amazon, Blue Cross Blue Shield and Anthem have agreed on building the infrastructure and standards necessary to make medical claims data easier for patients to access in an effort called the CARIN Blue Button data model.

Photo: JamesBrey, Getty Images

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Amgen cancer drug with ‘undruggable’ target shows more progress

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A drug that targets a protein long considered “undruggable” has racked up responses in patients with two additional cancer types, following initial response data in lung cancer presented at a conference last month.

Thousand Oaks, California-based Amgen said in its second quarter earnings Tuesday that the drug, AMG 510, had produced tumor responses in patients with colorectal and appendiceal cancer. Prior data from the ongoing Phase I/II study, which Amgen presented at the American Society of Clinical Oncology meeting last month, had shown responses in patients with non-small cell lung cancer and stable disease – but not objective tumor responses – in four patients with colorectal cancer.

In a note to investors, Cowen analyst Yaron Werber called the new data “encouraging.” The fact that the drug is now also showing initial responses in [gastrointestinal] tumors in a handful of initial patients addresses one of the lingering concerns about the data at ASCO where there were no responses in GI at that time as patients were on lower doses,” he wrote.

The patients with colorectal cancer and appendiceal cancer had been receiving the 960mg dose of the drug.

AMG 510 targets KRAS G12C and is the first drug to show activity in KRAS mutations, which are commonly expressed in many cancers but have long eluded drug treatment. KRAS G12C is the most common KRAS mutation and is estimated to occur in 13 percent of lung cancers and 1-3 percent of other solid tumors. However, while RAS proteins in general have been seen as undruggable do not have “pockets” that drugs can effectively bind to, an expert said in May that KRAS G12C in particular has a configuration that makes it more readily druggable than other KRAS mutations.

Several other companies are also developing KRAS inhibitors. Most recently, earlier this month, Redwood City, California-based Revolution Medicines said it had closed a $100 million Series C funding round that it would put toward pipeline programs that include drugs targeting RAS mutations, including KRAS G12C. And last month, Frontier Medicines launched with a $67 million Series A round, which it also plans to use to develop drugs that have “undruggable” targets.

But by far, AMG 510 remains ahead of the pack.

In a conference call with investment analysts Tuesday, Amgen Executive Vice President for Research and Development David Reese said that enrollment in the Phase I/II trial’s monotherapy expansion cohort had completed. The trial is now enrolling patients with NSCLC in an arm that combines AMG 510 with a PD-1 inhibitor.

Reese added during the call that in the coming days, the company plans to start enrolling patients in the Phase II portion of the Phase I/II study, which could potentially be used for Food and Drug Administration approval.

Photo: Alaric DeArment, MedCity News

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ThirdEye Gen partners with Dolphin Medical Imaging to bring mixed reality tech to healthcare

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The promise of mixed reality – which involves the merging of real and virtual worlds through a technological device – has led investors to pour billions into startups like Magic Leap and a major effort from Microsoft to develop their HoloLens product.

While the entertainment and gaming applications for the technology are clear, mixed reality has seen increasing use in industrial and enterprise settings.

Mixed reality glasses startup ThirdEye Gen is betting hard on the technology’s intersection with healthcare and has developed a partnership with handheld ultrasound company Dolphin Medical Imaging to bring their devices into the clinic.

Based in Princeton, New Jersey, ThirdEye Gen is not as well capitalized as some of its competitors, but has developed smartglasses that CEO Nick Cherukuri touts as much more portable and affordable than existing options on the market.

The company’s X2 mixed reality smartglasses are about half the size of the Microsoft Hololens and retail for $1,950, compared to $3,500 for Microsoft’s device.

Initially the idea being the collaboration with Dolphin Medical is to use the device to make it easier for clinicians to find blood vessels for the placement of catheters. Currently, Dolphin Medical’s technology is linked to a tablet or mobile device, integrating ThirdEye’s glasses would beam the image directly into the user’s eyes.

Eventually the companies are looking to expand the partnership to develop new applications for use in pre-hospital and inpatient emergency and critical care.

Dolphin Medical Chief Medical Officer Mel Harris described the added benefit as “the whole being greater than the sum of the parts.”

“Sure you can see an image off a tablet, but when you’re a medic in a pre-hospital setting or dealing with a critical care case, you want information at the point of care immediately right in front of your eyes with great mobility and ease of access,” Harris said.

Cherukuri said the company’s enterprise strategy led the team to develop a form factor which can be worn for multiple hours comfortably, has the ability to work in different lighting situations and is scalable for a large workforce because of its lower price point.

ThirdEye does only limited software development internally and instead collaborates with more than 1,000 software development partners globally to build new use cases and applications.

Outside of the company’s work with Dolphin, Cherukuri pointed to other healthcare use cases that have emerged like helping the visually impaired and providing more effective remote telehealth support for clinicians.

Of course, as in the case with any emerging technology, there’s no guarantee of success. The virtual reality and mixed reality space is littered with companies that had big ideas, but couldn’t pull them off.

In fact, Harris started his own mixed reality company focused on vascular previously that failed to gain momentum in the market.

So what makes now the right time for a company like ThirdEye to make a splash in healthcare?

“The tipping point of ultrasound by non-physicians has been reached,” Harris said. “What Dolphin has done with ThirdEye is simplified the technology, decreased the cost and package it with a wearable computer capable of handling an enormous amount of information to better optimize medical care.”

Picture: ThirdEye Gen

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HEALTH

Fat Burners: Foods, Exercises and Side Effects

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Burning of fat plays a major role in any individual’s weight loss aspirations. While there are several fat burners one can turn to in order to achieve these goals, it is advised that one stick to natural sources. We discuss all you need to know about fat burners below.

Table of Contents

Natural fat burners

Although your aim may be to burn fat quickly and get into shape faster, it is not healthy to do so. This could lead to rapid weight gain the moment you deviate from your weight loss diet. The availability of artificial fat burners may tempt your to go down that route but these come with harmful side effects that we will discuss later in this article.

These fat burners help boost your metabolism, and thus increases the amount of fat you burn. Opt for natural fat burning foods over artificial fat burning supplements that are available to you, since they can adversely affect your health.

Combine the consumption of these foods with an active lifestyle. As a result, your body will use higher amounts of fat for energy.

Fat burning foods

As mentioned earlier, it is best to opt for natural fat burning sources, rather than artificial supplements. Eating these foods will go a long way in helping you burn fats at a healthy rate.

1. Apples

The reason why you should eat apples is that these fruits contain flavonoids. It is a natural chemical found in plants, which is responsible for burning fat. According to a study published in 2017, researchers made an important discovery. They found a correlation between flavonoid intake and lower waist circumference and body mass index.Apples help in burning fat

2. Brown rice

In several parts of India, eating white rice is the staple diet. However, you should replace it with brown rice, as this food in its natural state is beneficial. The reason is that your body isn’t efficient in consuming this fat burning food, which helps you lose weight.

A recent study published in 2017 shows the link between whole grains and weight loss. Researchers observed 49 men and 32 women for six weeks to understand the impact of whole grains. They discovered that there is an association with the consumption of these food types and reduction in obesity and body weight.

3. Chilli

If you like spicing up your food with chillies, continue to do so. They are excellent fat burning foods, due to the presence of capsaicin. When you add this to your diet, it makes you feel full. As a result, you avoid overeating and stuffing yourself with excess calories.

Researchers discovered in 2018 that capsaicin is responsible for increasing your metabolism. Adding chillies to your diet is beneficial, as it reduces fat mass and body fat.

4. Coffee

Coffee is one of the top beverages in the world due to the presence of caffeine. It helps enhances your physical and mental performance while improving your mood. On top of that, it also falls in the category of fat burning foods.

When you consume coffee, it increases your metabolism. During this period, combining it with exercise will help burn greater amounts of fat. You should only consume 1 – 4 cups of coffee every day. Excess amounts of caffeine will keep you awake at night.

5. Eggs

Eggs are a crucial part of several popular diets, as it is full of nutrients. The best part about it is that they are excellent fat burning foods. When you add eggs to your meal, you feel full for a couple of hours. As a result, you consume a lower amount of calories, which in turn helps reduce body fat. Eggs contain protein, which is responsible for enhancing your metabolic rate.

6. Fatty fish

Most of the diets always include fatty fish, as it is quite healthy. Mackerel and sardines have high amounts of omega-3 fatty acids. These nutrients aid in eliminating body fat, helping you lose weight faster. The presence of high-quality protein makes you feel full for longer periods. Also, it improves your metabolic rate, which helps digest carbs and fat quickly.

Another reason is that it reduces the production of cortisol, a stress hormone. When secreted in large amounts, it stores greater amounts of fat in your body.

7. Green tea

There are several reasons which support why green tea is healthy. It contains moderate amounts of caffeine, which enhances metabolism. Also, it contains high levels of epigallocatechin gallate (EGCG). Due to the presence of this antioxidant, your body burns fat at a faster rate. Make sure you only have a maximum of four cups every day. By following this strategy, you will observe greater health benefits.Drinking green tea helps burn fat

8. Olive oil

Out of all the healthiest oils you can consume, olive oil is on top. By cooking with this edible oil, it increases HDL cholesterol, while bringing down triglycerides. As a result, your body releases GLP-1, which helps you remain full for longer periods.

Also, a study published in 2018 showed an increase in fat loss when consuming extra virgin olive oil. The best way is to add this edible to cooked food or salad, to observe benefits.

Fat burning diet plan

Consuming natural fat burners can be crucial to weight loss. However, it is best to follow a particular diet plan in order to achieve your weight loss goals. That said, one must consult a nutritionist before choosing to follow any meal plan.

Time Meal
6:30 AM Lukewarm water with 1 tsp apple cider vinegar
8:30 AM 1 bowl of oats porridge (low fat milk 1 cup, 1 chopped apple, chia seeds 1 tsp, oats 30 g)
10:00 AM 1 cup green tea
1:30 PM 1 bowl of carrot tomato onion salad with lemon olive oil dressing 1 tbsp
1 katori of brown rice
1 katori rajma curry with less oil
1 katori cabbage sabji
4:00 PM 1 cup green tea
6:00 PM Steamed sprouts chat (1 bowl with cucumber + tomato + onion + lemon juice + rock salt)
8:00 PM 2 multigrain roti
1 katori soyabean mushroom curry
1 bowl capsicum onion salad
10:00 PM 1 cup green tea
  • Start your day with a glass of lukewarm water and a teaspoon of apple cider vinegar.
  • For breakfast, have a bowl of oats porridge.
  • Drink 3 cups of green tea spaced out through the day.
  • Eat brown rice, cabbage sabji, and rajma curry along with a bowl of carrot tomato onion salad for lunch.
  • Have a bowl of steamed sprouts chat as an evening snack.
  • For dinner, eat 2 multigrain rotis along with a katori of soyabean mushroom curry and a bowl of capsicum onion salad.

While a diet plan like this may help you burn fat over time, it is ideal to follow a balanced diet with more nutrients as per your requirements. Find the best Indian Diet Plan for weight loss here.

Recipes

Eating the right foods are key to burning fat in the body. Try the following delicious recipes and keep your weight loss journey going.

Steamed sprouts chat

Ingredients

  • Moong beans, sprouted and steamed 1 cups
  • Small or medium-sized onion, finely chopped 1
  • Medium-sized tomato, finely chopped 1
  • Green chilli, finely chopped 1 (optional)
  • Red chilli powder ¼ tsp
  • Chaat masala ½ or 1 tsp (optional)
  • Lemon juice 1 tsp or as required
  • 1 cucumber chopped
  • Few coriander leaves and lemon slices for garnishing
  • Rock salt or black salt to taste

Preparation

  1. Mix all the ingredients listed above, except salt and lemon juice, with sprouted beans in a bowl.
  2. Season with salt, lemon juice and garnish with lemon slices and coriander leaves just before serving.

Oats porridge

Ingredients

  • Oats – one-third cup
  • 1 cup water
  • Half cup low fat milk
  • 1 tsp cinnamon powder
  • 1 pinch salt
  • Half apple, half sliced and half chopped
  • 1 tsp honey
  • 5 almonds, chopped

Preparation

  1. In a deep pot, add oats along with water, milk, salt, and cinnamon.
  2. Begin to boil the mixture and then simmer it for about 5-6 minutes with occasional stirring.
  3. Add the chopped apples and cook for another couple of minutes till the oatmeal is thick and creamy, and the apples have slightly softened.
  4. Remove the mixture in a serving bowl. Top it with the remaining apple slices, slivered almonds, and a drizzle of honey

Fat burning exercises

While consuming fat burning foods, supplements, and fruits, you need to complement it with exercise. Given below are a handful of different movements you must practice every day:

1. Bear crawl

Although it looks like a simple exercise, it works on your entire body. You need to go down on all fours, without your knees or elbows touching the ground. Start walking forward and backwards for one minute. Make sure your back is straight at all times.

2. Goblet squat

It is an exercise where you don’t place immense pressure on your back. As a result, it focuses on your thighs, which helps burn fat. Hold a kettle ball with two hands and go into the squat position. Do ten reps every minute and ensure your back is straight.

3. Jump rope

Jump rope is a high-intensity workout which will make sure you work up a sweat quickly. You need to skip over a rope for two minutes straight to start burning the fat.Skipping can help burn fats

Artificial fat burner side effects

While artificial fat burners can help with almost immediate weight loss, you can gain back this weight just as quickly. These fluctuations in weight can be harmful for your body. In addition to that, artificial fat burners can also have the following side effects:

1. Allergies

Fat burners are commonly associated with body allergies. Certain ingredients of these pills tend to create reactions inside the consumer’s body. Some of the common symptoms of these allergies are itching, stomach upsets, etc.

2. Insomnia

You could also lose sleep as another side effect of consuming fat burners. For example, caffeine interferes and jeopardises the normal body metabolism. A common result of this is the loss of sleep. The fat burner, ephedrine is also known to alter one’s regular sleep patterns.
Excessive consumption of these fat burners can lead to one’s sleep patterns being impacted negatively for good.

3. Heart Risk

Several ingredients found in fat burning pills are known to be harmful to the heart. Certain fat burners have also been removed from the market due to their interference with the heart.

One such fat burner is sibutramine, which resulted in major heart damage, that led to strokes and heart attacks. Another substance called bitter orange showed side effects that can lead to heart attacks.

4. Behavioural Change

These pills are often accompanied by changes in behaviour. One of the areas this is seen in is one’s eating patterns. Their appetite may become resistant to eating certain foods, that could bring fluctuations in the nervous systems.

It is also common to see mood swings, rise in anxiety levels, higher blood pressure, and as discussed earlier, insomnia.

5. Other Complications

Certain ingredients in these pills can lead to mental and emotional disturbances, creating mental health issues. In certain cases, people have to deal with problems like addiction, with these pills behaving like drugs.

Summary

Although a lot of people wish to shed kilos in a shorter span of time, it is not recommended for one to do so. Quick weight loss can have several side effects that can be harmful to the body. It is ideal to aim to lose weight steadily over a longer period of time by following a balanced diet. Nutritionists the world over advise against the use of artificial fat burners, and recommend that you try to lose weight through natural means instead.

Frequently Added Questions

Q. What foods help burn belly fat?

A: There is no quick fix for fat loss. One needs to target overall body fat rather than that from a particular area in the body. A healthy diet coupled with good exercise will give consistent results. Adding foods which boost metabolism will give the needed extra support for fat loss. These include whole grains, fiber rich fruits and vegetables, lean meats, fatty fish, green tea, nuts and seeds.

Q. What fruits and vegetables burn the most fat?

A: All fiber rich fruits and vegetables will help in fat loss. These include pears, apples, melons, coloured peppers, cruciferous vegetables like cabbage, broccoli as well as leafy greens.

Q. How do I lose 10 pounds in a week?

A: This is an unrealistic goal. Focus on consistent long term weight loss of about a pound every week, with a balanced diet rich in nutrients than drastic weight loss by doing crash diets.

Q. How can I lose fat quickly?

A: There is no quick fix for fat loss. Fat takes a long time to deposit in the body due to faulty lifestyle and to get rid of that, one needs to include a healthy lifestyle with a balanced diet and regular exercise to see results.



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Trump administration proposes allowing some drug importation

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A new proposal from the Trump administration would take steps toward allowing importation of drugs from other countries.

The Department of Health and Human Services on Wednesday proposed two potential pathways to allow the importation of drugs from foreign markets, part of a broader effort bring down drug prices. One would allow importation from Canada through pilot projects, while the other would allow manufacturers to go around distributors and import their own products directly from other countries.

“Today’s announcement outlines the pathways the administration intends to explore to allow safe importation of certain prescription drugs to lower prices and reduce out-of-pocket costs for American patients,” HHS Secretary Alex Azar said in a statement. “This is the next important step in the administration’s work to end foreign freeloading and put American patients first.”

Under the first pathway, HHS and the Food and Drug Administration would use authority provided under current federal law to authorize pilot projects by states, wholesalers and pharmacists outlining ways to import drugs from Canada that are versions of FDA-approved products manufactured in ways consistent with U.S. regulatory standards.

However, there’s a catch. Because it would be based on current federal law, it would exclude products that are controlled substances, biologics, infused and intravenously injected drugs, drugs inhaled during surgery and any drug with a Risk Evaluation and Mitigation Strategy, along with certain parenteral drugs. Moreover, drugs would be eligible only if they contain active pharmaceutical ingredients made at the same manufacturing plants used to produce APIs for the products sold in the U.S.

The second pathway would allow manufacturers of FDA-approved drugs to import versions they sell in foreign countries, using a new national drug code that would potentially allow them to offer lower prices than those required by their current contracts with distributors, provided they could demonstrate to the FDA that the foreign versions were the same as the U.S. versions. Drugs covered under this pathway could include insulin and medicines for diseases like rheumatoid arthritis, cardiovascular disorders and cancers.

“The Administration has reason to believe that manufacturers might use this pathway as an opportunity to offer Americans lower cost versions of their own drugs,” an accompanying action plan put out by the FDA and HHS read. “In recent years, multiple manufacturers have stated (either publicly or in statements to the Administration) that they wanted to offer lower cost versions but could not readily do so because they were locked into contracts with other parties in the supply chain.”

While welcoming the plan, Senate health committee Chairman Lamar Alexander, R-Tennessee, expressed reservations. “The key for me is whether this plan preserves the Food and Drug Administration’s gold standard for safety and effectiveness,” he said in a statement. “Millions of Americans every day buy prescription drugs relying on the FDA’s guarantee of quality.”

Current FDA regulations prohibit importation of unapproved drugs, which includes foreign-made versions of drugs that are approved in the U.S. and “have not been manufactured in accordance with and pursuant to an FDA approval.”

The administration has long accused other countries of “freeloading” off of American biopharmaceutical innovation by forcing Americans to pay more for drugs than people in other countries. However, experts have said this is misleading because every country makes its own decisions around pricing and reimbursement. Indeed, Medicare’s statutory inability to negotiate drug prices – as agencies of universal healthcare systems abroad do – is a consequence of domestic policy, not the policies of foreign countries.

Photo: Alex Wong, Getty Images

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FOOD

Summer Pasta Salad – USA Vegan Magazine

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This delectable pasta salad contains many different textures and flavors. It’s perfect for potlucks or gatherings around the BBQ!

 

 

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Summer Pasta Salad

  • Author: Sophie
  • Prep Time: 20
  • Cook Time: 10
  • Total Time: 30 minutes
  • Yield: 8

Ingredients

  • 2 1/2 cups vegetable broth
  • 1 cup orzo pasta, uncooked
  • 4 tbsp olive oil
  • 2 cups tomatoes, diced
  • 1 cup cucumber, diced
  • 1 bell pepper
  • 6 green shallots, chopped
  • 3 tbsp parsley
  • 3 tbsp white balsamic vinegar
  • 2 cloves garlic, crushed
  • 1/2 tsp salt

Instructions

  1. In a saucepan, bring broth to a boil.
  2. Add the orzo and boil for 10 minutes.
  3. Drain. Place in a bowl with 1 tablespoon olive oil.
  4. Add all the vegetables (tomatoes, cucumbers, peppers, shallots) to the orzo.
  5. In a small bowl, mix together the balsamic vinegar, remaining oil, garlic, salt, pepper, and parsley.
  6. Add the dressing to the orzo and mix well.



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Surescripts fires back at Amazon by kicking vendor ReMy Health off its network

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In response to the threat of legal action from Amazon’s PillPack for cutting off access to prescription data, Surescripts has booted the third-party vendor by which Amazon received the information from its network citing “fraudulent activity.”

Surescripts decided to bar third-party data vendor ReMy Health from accessing the company’s internal data and said that it is in the process of terminating its contract with the company and turning the matter over to the FBI because of what it characterizes as alleged violations of state and federal law.

PillPack did not contract directly with Surescripts and used ReMy Health as a go-between who would collect, clean and share Surescripts medication data, which would be used to inform its pharmaceutical sales practices.

When Surescripts got wind of this activity, it cut off PillPack’s access to the data through ReMy Health.

Without linked prescription data, Amazon would be forced to manually contact patients to collect the information, a laborious and error-prone process that directly contrasts with its promise of a simpler and more efficient drug purchasing.

According to Surescripts, it contracted with ReMy Health to give providers access to patient medication histories and e-prescribing benefits and when confronted with the fact that nearly all the company’s data requests were coming from one source, ReMy assured its partner that they were working with multiple providers caring for patients in hospitals.

Surescripts alleges that it later found out that PillPack was the company’s primary customer and as an organization that doesn’t function as a hospital or clinician providing clinical care services to patients is not subject to access to patient medication histories.

Furthermore, Surescripts says that instead of using its own National Provider Identification (NPI) number, Pillpack incorrectly used NPIs that were associated with random healthcare providers.

“Either ReMy Health or its customers concealed unauthorized access to the Surescripts network by fraudulently using third-party providers’ identifying information to access the system – even though those providers appear to be entirely unrelated to the patients whose information was requested,” Surescripts CEO Tom Skelton said in a statement.

“Surescripts has spent nearly 20 years establishing trusted relationships and legal agreements with hundreds of data suppliers and EHR vendors across the country to securely exchange health information. These agreements ensure that the information we exchange is only used for patient care and not for the commercial benefit of any one data supplier. These agreements also help ensure that patient data is properly secured.”

Surescripts is a major player in the medication data and e-prescription space and is owned in part by industry incumbents including CVS Caremark, Express Scripts and Medco Health Solutions.

Surescripts has long been accused of anticompetitive practices and has been involved in a recent battle with the FTC over allegations that it has illegally monopolized the e-prescription market.

Amazon, which purchased PillPack last year for around $750 million as part of its larger ambitions in the healthcare space. The company, which intends to disrupt the existing way prescription medication is sold and distributed has continued to butt heads with major market players as it tries to shoulder its way into the industry.

“A pharmacist’s job is to perform interaction checks, drug utilization reviews, and provide other clinical services. To do this, pharmacists need a comprehensive understanding of the medications each customer is taking. That’s why customers authorize PillPack, as a healthcare provider, to assemble their medication history,” PillPack spokesperson Jacquelyn Miller said in a statement.

“Given that Surescripts is, to our knowledge, the sole clearinghouse for medication history in the United States, the core question is whether Surescripts will allow customers to share their medication history with pharmacies and if not, why not?”

Picture: Ligorko, Getty Images

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Celgene filing plans potentially mean two more CAR-Ts on the market by end of next year

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Assuming everything goes according to plan, the market for CAR-T cells in the U.S. could have two more players – one for lymphoma and one for multiple myeloma – by the end of 2020.

Summit, New Jersey-based Celgene said in its second quarter 2019 earnings Tuesday that it plans to file for Food and Drug Administration approval of the CAR-T lisocabtagene maraleucel, or liso-cel, in diffuse large B-cell lymphoma (DLBCL) during the fourth quarter of this year. The company also anticipates filing for approval of the CAR-T bb2121 – also known as idecabtagene vicleucel, or ide-cel – in multiple myeloma during the first half of next year.

In a note to investors, Cowen analyst Yaron Weber wrote that FDA approval of liso-cel is expected in the middle of 2020, following likely data from the registration-directed Phase I TRANSCEND NHL 001 study in December at the American Society of Hematology meeting. Meanwhile, he noted, Celgene’s guidance anticipates approval for ide-cel in the second half of 2020. However, he wrote that it is unclear if data from the Phase II KarMMa study of ide-cel will be at ASH, given that the study only completed enrollment in November of last year.

In January, Celgene and New York-based Bristol-Myers Squibb reached an agreement whereby the latter would acquire the former for $74 billion. Celgene itself acquired Seattle-based Juno Therapeutics, the company developing liso-cel, in January 2018 for $9 billion.

Updated data from the liso-cel trial were presented at the American Society of Clinical Oncology’s annual meeting last month, showing that among six DLBCL patients who had secondary central nervous system lymphoma, four achieved complete responses. Data from the 2017 ASH meeting among 68 DLBCL patients showed a 75 percent overall response rate, including a 56 percent complete response rate.

Notably, the high efficacy rates came without as much of the toxicity that has characterized CAR-T therapies. Cytokine release syndrome – or CRS, a constellation of immune system reactions common with CAR-Ts – occurred in only 30 percent of patients, with only one case of life-threatening CRS. Neurotoxicity occurred in 20 percent of patients, with 14 percent experiencing serious or life-threatening events.

By contrast, the clinical trial that led to the approval of another CAR-T therapy in DLBCL, Gilead Sciences’ Yescarta (axicabtagene ciloleucel), showed CRS in 94 percent of patients, with 13 percent experiencing events that were serious or worse. Neurotoxicity occurred in 87 percent of patients, with 31 percent experiencing events that were serious or worse. With Novartis’ Kymriah (tisagenlecleucel), CRS occurred in 74 percent of subjects, including 23 percent who experienced serious or worse events. Neurotoxicity occurred in 58 percent of patients, including 18 percent who experienced serious or worse events.

Photo: CGToolbox, Getty Images

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Where digital health misses the mark, a validated community health program may win

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A petite woman, Dr. Shreya Kangovi, has an outsize vision.

As the founding executive director of the Penn Center for Community Health Workers, a national center of excellence, Kangovi wants to translate nationwide the success Penn Medicine has seen in implementing the community health worker program she helped develop.

“If you look at the map of the United States there are hot spots where where we can clearly see life expectancy being determined by where you live and your income. So If you drill into those hot spots, you see real life issues – things like housing, transportation, trauma, child care.” Kangovi, who is trained physician, said in a recent interview in her office in downtown Philadelphia. “My center’s catchphrase to get us out of bed in the morning is ‘we want to make those red hot spots blue.’ ”

Philadelphia is no stranger to this “hot spots” phenomenon with life expectancies varying disturbingly between zip codes barely a few miles apart. And as Kangovi began researching community health worker programs in 2010, what became clear is that people represent the cornerstone of any successful, evidence-based, scientifically-developed CHW program that aims to address the social determinants of health. There aren’t any tech-based silver bullets.

The limitations of a tech-based approach
At a time that startups in Silicon Valley and around the country lionize digital health as the messiah that will rein in chronic diseases and save U.S. healthcare, a conversation with Kangovi illuminates the limitations of technology.

“A lot of these apps are based on a fundamental, theoretical premise — knowing your numbers is a good thing. I am going  to tell you your sugar, your weight, or your blood pressure and you will take that information and say, ‘I ate a lot of cookies last week and this is motivating me to to get back into the gym.’”

Such people have a learning response. But others can have a quite different reaction.

Dr. Shreya Kangovi, founding executive director, Penn Center for Community Health Workers, is passionate about healthcare equity

“People who face failure and adversity a lot may have to develop avoidance as a coping mechanism and you know those of us who can throw money at the problem, we’re learners because we can solve those problems,” Kangovi said. “If you check your glucometer and it says 300 everyday and it’s because you are short on your rent and it’s so stressful that it will make you eat, that glucometer is not going to pay your rent for you.”

She added people have different “behavioral phenotypes” and on bad days even wealthy people with means may choose to avoid rather than confront the status of their health.

Another healthcare executive, who is well aware of Kangovi’s work in the field and applauds her achievements, echoed her.

“I would urge us to not use simple shorthands like people with socioeconomically challenged situations need X and people who are wealthy need Y,” said Dr. Sachin Jain, president and CEO of CareMore Health, a division of Anthem, in a phone interview last week. “I think the most important observation is that people are people. There’s lots of different kinds of people within all income categories and so there are wealthy people that can benefit from community health workers and poor people who can benefit from community health workers.”

Jain also broadly agreed with Kangovi that the potential of digital health as conceived by techies smacks of preconceived notions of about how actively engaged people want to be with their health.

“The digital health movement has largely grown out of assumptions about patient behavior by nonsick people,” Jain declared. “A lot of the people who are developing the solutions are building solutions for what they would need, what they would want, but not recognizing that they might want different things when they are actually sick. Many patients don’t want to be active patients. ”

There are other, structural reasons why digital health may fail with certain patient communities. To describe those, Kangovi launched into a lengthy explanation:

Why don’t lower income people who really have struggles with diabetes use these apps? No. 1, there’s still a digital divide. We act like everybody has the same tools. They don’t. We’re doing a study where we are focusing on individuals that have diabetes who come from high poverty zip codes and the diabetes is in poor control. Only 30 percent of the people have a smartphone in that population. We initially were thinking that we would combine community health workers support with some smartphone-based glucometer tracking but we couldn’t. People don’t have smartphones. And even if they have the device they may not have the data.

So what can community health workers do to help a stressed patient? They can develop a meaningful relationship with them, earn their trust and address these challenges. For the person worried about rent, the community worker can connect him or her to the right person who can advocate for the patient with the patients’ landlord for instance, Kangovi said.

Avoiding the 5 pitfalls of community health workers program
The success of any CHW program is largely dependent on how well you address the reasons why such programs fail. Before developing the IMPaCT program at Penn — whose model has been described in JAMA showing hospital admissions rates falling 65 percent and a ROI of $2 for every dollar spent on the program — Dr. Kangovi thoroughly researched the subject. Her background in global health and research made her dive deep into the medical literature through which she identified five causes that have hamstrung CHW programs throughout history:

  • high turnover of workers, sometimes as high as 50-77 percent;
  • lack of a proper infrastructure to support the community health workers;
  • too diseases-specific or clinical focused;
  • no balance between medical and community-based work
  • flawed metrics to judge program success

One of the first things Kangovi and her team did was to identify the needs of the community that they were trying to lift up. They conducted 1,500 patient interviews and then based on those needs, they tried to hire the community workers who would become full-time employees of the program. Choosing the right candidate is key.

“We don’t post a job on Indeed.com. We circulate it through soup kitchens or churches where there are volunteers. And then we have a very easy paper applications but we do it mostly on meet and greet where we can observe interpersonal skills,” Kangovi said.

She added that personality tests, behavior assessment can also be conducted and the IMPaCT program has also used organizational psychology “which many other industries have but healthcare has lagged” to hire community workers. Kangovi also made sure that proper training and support is available for the community workers. As a result, the IMPaCT program at Penn has had a turnover of only 1.7 percent compared with at least 50 percent experienced by other programs, according to a NEJM paper that Kangovi authored.

But an equally important aspect of the program is staying away from a doc/nurse focus who, even with the best intentions, are not well suited to relate to patients’ life experiences.

“Doctors and nurses of a different background say, “Why is this person paying for TV when they don’t have $3 for a medication?” Whereas a person who has been there can say, “Well that’s the thing that is keeping them from blowing their brains out right now, so I get it.’ So that is why this concept of the community health worker and the concept of shared experience is important.”

Jain pointed at another aspect for why community health workers is so vital. For a variety of reasons, certain populations lack trust of the healthcare system at large. He observed this as CareMore Health began serving Medicaid patients in Tennessee four years ago.

“The trick in Medicaid is getting people to want to trust you, to want to use the resources that are available to them,” he said. “People who are from the community, know the community and are of the community can often times play a valuable role in bridging the gap of trust that exists between various patient populations.”

Developing a scientific method of evaluation
But developing a good CHW program doesn’t simply begin and end with hiring people from the community and expecting that the connection they share will magically yield great returns in terms of good medical outcomes. That’s where a good evaluation system play a role. Kangovi said that what plagued CHW programs is that health systems would take a group of very sick patients, intervene with some community health worker program and see hospital admission rates fall among this group. And when they fell, program leaders patted themselves on the back for a job well done. Ultimately though, the hospital rates would rise again leading organizations to abandon CHW programs.

Yet the real problem was wrong metrics and not recognizing that only comparing sick people against themselves can lead to the mathematical problem of regression to the mean.

“They’ve had a bad year, they’ve been in the hospital 365 times and so there’s no way to go but down,” she explained of hospital rates falling back after being high for a period. “Life goes in ups and downs and if you choose an outlier point and you do nothing at all they will regress to the mean.”

What the IMPaCT program has done by contrast is run randomized control trials where patients are divided into treatment and control arms solely on the basis of whether they are receiving the CHW intervention,  all other things being equal. Three RCT studies done on IMPaCT program show that hospital rates fell 65 percent among those who received that CHW compared to those who didn’t.

Kangovi and her team have also developed a cloud-based application that allows community health workers to input patient information through their phones or laptops after interacting with them. Supervisors can monitor individual performance of those community health workers and make adjustments where necessary.

To date, the IMPaCT program has served more than 10,ooo people in the Philadelphia region. The Penn Center for Community Health Workers, which officially launched in 2014, has 57 full time equivalents, 30 of whom are community healthcare workers. The Center has received grants from the National Institutes of Health as well as the Patient Centered Outcome Research Organization(PCORI). Penn Medicine has invested $3 million and the CHW program is part of its annual budget though Kangovi did not say how much it invests per year. The Center has an annual budget of $4.5 million.

Included within its budget, is a revenue stream through partners. These are essentially other integrated health systems, payers, state Medicaid organizations,  or other institutions, that are using the IMPaCT model to run a scientifically-validated community health workers program in their own regions. Kangovi’s team at the Center can help external organization with planning, hiring, training, launching, troubleshooting and evaluating their programs. Kangovi said the model is being used by 30 organizations across 15 different states including the Veterans Health Administration.

Disseminating the Penn model
One such organization that wanted to upgrade its community health worker program is Siloam Health, a Nashville-based Christian nonprofit. In a recent phone interview, Amy Richardson, Siloam Health’s chief community health officer said that the organization looks after nearly 4,000 patients, 90 percent of whom are foreign born, through a primary care clinic. Most of these patients do not have health insurance.

Siloam launched a CHW program about four years ago and the goal was to improve the health of patients in four different communities — the Latino, Arab, Burmese and Nepali populations. But over time it became clear that Richardson was managing four different CHW programs rather than a single, cohesive one. The program had part-time community health workers and about a year ago the decision was made to bring them in-house and make them full-time. But at around the same time, Richardson was introduced to Kangovi through a Siloam board member.

Siloam has now replicated the IMPaCT model and Richardson couldn’t be happier. The program is more streamlined and structured and her community health workers feel less exhausted. For instance, before the IMPaCT model was instituted, the community health worker in charge of managing patients in the Latino community had to adjust schedules constantly to make sure that she could serve patients some of whom worked days and some nights. Now, she has set hours and her patients have also adjusted to know when she is available. The format can be adjusted when needed.

“It’s still flexible enough to vulnerable populations’ schedules but it’s not letting the community run the health worker to the ground,” Richardson said. “So it’s something sort of simple, but was revolutionary to the way we are taking care of our employees.”

Siloam also serves the Nepali-speaking population struggle with loneliness and lack of relevance, especially the older generation who have come to the U.S. mainly as refugees. They are also unaware of how to take their medications and refill prescriptions, Richardson said. The community health worker assigned to this group helps by not only helping to educate them and their family members to navigate the health system but also make them reconnect with each other.

While no formal study has been launched to evaluate the one-year program, Richardson reports no turnover among the four full-time CHWs and improving obesity rates and A1c levels among the program participants.

“It’s not surprising that these medical outcomes would improve as we focus on the social factors affecting health, but it’s still revolutionary in the healthcare world,” Richardson said.

She added that one of the most appealing things about the IMPaCT model — aside from the rigorous framework and the assistance from Kangovi’s team — is the cloud-based data collection system.

“Before, I was tweaking our data collection system every year trying to figure out the best way to track our community health workers activities and then patient outcomes,” she said.

Ultimately, though, Richardson,  like Kangovi and Jain, pointed to the power of the human connection as the vital element in any CHW program.

“We are influenced by those around us whether we are a more educated health care user or someone who has very low health literacy,” she said. “We change because of relationships.”

Photo: kate_sept2004, Getty Images and Arundhati Parmar

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Cerner taps Amazon Web Services in the escalating cloud wars

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Kansas City-based health IT giant Cerner has chosen to partner with Amazon Web Services as the company looks to enable its customers with more cloud-based services and tools.

The deal makes AWS the preferred cloud provider of Cerner who will use the cloud computing platform to power new health-oriented innovations that are intended to improve clinical experiences and increase efficiency through the use of AI and machine learning.

The collaboration will boost the business of both companies against the backdrop of tech giants like Amazon, Google and Microsoft vying for healthcare market share in the industry’s shift to cloud-based infrastructure.

Cerner is positioning the collaboration as part of the company’s larger digital transformation from its core business as an EHR provider into a service provider utilizing the reams of data collected within those systems.

“Our work with Amazon and AWS is a key component for the next chapter at Cerner,” Cerner CEO Brent Shafer said in a statement

“As we work to transform Cerner, we are joining forces with Amazon and AWS to help fuel our strategy of making Cerner more agile in order to deliver faster, more scalable and secure solutions to clients and patients.”

The company has already worked with Amazon on a number of initiatives including its HealtheIntent population health management software, which allows clinicians to exchange and share data at scale.

Through the use of Amazon SageMaker, the tech company’s machine learning platform, Cerner has built and implemented systems to help researchers use anonymized patient data to build predictive models and algorithms.

“Health care and life sciences companies trust AWS with their mission-critical workloads, knowing that they can securely and easily invent new ways to interact with their patient populations and quickly scale the approaches that are effective,” AWS CEO Andy Jassy said in a statement.

“AWS is providing Cerner with the broadest portfolio of innovative analytics and machine learning services that will empower them to gain new clinical and business insights that have the potential to transform patient care delivery.”

Photo: shylendrahoode, Getty Images

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