Have we finally turned a corner with drug pricing?

Drug developers, economists, and politicians are smart people. But maybe a four-year-old could have predicted this one: What goes up, must come down.

Are drug prices finally on the way down?

Looking at some of the major 2017 approvals thus far, there is some evidence to suggest the culture is slowly shifting.

Even Teva Pharmaceuticals appears to have turned a new leaf. On Tuesday, the Israeli company announced that its Huntington’s disease therapy Austedo (deutetrabenazine) had received an FDA nod. Rather than altering the course of the disease, it helps treat patients’ involuntary movements.

Leerink analyst Jason Gerberry reported that Austedo will be priced at around $60,000 a year. That compares to an older version of the drug called Xenazine (tetrabenazine), which sells for $152,000 per year. A generic version goes for $96,000.

Austedo caps off a progressive few weeks.

In late March, Roche subsidiary Genentech got the green light to market Ocrevus (ocrelizumab) for relapsing-remitting and primary-progressive multiple sclerosis (the latter being an industry first).

Genentech announced an intended list price of $65,000 — pretty reasonable given the drug delivered a 47 percent reduction in annualized relapse rates compared to Rebif, a first-generation MS therapy that sells for around $86,000.

On the same day, Regeneron Pharmaceuticals’ Dupixent (dupilumab) was approved for moderate-to-severe eczema. It got stamped with a list price of $37,000 a year, a significant discount on older drugs that sell for around $50,000 per year.

Based on EvaluatePharma’s predictions, Ocrevus and Dupixent will be the highest grossing drugs to enter the market in 2017. The pricing on those drugs matters.

Also in March, Newron Pharmaceuticals finally earned U.S. marketing authorization for Xadago (safinamide), an iterative MAO-B inhibitor for the treatment of Parkinson’s disease. The drug was already approved for sale in Europe.

Xadago doesn’t represent a huge therapeutic gain and Newron – to its credit –priced it that way. Without insurance, a 30-day supply of the drug will cost $670, to be marketed in the United States by US WorldMeds.

This all comes in stark contrast to Marathon Pharmaceuticals, the outlier in the conservative pricing trend. But the public, political and industry reaction to its proposed list price speak volumes too.

After receiving marketing approval for its Duchenne muscular dystrophy drug, Marathon slapped an $89,000 price tag on what is essentially a decades-old corticosteroid, available overseas for around $0.60 per dose.

Marathon eventually backed down after much outcry from the media and a harshly worded letter courtesy of Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings, (D-Md.). Marathon has since sold the franchise to PTC Therapeutics.

It seems there’s no longer any tolerance for the ‘how far can we push this’ approach. The smart players are instead asking ‘what is reasonable and sustainable in our current healthcare climate?’

But it’s early days. A handful of good examples doesn’t signal an industry shift. That will take many more years and wider changes to the healthcare system.

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How 16 insurance policies stack up for substance use disorder benefits

Unfortunately, a chasm has separated primary care and behavioral health for many years in the U.S. This division is being repaired as the healthcare field recognizes the importance of behavioral health.

Dr. Itai Danovitch, chairman and associate professor of Cedars-Sinai Medical Center’s department of psychiatry and behavioral neurosciences, agrees.

“It’s now broadly recognized that in order for people to have good health outcomes, it’s not sufficient to pay attention to medical health,” he told MedCity in a phone interview. “You have to also address their mental health, which includes substance abuse.”

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Indeed, substance abuse is a crucial part of healthcare coverage today. But depending on your health insurer’s offerings, your benefits may strongly differ.

A recently published study by Dr. Danovitch and Dr. David Kan, assistant clinical professor at the University of California at San Francisco’s department of psychiatry, analyzes these differences. Titled The Addiction Benefits Scorecard: A Framework to Promote Health Insurer Accountability and Support Consumer Engagement, the study was published in the Journal of Psychoactive Drugs.

The study is based on a previous project headed up by Dr. Danovitch and Dr. Kan: the Consumer Guide and Scorecard. In 2014, the California Society of Addiction Medicine created an assessment framework (based on criteria from the American Society of Addiction Medicine) for rating the quality of substance use disorder treatment benefits offered by 10 insurers on California’s marketplace, Covered California. A panel of physicians then rated the 16 bronze-level plans across seven total categories, such as pharmacy benefits and outpatient benefits.

The result is the Consumer Scorecard, which clearly shows how the policies stacked up overall and in each category.

“The plans themselves had a fair amount of heterogeneity,” Dr. Danovitch said. A few specific plans tended to perform well across all seven categories, while another set of plans tended to perform poorly across all the categories, he noted.

However, Dr. Danovitch also pointed out a few caveats. “One is that the question of what’s in insurance plans is a moving target because it changes every year,” he said. “It’s certainly changed by now.”

Another is evaluating the difference between “what insurers said they offered and what they actually offered,” Dr. Danovitch said. “We did contact insurers to help sort out areas where there was a lack of clarity, but we didn’t get much of a response.”

In 2015, 20.8 million Americans met the criteria for a substance use disorder. But less than 11 percent of them receive treatment, according to the Substance Abuse and Mental Health Services Administration. “[Substance use disorders] are treatable, yet most people don’t get treatment or don’t get treatment that’s adequate,” Dr. Danovitch said.

Substance use disorders are clearly a problem. But then why don’t insurers cover everything they should? Dr. Danovitch says it’s because the population isn’t speaking up about it. “Insurers need to cover this, but they won’t until everybody expects it,” he said. “The population has to develop expectations about what their entitlements are in order to hold insurers accountable.”

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Insurance navigator Wellthie looks beyond healthcare with $5M Series A round

Wellthie, a health insurance navigation startup launched by a former Anthem Blue Cross Bue Shield product development executive, has raised $5 million in a Series A round, according to a company blog post. The new funding will be used to bolster the New York-based company’s sales and marketing muscle as it prepares to expand into vision, dental and life insurance in the second quarter, Sally Poblete, Wellthie Founder and CEO, told MedCity News in a phone interview.

IA Capital Group led the investment round with participation from Aflac Corporate Ventures. Last month, Aflac announced plans to set up a $100 million fund to invest in early stage companies relevant to Aflac’s core business. Some of the angel investors from the insurance industry that have backed Wellthie include Mike Battaglia, former chief consumer officer at Humana, Dr. Bill Winkenwerder, a former co-CEO of Highmark Blue Cross Blue Shield, and Sam Havens, a former CEO of Prudential Healthcare.

“What’s unique and exciting about this round is insurance industry luminaries are putting in their own money,” Poblete said. “It shows that the support we’re getting is from people deep within the industry.”

Poblete said she sees the business as a way to support insurance brokers that work with small businesses and carriers with technology by improving decision support and providing other robust features.  For brokers, Wellthie can do scenario planning, provide a virtual storefront and give medical and ancillary quotes through a shopping and enrollment platform. For insurers, it can help them manage small group and individual members and drive growth. Wellthie’s platform also helps payers do market analysis based on members’ purchasing behavior. 

Wellthie and other technology companies have developed customer relationship management products to help insurance companies become more consumer-focused and their plans easier to understand.  As the insurance industry waits for the GOP to put their own legislative stamp on insurance reform, it will be interesting to see whether insurance companies will rely more on health tech companies like Wellthie.

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Will Anthem exit the ACA exchanges?

Anthem could be the next insurer on the block to depart from the Affordable Care Act exchanges.

A recent report from Jefferies analysts, who claimed they met with Anthem, found the insurer might be planning to drop from the exchanges next year. Analysts David Windley and David Styblo said Anthem “is leaning toward exiting a high percentage of the 144 rating regions in which it currently participates.”

Bloomberg initially reported news of the Jefferies analysis.

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According to the report, Anthem told Jefferies analysts that “regulatory advocacy needs to progress significantly in the next ‘month or so.’” In Anthem’s opinion, “[i]mprovements such as eligibility verification, more rigid special enrollment periods, shortening of premium grace periods are steps in the right direction, but not enough,” the analysts wrote, according to CNBC.

Anthem, which sells plans under the Blue Cross Blue Shield Brand, has a little more than 800,000 individual exchange plan customers in 14 states.

However, the insurer hasn’t been doing so hot fiscally, according to Bloomberg Intelligence. It lost approximately $374 million on individual plans in 2016. Its 2017 financial goals are moderate, and an estimated 8.6 percent of its revenue will come from individual plans.

If Anthem does decide to pull back, it could create the most significant coverage gaps in states like Colorado, Georgia, Kentucky, Missouri and Ohio, according to a New York Times report. An analysis from the Robert Wood Johnson Foundation determined an Anthem departure would leave people in almost 300 counties without an insurance carrier.

The insurer’s potential exit isn’t altogether surprising. Anthem CEO Joseph Swedish hinted at it during a call regarding fourth quarter results with Wall Street analysts. “We will make the right decisions to protect the business,” he said, according to Bloomberg. “If we can’t see stability going into 2018, with respect to either pricing, product or the overall rules of engagement, then we will begin making some very conscious decisions with respect to extracting ourselves.”

In an emailed statement to Bloomberg, Anthem said it’s working with the Trump administration “to emphasize the importance of regulatory and statutory changes in order to ensure sustainability and affordability of the individual market for consumers” and that it will “actively pursue policy changes that will help with market stabilization and achieve the common goal of making quality healthcare more affordable and accessible for all.”

Anthem’s likely departure points to a larger trend among insurers offering plans on the ACA exchanges. Earlier this year, Humana said it will completely stop offering individual plans on the exchanges in 2018. UnitedHealth Group and Aetna have also scaled back on their ACA offerings.

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Nearly half of physicians support single-payer system

The current healthcare landscape is ever-changing, complex, fragmented and a thousand other adjectives. From cybersecurity to quality, policy changes to rising drug costs, there are myriad issues in the industry that are worth addressing.

For physicians, the complicated healthcare environment is only exacerbated by the country’s current insurance system. A recent LinkedIn survey found 48 percent of physicians support a single-payer healthcare system, according to a post by LinkedIn’s healthcare news editor Beth Kutscher.

“It was a surprising number,” Kutscher told MedCity in a phone interview.

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Another 32 percent of respondents were opposed to the idea of a single-payer system and 21 percent said they didn’t know.

The survey, which was part of a larger LinkedIn survey, was conducted between February 7 and February 19. A total of 511 United States physicians responded, 449 of whom are currently practicing. The participants, who come from various specialties, were selected at random. All the respondents noted in their profile that they have an MD degree, Kutscher said.

Why do almost half of the surveyed physicians favor a single-payer system? Some pointed to patients who move from provider to provider through the years.

“There was also a strong human rights theme that came out of the survey,” Kutscher said.

Other respondents noted the inconvenience of negotiating with numerous insurance companies. This frustration was fairly common. Fifty-four percent of physicians claimed they spent time negotiating with insurers. “It’s notable that more than half are actually doing it themselves,” Kutscher said. On average, they spent about four hours per week doing so. “That’s time out of their day. If all patients were in a single platform, [physicians] wouldn’t have to worry about these things,” Kutscher added.

Additionally, 64 percent of respondents said they’ve put new measures into place to ensure payment from patients with high-deductible health plans. Thirty-three percent said they offer payment plans, while 26 percent demand upfront payment. Another 19 percent said they bring on additional team members such as financial counselors to ensure timely payment from HDHP patients.

What about the 32 percent of respondents who said they oppose a single-payer system? Many said they think it could cut down competition or suppress innovation initiatives. Other opposers said they “fear it would give the government too much power over reimbursement rates or that they mistrust the government’s ability to create a viable single-payer system,” according to Kutcher’s post.

The statistics from LinkedIn’s survey show physicians are varied in their opinions about what should happen next in the U.S.  healthcare system. But given last week’s AHCA failure, it looks like we’re staying where we are for right now.

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Roche’s new MS drug Ocrevus is already a remarkable success

Late Tuesday, the FDA gave Roche subsidiary Genentech the final green light to market Ocrevus (ocrelizumab), a monoclonal antibody for the treatment of multiple sclerosis (MS).

We’ve seen this drug before. It’s an updated version of Rituxan (rituximab), first approved in 1997. Both share the same anti-CD20 mechanism of action, though the manufacturing is slightly different (Ocrevus is fully humanized to reduce the likelihood of an immune response).

It’s an old drug, with a lot more to give. Here are just some of the ways Ocrevus and Rituxan are changing the medical landscape.

It’s the first disease-modifying drug for the most severe form of MS

Approximately 85 percent of patients are diagnosed with relapsing-remitting MS. This subtype is characterized by periods of disease stability, ‘attacks’ when symptoms worsen, and then a gradual recovery of some of the lost function as the disease subsides once again.

By comparison, primary-progressive multiple sclerosis (PPMS) is a downward slope with no flat ground. It affects around 10 percent of MS patients, who experience a steady worsening of symptoms.

Since the 1990s, many different therapies have been approved for relapsing-remitting MS. However, none have been able to alter the course of PPMS.

In a study of 732 patients with a primary-progressive diagnosis, Ocrevus substantially delayed the advance of the disease. It’s far from a cure and many patients didn’t respond — but something is better than nothing.

It runs counter to the longstanding belief that MS is driven by T-cells 

Both Ocrevus and Rituxan target a specific receptor called CD20, which is expressed on the surface of mature B-cells. This means the drug can selectively eliminate a core component of the immune system, which gives rise to certain lymphomas, leukemias, and autoimmune diseases.

After gaining approval in 1997 for the treatment of non-Hodgkin’s lymphoma, scientists began researching Rituxan’s potential to treat rheumatoid arthritis (RA), a B-cell mediated autoimmune condition. In 2006, it won approval for RA patients that didn’t respond to the frontline therapies.

Multiple sclerosis was not a natural fit, as Ron Winslow wrote in STAT. The disease is caused by an autoimmune destruction of the myelin sheath surrounding nerve cells. This impairs the nerve’s ability to send signals within and between the brain, spinal cord and the rest of the body.

For years, the scientific consensus was that the MS was driven by T-cells, operating independently of B-cells. They somehow penetrate the blood-brain barrier and are found at the scene of the crime, in and around the characteristic lesions that form in the brain.

The approval of Ocrevus, which targets B-cells, not T-cells, is a final endorsement of scientists who argued both arms of the adaptive immune system play a role. T-cells may inflict the damage, but B-cells are a co-conspirator, potentially by presenting antigens, secreting chemical signals known as cytokines, or through the production of targeted antibodies.

It’s forecast to be a blockbuster MS franchise

Prior to the approval, Evaluate Pharma estimated that Ocrevus would hit global sales of close to $4 billion in 2022.

Genentech has since announced an intended list price of $65,000. That’s reasonable, given the drug delivered a 47 percent reduction in annualized relapse rates compared to Rebif, a first-generation MS therapy that sells for around $86,000.

Biogen’s Tecfidera entered the MS market at $55,000 per year in 2013 and clocked up $2.9 billion in sales in the first year. Trials had shown it reduced relapse rates by 67 percent when compared to a placebo.

Of note, Ocrevus will be delivered via intravenous infusion twice a year. Convenience-wise, that’s somewhere between the cumbersome subcutaneous Rebif injections three times per week and the ease of the once-daily oral Tecfidera pill.

There’s plenty more in the tank

As Ocrevus enters the game, Rituxan powers on.

Roche collected $7.3 billion from Rituxan sales in 2015. While the figure is projected to decline over the coming years, it’s still on track to make around $5 billion per year by 2020.

Developed by Biogen Idec, who later partnered with Genentech, Rituxan was designed as a cancer therapy. And yet it has gone on to enhance the quality of life and lifespan of patients with various autoimmune diseases.

It looks promising in systemic lupus erythematosus trials, another B-cell mediated autoimmune condition that lacks any effective treatments. It’s being studied in autoimmune anemias, Sjogren’s syndrome, autoimmune pancreatitis — the list goes on. Rituxan is even being used off-label to prevent organ rejection in transplant patients.

Against all odds, the B-cell depletion effects have also shown early promise in treating chronic fatigue syndrome — a condition that confounds the medical community.

Most recently, Genentech began enrolling patients in Phase 3 trials of Rituxan in pemphigus vulgaris (PV), an autoimmune skin condition.

If that’s not a successful drug, I don’t know what is.

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Can “pre-hospice” programs support the push towards value-based care?

Gerald Chinchar isn’t quite at the end of life, but the end is not far away. The 77-year-old fell twice last year, shattering his hip and femur, and now gets around his San Diego home in a wheelchair. His medications fill a dresser drawer, and congestive heart failure puts him at high risk of emergency room visits and long hospital stays.

Chinchar, a Navy veteran who loves TV Westerns, said that’s the last thing he wants. He still likes to go watch his grandchildren’s sporting events and play blackjack at the casino. “If they told me I had six months to live or go to the hospital and last two years, I’d say leave me home,” Chinchar said. “That ain’t no trade for me.”

Most aging people would choose to stay home in their last years of life. But for many, it doesn’t work out: They go in and out of hospitals, getting treated for flare-ups of various chronic illnesses. It’s a massive problem that costs the health care system billions of dollars and has galvanized health providers, hospital administrators and policymakers to search for solutions.

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Sharp HealthCare, the San Diego health system where Chinchar receives care, has devised a way to fulfill his wishes and reduce costs at the same time. It’s a pre-hospice program called Transitions, designed to give elderly patients the care they want at home and keep them out of the hospital.

Social workers and nurses from Sharp regularly visit patients in their homes to explain what they can expect in their final years, help them make end-of-life plans and teach them how to better manage their diseases. Physicians track their health and scrap unnecessary medications. Unlike hospice care, patients don’t need to have a prognosis of six months or less, and they can continue getting curative treatment for their illnesses, not just for symptoms.

Before the Transitions program started, the only option for many patients in a health crisis was to call 911 and be rushed to the emergency room. Now, they have round-the-clock access to nurses, one phone call away.

“Transitions is for just that point where people are starting to realize they can see the end of the road,” said San Diego physician Dan Hoefer, one of the creators of the program. “We are trying to help them through that process so it’s not filled with chaos.”

The importance of programs like Transitions is likely to grow in coming years as 10,000 baby boomers — many with multiple chronic diseases — turn 65 every day. Transitions was among the first of its kind, but several such programs, formally known as home-based palliative care, have since opened around the country. They are part of a broader push to improve people’s health and reduce spending through better coordination of care and more treatment outside hospital walls.

But a huge barrier stands in the way of pre-hospice programs: There is no clear way to pay for them. Health providers typically get paid for office visits and procedures, and hospitals still get reimbursed for patients in their beds. The services provided by home-based palliative care don’t fit that model.

In recent years, however, pressure has mounted to continue moving away from traditional payment systems. The Affordable Care Act has established new rules and pilot programs that reward the quality rather than the quantity of care. The health reform law, for example, set up “accountable care organizations” networks of doctors and hospitals that share responsibility for providing care to patients. They also share the savings when they rein in unnecessary spending by keeping people healthier. Those changes are helping to make home-based palliative care a more viable option.

In San Diego, Sharp’s palliative care program has a strong incentive to reduce the cost of caring for its patients, who are all in Medicare managed care. The nonprofit health organization receives a fixed amount of money per member each month, so it can pocket what it doesn’t spend on hospital stays and other costly medical interventions.

‘Something that works’

Palliative care focuses on relieving patients’ stress, pain and other symptoms as their health declines, and it helps them maintain their quality of life. It’s for people with serious illnesses, such as cancer, dementia and heart failure. The idea is for patients to get palliative care and then move into hospice care, but they don’t always make that transition.

The 2014 report “Dying in America,” by the Institute of Medicine, recommended that all people with serious advanced illness have access to palliative care. Many hospitals now have palliative care programs, delivered by teams of social workers, chaplains, doctors and nurses, for patients who aren’t yet ready for hospice. But until recently, few such efforts had opened beyond the confines of hospitals.

Kaiser Permanente set out to address this gap. Nearly 20 years ago, it created a home-based palliative care program, testing it in California and later in Hawaii and Colorado. Two studies by Kaiser and others found that participants were far more likely to be satisfied with their care and more likely to die at home than those not in the program. (Kaiser Health News, which produces California Healthline, is not affiliated with Kaiser Permanente.)

One of the studies, published in 2007, found that 36 percent of people receiving palliative care at home were hospitalized in their final months, compared with 59 percent of those getting standard care. The overall cost of care for those who participated in the program was a third less than for those who didn’t.

“We thought, ‘Wow. We have something that works,’” said Susan Enguidanos, an associate professor at the University of Southern California’s Leonard Davis School of Gerontology, who worked on both studies. “Immediately we wanted to go and change the world.”

But Enguidanos knew that Kaiser Permanente was unlike most health organizations. It was responsible for both insuring and treating its patients, so it had a clear financial motivation to improve care and control costs. Enguidanos said she talked to medical providers around the nation about this type of palliative care, but the concept didn’t take off at the time. Providers kept asking the same question: How do you pay for it without charging patients or insurers?

“I liken it to paddling out too soon for the wave,” she said. “We were out there too soon. … But we didn’t have the right environment, the right incentive.”

A bold idea

Dan Hoefer’s medical office is in the city of El Cajon, which sits in a valley in eastern San Diego County. Hoefer, a former hospice and home health medical director and nursing home doctor, has spent years treating elderly patients. He learned an important lesson when seeing patients in his office: Despite the medical care they received, “they were far more likely to be admitted to the hospital than make it back to see me.”

When his patients were hospitalized, many would decline quickly. Even if their immediate symptoms were treated successfully, they would sometimes leave the hospital less able to take care of themselves. They would get infections or suffer from delirium. Some would fall.

His patients were like cars with 300,000 miles on them, he said. They had a lot of broken parts. “You can’t just fix one thing and think you have solved the problem,” he said.

And trying to do so can be very costly. About a quarter of all Medicare spending for beneficiaries 65 or older is to treat people in their last year of life, according to a report by the Kaiser Family Foundation. (Kaiser Health News, which produces California Healthline, is an editorially independent program of the foundation.)

Hoefer’s colleague, Suzi Johnson, a nurse and administrator in Sharp’s hospice program, saw the opposite side of the equation. Patients admitted into hospice care would make surprising turnarounds once they started getting medical and social support at home and stopped going to the hospital. Some lived longer than doctors had expected.

In 2005, the pair hatched and honed a bold idea: What if they could design a home-based program for patients before they were eligible for hospice?

Thus, Transitions was born. They modeled their new program in part on the Kaiser experiment, then set out to persuade doctors, medical directors and financial officers to try it. But they met resistance from physicians and hospital administrators who were used to getting paid for seeing patients.

“We were doing something that was really revolutionary, that really went against the culture of health care at the time,” Johnson said. “We were inspired by the broken system and the opportunity we saw to fix something.”

Despite the concerns, Sharp’s foundation board gave the pair a $180,000 grant to test out Transitions. And in 2007, they started with heart failure patients and later expanded the program to those with advanced cancer, dementia, chronic obstructive pulmonary disease and other progressive illnesses. They started to win over some doctors who appreciated having additional eyes on their patients, but they still encountered “some skepticism about whether it was really going to do any good for our patients,” said Jeremy Hogan, a neurologist with Sharp. “It wasn’t really clear to the group … what the purpose of providing a service like this was.”

Nevertheless, Hogan referred some of his dementia patients to the program and quickly realized that the extra support for them and their families meant fewer panicked calls and emergency room trips.

Hoefer said doctors started realizing home-based care made sense for these patients — many of whom were too frail to get to a doctor’s office regularly. “At this point in the patient’s life, we should be bringing health care to the patient, not the other way around,” he said.

Across the country, more doctors, hospitals and insurers are starting to see the value of home-based palliative care and are figuring out how to pay for it, said Kathleen Kerr, a health care consultant who researches palliative care.

“It is picking up steam,” she said. “You know you are going to take better care of this population, and you are absolutely going to have lower health care costs.”

Providers are motivated in part by a growing body of research. A study published in January showed that in the last three months of life, medical care for patients in a home-based palliative care program cost $12,000 less than for patients who were getting more typical treatment. Patients in the program also were more likely to go into hospice and to die at home, according to the study.

Two studies of Transitions in 2013 and 2016 reaffirmed that such programs save money. The second study, led by outside evaluators, showed it saved more than $4,200 per month on cancer patients and nearly $3,500 on those with heart failure.

The biggest differences occurred in the final two months of life, said one of the researchers, Brian Cassel, who is palliative care research director at the Virginia Commonwealth University School of Medicine in Richmond.

One reason for the success of these programs is that the teams really get to know patients, their hopes and aspirations, said Christine Ritchie, a professor at UC San Francisco’s medical school. “There is nothing like being in someone’s home, on their turf, to really understand what their life is like,” she said.

A home visit

Nurse Sheri Juan and social worker Mike Velasco, who both work for Sharp, walked up a wooden ramp to the Chinchars’ front door one recent January morning. Juan rolled a small suitcase behind her containing a blood pressure cuff, a stethoscope, books, a laptop computer and a printer.

Mary Jo Chinchar was already familiar with Transitions because her mother had been in the program before entering hospice and dying in 2015 at the age of 101. Late last year, Gerald Chinchar’s doctor recommended he enroll in it, explaining that his health was in a “tenuous position.”

Chinchar, who has nine grandchildren and four great-grandchildren, likes to tell stories about his time in the Navy, about traveling the country for jobs and living in San Francisco as a young man.

He has had breathing problems much of his life, suffering from asthma and chronic obstructive pulmonary disease — ailments he partly attributes to the four decades he spent painting and sandblasting fuel tanks for work. Chinchar also has diabetes, a disease that led to his mother’s death. He recently learned he had heart failure.

“I never knew I had any heart trouble,” he said. “That was the only good thing I had going for me.”

Now he’s trying to figure out how to keep it from getting worse: How much should he drink? What is he supposed to eat?

That’s where Juan comes in. Her job is to make sure the Chinchars understand Gerald’s disease so he doesn’t have a flare-up that could send him to the emergency room. She sat beside the couple in their living room, its bookshelves filled with titles on gardening and baseball. A basket of cough drops and a globe sat on a side table.

Any pain today? Juan asked. How is your breathing? Are you more fatigued than before? Is your weight the same? He replied that he had gained a few pounds recently but knew that was because he’d eaten too much bacon.

At this point in the patient’s life, we should be bringing health care to the patient, not the other way around.

Posted on the couple’s refrigerator was a notice advising them to call the nurse if Gerald had problems breathing, increased swelling or new chest pain.

Juan checked his blood pressure and examined his feet and legs for signs of more swelling. She looked through his medications and told him which ones the doctor wanted him to stop taking. “What we like to do as a palliative care program is streamline your medication list,” she said. “They may be doing more harm than good.”

Mary Jo Chinchar said she appreciates the visits, especially the advice about what Gerald should eat and drink. Her husband doesn’t always listen to her, she said. “It’s better to come from somebody else.”

A nearly impossible decision

On a rainy January day, doctors, nurses and social workers gathered in a small conference room for their bimonthly meeting to discuss patient cases. Information about the patients — their hospitalizations, medications, diagnoses — was projected on the wall. Their task: to decide if new patients were appropriate for Transitions and if current patients should remain there.

It’s nearly impossible to predict how long someone will live. It’s an inexact algorithm based on the severity of their disease, depression, appetite, social support and other factors. Nevertheless, the team tries to do just that, and they may recommend hospice for patients expected to live less than six months.

That was the case with an 87-year-old woman suffering from Alzheimer’s disease. She had fallen many times, slept about 16 hours a day and no longer had much of an appetite. Those were all signs that the woman may be close to death, so she was referred to hospice.

Patients typically stay in Transitions about seven or eight months, but some last as long as two years before they stabilize and are discharged from the program. Others go directly to hospice, and still others die while they are still in Transitions.

The group turned its attention to an 89-year-old woman with dementia, who believed she was still a young Navy wife. She suffered from depression and kidney disease, and had been hospitalized twice last year.

“She’s a perfect patient for Transitions,” Hoefer told the team, adding that she could benefit from extra help. Another good candidate, Hoefer said later, was El Cajon resident Evelyn Matzen, who is 94 and has dementia. She had started to lose weight and was having more difficulty caring for herself. They took her in because “we were worried that it was going to start what I call the revolving door of hospitalization,” Hoefer said.

About eight months after she joined the program, Matzen sat in Hoefer’s office as he checked her labs and listened to her chest. Her body was starting to slow down, but she was still doing well, he told her. “Whatever you are doing is working.”

Bill Matzen, who accompanied his mom to the appointment, said she had started to stabilize since going onto Transitions. “She is on less medication, she is in better condition, physically, mentally, the whole nine yards,” he said.

Hoefer explained that frail elderly patients have fewer reserves to tolerate medical treatment and especially hospitalization. Bill Matzen said his mother leaned that the hard way after a recent fall. Though the Transitions nurse had come to see her, the Matzens decided to go to the hospital because they were still concerned about a bruise on her head. While she was in the hospital, Evelyn Matzen started hallucinating and grew agitated.

Being in the hospital “kicks her back a notch or two,” her son said. “It takes her longer to recover than if she had been in a home environment.”

A changed climate

Outpatient palliative care programs are cropping up in various forms. Some new ones are run by insurers, others by health systems or hospice organizations. Others are for-profit, including Aspire Health, which was started by former senator Bill Frist in 2013.

Sutter Health operates a project called Advanced Illness Management to help patients manage symptoms and medications and plan for the future. The University of Southern California and Blue Shield of California recently received a $5 million grant to provide and study outpatient care.

“The climate has changed for palliative care,” said Enguidanos, the lead investigator on the USC-Blue Shield project.

Ritchie said she expects even more home-based programs in the years to come, especially if palliative care providers work alongside primary care doctors. “My expectation is that much of what is being done in the hospital won’t need to be done in the hospital anymore and it can be done in people’s homes,” she said.

Challenges remain, however. In addition to questions about reimbursement, not enough trained providers are available. And some doctors are unfamiliar with the approach, and patients may be reluctant, especially those who haven’t clearly been told they have a terminal diagnosis.

Now, some palliative care providers and researchers worry about the impact of President Donald Trump’s plans to repeal the Affordable Care Act and revamp Medicare.

“It would be horrible,” Kerr said. “Before, we had an inkling that this was helping a lot of folks. Now we know it is really helping.”

Gerald Chinchar, who grew up in Connecticut, said he never expected to live into old age. His father, a heavy drinker, died of cirrhosis of the liver at 47. In his family, Chinchar said, “you’re an old-timer if you make 60.”

Chinchar said he gave up drinking and is trying to eat less of his favorite foods — steak sandwiches and fish and chips. He just turned 77, a milestone he credits partly to the pre-hospice program.

“If I make 80, I figured I did pretty good,” he said. “And if I make 80, I’ll shoot for 85.”

KHN’s coverage in California is funded in part by Blue Shield of California Foundation.

Photo: IvelinRadkov, Getty Images

Dexcom will reap benefit as CMS posts criteria for Medicare coverage of CGMs

The Centers for Medicare and Medicaid Services has released guidelines on Medicare coverage for continuous glucose monitors, and one medtech company stands to make a whole lot of money from the change.

San Diego-based DexCom is the only manufacturer of a continuous glucose monitor (CGM) defined as therapeutic, meaning patients can make treatment decisions using the device. The DexCom G5 Mobile System provides the glucose level, the direction and rate of change, and uses built-in customizable alarms to alert wearers when their glucose is too low or too high. Low glucose levels can induce seizures, loss of consciousness, coma and death.

DexCom, diabetes professional societies, endocrinologists, the American Diabetes Association and the Juvenile Diabetes Research Foundation (JDRF) have been working on this with CMS for years, according to DexCom CEO Kevin Sayer.

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“It does expand our patient base to a group of people who really need this technology,” Sayer said in a phone interview. “It’s more than a nice business opportunity. It’s going to be a life-changing experience for these people. It will be something that will be fun to be part of.”

CMS announced its decision to cover the monitors for Medicare patients in January, and this week said that patients who have either Type 1 or Type 2 diabetes and who must intensively manage their insulin will be able to obtain reimbursement for the devices.

To get the coverage, beneficiaries must meet four criteria, according to CMS:

  • Have a diagnosis of Type 1 or Type 2 diabetes;
  • Have used a home blood glucose monitor and performing four or more blood sugar tests per day;
  • Take multiple daily injections of insulin or use a continuous subcutaneous insulin infusion pump;
  • Have a treatment regimen that requires them to make frequent adjustments based on their blood sugar test results.

“These definitions would apply to almost everyone with Type 1 diabetes,” JDRF senior vice president for advocacy and policy Cynthia Rice said in a phone interview. “It might not apply to everyone with Type 2 diabetes.”

JDRF raises money for research and awareness of Type 1 diabetes, which is usually diagnosed in children and young adults. People aged 65 and older who have Type 1 diabetes have usually been suffering from it for decades, and are more susceptible to low blood sugar because their bodies are less able to detect it, Rice explained.

“Lows can happen at night or during the day,” Rice said. “But at night, one of the advantages of the alarm is that other family members can hear it.”

DexCom began ramping up its production following CMS’ January decision. The company plans to open a second factory, in Arizona, in 2018, Sayer said. About 75 percent of the 200,000 patients who use the G5 are based in the United States and most are covered by commercial insurance, he added. Sales have grown from $66 million in 2011 to $571 million in 2016.

Medicare will reimburse for CGMs at a rate of $250 to $275 per month or about $3,000 per year, which covers rental of a durable component and purchase of disposable accessories, Sayer noted. The other major manufacturer of CGMs, Medtronic, does not have the proper FDA labeling for to obtain Medicare coverage. The company did not respond to requests for comment.

Private insurers began covering CGMs in 2008 and 2009, according to Rice.

“It took a long time to get CMS here, but it’s wonderful that they have taken this step,” Rice said. “We’re really pleased with their decision in January, and what happened yesterday really makes it real, makes it ready to implement. So many people will benefit from having access to this important technology.”

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As House health bill vote nears, what would be consequences of dumping essential benefits?

A last-minute attempt by conservative Republicans to dump standards for health benefits in plans sold to individuals would probably lower the average consumer’s upfront insurance costs, such as premiums and deductibles, said experts on both sides of the debate to repeal and replace the Affordable Care Act.

But, they add, it will likely also induce insurers to offer much skimpier plans, potentially excluding the gravely ill, and putting consumers at greater financial risk if they need care.

For example, a woman who had elected not to have maternity coverage could face financial ruin from an unintended pregnancy. A healthy young man who didn’t buy drug coverage could be bankrupted if diagnosed with cancer requiring expensive prescription medicine. Someone needing emergency treatment at a non-network hospital might not be covered.

What might be desirable for business would leave patients vulnerable.

“What you don’t want if you’re an insurer is only sick people buying whatever product you have,” said Christopher Koller, president of the Milbank Memorial Fund and a former Rhode Island insurance commissioner. “So the way to get healthy people is to offer cheaper products designed for the healthy people.”

The proposed change could give carriers wide room to do that by eliminating or shrinking “essential health benefits” including hospitalization, prescription drugs, mental health treatment and lab services from plan requirements — especially if state regulators don’t step in to fill the void, analysts said.

The Affordable Care Act requires companies selling coverage to individuals and families through online marketplaces to offer 10 essential benefits, which also include maternity, wellness and preventive services — plus emergency room treatment at all hospitals. Small-group plans offered by many small employers also must carry such benefits.

Conservative House Republicans want to exclude the rule from any replacement, arguing it drives up cost and stifles consumer choice.

On Thursday, President Donald Trump agreed after meeting with members of the conservative Freedom Caucus to leave it out of the measure under consideration, said White House Press Secretary Sean Spicer. “Part of the reason that premiums have spiked out of control is because under Obamacare, there were these mandated services that had to be included,” Spicer told reporters.

Pushed by Trump, House Republican leaders agreed late Thursday to a Friday vote on the bill but were still trying to line up support. “Tomorrow we will show the American people that we will repeal and replace this broken law because it’s collapsing and it’s failing families,” said House Speaker Paul Ryan (R-Wisconsin). “And tomorrow we’re proceeding.” When asked if he had the votes, Ryan didn’t answer and walked briskly away from the press corps.

But axing essential benefits could bring back the pre-ACA days when insurers avoided expensive patients by excluding services they needed, said Gary Claxton, a vice president and insurance expert at the Kaiser Family Foundation. (Kaiser Health News is an editorially independent program of the foundation.)

“They’re not going to offer benefits that attract people with chronic illness if they can help it,” said Claxton, whose collection of old insurance policies shows what the market looked like before.

One Aetna plan didn’t cover most mental health or addiction services — important to moderate Republicans as well as Democrats concerned about fighting the opioid crisis. Another Aetna plan didn’t cover any mental health treatment. A HealthNet plan didn’t cover outpatient rehabilitative services.

Before the ACA most individual plans didn’t include maternity coverage, either.

The House replacement bill could make individual coverage for the chronically ill even more scarce than a few years ago because it retains an ACA rule that forces plans to accept members with preexisting illness, analysts said.

Before President Barack Obama’s health overhaul, insurers could reject sick applicants or charge them higher premiums.

Lacking that ability under a Republican law but newly able to shrink benefits, insurers might be more tempted than ever to avoid covering expensive conditions. That way the sickest consumers wouldn’t even bother to apply.

“You could see even worse holes in the insurance package” than before the ACA, said Sabrina Corlette, a research professor at the Center on Health Insurance Reforms at Georgetown University. “If we’re going into a world where a carrier is going to have to accept all comers and they can’t charge them based on their health status, the benefit design becomes a much bigger deal” in how insurers keep the sick out of their plans, she said.

Michael Cannon, an analyst at the libertarian Cato Institute and a longtime Obamacare opponent, also believes dumping essential benefits while forcing insurers to accept all applicants at one “community” price would weaken coverage for chronically ill people.

“Getting rid of the essential health benefits in a community-rated market would cause coverage for the sick to get even worse than it is under current law,” he said. Republicans “are shooting themselves in the foot if they offer this proposal.”

Cannon favors full repeal of the ACA, allowing insurers to charge higher premiums for more expensive patients and helping consumers pay for plans with tax-favored health savings accounts.

In an absence of federal requirements for benefits, existing state standards would become more important. Some states might move to upgrade required benefits in line with the ACA rules but others probably won’t, according to analysts.

“You’re going to have a lot of insurers in states trying to understand what existing laws they have in place,” Koller said. “It’s going to be really critical to see how quickly the states react. There are going to be some states that will not.”

Mary Agnes Carey and Phil Galewitz contributed to this story.

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White House delivers ultimatum on healthcare bill, setting scene for dramatic House vote Friday

There’s so much drama on Capitol Hill today and this evening. After years of failed attempts, the Republicans are finally positioned to repeal and replace the Affordable Care Act. But the vote, which was expected to take place Thursday, was delayed as it became clear that there weren’t enough votes from the conservative members of the “Freedom Caucus” and moderate members of the House Republicans to push the bill through.

Who would have thought there was so much diversity in the Republican party?

Republican leadership met with White House officials and party members Thursday evening to sway undecided or no voters to a yes. The White House also delivered an ultimatum to Republicans considering a no vote: Negotiations are over. Vote yes or move on with Obamacare.

If the bill is defeated, what would that say about the Trump’s negotiating skills? After all, Press Secretary Sean Spicer quipped at a media briefing yesterday, “There is no Plan B”.

The turn of events provoked plenty of discussion about what this vote means for the Republican party’s identity, whether Trump is setting House Speaker Paul Ryan as a scapegoat and evaluating the job Trump has done selling the healthcare bill to the American voters.

Amidst the drama, there was some room for a little comedy

And some apologizing…

A Congressional Budget Office Report published Thursday afternoon contended that under the revised bill 24 million would still lose their health insurance by 2026, despite reducing savings in federal spending.

The Republicans occupy a position they have strived to be in for years and yet as the bill makes it final approach to the floor of the House, Congressmen are feeling the full weight of this vote and the growing realization that some of the constituents will like it but many of them won’t. Just as passing ACA led many Americans to lose insurance when their previous plans became voided by the Act’s requirements, there will be winners and losers with this bill as well.

At the very least, there will be a lot of questions to address in the next 24 hours, whatever the outcome.

Photo: Justin Sullivan, Getty Images