Medicare Advantage value-based plan enrollment tripling for 2020

• The number of Medicare Advantage members enrolled in plans with value-based payment designs more than tripled from 2019 to 2020, CMS said Thursday.
• Approximately 1.2 million beneficiaries joined plans in the Value-Based Insurance Design Model for coverage next year offered by 14 MA organizations across 30 states and Puerto Rico. That’s up from only 440,000 beneficiaries, 10 MA organizations and seven states in 2019.
• CMS also opened up applications Thursday for MA plans to test allowing MA enrollees to access the Medicare hospice benefit starting in 2021, in an attempt to coordinate care for MA beneficiaries in palliative and hospice care.

CMS has been pushing to enroll more Medicare beneficiaries in value-based plans in a bid to lower costs while improving quality. The VBID Model allows payers to test alternative payment strategies in MA plan design. This can include targeting plan design based on an enrollee’s chronic condition or income status, among other socioeconomic characteristics.

A slew of large payers are participating in the model that CMS innovation center CMMI launched in 2017, including CVS Health-owned Aetna, UnitedHealth Group and Humana.

CareOregon, Capital District Physicians’ Health Plan, Highmark Health, Innovacare, Medical Card System, New York City Health and Hospitals Corporation, Sentara, UPMC Health System, WellCare and Blue Cross Blue Shield in Michigan and Rhode Island are also participating in the VBID Model for 2020.

Seniors account for a disproportionately large share of healthcare spending and more are using hospice: 1.5 million Medicare beneficiaries were enrolled in hospice care in 2017, a 4.5% increase from the prior year.

Despite this, the Medicare hospice benefit hasn’t been overhauled since it was added as a Medicare covered benefit almost four decades ago, according to the Medicare Payment Advisory Committee. During that time, hospice spending has continued to mount, growing more than 400% between 2000 and 2012 alone.

The average hospice length of stay has increased from 53 days to 89 days, while the median length of stay has remained flat at 17 days, according to CMS.

In the new model, MA beneficiaries can elect the hospice benefit in their MA plan, but they’ll still have access to the hospice benefit in traditional, fee-for-service Medicare. The goal is to give seniors additional access to palliative care, transitional concurrent care and hospice-specific supplemental benefits, CMS said.

Currently, MA beneficiaries who want to receive hospice benefits get the majority of that coverage through FFS Medicare, while their MA coverage is only responsible for supplemental benefits. That hospice “carve-out” from MA can result in a web of rules that complicates coverage and makes it difficult to determine who’s accountable for their care.

Experts have foreseen this folding-in for a while now, with Dan Mendelson of Avalere Health telling Healthcare Dive last year the siloing of MA and hospice benefits “makes no sense.”

And hospice is a lucrative area for payers, sparking a recent flurry of M&A. Humana has been particularly aggressive in that arena, acquiring home health and hospice giant Kindred in 2017 for $4.1 billion, hospice operator Curo for $1.4 billion in April last year and hospice pharmacy and PBM Enclara earlier this month.

https://www.healthcaredive.com/news/ma-value-based-plan-enrollment-tripling-for-2020/569519/

UnitedHealth, Anthem, Cigna roped into House surprise billing probe

• The House Energy and Commerce Committee is expanding its investigation into surprise billing practices by calling on some of the nation’s largest insurers and physician staffing firms to provide information and documents on the practice, lawmakers said Thursday.
• The committee sent letters to UnitedHealth Group, Anthem and Cigna asking for information about in-network and out-of-network pricing and the frequency of surprise billing in their plans.
• Private-equity backed Envision Healthcare and Team Health also received letters from the committee.

Despite bipartisan support to eliminate surprise billing, Congress has punted the issue to next year, amid competing congressional proposals and pushback from doctors, hospitals and insurers.

Senate Health Committee Chairman Lamar Alexander, R-Tenn., said in a statement Monday it will be a top legislative priority next year.

Still, the House Energy and Commerce Committee is pushing ahead on investigations to better understand the forces behind the practice that can sometimes leave patients on the hook for pricey medical bills after they inadvertently get out-of-network care despite being at an in-network facility.

“We are concerned about the impact of surprise billing on the nation’s rising health care costs and the devastating effect that the practice is having on Americans,” the leaders of the committee said in a statement on Thursday.

The committee has requested insurers and physician staffing groups answer a slew of questions and provide them to the committee no later than Jan. 9, according to the letters.

Of the letters sent to insurers, one question asks for how many beneficiaries were responsible for an out-of-network bill despite receiving care at an in-network facility over the past five years.

The committee is seeking a comprehensive list of facilities and providers that have agreed to in-network works and a list of the physician staffing firms that work at those hospitals and have also agreed to in-network rates. It also wants to know the average in-network reimbursement rate for each of the physician services covered by the plan that are provided by the physicians affiliated with a physician staffing company.

The issue of surprise billing has garnered numerous studies and attracted the attention of lawmakers and the press reporting on families stuck in the middle slapped with eye-popping bills.

Research has shown that surprise bills are somewhat common. As many as one in five emergency room visits results in a surprise bill, according to Health Affairs. Nearly 70% of air ambulances were out-of-network in 2017, according to a separate government report.

Another recent study showed that if some specialties were banned from billing out-of-network charges, healthcare spending for those with employer-sponsored insurance would fall by 3.4%, or about $40 billion annually.

https://www.healthcaredive.com/news/unitedhealth-anthem-cigna-roped-into-house-surprise-billing-probe/569520/

Homology unveils first data for PKU gene therapy, marking early milestone

• Homology Medicines on Tuesday disclosed the first clinical data for its experimental gene therapy treatment for phenylketonuria, or PKU, announcing interim results from the first three patients treated.
• While too early to conclude much about the treatment’s benefit, Homology’s readout marks a step forward for clinical research on the rare inherited disorder, a focus for several other drug developers as well.
• The first two participants on a low dose did not see a reduction in an amino acid that builds up in the bodies of those with PKU. A third saw an early but more pronounced effect from treatment. Shares in the biotech fell in post-market trading.

Rare disease drugmaker BioMarin sells two therapies for PKU, a metabolic disease caused by a genetic inability to break down an amino acid found in protein-containing foods and artificial sweeteners.

But, like many inherited diseases with clear genetic roots, the condition is newly a target for gene therapy biotechs like Homology.

Tuesday’s update includes data from the first three adults with PKU treated with Homology’s gene therapy, known as HMI-102.

Two patients received the lowest dose, while one received a higher dose. Homology is not providing the exact dose levels, citing competitive reasons. A fourth patient received the higher dose after Dec. 2, the cut-off for compiling results, Seymour said.

While the trial will track these patients for one year, this first glimpse included data on only the first few months following treatment of the three patients.

Both trial participants on the low dose did not experience a reduction in phenylalanine, or Phe, the critical amino acid in PKU. Over time, high levels of Phe can lead to intellectual disabilities and brain damage.

Homology is more optimistic about the third patient, who saw a reduction in Phe and a corresponding increase in tyrosine, another amino acid that is typically at lower levels in PKU patients, after receiving the higher dose.

Homology’s Phase 1/2 trial is still in initial stages, with the potential to increase dosing in the future. Albert Seymour, the biotech’s chief scientific officer, said in a Tuesday interview that decisions on dose escalation are likely to be made when more data is available in a planned mid-2020 update.

Seymour said this small amount of data gives him confidence that HMI-102 successfully delivers the PAH gene into cells. ​For the two patients on the low dose, the company measured vector copy numbers in the blood, which is evidence the therapy is present, he said.

Reduced Phe and increased tyrosine in the third patient also suggest HMI-102’s activity. After four weeks, Phe levels declined by 48% compared to baseline, while tyrosine levels rose by 85%.

By comparison, BioMarin’s Palynziq (pegvaliase) showed a roughly 62% reduction in Phe levels among patients treated with a 20 mg once daily dose of the enzyme substitution therapy.

Without data from more patients over a longer time period, Homology’s therapy will be hard to assess. Next year could prove critical, though, as BioMarin is preparing to start a Phase 1/2 study of its own PKU gene therapy early in 2020.

Sangamo Therapeutics, meanwhile, announced on Tuesday plans to begin clinical study of a PKU gene therapy in 2021.

“We do feel we are considerably ahead of all the competition in the gene therapy space,” Seymour said, referring to the PKU work from BioMarin and Sangamo.

Other approaches are getting attention, too. Rubius Therapeutics, Synlogic and Codexis have PKU therapies in clinical testing, while Moderna and Agios Pharmaceuticals have both said they are doing preclinical research on the disorder.

https://www.biopharmadive.com/news/homology-first-data-pku-gene-therapy/569275/

AstraZeneca lupus drug shows promise, but enough for FDA?

• AstraZeneca’s lupus drug anifrolumab reduced disease activity in nearly half of patients in the TULIP-2 trial, significantly more than the 32% of patients on placebo who saw improvement. The results of the trial were published Wednesday in the New England Journal of Medicine.
• Anifrolumab failed to show a significant benefit in an earlier trial using a different clinical measurement, raising questions over whether the Food and Drug Administration would approve the drug without a second positive pivotal trial.
• If approved, anifrolumab would compete against GlaxoSmithKline’s Benlysta, which had sales of 473 million pounds, or around $617 million, in 2018. GSK yesterday announced results from a Benlysta trial in patients with a kidney complication called lupus nephritis.

TULIP-2, AstraZeneca’s study, used a scale called BICLA, which measures improvement based on disease activity, organ health, physician assessment and several other components.

This differs from the measurement in TULIP-1, which used something called the SLE Responder Index 4. GSK used the SRI in two of the three clinical trials it ran to win approval of Benlysta (belimumab).

Using SRI, Benlysta produced an improved response of a similar magnitude as anifrolumab — a 9 percentage point improvement in patient response over placebo in one trial and 14 percentage points in another.

However, in TULIP-1, the AstraZeneca trial using this scale, anifrolumab generated a response in 36% of patients, compared with 40% of patients taking placebo. Benlysta stimulated a response in 43% and 58% of patients when measured by the SRI.

Lupus is a complex autoimmune disorder that affects patients differently, requiring complicated measurement of improvement. This can lead to mixed trial results, as happened when GSK was seeking approval for Benlysta and a Phase 3 trial using yet another set of measurements failed to show the drug’s efficacy.

In an editorial accompanying the NEJM article on TULIP-2, Jane Salmon of Weill Cornell Medical School and Timothy Niewold of New York University Medical School write that BICLA and the SRI weight patient response differently, which can account for the different trial outcomes.

BICLA measures partial responses while SLE counts only complete responses, for example, and only SLE measures blood biomarkers, they write. In addition, SRI puts more weight on arthritis than rash, according to the two rheumatologists.

Benlysta was the first drug for lupus since 1955 when GSK launched it in 2011, so the FDA is keenly aware of the need for more treatment options. However, it will need to balance the demand for more drugs against the mixed clinical results in making its decision to clear the way for AstraZeneca to submit anifrolumab for review.

https://www.biopharmadive.com/news/astrazeneca-lupus-drug-anifrolumab-nejm/569426/

New evidence strengthens link between vitamin E acetate and vaping illness

New evidence strengthens the suspected link between a substance known as vitamin E acetate and the outbreak of serious lung illnesses tied to vaping and e-cigarette use, U.S. health officials said Friday.

Researchers tested lung fluid samples from 51 patients with vaping-related illness, dubbed EVALI. They found vitamin E acetate — a sticky substance used as an additive or thickening agent in some vaping products — in 48 of the samples. They didn’t find any vitamin E acetate in lung fluid taken from healthy patients, suggesting the chemical played a role in making people sick.

There have been 2,506 people hospitalized with EVALI across all 50 states, Washington, D.C, Puerto Rico, and the U.S. Virgin Islands. Health officials have confirmed 54 deaths associated with the outbreak.

Most of those sickened reported vaping THC, the active ingredient that gives marijuana its high. Many of those patients bought their products from friends or informal sources, including online and in-person dealers. As the case count climbed, health officials scrambled to find a culprit causing the illnesses.

In November, the Centers for Disease Control and Prevention reported it had zeroed in on vitamin E acetate as a “potential toxin of concern.” Lab testing revealed the substance in every sample of lung fluid collected from 29 patients with vaping-related illness.

The new study backed up those findings in a larger, more geographically diverse sample of patients from 16 states. Researchers also looked for other potentially harmful additives during the testing, such as plant oils. One patient sample tested positive for coconut oil, while another contained an e-cigarette additive called limonene. The study also found THC in 40 of 47 samples from patients with EVALI.

The tests didn’t find vitamin E acetate in samples from three of the EVALI patients. But the study’s authors noted that since there is no test to formally diagnose the condition, it’s not possible to confirm that those patients had EVALI.

Vitamin E acetate is commonly used in supplements and skin creams. It is generally seen as safe when swallowed or used topically in moderate amounts. But research suggests that inhaling the substance can impair lung function, causing serious illness.

Health officials have said there is a need for more research on the potential link between vitamin E acetate and vaping illnesses, including animal studies that could show whether the substance directly causes the lung injury. They have also said it is too soon to rule out whether there are also other culprits at play in the outbreak.

The CDC has warned the public not to add vitamin E acetate or any other substances not intended by the manufacturer to their vaping products. Health officials also recommend that people avoid vaping products that contain THC, particularly those that were obtained from informal sources.

https://www.statnews.com/2019/12/20/new-evidence-strengthens-link-between-vitamin-e-acetate-and-vaping-illness/

E-Cigarette Influencers to Be Banned From Instagram, Facebook

Social media influencers who market electronic cigarette products will be banned from Facebook and Instagram, the companies say.

Instagram said that global enforcement of the new policy will begin “in the coming weeks,” and Instagram owner Facebook said its policy will begin next year, CBS News reported Wednesday. E-cigarette product advertising is already banned on both platforms.

“With the right policy, Facebook and Instagram are uniquely positioned to cut off Big Tobacco’s easiest access point to kids and young people around the world,” Matthew Myers, president of the Campaign for Tobacco-Free Kids, said in a statement to CBS MoneyWatch. “Updates to Facebook and Instagram policies on influencer marketing are desperately needed.”

CBS News Article

https://www.physiciansbriefing.com/family-practice-5/electronic-cigarettes-970/e-cigarette-influencers-to-be-banned-from-instagram-facebook-753211.html

Unhealthy Eating Habits Cost U.S. $50 Billion a Year: Study

Healthier eating could save the United States more than $50 billion a year in health care costs associated with heart disease, stroke, type 2 diabetes and related illnesses, according to a new study.

An unhealthy diet is one of the leading risk factors for poor health and accounts for up to 45% of all deaths from these cardiometabolic diseases, the researchers noted.

But the economic cost of illnesses caused by poor eating habits hadn’t been tallied.

In this study, researchers from Brigham and Women’s Hospital and Tufts University in Massachusetts created a model to measure the impact of 10 food and nutrient groups on cardiometabolic disease costs for Americans aged 35 to 85 years. Those 10 groups were fruits, vegetables, nuts/seeds, whole grains, unprocessed red meats, processed meats, sugar-sweetened beverages, polyunsaturated fats, seafood omega-3 fats and sodium.

The researchers first looked at the effects of current eating habits and then did a recalculation if Americans ate the healthiest amounts of the 10 food/nutrient groups.

The study authors concluded that poor eating habits cost the United States about $300 per person, or $50 billion, a year and accounted for 18% of heart disease, stroke and type 2 diabetes costs.

Of those costs, 84% was for acute care, the researchers reported. Costs were highest for people with Medicare ($481 per person) and for those who were eligible for both Medicare and Medicaid ($536 per person).

The study was published Dec. 17 in the journal PLOS Medicine.

“There is a lot to be gained in terms of reducing risk and cost associated with heart disease, stroke and diabetes by making relatively simple changes to one’s diet,” said study co-author Dr. Thomas Gaziano, of the division of cardiovascular medicine at Brigham and Women’s Hospital, in Boston.

“Our study indicates that the foods we purchase at the grocery store can have a big impact. I was surprised to see a reduction of as much as 20% of the costs associated with these cardiometabolic diseases,” he added in a hospital news release.

Gaziano said the study illustrates the need for incentives for healthier eating habits, because improved diets have the potential “to have a big impact and reduce the health and financial burden of cardiometabolic disease.”

More information

Visit the U.S. National Library of Medicine to find some healthy recipes.

SOURCE: Brigham and Women’s Hospital, news release, Dec. 17, 2019

https://consumer.healthday.com/public-health-information-30/health-cost-news-348/unhealthy-eating-habits-cost-u-s-50-billion-a-year-study-753100.html