Novartis presents first-of-kind histology data with kidney transplants

Novartis has announced first-of-its-kind histology data with iscalimab (CFZ533), suggesting the extended survival of transplanted organs may be possible.

The early stage data suggest that with investigational compound iscalimab it may be possible to prolong the durability of transplanted kidneys as well as to potentially improve long-term outcomes for kidney transplant patients.

The data, presented at the American Transplant Congress (ATC), examine whether calcineurin-free treatment with iscalimab preserves the quality of transplanted kidney grafts.

In this analysis, iscalimab demonstrated lower chronic allograft damage index (CADI) scores compared with tacrolimus (current standard-of-care), with normal renal histology seen in three of five patients (60%) on iscalimab vs none of seven on tacrolimus.

Low CADI scores have been associated with improved long-term outcomes. The findings, although in a limited number of patients, are to be confirmed in an ongoing Phase IIb trial (Cirrus I, NCT03663335).

Iscalimab is a new, fully human, monoclonal antibody preventing cluster of differentiation 40 (CD40) pathway signaling and activation of CD40+ cell types.

The analysis presented at the ATC included patients from this study that underwent either routine biopsies or biopsies as part of a follow-up protocol. The data was reviewed and scored by a blinded pathologist using the established Banff criteria and CADI.

Less than half of donated kidneys last 10 years, so durability is a significant unmet need for patients who are living with or waiting for a transplant. More than 100,000 patients are on the US transplant waiting list with a chronic shortfall of donors.

Eric Hughes, Global Development Unit Head, Immunology, Hepatology and Dermatology, said: “Extending the life of transplanted kidneys would mean fewer patients going back on dialysis or needing a second transplant – relieving pressure on waiting lists that in the US are already three-to-five years long.

“In our journey to reimagine care for patients, I’m excited about the potential of durable transplants becoming a reality.”

Novartis presents first-of-its-kind histology data with iscalimab

Anthem to acquire behavioral health program

Anthem, Inc. (NYSE:ANTM) today announced that the company has entered into a definitive agreement to acquire Beacon Health Options (Beacon), the largest independently held behavioral health organization in the country. Beacon currently serves more than 36 million individuals across all 50 states, including nearly 3 million individuals under comprehensive risk-based behavioral programs. The acquisition aligns with Anthem’s strategy to diversify into health services and deliver market-leading integrated solutions and care delivery models that personalize care for people with complex and chronic conditions.

“As Anthem works to improve lives, simplify healthcare and serve as an innovative and valuable partner, we’re focused on providing solutions that address the needs of the whole person,” said Gail K. Boudreaux, President and CEO, Anthem. “With an extensive track record in behavioral health, Beacon fits well with our strategy to better manage the needs of populations with chronic and complex conditions, and deliver integrated whole health solutions. Together with Beacon, we will enhance our capabilities to serve state partners, health plans and employer groups as they seek to address consumer behavioral health needs.”

The acquisition of Beacon will offer Anthem the opportunity to combine its existing behavioral health business with Beacon’s successful model and support services to fully scale integrated behavioral and physical health capabilities to customers and consumers nationwide. Collectively, both businesses will be able to enhance whole person care and improve overall health outcomes with a stronger portfolio of specialized products, more clinical expertise, improved analytics and health data, and broader provider networks and relationships. The combination will also create one of the most comprehensive behavioral health networks capable of offering more accessible and affordable care for consumers throughout the country.

Upon completion, Beacon, combined with Anthem’s behavioral health business, will operate as an integrated team within Anthem’s Diversified Business Group. Russell C. Petrella, Ph.D., Beacon Health Options President and CEO, as well as other key members of Beacon’s senior team, will join Anthem’s Diversified Business Group to lead the efforts to offer innovative behavioral health solutions and further expand this business.

https://www.businesswire.com/news/home/20190606005173/en/Anthem-Acquire-Beacon-Health-Options

Telemedicine Makes The Living Room The Next Frontier For Healthcare Real Estate

Urgent and ambulatory care facilities are driving patient traffic away from main hospital campuses and into retail centers, but even the two burgeoning sectors in healthcare treatment aren’t immune to disruption.

The number of Massachusetts urgent care clinics grew from 18 to 145 between 2010 and 2018. Retail clinics, which are usually just staffed with nurse practitioners, went from 20 to 54 in the same period. The migration of treatment away from a main hospital is cost-effective as urgent care visits typically cost $150, with patients getting a $33 copay, according to the Massachusetts Health Policy Commission. Hospital emergency room visits typically cost just shy of $900.

But panelists at Bisnow’s National Healthcare New England event Thursday said patients want even more convenience than an urgent care center down the road from their home.

“We’re all in for a rude awakening,” Boston Medical Center Director of Ambulatory Operations Pamela Nettles-Gomez said. “Even if there is an urgent care center within 2 miles or closer, what I’m seeing with patients and my own friends is they are starting to get their care on a phone through an app. That’s a huge disrupter, and it’s not easy to compete with.”

Improved technology and an era where most patients have access to a smartphone are moving treatments out of the exam room and into one’s living room.  Telemedicine, when a doctor treats a patient via video conference or even just photos, is increasingly offered in everything from dermatology to psychiatry. Patients can reach a doctor within minutes, get treated and have a prescription to a pharmacy without having to leave the couch.  Doctors Without Borders now utilizes telemedicine from remote locations to get second opinions from doctors in its global network.

North America is a leading market for telemedicine, which has a current market value of nearly $7B, according to a report released Tuesday by Persistence Market Research. That number is expected to increase more than fivefold in the next 10 years , as 68% of U.S. physicians said they were strongly inclined to utilize remote patient monitoring and telemedicine in the future.

“We’re all working on trying to get up to speed with other industries in terms of technology and our own telestrategies,” Nettles-Gomez said.

The Steward Health Care System, the largest private hospital operator in the U.S., utilizes telemedicine in a variety of ways both on and off hospital campuses, which include St. Elizabeth’s Medical Center in Brighton and Norwood Hospital.  Intensive care unit patients are telemonitored from a center in Westwood, according to Steward Executive Vice President of the Northeast Hospital Region Dr. Mark Girard. The practice has helped reduce lengths of stay in the ICU as well as a decrease in morbidity and mortality rates.

“The telepresence in the ICU has been very comforting to the patients,” Girard said. “It takes a little getting used to the monitor, but they are very comforted they are being monitored by a doctor 24/7, 365.”

Steward also utilizes telehealth as a care management tool and to integrate behavioral health and physical health services. Since access to behavioral or mental health services is often difficult, Girard said payment providers incentivize healthcare providers to offer treatment any way they can, including telemedicine in lieu of in-person visits.  The telemedicine shift is also having an impact on the economics of primary care physician practices.

“Primary care physicians typically made their income on the quick and easy visits that supplemented the hourlong visits they spent with their chronic care patients, where they get paid maybe twice as much as they would on a sore throat where they spend five minutes,” Mount Auburn Cambridge President and Chairman Dr. Barbara Spivak said.

Quick visits were a key part of a primary care physician’s business model, but now those are being siphoned away by urgent care centers and, more recently, telemedicine providers.  Spivak expects primary care physicians to adapt in coming years by dealing primarily with chronic care conditions. That has real estate ramifications, as exam rooms will need to be larger and wheelchair-accessible.  While the tech disruption is almost certain to have further physical impact on U.S. healthcare, panelists at last week’s event still didn’t expect a complete brick-and-mortar death when it comes to getting treated for an ailment.

“I think there will still be plenty of bricks-and-mortar, but what those facilities will look like will change dramatically,” Brigham and Women’s Faulkner Hospital President David McCready said.

https://www.bisnow.com/boston/news/healthcare/with-most-us-doctors-online-telemedicine-guaranteed-to-upend-healthcare-real-estate-99268

‘Secret Shopper’ Study Finds Many Who Need Addiction Treatment Can’t Get It

When people who are addicted to opioids make the difficult decision to quit, the last thing they need to face are barriers to treatment.

Yet, a new “secret shopper” study suggests most addicts seeking a prescription for buprenorphine — which helps people stop using opioids — would have trouble even getting an appointment with a doctor qualified to dispense the drug.

When researchers called doctors’ offices posing as addicts who wanted to get a prescription for buprenorphine so they could stop using heroin, 46% of those who said they had Medicaid were denied an appointment, while 38% of those who said they would pay in cash were turned away.

“When people are seeking treatment, you want to make it as easy as possible. But our study showed you have to be quite persistent. That can be tough and might lead to them giving up,” said study senior author Dr. Michael Barnett. He’s an assistant professor of health policy and management at the Harvard T.H. Chan School of Public Health in Boston.

Barnett said buprenorphine is “a long-acting medication that stimulates the same receptors in the brain as opioids. It helps quash cravings without the euphoria or high of opioids. It lets people get back to their life.”

The challenge in prescribing it, however, is that people have to be in mild to moderate withdrawal before they can be given the drug. Paradoxically, if you are high on opioids and you take buprenorphine, it sends you into an immediate and difficult withdrawal. So, it must be carefully administered by someone who’s had the right training, Barnett explained.

Providers have to obtain a federal waiver to be able to prescribe buprenorphine. Doctors have to have eight hours of training, and nurse practitioners and physician assistants need 24 hours of training. Fewer than 6% of doctors in the United States have these waivers. And even those who do aren’t always actively prescribing the drug.

The U.S. Substance Abuse and Mental Health Services Administration maintains a public list of doctors who agreed to be listed when they obtained their waivers to prescribe buprenorphine.

For the study, two female researchers called the doctors on this list. They posed as heroin addicts seeking an appointment for a buprenorphine prescription. They posed as either a patient with Medicaid or someone who would pay with cash. Each doctor’s office was called twice, several weeks apart.

The researchers planned to call nearly 1,100 providers in six states. However, 530 of the providers were culled from the list because they had invalid contact information (such as a non-working phone number) or they were no longer prescribing buprenorphine.

Some of the remaining doctors couldn’t be reached. For example, their phone may have gone to voicemail instead of a live person. The researchers completed just over 430 calls as a Medicaid patient, and nearly 420 as a cash payer.

Only between half and two-thirds of doctors scheduling an appointment planned to give a prescription on the first visit.

One bright spot the study found was when researchers did find a doctor willing to book an appointment, the wait time was often less than two weeks.

“We do have a prescriber workforce that is open for business and ready to help, but it may be hard for patients to find these providers in those directories,” Barnett said.

As to why people, particularly the Medicaid group, had trouble getting an appointment, Barnett said there are a number of reasons why. One is that Medicaid may put up barriers to prescribing buprenorphine, such as requiring a prior authorization before prescribing the medication. Also, he said, some doctors didn’t want to accept cash payments.

And, he said, there may still be a stigma against these patients. “They’re just people. It’s like treating any other chronic illness, and buprenorphine can literally turn people’s lives around,” Barnett explained.

The findings were published June 3 in the Annals of Internal Medicine.

Dr. Pooja Lagisetty, an assistant professor at the University of Michigan and a primary care physician herself, co-wrote an editorial that accompanied the study. “There was a big difference between those willing to take Medicaid versus the self-pay patients. It makes you question whether insurance may not be reimbursing enough,” she said.

“Addiction is a disease, and people do better on this medication when they’re on it long term. We need to make sure providers are being appropriately reimbursed for the care they’re providing,” Lagisetty said.

Dr. Paul Earley, president of the American Society of Addiction Medicine, said, “What’s most disconcerting is that some of the states with the worst opioid overdoses are where people had a harder time getting an appointment.”

Earley said in this age of data, it shouldn’t be too hard to ask a doctor to be sure to update their information on the list every year, so that people trying to get help aren’t frustrated by calling numbers that are out-of-date and aren’t working.

He also said that doctors seeking the federal waivers that allow them to prescribe should set up a system for caring for these patients. Earley said they need urine testing to be sure they’re taking the medication as they should, and that they need to be called more often with appointment reminders.

“All of those things require a certain amount of work to set up,” he said. But it can be done successfully, Earley noted, pointing to the doctors who were able to see patients quickly in this study.

More information

Learn more about buprenorphine from the U.S. Substance Abuse and Mental Health Services Administration.

SOURCES: Michael Barnett, M.D., M.S., assistant professor, health policy and management, Harvard T.H. Chan School of Public Health, and assistant professor, Harvard Medical School, and primary care doctor, Brigham and Women’s Hospital, Boston; Pooja Lagisetty, M.D., M.Sc., assistant professor, division of general internal medicine, University of Michigan, Ann Arbor; Paul Earley, M.D., president, American Society of Addiction Medicine; June 3, 2019, Annals of Internal Medicine

https://consumer.healthday.com/mental-health-information-25/addiction-news-6/secret-shopper-study-finds-many-who-need-addiction-treatment-can-t-get-it-747092.html

AHA among groups opposing price transparency in info-blocking rule

Healthcare groups including the American Hospital Association came out strong against a suggestion that the Office of the National Coordinator for Health Information Technology require providers to disclose price information as part of its proposed rule.

The ONC in February released its long-awaited information-blocking proposal as a companion to the CMS’ interoperability proposed rule. The ONC’s rule outlines how regulators will require providers to share health data with patients, as well as steps to discourage healthcare organizations from creating barriers to data exchange.

But what data is included in that mandate has proved a point of contention.

In its proposal, the ONC asked stakeholders to weigh in on whether providers should offer patients information on how much they would be charged for certain services. “ONC has a unique role in setting the stage for such future actions by establishing the framework to prevent the blocking of price information,” the rule reads.

However, adding price information to the broader umbrella of health data that’s required to be shared with patients would go “well beyond what Congress intended and would seriously harm patients, hospitals and other healthcare providers,” the AHA wrote in a letter to the agency, arguing that the mandate extends past the goals of the 21st Century Cures Act. The data-blocking rule was a provision of the 21st Century Cures Act.

One of the AHA’s concerns is that publicly sharing price information would disrupt negotiations with payers.

Blue Shield of California raised a similar concern in a letter to the ONC, suggesting the agency should solely focus on providing patients with information on out-of-pocket costs, rather than on providers’ negotiated rates with health plans.

“We urge ONC to ensure any future proposals related to pricing information exclude plans’ proprietary pricing information and protect market negotiations between health plans and providers,” the health insurer wrote.

Other groups were more supportive of the idea, although they requested the ONC separate any rulemaking on price information from the information-blocking proposal.

The federal Health Information Technology Advisory Committee in May cautioned that tying price transparency to the information-blocking proposal would have an “unintended consequence of slowing down the finalization of the current ONC rule,” and recommended the ONC convene a price-transparency task force to consider the idea.

“As a task force, we absolutely agreed that we want to enable price transparency,” Andrew Truscott, co-chair of HITAC’s information-blocking task force and Accenture’s managing director for health and public service, said at the May meeting. “We believe that (price transparency) needs to be given a focus.”

Software company Wolters Kluwer voiced a similar sentiment in a letter to the ONC.

“We generally support including price information within the scope of (electronic health information) for purposes of information blocking, but not in the short-term,” the company wrote, noting price information is difficult to calculate, as it it requires knowing details of an individual patient’s insurance status.

“Factors such as insured status, in-network status, insurance deductibles, insurance co-pays and co-insurance add significant complexity to presenting usable information on price and until those factors are adequately addressed, it makes little sense to include price within the definition of EHI,” Wolters Kluwer wrote.

However, a review of individual comments submitted to the ONC—many of which come from patients sharing stories about expensive medical treatments—suggested there is demand for improving how providers share information on price. One submission from an anonymous commenter simply reads: “We want price transparency!”

Holy Name Medical Center in Teaneck, N.J., also expressed support for the inclusion of price information, arguing that current guidelines related to chargemaster prices are “woefully insufficient” as “the public should have the right to see which hospital systems and healthcare providers are driving higher costs.”

“The current healthcare market is a complex system of secret deals and discounts between insurance companies and healthcare providers,” the hospital wrote to the ONC. “In order to truly lower costs for consumers, we need greater transparency in the marketplace.”

https://www.modernhealthcare.com/politics-policy/aha-among-groups-opposing-price-transparency-info-blocking-rule

Judge signals broad CVS-Aetna antitrust concerns

A federal judge who has refused for months to sign off on the $69 billion CVS-Aetna merger reiterated on Tuesday that he wants to look at any potential harm that the deal might cause for the public.

U.S. District Judge Richard Leon in Washington, D.C., kicked off a three-day hearing as he considers whether to sign off on the U.S. Justice Department’s approval of the merger. The judge must finally authorize the government’s decision under the Tunney Act, but it isn’t clear whether he can actually stop the CVS-Aetna deal as the two companies are largely operating as one.

During testimony on Tuesday, Judge Leon asked the American Medical Association’s expert witness Neeraj Sood whether his review of the merger should stop at Aetna’s divestiture of its Part D business, which was where the government had focused its antitrust scrutiny.

“Should I limit myself to (prescription-drug plans) or look at how these entities that have merged will impact the greater market?” Leon said.

Sood, a University of Southern California professor and director of research at USC’s Schaeffer Center for Health Policy & Economics, demurred that he wasn’t a lawyer but told Leon that from his personal vantage point the merger did raise broad concerns about competition that could affect the public outside the Part D market.

He also framed the transaction as a purchase of Aetna’s 21 million enrollees, who could be potentially steered toward CVS Health business offerings.

But of the prescription-drug plan business in particular, Sood argued that WellCare is already a weaker company that will likely lose market share even after acquiring Aetna’s Part D business and won’t mitigate the effects of consolidation.

The Justice Department demanded that Aetna divest its Part D business before approving the merger late last year. WellCare bought the business for just over $107 million, and it represents about 2.2 million enrollees. That leaves WellCare with a profit of only about $3 per year per enrollee, Sood said.

He also contended that with CVS will have an incentive to undermine WellCare as its PBM, since it owns a competitor. That could happen through lower rebates, slower claims processing or poor formulary design.

Sood’s testimony about the pharmacy benefit manager market, where CVS Health is already one of the top three players, coincides with a broader scrutiny of the PBM business model across Washington. The Senate health committee and various lawmakers have proposed legislation to make it more clear where money is changing hands in the opaque system. The Trump administration has yet to finalize a proposal to require PBMs to send all rebates on to their customers.

The PBM market is already concentrated and additional consolidation will raise premiums, Sood said.

Even in the best-case scenario for WellCare, Sood predicted that several of the 35 regional markets for Part D will show the effects of consolidation in higher prescription-drug plan premiums. He cited three separate studies that show consolidation leads to higher premiums from overlapping plans, by a minimum of nearly 5%.

CVS Health, along with Express Scripts and Optum, control 70% of the Medicare prescription-drug market nationally. Both ExpressScripts and Optum are owned by other major insurers—Express Scripts by Cigna and Optum by UnitedHealth.

https://www.modernhealthcare.com/legal/judge-signals-broad-cvs-aetna-antitrust-concerns

HHS to Stop Fetal Tissue Research Within NIH

The federal government will stop funding intramural research at the National Institutes of Health (NIH) involving fetal tissue derived from elective abortions, the Department of Health and Human Services said Wednesday.

“Promoting the dignity of human life from conception to natural death is one of the very top priorities of President Trump’s administration,” the department said in a statement. “Intramural research that requires new acquisition of fetal tissue from elective abortions will not be conducted.”

The department said current NIH-funded research at academic centers with abortion-derived fetal tissue can continue, however, and new projects can still be funded, though only after a special ethics review.

The HHS statement began by explaining that the department had terminated an agreement between Advanced Bioscience Resources and the FDA that provided human fetal tissue from elective abortions to develop testing protocols.

“The department was not sufficiently assured that contract included the appropriate protections applicable to fetal tissue research or met all other procurement requirements,” the statement said. “As a result, HHS also initiated a comprehensive review of all HHS research involving human fetal tissue from elective abortions to ensure consistency with statutes and regulations governing such research, and to ensure the adequacy of procedures and oversight of this research in light of the serious regulatory, moral, and ethical considerations involved.”

During the audit and review process, the agency had temporarily been extending a contract with the University of California San Francisco that involved research using fetal tissue. “The current extension expires on June 5, 2019, and there will be no further extensions,” the HHS said.

Current extramural fetal tissue research funded by NIH grants — that is, conducted at universities and other centers outside the NIH — won’t be affected by the new policy, but “[for] new extramural research grant applications or current research projects in the competitive renewal process (generally every 5 years) that propose to use fetal tissue from elective abortions and that are recommended for potential funding … an ethics advisory board will be convened to review the research proposal and recommend whether, in light of the ethical considerations, NIH should fund the research project — pursuant to a law passed by Congress,” the statement said.

Anti-abortion groups welcomed the decision. “The Trump Administration has rightfully taken action to separate federal research funding from the abortion industry,” Melanie Israel, a research associate at the Heritage Foundation, a right-leaning think tank, said in a statement. “Good science and life-affirming, ethical research aren’t mutually exclusive. Indeed, it is ethically derived sources — such as discarded surgical tissue and adult stem cells — that have contributed to successful treatments for a variety of ailments, not tissue obtained from elective abortions.”

But others were not happy. “The ATS [American Thoracic Society] is very disturbed by the administration’s actions to halt certain NIH scientific research using fetal tissue,” ATS Research Advocacy Committee Chair Veena Antony, MD, said in a statement. “Scientific research using fetal tissue is vital for the development of new treatments for many deadly diseases and conditions, such as cystic fibrosis and acute lung injury. There are no alternative research models that can replace all fetal tissue research.”

“The ATS urges the administration to restore federal funding for fetal tissue research across all agencies, including all intramural and extramural research, so that these efforts to develop life-saving treatments and cures can continue,” she said.

“I think it’s ultimately a terrible, nonsensical policy,” Larry Goldstein, distinguished professor in the University of California San Diego’s department of cellular and molecular medicine, who has advised scientific groups that use fetal tissue, told the Washington Post. “Valuable research that is directed at helping to develop therapies for terrible diseases will be stopped. And tissue that would be used will be thrown out instead.”

In the meantime, the HHS said it is looking at other ways to conduct research. “In December 2018, NIH announced a $20 million funding opportunity for research to develop, demonstrate, and validate experimental models that do not rely on human fetal tissue from elective abortions. HHS is committed to providing additional funding to support the development and validation of alternative models.”

https://www.medpagetoday.com/publichealthpolicy/ethics/80274