Innate's Cancer Therapeutics Closing In On Targets

 Many of Innate Pharma’s cancer-fighting products have recently made clinical progress. BioSpace connected with Yannis Morel, Ph.D., executive board member and head of product portfolio strategy and business development, to get an inside look at the science behind a few of the Marseille, France-based company’s therapeutics.

“We specialize in immuno-oncology, and particularly in the development of new therapeutic antibodies that harness the innate immune system,” Morel said.

Innate has developed several blocking and therapeutic antibodies that trigger the immune system to fight cancer. “We started out working with NK (natural killer) cell checkpoint inhibitors, and more recently have moved into the field of multispecific antibodies, also called NK cell engagers (NKCEs),” he continued.

Morel has been with the company for more than two decades and started out on the immunology team as a scientist in 2001. He shared that he earned his Ph.D. in the early days of immuno-oncology. “I was a researcher in academia and was really excited by the innovative possibilities and the pathways to make potential new drugs that would contribute to improved cancer patient outcomes. Next door to my lab, this biotech company, Innate Pharma, was just starting. I was so excited by the project that I joined.”

 T-cell Lymphoma Therapy Sees Encouraging Phase II Data 

One of the very first products the company developed, lacutamab (IPH4102), targets KIR3DL2, a tumor-associated antigen related to T-cell lymphoma. Morel said the product “depletes cells that express the KIR3DL2 antigen.”

Lacutamab was first examined in a Phase 1 clinical trial from 2015 to 2017 that involved 44 patients with Sézary syndrome, mycosis fungoides, a type of cutaneous T-cell lymphoma and primary cutaneous T-cell lymphoma (CTCL). Findings from the trial were published in The Lancet Oncology, with the authors stating that “if confirmed in future trials, IPH4102 could become a novel treatment option for these patients.”

“We had very encouraging data at the end of Phase I with strong monotherapy activity even in late-stage patients after multiple lines of treatment,” Morel said.

Lacutamab continues to be investigated clinically today. “In our ongoing Phase II trial, we have cohorts addressing patients who are suffering from mycosis fungoides. Some patients are KIR3DL2 negative, and some are KIR3DL2 positive. We recently presented some very encouraging preliminary data supporting our biological hypothesis,” Morel said. The company expects to present more data later this year on both tumor activity and longer periods of follow-up with patients.

Key Late-Stage Asset Reaches Phase III 

Another of Innate’s products, co-developed with AstraZeneca, is monalizumab. The blocking antibody also provokes an anti-tumor response. “This product targets a checkpoint molecule called NKG2A. NKG2A is an inhibitory checkpoint, like PD-1, that is expressed both on NK cells, and very interestingly, on tumor-infiltrating CD8 T cells,” Morel explained.

He added that “the last six to nine months have been very rich for monalizumab.” The product is currently in two Phase III trials. One trial, INTERLINK-1, utilizes the product in combination with cetuximab to treat head and neck cancer patients.

The other, PACIFIC-9, is investigating the product in combination with durvalumab in patients suffering from unresectable, Stage III non-small cell lung cancer (NSCLC). “There is a biological hypothesis that by blocking NKG2A, we can increase the efficacy of the PD-L1 blockade,” Morel said.

After the first patient in this trial was dosed earlier this year, Chief Executive Officer Mondher Mahjoubi commented in a press release that the company is “very pleased that our key late-stage asset, monalizumab, has progressed into a second Phase III trial with our partner, AstraZeneca. The launch of PACIFIC-9 represents an important financial milestone for Innate, as it triggers a $50 million milestone payment that reinforces our cash position.”

The company announced in early June that another of its products, a blocking monoclonal antibody known as IPH5201, will be moving forward in a Phase II study. Developed in collaboration with AstraZeneca, this product intends to trigger anti-tumor functions in lung cancer patients.

ANKET Platform Potently Activates NK Cells Against Tumors

In a 2021 interview with BioSpace, Innate CSO Eric Vivier, Ph.D., DVM highlighted the company’s proprietary ANKET (Antibody-based NK cell Engager Therapeutics) platform, which serves as an alternative to T-cell therapy and works to safely eradicate tumors.

The platform creates multispecific synthetic molecules that bind receptors on tumors and associated antigens. Morel explained that the first project using ANKET in partnership with Sanofi targeted CD123, a tumor antigen for acute myeloid leukemia. “Our first-generation molecule is highly specific. It binds on one end of the tumor, and on the other end, the molecule activates NK cells via NKp46 and CD16, which yields very potent activation of NK cells against the tumor,” he said.

Today, the platform’s third-generation molecules are even more efficient. “In our latest innovation, we further improved these molecules by adding a cytokine in the engager molecule. Now, we can increase the number of NK cells significantly, causing even more anti-tumor effects,” Morel continued.

In addition to these products, the company has many others in various stages of development. “We have assets that are targeting several mechanisms of action,” he shared. “We also have a next wave of innovations with our ANKET platform, which is very modular. Based on the binder we incorporate into our molecules, we can replicate this product on any kind of tumor antigen.”

Morel added that, in addition to the Sanofi program, Innate is working on other so-far undisclosed tumor antigens. “This will lead to multiple products in various disease areas,” he said.

https://www.biospace.com/article/innate-is-ramping-up-clinical-development-of-oncology-assets-/

eFFECTOR Takes Road Less Traveled to Maximize Cancer Treatment

 eFFECTOR Therapeutics is pioneering the development of selective translation regulation inhibitors (STRIs), a class of therapies that block the production of disease-driving proteins common in cancer.  

Interim results from studies of STRI therapies in breast cancer patients have shown that the therapies are safe, operate as designed and are effectively showing signs of clinical activity.  

In an interview with BioSpace, Steve Worland, president and CEO of eFFECTOR, said he is especially excited about STRIs because of the history they are already making.  

"This is the first agent of this class that's ever gone into clinical development," Worland said. "So it's very exciting."  

How Do STRIs Work?

Cancer cells rely on the synthesis of proteins to multiply and spread. When STRIs are used, this protein synthesis is blocked at the central node, also called eukaryotic initiation factor 4F (elF4F), where two cancer pathways would normally converge, causing cancer to multiply and spread. Blocking this production would inhibit further creation of disease-driving proteins while still preserving the cell's normal and healthy state.  

STRIs can work alongside existing therapies and potentially other drugs still in development. If STRIs are found to be widely safe and effective for cancer patients, they could be put to use before a patient has to undergo chemotherapy.  

According to Worland, once breast cancer progresses to a certain point, there is a limited number of options for patients until undergoing chemotherapy.  

"What we're hoping is, with a well-tolerated regimen, to be able to craft a second non-chemotherapy regimen that patients could take before moving on to chemotherapy," he said. 

Worland presented data about the first studies on STRIs at the American Society of Clinical Oncology (ASCO) annual meeting in early June. eFFECTOR reported that STRIs have proven to be safe for the patients tested while working to block the production of cancer-related proteins without harming other non-dangerous cells.  

Worland said the clinicians involved with the data were "very pleasantly surprised that it was as safe as it was while still having the effects that it did." 

A Closer Look

Most of the studies on STRIs so far have focused on ER-positive or estrogen-receptive breast cancer. This means that patients with this type of cancer have cancer cells that grow in response to the hormone estrogen. A majority of breast cancers are considered ER-positive, according to the National Library of Medicine. 

Worland said the studies started with these breast cancer patients because there is already a large quantity of research to support the importance of protein production in this type of cancer. He said he knew it was an "opportune area to explore" and that, if successful, it could make a difference in the way breast cancer is treated.  

The experimental group of eFFECTOR's Phase I/II clinical trial is heterogeneous – of the women involved, each is in a different place in their breast cancer treatment regimen. Despite many patients already undergoing other therapies, the STRI drug in question, called zotatifin or "zota" for short, was still noticeable. 

In a press release, Wordland said zota has been "generally well-tolerated" in the clinical trials and shows "very compelling preclinical activity, including in combination with palbociclib for breast cancer."  

The first two phases of the clinical trial focused on dose escalation. As the doses of zota slowly increased over time, clinicians measured reactions among the patients and monitored the results. So far, zota has proven to not only be safe but also effective among certain patients in slowing the protein production of ER-positive breast cancer cells.  

What Comes Next?

Now that the proper dosage of zota has been determined for a varying group of women, Worland explained that it's important to pinpoint the genetics that work best with the way zota operates. Even looking at just ER-positive breast cancer, there is an assortment of genetics that comes into play that would have an effect on the way zota works with a person's cells. 

"The hope would be that we could further refine that and identify the group that is most responsive to our drug," he said. 

New data regarding the way zota works in individuals with ER-positive breast cancer will be available by the first quarter of next year. Worland also believes that STRIs could be effective in other forms of cancer. 

"One of the exciting things about the drug is it hits networks that are very important for cancer cells, but again, it's quite selective so we think we can go in a couple of other areas as well," he said. 

There is currently a KICKSTART study for patients with non-small cell lung cancer. The study will measure the productivity of adding STRI therapy to existing immunotherapy for lung cancer patients. The STRI drug, called tomivosertib, is an immunotherapy treatment that will halt the production of these specific cancer cells in the body, therefore protecting the immune system.  

More data regarding the way these STRI drugs work can be expected at the end of this year and early in 2023. 

https://www.biospace.com/article/effector-takes-road-less-traveled-to-simplify-cancer-treatment-/

Battery material lithium isn't a health threat -industry groups

 Classifying lithium as hazardous endangers EU carbon goals

* EU member states giving views on lithium proposal

LONDON, July 4 (Reuters) - Electric vehicle battery material lithium should not be classified as a hazardous substance by the European Union because the scientific evidence on which the proposal is based is weak, seven industry groups said.

Lithium was added to the EU's list of critical raw materials in 2020 because it is important for electric vehicles which are key to meeting targets for cutting carbon emissions.

The proposal by the European Chemicals Agency (ECHA), which cited studies based on lithium containing medicines used over the long term as a treatment for mood disorders, wants to classify lithium salts as dangerous for human health.

"The analysis finds only a "quite weak association" between lithium exposure and developmental effects, said Violaine Verougstraete, chemicals management director at Eurometaux, which represents the metal industry.

"For fertility, the opinion is based on selected studies with serious limitations, contradicted by more robust guideline studies which showed no effect of lithium exposure."

EU member states are currently giving their views on the proposal to a committee which meets on July 5-6 to discuss chemicals including lithium that have been recommended for classification as dangerous.

A final decision is expected at the end of 2022 or beginning of 2023.

Classifying lithium as dangerous would have a major impact on Europe's energy transition goals, the industry groups including Eurometaux and Recharge, the European industry association for rechargeable lithium batteries, said in a letter to the EU.

"Europe is at a critical period in its energy transition, needing to stimulate new investment into a full electric vehicle battery value chain," the groups said.

"Europe is playing catch-up with China, which is already over a decade ahead, now controlling most global processing for lithium and other battery metals ... Europe has a narrowing window of opportunity to attract the investments needed, and lithium is a central material to our success."

Classifying lithium as hazardous will hamper investment in European refining and recycling capacity and give an advantage to companies in the electric vehicle battery supply chain outside the European Union, the letter said.

The proposal doesn't ban lithium imports, but if legislated it will add to costs for processing companies from more stringent rules controlling processing, packaging and storage.

https://www.marketscreener.com/news/latest/Battery-material-lithium-isn-t-a-health-threat-industry-groups--40890608/

House hearing ups ante on Medicare Advantage reform

 Political will seems to be growing to reshape the increasingly popular Medicare Advantage program.

At a House Energy and Commerce committee hearing on Tuesday, lawmakers on both sides of the aisle called for more oversight of MA following watchdog reports that found impediments to receiving covered care, including improper denials of prior authorization requests, and plans gaming the system in exchange for more funding from Medicare.

Witnesses at the hearing — officials from the Government Accountability Office, HHS Office of Inspector General and congressional advisory board MedPAC — also pointed to higher rates of beneficiary disenrollment in their last year of life and opaque plan data, which can complicate oversight efforts.

Surveys have shown MA remains extremely popular with beneficiaries, attracted by lower co-pays and supplemental benefits like vision coverage and telehealth. In the program, Medicare pays private plans a capitated monthly rate to provide care for their beneficiaries based on the severity of their beneficiaries’ needs.

The hearing comes amid inflamed industry debate over the future of MA.

For-profit hospital lobby Federation of American Hospitals submitted a letter for the record sharing concerns over some MA plans denying patient care and having inadequate care networks.

Meanwhile, MA trade group Better Medicare Alliance sent a letter to the CMS on Monday urging the agency to safeguard the program as Congress mulls changes to Medicare.

But as Medicare’s hospital benefit — part of which funds MA — limps towards insolvency, lawmakers appear poised to target the growing MA program in a bid to crack down on improper payments and care denials.

“This is something that I think is very much bipartisan,” said Rep. Gary Palmer, R-Ala.

Coverage delays and denials

It’s not the first time lawmakers have zeroed in on MA oversight as a strategy to save Medicare money: In a Senate hearing on Medicare insolvency in February, Sen. Elizabeth Warren, D-Mass., said “the Medicare system is hemorrhaging money on scams and frauds” due to insurers taking advantage of the program’s rules to increase profits.

Even amid rising congressional criticism of MA, lawmakers on Tuesday reiterated their support for the program overall, which covered roughly 27 million Americans in 2021.

That’s more than a third of all Medicare beneficiaries, though MA is expected to swell to cover half of all Medicare members by 2030.

But lawmakers said they are increasingly concerned about disparities in the quality of coverage offered by Medicare Advantage plans compared to traditional Medicare plans, along with unscrupulous practices in the program resulting in higher reimbursement for MA organizations.

A GAO report found MA beneficiaries in their last year of life disenroll from MA in favor of traditional Medicare at a rate two times higher than other MA members, suggesting the plans may not support high-cost and specialized care, testified Leslie Gordon, GAO’s acting director for healthcare.

Gordon called it a “red flag” for the program that requires more scrutiny from CMS.

In addition, an HHS OIG report published April found MA organizations wrongly denied members care, with plans turning down 18% of payment requests that should have been approved.

Erin Bliss, OIG assistant inspector general in the Office of Evaluation and Inspection, testified plans sometimes use internal critical criteria that are not required by Medicare. In one example, an MA plan denied a medically necessary CT scan to diagnose a serious disease, citing that the patient hadn’t yet received an x-ray, Bliss said.

When appealed, plan denials were reversed 75% of time, a rate DeGette called “alarmingly high.”

“We are concerned that patients are receiving the timely care they need in those situations,” Bliss said.

OIG also found plans denied 13% of prior authorization requests that would have been approved under traditional Medicare.

Rep. Michael Burgess, R-Texas, suggested policymakers consider requiring insurers to forego prior authorization for doctors with a consistent track record of submitting accurate data. That strategy, called “gold carding,” is already used in some states, including Texas and West Virginia, to pare back on prior authorization delays.

MA payment reform

Along with coverage restrictions, lawmakers at Tuesday’s hearing asked witnesses about the scope and severity of improper MA payments in a bid to zero in on specific solutions Congress and the CMS can enact.

Though MA has potential to save the Medicare program money, “the current incentives for MA plans are not adequately aligned with the Medicare program,” said James Mathews, MedPAC executive director.

“Substantial reforms are urgently needed,” especially in light of Medicare’s “profound” financial problems, Mathews said.

In 2022, the average MA plan bid was 85% of fee-for-service spending, Mathews said. However, Medicare pays plans 104% of fee-for-service costs.

That imbalance is partially due to plans making patients appear sicker than they are to get extra payments from the government, witnesses said. The practice, called “coding intensity,” resulted in an estimated $12 billion in excess Medicare spending in 2020, according to MedPAC data.

Methods include chart reviews, where plans identify and add patient diagnoses that aren’t included in the service record, and health risk assessments, where plans contract with vendors to visit beneficiaries homes and conduct assessments, finding new diagnoses that often aren’t backed up by other records, according to Bliss.

GAO estimates that roughly a tenth of Medicare payments to MA plans in 2021 were improper, Gordon said.

To try to tamp down on coding intensity, the CMS should conduct targeted oversight of MA plans that routinely use these tools, and reassess whether chart reviews and in-home assessments are allowed to be sole sources of diagnoses for payment purposes, witnesses said. In addition, MA should improve care coordination for enrollees who receive health risk assessments. 

The CMS should also consider replacing the quality bonus program and change its approach to calculating MA benchmarks, Mathews said.

In addition, the agency should require and validate data for completeness and accuracy before risk-adjusting payments through methods like medical record reviews, Gordon said.

Gordon also suggested the agency conduct more timely audits, as the CMS is currently missing out on recouping hundreds of millions of dollars in improper payments.

https://www.healthcaredive.com/news/house-hearing-medicare-advantage-reform/626222/

Companies see a future for smart implants. Doctors are waiting for proof.

 If a knee talks, who’s listening? 

That’s the question facing orthopedic surgeons and rehab physicians as they learn to work with a new knee replacement that incorporates sensors and processors to send data about how the joint works from deep inside the patient’s body. 

It’s one of a growing number of devices sending data to physicians to help them monitor their patients, including continuous glucose monitors and wearables to monitor for heart arrhythmia. With this influx of information, medtech companies are still ironing out how to make the data useful for doctors.

“This field is still very nascent,” said Jay Pandit, a cardiologist and the director of digital medicine for the Scripps Research Translational Institute in San Diego, noting that physicians simply haven’t got time to look at the raw data now flooding in from wearables — and soon from implantable devices. 

Data still are far from being user-friendly, often requiring the physician to have a dedicated analyst reviewing the data on a third-party website, Pandit said. Most doctors have just seven to 10 minutes to meet with a patient, review their records and come up with a care plan, so there’s no time to analyze reams of raw data, he added.

Since the pandemic, the enthusiasm for remote patient monitoring devices has increased, but there aren’t any overarching guidelines on how to manage the data generated by these devices, Pandit said.

Still, that hasn’t curbed plans by smart-knee manufacturers.

“The talking knee is a reality,” Indiana-based Zimmer Biomet announced at the American Academy of Orthopaedic Surgeons’ conference last year. The company was presenting its new knee-implant extension with an embedded sensor just days after receiving de novo clearance from the Food and Drug Administration. 

Now, Zimmer, which developed the device along with California-based Canary Medical, Inc., a company that creates sensors for medical devices, has begun selling the smart knee implant, called Persona IQ. It can measure a patient’s range of motion, step count, stride length, and walking distance from inside the human body. Still, physicians don’t yet know how to use this data to help patients. 

“Turning it from ‘I have data on a patient,’ to ‘I can make a diagnosis for a patient,’ or ‘I can tell a patient what they need to do differently,’ it’s going to take some time,” said Matthew Hepinstall, an associate professor of orthopedic surgery at New York University’s Grossman School of Medicine, and co-director of its Center for Computer Navigation and Robotics.

Eventually, sensors will detect problems with implants, help patients adjust their gait or provide data to predict patient outcomes. Meanwhile, competitors are creating systems that use wearable sensors to track patient recovery and hinting at their own plans for sensor-embedded implants. 

Bill Hunter, Canary’s founder and chief executive, said in an interview that medical technology companies are already unleashing a wave of sensor-loaded devices in other sectors.

“Having this ability for the device to provide the clinician with actual feedback from inside the body has implications in most every major medical device,” he said. “So I do believe that you will see this showing up in all kinds of different ways.”

Canary Medical designed a hollow extension to a stem that contains a battery, accelerometer, gyroscope and pedometer to track activity data.

Permission granted by Canary Medical

 

What can the data say? 

Zimmer’s first challenge will be persuading physicians to use its Persona IQ device over traditional knee implants, Hepinstall said.  

“I’m waiting for the wearable sensors to give enough data and for us to have enough experience with wearable sensors to understand how to act on that data before implanting something in one of my patients,” he said, adding that the sensor’s size means surgeons have to remove more bone when implanting a smart knee. 

Still, said Hepinstall, “somebody’s got to put these devices in people for us to learn what they can do. Monitoring patients remotely in some way is a major priority.”

When new forms of data come in, it takes time to learn how to interpret and apply that information, Hepinstall added. 

“Any time you get new information, types of information you didn’t get before, it’s not necessarily easy to figure out how to use that information effectively at first,” he said.

The data collected by these smart implants are similar to those tracked by wearable devices worn on the outside of the knee and connected to smartwatches. The main difference is in cost and compliance, physicians said, since about 30% of people stop using wearables, according to a 2016 survey by Gartner.

Taking data on a patient’s stride, gait and speed could help develop recovery curves to predict how patients will adapt to their implants, said Fred Cushner, Canary’s chief medical officer. 

It also may be able to teach physicians how to reduce pain after a replacement and how best to position the replacement joint, he added. Cushner helped develop the sensors. 

“You have to do studies, but everybody is inclined to believe that we’ll be able to answer some of those unknown questions” once surgeons begin implanting smart knees and the data starts coming in, said Cushner, who is also an associate professor and orthopedic surgeon at the Hospital for Special Surgery in New York.

He noted that the smart knee is only cleared by the FDA to track a patient’s activity and isn’t indicated to support clinical decision making. 

Data coming from inside the patient’s body also may help scientists design better knees, said Peter Sculco, also an associate professor of orthopedic surgery at the Hospital for Special Surgery.

“That is an incredible treasure trove of research,” said Sculco, who consults for Zimmer but wasn’t involved in the development of the device.

What excites him about the smart knee?

“The ability to be able to compare and contrast the different ways we put our knee replacements in, their alignment, their balance, the designs that we use, the type of plastic we use, and then to somehow look at this gait-level data and say, ok, maybe this is a better way to do a knee replacement,” he said.

Zimmer confirmed it has additional studies planned of its Persona IQ device, though it didn’t share the specifics. 

Starting with the knees

Commercial pressures are rising on joint-replacement manufacturers as the procedure shifts to ambulatory surgery centers and implants are increasingly viewed as a commodity. 

“They have been an area where companies have faced incremental pricing pressure every year,” said Ryan Zimmerman, an analyst at institutional brokerage BTIG. “For companies that are looking to differentiate themselves, adding a smart implant component makes a lot of sense.” 

Knees are Zimmer’s largest source of revenue and the company reported knee sales rose 8% in the first quarter of this year, and 11% in 2021 from a year earlier. In a May earnings call, the company declined to comment on whether Persona IQ would be material to the growth of its knee business this year or next. 

“I won’t talk about the number of hospitals that have been onboarded, but it is significant,” Zimmer COO Ivan Tornos told investors. “The patient pipeline is also significant, above our expectations.” 

Knees, and the implants that go into them, are also a good place to start using sensors, added Canary Medical’s Cushner.

They offer scientists more “real estate”  as Canary develops a smaller version of its sensor, he added. In Zimmer’s knee, the sensor is attached to the stem, which is drilled into the patient’s tibia. 

Knee revenue in 2021

Company	2021 knee revenue
Zimmer Biomet	$2.65 billion
Stryker	$1.85 billion
Johnson & Johnson	$1.33 billion
Smith & Nephew	$876 million

SOURCE: Annual earnings reports

Cyborg revolution

The smart knee is part of a broader strategy by Zimmer to augment its products with its own robotics and technology, said Liane Teplitsky, the firm’s president of global robotics and technology and data solutions. 

The sensors work much like pacemakers, she said.

“The information gets automatically downloaded to a base station that the patient has in their home, and [is] then uploaded to the cloud,” Teplitsky said.

During surgery to implant the knee, Zimmer’s surgical robots collect data and surgeons use HoloLens smart glasses (made by Microsoft) to guide themselves through instrument assembly.

The smart knee connects to an iPhone application called Mymobility, which can pull in kinematic data from the implant and a patient’s Apple Watch to track exercise after surgery.  

“Everything that we’re thinking about now bringing to the marketplace will either generate data or collect data,” Teplitsky said. Eventually, Zimmer will be using sensors in more of its implants, including cementless knees and shoulders. Canary Medical already has patented sensors for heart valves, spinal implants and stent grafts. 

Zimmer also has used data from the Mymobility app to power a feature called WalkAI intended to predict which patients may have a slower gait 90 days after hip or knee surgery. The company will need clearance from the FDA to use the data to make care recommendations. 

“You can go from being able to predict to then being able to recommend,” Teplitsky said. “That’s still the future. We can make no claims around that yet today, but that’s ultimately the goal.”

A view of the physician dashboard for Zimmer Biomet’s Mymobility system.

Permission granted by Zimmer Biomet

 

Other companies look to sensors

Zimmer’s competitors have yet to introduce their own smart knee implants, but they are betting on the need for data, largely through wearables. 

Stryker, the second largest maker of knee implants by revenue, last year acquired OrthoSensor, whose technology is incorporated in knee implants to help surgeons balance the knee during surgery. Zimmer and Smith & Nephew, the fourth-largest kneemaker, have used OrthoSensor’s technology in their knee-replacement systems. 

Stryker also uses OrthoSensor’s wearable sensors, which are attached above and below a patient’s knee, to track their range of motion, gait and other information before and after a procedure. 

“It’s all about information that the surgeon is able to use for each and every unique patient that’s out there. And its application is definitely for both pre-surgery to get some baseline type information for a shorter period of time, and then up to 90 days after surgery, so that you can really see progress,” said Don Payerle, Stryker’s president of joint replacement.

Stryker likely will begin adding sensors to implanted products as well, said Richard Newitter, an analyst with financial services firm Truist. 

Johnson & Johnson also is working on smart implants, according to Shagun Singh, an analyst with RBC Capital Markets.

“They said they own over 50% share of the trauma market. And so they want to go to that market first,” Singh said.

Looking to the future

The technology may be nascent, but sensors that will allow patients and physicians to monitor their health and improve outcomes have become an “area of important focus and development” for the medical device industry, said Truist’s Newitter. 

“It’s not just about the actual implant itself anymore — it’s about building an entire digital ecosystem around the care continuum for surgery,” Newitter said.

To be sure, sensors come at a cost. Zimmer prices its sensor-equipped implants at $1,000 more than those without sensors, notes RBC’s Singh. 

It likely will be a few more years before there’s enough data to show the sensors can improve health outcomes and lower costs for insurers, according to Newitter.

“We’re interested to see if it takes off, similar to robotics,” said Zimmerman of BTIG. If it does, “you should see a lot of the other companies follow suit,” Zimmerman added.

https://www.healthcaredive.com/news/zimmer-biomet-canary-smart-knee-implants/626418/

HHS issues guidance on when providers may be forced to share patient information

 

• Healthcare providers are not permitted to disclose patient health information unless faced with a court order, the HHS said Wednesday in an attempt to provide clarity following the overturning of Roe v. Wade.  
• In the absence of a court order, federal privacy rules about sharing health information — like whether a person obtained an abortion — is not a permitted disclosure, the HHS guidance says. 
• The department also warned patients that data collected by third-party apps, such as period trackers, is not protected health information under federal rules and could be shared with other entities.        

The HHS Office for Civil Rights issued privacy guidelines Wednesday to provide clarity on how to protect patient health information following the Supreme Court’s ruling that ends the constitutional right to abortion. 

The guidance comes as providers and patients have expressed concerns about privacy and the release of patient health information that is protected under the Health Insurance Portability and Accountability Act, commonly referred to as HIPAA.

The HHS explained that disclosures without patient authorization “are permitted only in narrow circumstances.”

The health agency laid out examples for providers on when they may be compelled to turn over patient information. 

If a person shows up to an emergency room with complications from a miscarriage at 10-weeks pregnant and a hospital worker suspects the person induced the miscarriage with a medication abortion, providers would not be forced to notify law enforcement if the state bans abortion after six weeks. 

However, HHS seemed to indicate that providers may be forced to share that information in states that may require such reporting. 

“Where state law does not expressly require such reporting, the Privacy Rule would not permit a disclosure to law enforcement,” HHS said. 

In another example, HHS said that providers are not permitted to disclose information if law enforcement shows up at a clinic requesting abortion records.

However, if a law enforcement officer had a court order, clinics may disclose only the information requested in the order. The federal privacy rule would permit this disclosure but does not require it, HHS said.

The guidance follows the Supreme Court ruling last week that struck down the constitutional right to an abortion, ending nearly 50 years of protected access to the procedure in the U.S. 

The end of Roe has already caused confusion at some large health systems as they grapple with the new legal landscape now that federal protection has been peeled back and the regulation of abortion is up to each individual state.

https://www.healthcaredive.com/news/hhs-guidance-when-providers-forced-to-share-patient-abortion/626398/

CMS wants Tennessee to change Trump-approved Medicaid block grant plan

 

• The Biden administration is asking Tennessee to make fundamental changes to its plan to create a Medicaid block grant program in the state.
• The state’s controversial Medicaid plan was approved in the final days of the Trump administration. But the CMS held a federal public comment period through September that resulted in “significant concerns” for regulators about whether Tennessee’s policy promotes the objectives of Medicaid, according to a new letter to the director of TennCare, Tennessee’s Medicaid program.
• The letter sent Thursday requests that Tennessee submit a new financing and budget neutrality model based on a traditional per member per month cap, instead of an aggregate cap, among other modifications.

Tennessee took a notable step to realize a long-held conservative goal in early 2021, when the Trump administration greenlit a waiver allowing the state to use a modified block grant in its Medicaid program.

Under the 10-year waiver, Tennessee receives a lump sum of money annually from the federal government. Tennessee can keep up to 55% of any amount spent below the funding cap and reinvest it in other programs, giving it significant power over how it spends federal dollars.

The waiver also allowed the state to create its own commercial-style formulary of covered prescription drugs without federal approval, and granted it authority to negotiate directly with drug manufacturers.

Tennessee said the waiver would allow it to spend money and be more flexible with benefits. But researchers said that capping federal funding — along with codifying incentives to spend below the cap — could result in the state restricting benefits to achieve savings, threatening low-income beneficiaries’ healthcare quality and access.

In an opinion piece published in The Tennessean in September, Karen Camper, a Democratic member of the state’s House of Representatives, called on the CMS to rescind the waiver entirely.

“Not rescinding the waiver undermines President Joe Biden’s health equity agenda, and marginalized Tennesseans will be the first to feel its negative impact. Setting a precedent with a program that wouldn’t need to be renegotiated for another 10 years is reckless and irresponsible,” Camper argued.

The CMS is now requesting that Tennessee make major changes to the proposal. Along with urging the state to find an alternative to its aggregate cap, federal regulators want Tennessee to modify its Medicaid terms and conditions to clarify that the state can’t cut benefits or coverage without amending its demonstration.

The agency also asked Tennessee to remove expenditure authority for pharmacy and associated pharmacy flexibilities from the demonstration. Additionally, Tennessee should include a request in the demonstration amendment for expenditure authority for state reinvestments to support with any savings, such as adult dental care or enhanced home services, the CMS said.

“Making these adjustments would significantly mitigate CMS concerns,” the letter says. The CMS requested Tennessee amend its demonstration by Aug. 30.

Oklahoma also tried for a block grant during the Trump administration, but later rescinded its waiver application.

https://www.healthcaredive.com/news/cms-tennessee-make-changes-medicaid-block-grant/626462/