... Reimbursement and Other Economic Considerations...

... How medical procedures are reimbursed plays a major role in how scalable they can be. New technologies often face problems in getting reimbursed because they do not fit well with established reimbursement codes. (...

... The Centers for Medicare & Medicaid Services offer a variety of programs for covering and reimbursing innovative technologies. (Miller)...

... To avoid as many issues as possible in obtaining coverage and reimbursement for a new technology, the best approach is to meet with regulators early in the development and testing process in order to understand ...

... To get evidence for the cost-effectiveness of new technologies, it would be useful to establish an industry-wide system of collecting, storing, and analyzing patient data. (Mahoney)...

... NOTE: This list is the rapporteurs’ summary of points made by the individual speakers identified, and the statements have not been endorsed or verified by the National Academies of Sciences, Engineering, and Medicine. They are not intended to reflect ...

... to the increased use of implantable brain stimulation, such as deep brain stimulation (DBS), with an examination of how reimbursement policies and other economic considerations affect the uptake of this and other medical technologies. Participants considered the current economic barriers and ... implantable brain stimulation from becoming scalable, discussed what ongoing or future approaches need to be taken to improve the benefit-cost ratio and allow brain stimulation to be scalable for wider application in central nervous system disorders, reviewed the current status of reimbursement for ... brain stimulation, and discussed opportunities to increase reimbursement....

... BILLING AND REIMBURSEMENT...

... Julie Brown, senior director for health economics and market access at Spark Biomedical, began by discussing her previous experience at Abbott Neuromodulation, where she was involved with its virtual ... concerning how clinicians using this remote clinic would bill for it. “We had a couple of questions,” she said. “Do we take the current codes and we make those adaptable to telehealth, or do we go get a completely new set of codes?”...

... to be achieved along the way.” This board game–like nature makes it important to educate all the relevant stakeholders so that everyone understands what is necessary....

... Health System (UPHS), spoke about that system’s funding. Penn Medicine is the umbrella organization comprising both UPHS and Penn’s Perelman School of Medicine, which together have a tripartite mission of clinical care, education, and research. UPHS includes six acute-care hospitals, ...

... Echoing what Brown had said in the previous talk, Mahoney said, “it gets into a game with insurance companies as to how we get reimbursed,” and the focus is on how to get their payments from public and private insurers. What is unusual about the funding model at Penn Medicine, he said, is ...

... research mission, making up for its operating deficit and adding to its capital investment. Another 15 percent of the clinical margin goes to support its teaching mission, while the remaining 25 percent goes ... clinical mission capital. “We made about $512 million last year, and $300 million of that or so went to supporting research,” he said, explaining that much of that goes to supporting good research ideas that do not ...

... This approach has led to significant breakthroughs at Penn Medicine, Mahoney continued. Two dozen drugs developed there have received U.S. Food and Drug Administration (FDA) approval in the past decade. Most recently, two researchers there, Katalin Karikó and Drew Weissman, were awarded the 2023 ...

... The system’s venture fund is focused on two things, he said: gene therapy and connected health. The goal of connected health is particularly relevant to implantable brain stimulation. “We are talking about patients being able ...

... that has a benefit category, meaning that we are allowed to statutorily cover that item, we look for several factors to determine if it is reasonable and necessary for our beneficiaries.” It is important to establish a causal relationship between the item or service and the desired outcome in a trial....

... patient, such as morbidity and mortality, physical functioning, and quality of life. The agency also looks for data on the durability of outcome, which is a very important piece of the information in making coverage ...

..., is investigated within an approved study, or with the collection of additional clinical information. CMS also has a Clinical Trials policy and a proposed program for transitional coverage for emerging technology. “That [program] is sort of a combination of our parallel review program and ... program,” she explained, “but it also brings in opportunities for the manufacturers [of Breakthrough Devices] to discuss benefit category and coding in addition to coverage.”...

... where a new device does not qualify for any of these other programs, CMS has specialized payment programs. “We have tried very hard to expand these innovative programs at CMS,” Miller concluded. However, it is still important to follow the correct procedures and regulations for each ...

... THE ADOPTION OF DEEP BRAIN STIMULATION TECHNIQUES...

... Peter Silburn, the foundation chair in clinical neurosciences at the University of Queensland and codirector of the Asia-Pacific Centre for Neuromodulation at the Queensland Brain Institute, offered a couple of thoughts about the adoption of DBS ...

... First, he said the concept of an ecosystem is useful when thinking about adoption of new technologies. In an ecosystem, he said, people get together and evolve in nodes, which can lead to some interesting outcomes because they evolve in parallel as well as sequentially and in an integrated way. “I ... if we go to adopt DBS across the world and various geographies and battle with their various systems,” he said, “we have to integrate health economics and also people who know how to get things across the line at ...

... The fact that many people, even technologically savvy people, do not realize that DBS is an established technology can be seen as a failure of...

... marketing, Silburn said. Henry Ford, the founder of Ford Motor Company, said that he was not selling cars, he was selling experiences, and a similar approach can be taken with DBS....

... each country has its own way of doing things. “What works in one country does not work in others.” But by focusing on the patient’s outcomes and safety and innovating at a fast pace, it should be possible to get an ecosystem of individuals working together to get the technology adopted around ...

... Barriers to Physician and Patient Adoption...

... issues holistically rather than piece by piece. Silburn agreed, saying, “We need to shift the paradigm from one single device to the patient experience.” He suggested partnering with marketing people to urge the public to focus on the overall experience rather than the specifics of any one piece of ...

... need to see compelling evidence for efficacy before it provides a national coverage determination. She added, however, that from her perspective, and not in an official CMS position, the reimbursement situation for DBS is “ahead of the game” because the procedure is already covered by Medicare, ...

... play a role in people’s decisions about getting DBS, said Miller. For example, patients often must travel a long distance to get the surgery, and then must worry about who is going to take care of the implant after the surgery. “Is there a local physician able to take care...

..., the less desirable it becomes for adoption, to physicians at least,” she said. How is the tension resolved between how the business model works (and wanting to move beyond single items) versus the desire to do less because simpler things are easier to adopt?...

... Mahoney answered that this is an issue he wrestles with. One approach is to focus on innovations and improvements in treatments and technologies once they are being used in the clinic, something he described as a “lost art.” Once something is in place, he said, “it’s got a ... the system more efficient. If we have 10 steps, can we get it to 9, to 8 . . . to 5? The patients, as Peter [Silburn] said, enjoy that experience, and costs will tumble down.”...

... that . . . we are looking for those outcomes that are important to the patient. . . . What we are looking for is [does the patient] feel better, and what can they do today that they weren’t able to do yesterday.” Miller also mentioned patient-centric scales such as pain levels, function, sleep, ... and the amount of medication the patient needs to take. A similar approach is true for neurological treatments, she said: “If the patient is treated ...

... that, it would be useful to find biomarkers that are objective rather than subjective. Even the Unified Parkinson’s Disease Rating Scale, a standard in the field, depends on when the examination is given, he noted....

...-centric,” she said, “but we also have to make sure we are committed to really good science, having these publications, having it peer-reviewed, and being able to present that to CMS.” That can be seen as a hurdle to reimbursement. “You can’t just get coverage,” Brown said. “You have to ... evidence that speaks to the outcomes and to the benefits.”...

... Exploring How to Encourage Innovation...

... Pathak wondered how innovation can continue to be encouraged, specifically in digital health and telemedicine. Miller offered the perspective of regulatory agencies. The best thing for innovators to do, she said, is to meet with CMS early to ...

... brings benefits in terms of health economics when the illnesses being addressed are chronic, so that the benefits may stretch out over decades and may involve many people other than the patient, such as caregivers and employers. Without years of patient history and with the patient potentially ... information that proves the benefits of a new therapy. Mahoney agreed that it is a difficult problem to solve. People do switch health systems and insurance companies every 2 or so years, he said. “Unless you are on Medicare, you are switching quite often.” He said that health care should ... , follow-up clinical data across medical centers that is put into a central repository not owned by any one institution. “That is what airlines do and so many industries do,” he said. “They share their back room. I think that would make it much more effective.”...

... means that people will not adopt the new, more efficient method because they cannot get reimbursed for it. “Now you could say, ‘Let’s go invest and come up with the new reimbursement code,’ but for startups that could actually be a killer,” he said. “Little startups desperately try to match ...

... to a more shared incentive “so everyone can economically benefit and truly be patient-outcome focused”?...

... “There isn’t an easy answer to this question,” Brown said. The coding system does have many advantages, such as the fact that it is brand-agnostic so that all devices, regardless of the manufacturer, use the same codes. But, she said, innovation often does outpace the current mechanisms ... place, and there is not an obvious way to address this....

... reiterated that innovators should speak to regulators early in the process of development. “You don’t want to be at the end of your pivotal trial and then start asking these sorts of things,” she said. “We try to educate people on this whole process. The thing the innovators have to do is avail ...