Latest from Medscape
Medscape
2 days ago
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- Medscape
Alternative Funders and Costly Meds: Are Patients Insured?
In the ever-evolving landscape of employer self-funded healthcare, cost-saving strategies emerge with promises of efficiency and reduced spending. Yet, for real patients — especially those battling chronic illnesses such as rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease — these quick-fix schemes can have devastating, unintended consequences. Among the most disruptive of these strategies in employer-funded health plans is the involvement of alternative funders: third-party entities inserted between patients and their essential therapies. Real patient stories most powerfully illustrate the physical, emotional, and financial harm they experience. Self-Insured Employers and Alternative Funder Programs Rising healthcare costs have led many employers to seek new ways to manage the growing expenses of self-insured health plans. Strategies such as alternative funder programs (AFPs) have been touted as ways to keep costs down and preserve financial stability for businesses. While these methods might give some relief to employer balance sheets, they can cause medication access delays and disruption, as well as added complexity, confusion, and stress for the patient. Madelaine (Mattie) A. Feldman, MD Essentially, AFPs contract with the employer to stop all coverage of the cost of expensive medicines, which includes most, if not all, of the biologic drugs. The AFPs will then apply for patient assistance from manufacturers and other programs under the guise of the patient being 'uninsured.' If assistance is obtained (free drug or copay cards), they will charge the employer a percentage of the price of the drug or card. Most manufacturer assistance programs have put up guardrails to prevent what they consider to be abuse of programs meant to help the truly 'uninsured.' If AFPs are unable to obtain free drugs, then they may try to source the medicine from outside of the United States, which manufacturers say is illegal. All of this creates delays in processing with denials and disruption of care for those relying on these specialty drugs. Employees are told they need to sign up for these programs or they may be responsible for the entire price of their medication, which often scares them into signing up, potentially giving the AFP years of access to very personal data. The Patient's Ordeal: When Savings Come Before Care Janelle Zeihen was diagnosed with Crohn's disease on February 14, 2022. Her diagnosis was delayed because her symptoms were initially mistaken for complications from recent pelvic radiation for cancer. Once properly identified, her gastroenterologist started her on vedolizumab (Entyvio, Takeda) infusions every 8 weeks and daily prednisone. This stabilized her condition, allowing her to eventually taper off prednisone. In January 2024, Zeihen's employer, Bedrock Healthcare, changed health insurance plans. She was told that vedolizumab would be covered only if she switched to home infusions via CVS's Coram home infusion service. Her disease remained controlled, but by August of that year, complications began when she was told her treatments would no longer be covered. Additionally, her gastroenterologist told her that she had been billed over $80,000 per infusion by Coram for the three infusions she had so far received in 2024, totaling $250,000. (In comparison, Medicare rates are only about $6500 per infusion.) This is when Zeihen's bureaucratic nightmare began. A nurse at the gastrointestinal doctor's office had worked with a certain rheumatology office manager and patient advocate, Nilsa Cruz, on difficult approvals for her patients in the past. She contacted Cruz to see if she could help to unravel the situation and hopefully get coverage for Zeihen to resume infusions at the rheumatologist's office. Cruz had many questions. Why was Zeihen supposedly covered for home infusion and then not covered? Why was she billed for three infusions that had already taken place? Did she have insurance or didn't she? Cruz spent more than 60 hours over 3 weeks reviewing paperwork, contacting insurances and third-party administrators, and spending time with Zeihen on her employer's employee/patient portal. She discovered that while Zeihen's insurance card listed Anthem, the plan was actually managed by Leading Edge Administrators, with provider-administered drug coverage handed over to Payer Matrix, an alternative funder. Cruz said that is when her 'heart sank.' She knew AFPs disrupted patient care and 'abused' patient assistance programs, resulting in many patients losing total access to treatments. Cruz found out after speaking with Anthem that they had mistakenly approved the home infusions in January 2024, but they were not actually responsible for administering or covering any costs to the plan. The company that Anthem was using to manage Zeihen's insurance plan, Leading Edge, had itself hired the AFP Payer Matrix to manage provider-administered drug coverage. Payer Matrix instructed Zeihen's employer, Bedrock, to exclude expensive biologics like vedolizumab from coverage. A Payer Matrix representative asked Cruz to apply for assistance from vedolizumab's manufacturer, Takeda, but Cruz said that she was obligated to tell Takeda that Payer Matrix was involved. Takeda denied the patient assistance request, suspecting improper use of their program for insured patients. Payer Matrix's nurse suggested to Zeihen that she change her medication to one from a different manufacturer from whom they may be able to get free drug. Zeihen was shocked that this 'insurance nurse' was trying to treat her without input from her gastroenterologist and she refused to agree to that. Cruz then went to Zeihen's employer for help, but the employer never responded to appeals or letters of medical necessity. Federal and state legislators/regulators and the Department of Labor were all copied on the communication. By now, Zeihen was left with overdue bills and denied treatments and no clear path to continue her medically necessary care. After persistent advocacy from Cruz, including contacting all involved parties, Anthem — who was not responsible for the coverage — agreed to cover all the vedolizumab infusions that Zeihen had received thus far in 2024 through Coram home infusion, as well as the next two scheduled treatments at the rheumatologist's office until the end of the year. This intervention relieved Zeihen from the $250,000 debt and allowed her to complete her treatment for the year. Where is Zeihen now? She was forced to leave her employer-covered insurance because the AFP in the plan had left her uninsured for the treatment that had been covered previously. She signed up for an exchange insurance plan, but her employer refused to cover any of the new exchange policy premiums, which were higher than her previous cost share. Ultimately, this resulted in her having to leave the full-time position with her employer. She now works part time and even though she lost many of the benefits of full-time employment, her Crohn's disease treatments are covered and the flares of her disease have subsided. She's not sure if her disease is better controlled because she is now getting her treatments in a timely manner or the fact that the stress, fear, and confusion caused by the AFP in her employer's plan is now gone. Why Employers Should Beware While pitched as a quick fix, AFPs may actually undermine employer goals in the long run. The administrative chaos can result in delayed or denied care, higher absenteeism, lost productivity, and even legal challenges if employees are saddled with unexpected medical debt. In addition, employers have a fiduciary duty to employees to prevent these costly arrangements that can cause psychological harm to employees. Furthermore, these programs can expose employers to reputational risk as stories of harmed workers spread. Zeihen's journey is emblematic of a growing problem in employer health benefits. The lure of immediate savings from AFPs often comes at an unacceptable cost to both employees and the organizations that depend on them. This story also displays the need for advocates like Cruz. Her dedication to patients and their well-being is exemplified in her perseverance and tenacity in finding a way to help Zeihen get the care she needed. I wish there were more 'Nilsa Cruzs' in this world. At the Coalition of State Rheumatology Organizations, we are fortunate to have the actual Nilsa Cruz in this story as part of our Payer Issue Response Team (PIRT). PIRT reviews 'payer' problems that are sent to us by rheumatologists around the country, and we do what we can to help solve them. While we can't solve every payer problem there is, we are grateful to be able to help those patients whose problems we can solve.
Medscape
2 days ago
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- Medscape
Medicare at 60: Good for Doctors, Patients?
Sixty years ago, Congress passed legislation that created Medicare . In 1966, its first year of implementation, there were 19.1 million enrollees. Almost a decade later, enrollment had grown to 22.5 million. Today, 68.8 million Americans have Medicare coverage, with about half enrolled in Advantage plans. The original idea for this insurance program was even bigger, with President Harry Truman endorsing universal coverage in 1945. As Medicare turns 60, Medscape convened an expert panel to discuss the successes — and shortcomings — of this landmark insurance program. Jen Brull, MD: For everyone on the panel, how might Medicare use AI (artificial intelligence) more generally over the next 50 years? Jonathan Gruber, PhD: As with many things, there's a right level of prior authorization, and we need to let data inform that. We need to be collecting a lot of data on who's using prior authorization, how it's being used, and how productive it is. And we need to recognize that the right answer is not "zero" or "every single visit." It's somewhere in between. We need to be putting more resources into studying that and figuring out what the right level is. I want to take a slightly more optimistic view of AI in two senses. One is, I think that right now a fundamental problem in healthcare is that not all people are practicing at the top of their professional abilities. We have doctors taking blood pressure in some places; doctors should never take a blood pressure. We have nurses who are unable to give pills in some places, and nurses should be perfectly qualified to give pills. I think AI can give us more confidence in allowing people to practice at the very top of their professional abilities. The other is long-term care. Elder loneliness is a huge problem in our country; proper long-term care is a huge problem. The attacks on immigration in this country — and there are attacks — are going to make the problems worse, because many of the caregivers in the United States are immigrants. My hope is that AI can play a productive role in helping provide care for our nation's elderly and disabled. So I have a slightly optimistic view of how AI can maybe make our healthcare system better. Improving Diagnosis Norman Ornstein, PhD: Let me give a slightly optimistic view. I have regularly read in the health and science sections in the Washington Post and The New York Times these stories about people who have horrendous health issues that go on for years that are undiagnosed or misdiagnosed until somebody realizes it's some rare thing that they had never encountered before, or you find a physician who'd encountered it once and they managed to deal with it and cure it. You can imagine AI being an enormous boon to physicians, allowing them to put in symptoms that somebody's having and a little bit of history and end up finding things that siloed physicians otherwise would not see. On the other hand, you can see AI being used, and sometimes misused, by insurance companies for billing purposes or to try to find ways to save money, but also to substitute for physicians — whether that will be a good thing or a bad thing. Claudia M. Fegan, MD: I think Jon made some very important points, that there are opportunities to use AI to assist physicians in diagnostic approaches. It also would be very beneficial in terms of identifying patients. We have a lot of patients who we are not touching, and there are preventive measures that we could take. Given a certain family history, given the vital signs, their weight and their background, you could anticipate certain problems that are not addressed. And I think that can push us to make better, data-driven decisions. It's an advantage that AI can provide, and we can easily put it in the hands of clinicians who are on the front line to make good decisions about patients going forward. But I think the threat here is insurance companies who may misuse it for other purposes, whether to deny coverage to people or to try to avoid expensive treatments that might be appropriate. Brull: Certainly, as one of the two primary care specialists in this group, I would say I'm very optimistic about AI and I see that it could be a team member. I also often say that I've never seen a chatbot give a hug to a patient. And as far as I know, patients don't just come to the doctor to plug their finger in and find out what's wrong. They come to partner, and so I think all of us see optimistic futures let's start with our two nonphysicians on the panel for this question. A Public Good Do you think Medicare has been good to the American people financially? Doctors complain all the time about reimbursement rates, but do you think those rates are reasonable? Let's start with you, Dr Ornstein. Ornstein: I think physicians in many instances have found ways around the lower reimbursement rates, which has often led to many unnecessary tests or other procedures so that they can get compensated adequately. I am very fearful, going back to a point that I made earlier, if these sequesters, this is the statutory Pay-As-You-Go plan that requires big cuts in Medicare because of the deficits being run up in the reconciliation bill, they limit them to 4% a year. But you know, that could even cut reimbursement rates more, and that will create a big problem. It may mean more physicians who decline to take Medicare, and that is going to create a burden for an awful lot of people along the way. Gruber: In terms of your specific question, what has it meant for the financial health of Americans, it has unambiguously been incredible. Amazing studies show that the introduction of Medicare led to massive reductions in the financial uncertainty facing elderly Americans with their medical spending. Has it been good for doctors? Unambiguously. It has been a huge boon to their business. One thing we know from every health economic study is, if you lower prices, more people use more medical care. Medicare did that. They lowered prices and people use more medical care. It's been a huge boon to the medical industry. I think the big question going forward is how to set the rates and in a way that balances our fiscal needs against the needs to have qualified physicians participate in Medicare. Quite frankly, it seems like the direction of that is clear: Medicare overpays subspecialists and underpays primary care doctors. And that's because the panel that set Medicare rates has been politically captured by the subspecialists. I find it hard to believe that if orthopedists made $700,000 instead of $1 million per year, they'd quit Medicare. But it is plausible that a primary care physician making $150,000 or $250,000 might actually quit Medicare. These are people who could go into other lucrative professions. I want to second Claudia's call for more data. We need to really understand how physicians will respond to reimbursements, and we need to set reimbursements in a way which balances these two needs. Ornstein: Let me add one thing. Just do a thought experiment. What if we'd never had Medicare? What if we didn't have any program with government support for a population of older Americans? The number of people who would've died prematurely, the number who would've used up every portion of their assets trying to cover just basic medical care, would've been enormously high. Society would've been so much poorer overall if there had been no Medicare. And if we see assaults on these programs, we're going to go back to having bankruptcies and people who won't get the care because they can't afford it. Brull: Dr Fegan, as a physician, what are your thoughts? Fegan: I think Medicare has made a tremendous difference. And if you just want to look at the data on life expectancy for Americans compared to other wealthy nations: If you look at the top 17 wealthiest countries in the world, we are really near the bottom up until age 65. And the dramatic change that occurs after 65 in terms of life expectancy in the United States, compared to other wealthy nations, is that we shoot to the top. And this is because Medicare has provided access to care for people who didn't have access to care. For physicians, and it really depends on the population of physicians you're talking about, it guaranteed that they were going to be compensated for patients that they may have been taking care of without appropriate compensation. The majority of hospitals in this country would not survive without Medicare. The majority of patients in hospitals in the United States are Medicare recipients. I would say that prior to the Affordable Care Act, 80% of our outpatients were unfunded and 56% of our inpatients were unfunded. Now we bounce between 60% and 65% of all our patients being funded, which made a tremendous difference for us. Medicare has made being a primary care physician feasible, whereas previously it was a financially precarious situation for many of them, in terms of being compensated for the services that they were providing. They might provide services for a chicken or for a free meal, as opposed to knowing that they would be paid at the end of the day, and they would know the rate they were going be paid. The challenge with Medicare is that it pays different rates within the city. I live in Chicago, and if you have an office downtown, the rate you receive is different from if you're on the South Side or West Side. We have to look at how we make those kinds of decisions. What We Pay Our Doctors Brull: Dr Ornstein, legislation in 1993 set targets for spending growth in physician services but did not account for inflation in practice costs. Why can't Congress seem to take care of the so-called doc fix? Ornstein: I think there are two reasons. One is obviously money. It means a lot more money, and they have been at least cognizant of the problems with the solvency of the program, looking at the long run. The second is that doctors have really not been a very effective lobby. To circle back to Medicare Advantage, I'd say the prime reason reimbursement rates are 130% or whatever, when they were supposed to be 90%, is because of the effectiveness of the insurance lobby with Congress. Congress could have stepped in and done something about that. If you look even, for example, at the Affordable Care Act, it was actually then-Senator Al Franken [D-Minn.] who said, 'If you're providing coverage under the Affordable Care Act, 85% of the money that you take in has to go back to patients.' There are ways for Congress to deal with this, but they respond to the lobbying that they get and the effectiveness that they've seen. And frankly, physicians have not been very effective. The physician community was extremely effective in keeping Medicare from being enacted for decades when the [American Medical Association] was an extraordinarily powerful lobby, until the Great Society and these enormous numbers of Democrats coming into Congress in 1964 enabled it to happen. But, if we're looking at weakness in lobbying efforts, physicians are in the top 10. More Pay Cuts Brull: Another one for you, Dr Ornstein. The recently passed budget reconciliation bill includes cuts in government spending. The Congressional Budget Office projected that this will include about $500 billion in mandatory reductions in Medicare spending between 2026 and 2034, or about a 4% reduction in payments to hospitals and physicians. Congress could act to block the cuts. Do you project that they will do so? And if they do not, what may be the effect on physicians and the program over the next decade? Ornstein: It's kind of interesting. We've had these so-called pay-go rules — pay-as-you-go — in one form or another since 1990 and the budget agreement that then-President George Herbert Walker Bush enacted with Congress, which was highly controversial because it violated the 'Read my lips: no new taxes" pledge. It has worked reasonably effectively, at least at different times. But in the past, when we have seen pay-go implemented, Medicare is one of the prime elements that gets these cutbacks or sequesters. Whenever it's happened, Congress has then stepped in and ameliorated it because they saw that it was going to have a bad effect. I'm not 100% sure it's going to happen this time. And the fundamental reason is that we know Republicans, certainly going back at least to the Newt Gingrich era in the House, have wanted to take over the Medicare program. Medicare as we know it would not exist if they had had their way. It would be in some other form. The sequesters don't allow cuts in Medicaid, but they have these big cuts in Medicare, and I think it's a dicey proposition. But let's just note, Jen, that if we do see these cuts, they will hit the reimbursement rates for hospitals and for physicians. Just start with hospitals for a minute, where we know the Medicaid cuts are going to have a devastating effect, especially on rural hospitals that have already been reeling even without these cuts. What we know is that if any hospital closes, it puts enormous pressure on other hospitals, and the other hospitals are not going to get the money. They're going to cut back on services. We've seen in Atlanta, for example, where an urban hospital had to close, and every other hospital found that their emergency room services were suddenly just completely overloaded. This system looks like it's separate parts private care, Medicare, Medicaid, but they're all interrelated, and it's like a set of dominoes. If one begins to fall, the others are affected by it. These cuts would be catastrophic if they are allowed to take place, and whether enough Republicans will join with Democrats to ameliorate that, which of course then means bigger deficits, we don't know for sure.
Medscape
2 days ago
- Health
- Medscape
Could Direct Primary Care's Popularity Be on the Rise?
Recent budget reconciliation legislation allows health savings accounts (HSAs) to cover Direct Primary Care (DPC) services. Here are the pros and cons. DPC Basics Unlike the setup of a traditional medical practice, DPCs provide services by charging membership fees. Historically, if an individual chose to be a DCP patient, they would pay membership fees on their own, with membership skewing towards those with the financial means to join. DPC Upsides for Providers and Patients DCP patient loads are smaller, allowing more timely, personalized care for patients. Those factors, along with unlimited access to their provider and the coverage of routine medical needs, are big upsides for members. A DCP practice enables providers to move away from the challenges associated with traditional healthcare models. DCP and HSA The new budget reconciliation law, in accordance with IRS guidelines, recognizes DCP memberships as a medical expense that HSA funds can pay for. Will DCP Become More Popular? Individuals previously unable to afford DPC memberships may now find value in utilizing their HSA funds for a more customized healthcare experience, especially if dissatisfied with their current care. Effects on the Traditional Healthcare System Shifts toward DCPs could increase the expenses involved in traditional practice, resulting in higher financial burdens for remaining patients who do not have an HSA, and therefore do not have the option to switch. The new law may also entice physicians to leave their current situation, which would leave practices with fewer providers. Bottom line: Now that HSA funds can be used for DCP memberships, a shift away from traditional practices is possible. The impact could be negative for some and beneficial for others.
Medscape
2 days ago
- Health
- Medscape
Medicare at 60: Care, Cost, Control
This transcript has been edited for clarity. Jen Brull, MD: Sixty years ago, Congress passed legislation that created Medicare. In 1966, its first year of implementation, there were 19.1 million enrollees. Almost a decade later, enrollment had grown to 22.5 million. Today, 68.8 million Americans have Medicare coverage, with about half enrolled in Advantage plans. The original idea for this insurance program was even bigger. It started as a plan for all Americans, with President Harry Truman endorsing universal coverage in 1945. Today we'll take a look back at how we got there and look ahead to the next 50-60 years. How might the future of medicine be shaped by Medicare policy? I'm Jen Brull, MD, president of the American Academy of Family Physicians. We represent nearly 130,000 family physicians across the country, residents, and medical students. I'm also a senior advisor for clinical strategy and physician well-being at Aledade, where I help physicians in independent primary care succeed in the shift to value-based care. I'm delighted to be joined by three outstanding panelists. Dr Claudia Fegan recently retired as chief medical officer at Cook County Health in Chicago, the third largest public health system in the country, providing care for over 190 years. She is also the national coordinator of Physicians for a National Health Program, which advances a universal health system. Thank you for being with us, Dr Fegan. Dr Jonathan Gruber is joining us from the Massachusetts Institute of Technology in Cambridge, where he chairs the economics department. He previously consulted for the administration of former President Barack Obama in crafting the Affordable Care Act. He was also instrumental in creating Massachusetts 2006 health reform law, which led the state to the lowest uninsured rate in the nation. Dr Norman Ornstein is a retired scholar from the American Enterprise Institute and co-host of the podcast Words Matter . He has written extensively about Medicare, privatization, Part D, and the program's inability to negotiate drug prices. He's also the author of numerous books, including Intensive Care: How Congress Shapes Health Policy . Thank you all for being here today, and let's get started. Five years from now, the last of the baby boomers will turn 65 and 1 in 5 Americans will have Medicare coverage. Dr Fegan, I know that many physicians debate about opting out of taking Medicare and perhaps only seeing patients with other insurance or going the direct primary care route. Paying the Doctor Brull: Can physicians survive without taking Medicare patients? Do you think more physicians will do so in the next decades? Claudia Fegan, MD: I think that the advancement of concierge medicine, where physicians are entering into direct financial agreements with the patients they're seeing, as opposed to using Medicare as a payer, is a trend. However, the majority of physicians in this country today are in an employment arrangement as opposed to being in private practice, which is where the majority of us were, say, 40 years ago. I would say that those large groups, as well as hospitals, cannot survive without Medicare. The majority of people over the age of 65 use Medicare as their insurance. As you pointed out, the majority of Medicare recipients today are now in Medicare Advantage plans, which are private plans. But without Medicare, I don't think it's economically feasible for the majority of physicians to survive. There will always be some who are catering to a group of patients who have the financial wherewithal to afford their care. But that is not the majority of Americans in this country. And more importantly, I would say that the majority of hospitals and large outpatient facilities cannot survive without payments or reimbursements from Medicare. Shaping Care Brull: Dr Gruber, you've done a lot of research on insurance policy design, like the use of copayments and formularies and decreasing utilization of unnecessary care and specific services that patients receive. How has Medicare policy impacted the types of drugs, imaging, and treatments that physicians can prescribe or perform? Jonathan Gruber, PhD: That's a great question. Thanks for having me here. Medicare influences [coverage] a lot through the copayments that they charge. Remember, Medicare, at least 30 years ago, was not actually that great of insurance. Most employer plans had very low copayments and deductibles. Medicare actually had relatively high copayments and deductibles. Today, Medicare looks more like a typical employer-provided health insurance plan in imposing copayments and deductibles on people using services. There is mixed evidence on the implications of that. My general read is that when you impose a copayment or deductible, people use less of all services, both necessary and unnecessary. But there does not look to be enormous evidence that, at least at the level of current Medicare copayments, it significantly impacts their health to be using less of those services. But then there's the long run, which is when Medicare covers services; it changes the shape of innovation in the United States. If Medicare says, "We're covering this surgery," people are going to innovate and create surgeries covered by Medicare. Setting Prices Brull: Medicare has a huge impact on the long-run structure of what is provided by healthcare in the United States, and that's important to consider as well. As a follow-up for anyone on the panel: As technological innovation in medicine advances, how might the program manage patient access and costs? Fegan: I think it's important to use data to make these decisions, and as clinicians, we appreciate — for example — peer-reviewed articles which compare whether something is a useful or beneficial service or not. You know the slogan about when you have a hammer in your hand, everything looks like a nail? When there's a new innovation, there's an inclination to want to use it. But I think the most important way to make these decisions is to do studies where we look at whether there's a real benefit to the innovation. And when clinicians use studies and examine outcomes, they make better decisions than just what happens to be the most exciting or innovative approach. Gruber: I want to strongly endorse that comment.I think we are facing what I call sort of a tsunami of incredibly effective but incredibly expensive new treatments, from GLP-1s for weight loss to new cell and gene therapies. Society is going to have to face a choice of how much we're willing to pay for those. And the only way to make that choice is not to leave it to the free market, because the free market is broken in healthcare. I teach basic economics, and I teach the reasons why the free market might not work. As Kenneth Arrow wrote in 1963, every one of those reasons applies to healthcare. Healthcare is a broken market. The government needs to be involved in setting prices, but the only way it can do so is with evidence on what works and what doesn't. This is what the rest of the world does. Norman Ornstein, PhD: Those are hard questions to ask, and we need to really invest resources in asking them. Let me just add that we don't know what impact artificial intelligence (AI) is going to have on the practice of medicine, at least not entirely. Something like 25 years ago, I went to a series of conferences with healthcare providers and talked about how I expected that within a short period of time — just as we saw with automobiles where you could plug something in and get a complete readout of what the issues were with the car — it wouldn't be long before people would go to a nurse practitioner, put their finger into a little device attached to a computer, and get a readout. And that would make general practitioners almost obsolete, and they would go right to specialists if there were issues. Obviously, that hasn't happened, but AI could be a game changer in terms of both providing great opportunities where physicians might miss things because they're siloed but also where it will change the whole provider community. The Medicare Advantage Paradox Brull: Dr Gruber, in 1997, Congress created Medicare Advantage plans as a way to help curb growing expenditures. About half of all beneficiaries are now enrolled in this type of coverage. We know that Advantage plans are more aggressive in using prior authorization. As these plans grow, what are the implications for patients and physicians in the coming years? Gruber: Economists don't often come to a fairly consistent answer on a question, but there are a lot of studies which I think perhaps surprisingly show that Medicare Advantage saves money. These plans deliver care more and cost-effectively. Medicare Advantage doesn't save federal spending, and I'll come back to that, but it delivers care more cost effectively without actually harming health in a measurable way. I know people are upset about prior authorization and other things, and I'm not saying it doesn't have negative effects on people's mental health and well-being, but the truth is, there are a number of nicely done papers now which show that people in Medicare Advantage plans aren't in immeasurably worse health as a result. So, I think care management can be productive. The problem is, and Norm is the expert on this, that we set up a program which was originally designed to save money and took on a life of its own. Remember: When we set up Medicare Advantage, it paid at first 95% and then 90% of what Medicare paid. It then went up to 132% of what Medicare paid. How can a program save money if it's paying 132% of the alternative? The answer is, because it became a goal that people should have managed care, not that Medicare should save money — and that's the problem. I think Medicare Advantage can be a proper part of a well-functioning system, but we have to fix the reimbursement so we're not overpaying the plans, and this is becoming the major money maker for all insurance companies in America. Who's Overseeing Utilization Management? Fegan: One of the problems with Medicare Advantage is that the insurance companies have learned to game the system and figured out how to get better reimbursement. The other problem with prior authorization is that the Kaiser Family Foundation published a study that showed Medicare Advantage averaged two prior authorizations per enrollee at a time period when traditional Medicare averaged only one prior authorization for every 100 enrollees. While prior authorizations may have an appropriate place, they're designed to decrease utilization and decrease particular services. Patients who have a prior authorization denied, less than 10% of them appeal that denial. But on the other hand, when the denials are appealed, over 80% of the denials are overturned. The prior authorizations use AI. I think what happens with the appeal is that it goes to a physician who thinks this was a reasonable study or care to provide and therefore they're overturned. So prior authorizations may work in terms of decreasing the amount of more expensive care and studies and medications, but it's not clear to me that they meet the standard of care that most physicians would like to give. Brull: You read my mind in terms of our next question. You have written about the practice of Medicare Advantage companies using AI to deny claims. I wonder if we could go into that a little bit more deeply. [Centers for Medicare & Medicaid Services] recently said it's going to experiment with AI for this same use, but for its traditional fee-for-service Medicare members, starting next year. I wonder if you could talk a little bit more about that. Fegan: Traditional Medicare uses prior authorization, but as I pointed out, much less often than Medicare Advantage. As a result, when traditional Medicare denies a prior authorization, it's not overturned on appeal the majority of the time. It would seem that it's been a more appropriate use of the prior authorization. Traditional Medicare continues to use prior authorizations, but in a more judicious manner. I have concerns about the large number of prior authorizations, because for certain populations, that prior authorization is difficult for patients to navigate. Sometimes patients are missing out on things that we would think to be appropriate care. I have concerns about AI. I think there's a place for it, but we have to be careful in terms of the data we put in to arm the AI. And there should always be a backup in which experts who have experience in that particular field can have a say if they disagree with what would be in an algorithm.
Medscape
2 days ago
- Health
- Medscape
ADA 2025: Clinical Trial Data on Incretin Therapies
This transcript has been edited for clarity. At the ADA meetings this year, incretin therapies were a big topic. There were many, many different studies presented on all sorts of new drugs and older drugs, and a large amount of interest in this. What I'm going to try to do is make it simple, and you're going to have to forgive me because many of these drugs have names that are almost impossible to pronounce. As far as I can tell, there were three main areas that involved incretins. One was newer agents that were different combinations of different kinds of drugs. I'm going to touch on those main areas where there were differences. The second is in terms of the forms for delivery, specifically a new oral form of incretin therapy that might be easier for patients to take. Third, longer duration of activity of these agents that might make it even easier for our patients to adhere to. First, I'm going to go to different combinations. The first is CagriSema, which is semaglutide plus cagrilintide, which is a long-acting human amylin analog. We all were familiar with amylin from a long while ago, as we had pramlintide. This takes that amylin analog and mixes it with a dose of 2.4 mg of semaglutide. The studies that they did are called REDEFINE, and they presented the full results of the phase 3 REDEFINE trials. In most of the studies on these newer agents, they basically study them in people who are overweight or obese without type 2 diabetes, as well as in people who are overweight or obese with type 2 diabetes. REDEFINE 1 looked at 3417 people who were overweight or obese and who didn't have type 2 diabetes. They saw 20% weight loss with this new agent compared to 15% with semaglutide 2.4 mg, or 12% weight loss with cagrilintide alone. In REDEFINE 2, there were 1206 people with obesity and type 2 diabetes compared to placebo. CagriSema conferred a 13.7% weight loss vs 3.4% with placebo. That's fairly standard for many of these drugs. You get weight loss and A1c reduction, and it's always a bit more in people without diabetes than those who have diabetes. Moving on to the next combination. There was the DREAMS-1 trial, looking at a once-weekly GLP-1 receptor agonist combined with a glucagon receptor agonist, which is called mazdutide. It was studied in people in China with type 2 diabetes. This showed a nice A1c reduction and significant weight loss at 24 weeks. This was a study in 319 individuals who were living in China. They had a number of different arms to this study, so they had a 4-mg dose, a 6-mg dose, and placebo. The study lasted for 24 weeks, and they saw A1c reductions of 1.4%-2%. There was weight loss that varied depending on the dose, at 5.6% or 7.8% in the two different arms. There were similar side effects. I think one of the truths of all of these trials is that the GI side effects occur with nearly all of these agents, some to a greater degree than others, but those were the major side effects in terms of this agent. They're now studying it in other individuals with type 2 diabetes. They compared it to dulaglutide and found a greater A1c reduction than with dulaglutide in one trial. They're also looking at it for weight loss in people without diabetes. There are a number of trials that are ongoing that will give us more data in terms of what this combination does in people with obesity and type 2 diabetes. The next trial is one that I find oddly fascinating, which is called the BELIEVE trial. Believe it or not, this is a trial in which they took semaglutide and mixed it with a monoclonal antibody that blocks activin type II receptors, with the hopes that that will improve muscle mass, maintain lean body mass, and decrease fat mass as people lose weight with this combination. They studied it in people who were living with obesity or overweight without type 2 diabetes, and they basically had a number of different comparisons. The monoclonal antibody is called bimagrumab. It's something that I'm not familiar with, but it was really interesting in terms of its effect. They had a number of different groups: a placebo group, a low-dose bimagrumab group, a high-dose bimagrumab group, a low-dose semaglutide group, and a high-dose semaglutide group, and then they had four different combination groups with low-dose or high-dose bimagrumab. They looked at all of these different permutations in a study sample size that was 507 individuals. They were hoping to see less loss of lean body mass, and they basically showed this. There was a 7.9% reduction in lean body mass with semaglutide alone, but if you gave them the monoclonal antibody, there was a 2.3% gain in lean body mass. When you combined the monoclonal antibody with semaglutide, you got a lesser reduction in lean body mass, a 2.6% reduction, which was compared to the 7.9% reduction with semaglutide alone. This is hopeful in the sense that this specific combination helps people lose less lean body mass. There were a whole bunch of other analyses they did to see about people being stronger and feeling better. It really does matter to not lose so much lean body mass. I'm still old fashioned and I really want to encourage people to exercise and eat well in order to help preserve lean body mass. We'll see what happens with this. I think it's a fascinating concept, but I also don't want to forget about lifestyle. The next trial was called ACHIEVE-1, and this was looking at an oral form of a GLP-1 receptor agonist known as orforglipron. They studied this in people with type 2 diabetes. What's different about this is that this is a small molecule. It's not a peptide GLP-1, so it's really easy to give. It's like any old pill that people take, so it doesn't have restrictions around how much water and when it's taken, etc. They did see benefit in terms of A1c reduction, some weight loss, about 8%, and it seemed like it worked, but it did have GI side effects and it didn't cause the same sort of A1c reduction or weight loss we see with some of the other injectable compounds. Still, it might be an interesting first step for people as they get used to GLP-1 receptor agonist therapy, and it may be easier for patients to take. The final compound I'm going to discuss is MariTide. This is a compound that is a GLP-1 receptor agonist and a GIP antagonist. This is a once-a-month agent. This was a 52-week trial in individuals who were obese or overweight without type 2 diabetes. They basically had three different doses they were studying and they did a bunch of different dosing frequencies. It seemed to me to be effective in terms of weight loss, as most of these drugs are, but it did have an incredibly high rate of GI side effects. When you look at that study in individuals without type 2 diabetes, the rates of nausea and vomiting were really high. At baseline, 25% of placebo patients reported nausea. In the treatment group, nausea was reported in 77%-87% of participants and vomiting was reported in 68%-92%. It usually occurred after the very first dose of the drug, with an incidence decreasing over time. I've never used a drug that had such a high rate of vomiting — nausea, potentially, but not vomiting. GI side effects were the main reason for people stopping it, and 14%-29% of individuals discontinued the drug due to adverse events. They also did a study in people with type 2 diabetes. It's interesting because they used a different survey to assess GI side effects, but they still had a very high rate of GI side effects, at 94% in the MariTide group vs 81% in the placebo group. Again, the most common GI side effects were nausea, vomiting, constipation, and diarrhea. Nausea rates ranged from 41% to 59% of people taking the MariTide, with vomiting in 45%-75% of participants. These GI side effects are really clear here, and I don't know that this is going to be something people are going to want to take. Once a month is nice, but it's not fun to vomit. I think it depends on how quickly people habituate to this and how one goes up on the dose. These GI side effects are an issue for all of us and our patients as we prescribe these drugs. I tend to start as low as I possibly can. I'm a fan of microdosing as much as possible to get people to tolerate these drugs because I think that the incretin class of drugs is so beneficial, not only in terms of glucose and weight loss, but also in its nonglycemic effects. I also don't want people to lose weight too fast because I think that it isn't healthy. I know that there are studies that are coming out that show that there are people who respond by very rapid weight loss, more commonly in women than in men. I think we need to be mindful of how we use these drugs, how quickly people lose weight, and how we encourage people in terms of leading a healthier lifestyle to avoid some of the side effects that can be associated with that sort of rapid weight loss. This has been Dr Anne Peters for Medscape.
