CMS Proposes Nearly 3.4% Cut in Medicare Physician Fees for 2024

/0 Comments/in /by

WASHINGTON — The Centers for Medicare & Medicaid Services (CMS) is proposing a nearly 3.4% cutopens in a new tab or window to the “conversion factor” used to set the Medicare Physician Fee Schedule for 2024, and physician groups are none too happy about it.

“The proposed 2024 Medicare Physician Fee Schedule (PFS) raises significant concerns for medical groups related to its 3.4% reduction to the conversion factor, which further increases the gap between physician practice expenses and Medicare reimbursement rates,” Anders Gilberg, MGA, senior vice president for government affairs at the Medical Group Management Association here, said Thursday afternoon in a statementopens in a new tab or window. (Disclosure: Gilberg is a member of the MedPage Today editorial board.) “Medicare already largely fails to cover the cost of furnishing care to beneficiaries, and the proposed cut to the 2024 conversion factor compounds the problem.”

“While the ACR [American College of Rheumatology] appreciates CMS’ continued recognition of the value of complex care provided by rheumatologists and other cognitive care specialists … we are gravely concerned that the proposed rule’s physician payment cuts contained in CMS’ conversion factor would add to physicians’ uncertainty about their continued ability to provide the highest quality of care to Medicare patients,” ACR president Douglas White, MD, PhD, said in a statementopens in a new tab or window.

The conversion factor is the multiplier that Medicare applies to relative value units (RVUs) to calculate reimbursement for a particular service or procedure under Medicare’s fee-for-service system. The 2024 conversion factor of $32.74 includes both a 2.17% decrease required for budget neutrality reasons and a 1.25% increase that was included in last year’s Consolidated Appropriations Act (CAA); the CAA also increased the 2023 conversion factor.

Those two percentages — a 2.17% decrease partially offset by a 1.25% increase — would normally be considered a 0.92% decrease in physician pay, but the percentages were calculated based on the original conversion factor for 2023 — $33.06 — which was then increased to $33.88 by the raise from the CAA; comparing that number to this year’s $32.74 number results in the nearly 3.4% cut. (See p. 1191 of the proposed ruleopens in a new tab or window for more details.)

The American Medical Association (AMA) also panned the cut, with AMA president Jesse Ehrenfeld, MD, MPH, calling it “a critical reminder that patients and physicians desperately need Congress to develop a permanent solution that addresses the financial instability and threatens access to care.”

“When adjusted for inflation, Medicare physician payment already has effectively declined 26% from 2001 to 2023 before additional inflation and these cuts are factored in,” Ehrenfeld said in a statementopens in a new tab or window. “Physicians are one of the only providers without an automatic inflationary increase … Physicians need relief from this unsustainable journey.”

There was one group that applauded the agency, however. “CMS showed its commitment to supporting value-based care and growing participation in accountable care organizations (ACOs) in this proposed rule,” Clif Gaus, ScD, president and CEO of the National Association of ACOs (NAACOS), which represents accountable care organizations, said in a statementopens in a new tab or window. “It addresses several issues that NAACOS has been advocating for, including improvements in quality reporting, more fair benchmarking policies, a smooth transition to a new risk adjustment model, keeping advanced payments for new ACOs who transition to risk, [and] helping ACOs who serve high-cost beneficiaries and others.”

“NAACOS thanks CMS for its continued leadership on this issue and its willingness to address the barriers standing in the way of clinicians and health systems who want to provide higher quality, more cost-effective, coordinated care for patients,” he said.

The fee schedule’s effects, however, vary by specialty. In the 2024 fee schedule, the big loser is interventional radiology, whose fees are estimated to decrease by an estimated 4%. Other losers were nuclear medicine, vascular surgery, and diagnostic radiology, whose fees will decrease by 3%.

The American Society for Radiation Oncology (ASTRO) was not happy with an estimated 2% cut for radiation oncologists and radiation therapy centers. “ASTRO is disappointed that CMS once again undervalues the impact of radiation oncology and intends to cut reimbursement by an additional 2% in 2024 for this essential cornerstone of cancer care,” Geraldine Jacobson, MD, MPH, chair of the ASTRO board of directors, said in a statementopens in a new tab or window.

“Medicare spends less on all radiation therapy services than it does on just three top cancer drugs, although radiation is utilized by twice as many beneficiaries,” she added. “Despite this outsized value, CMS has cut radiation oncology physician fee schedule payments by over 20% in the last decade – more than nearly all other physician specialties.

On the other side of the ledger, the total allowed charges for family practice and endocrinology will increase by an estimated 3%. A number of other specialties will see an estimated 2% increase, including clinical social workers, clinical psychologists, general practitioners, rheumatologists, and nurse practitioners, according to CMS.

For its part, CMS touted several new services that would be covered under the fee schedule. “In alignment with the goal of the Biden-Harris Administration’s Cancer Moonshot for everyone with cancer to have access to covered patient navigation services, CMS is proposing payment for Principal Illness Navigation services to help patients navigate cancer treatment and treatment for other serious illnesses,” the agency said in a press releaseopens in a new tab or window. “These services are also designed to include care involving other peer support specialists, such as peer recovery coaches for individuals with substance use disorder.”

The proposed rule also calls for coverage of some dental services for cancer patients. “Access to oral and dental health services that promote health and wellness allows people with Medicare to achieve the best health possible,” the release continued. “In this proposed rule, CMS is … proposing that payment can be made for certain dental services prior to and during several different cancer treatments, including, but not limited to, chemotherapy.”

Do-It-Yourself Medications: Self-Injected Drugs on the Rise

/0 Comments/in /by
July 14, 2023 – “I’ve always been a little wary of needles,” Heather, 65, a resident of Southern California, said as she reminisced about a long-ago high school biology class. The instructor asked them all to prick their finger to find out their blood type. It took her the whole hour to work up her nerve, said Heather, who asked that her real name not be used to protect her privacy, but she did it.

Several decades later, the challenge surfaced again. Her doctor decided to add the lowest dose of Ozempic (semaglutide), injected once a week, to her dose of oral metformin to help manage her blood sugar.

“It’s a tiny little needle, and it’s an automatic injector,” Heather told herself, yet she felt like she was right back in high school biology class. So her husband did the honors for the first dose. It wasn’t nearly as bad as she imagined, she said. The needle, she said, was short and fine.

“I felt the medicine going in a little bit and some stinging. The next week, I did it on my own,” she said.

Heather’s off the Ozempic now, her blood sugar managed well again just with metformin. But she, as well as the rest of us, should expect to be taking more injectables in the future, experts say. The era of do-it-yourself medicine, via self-injection at home, is here, growing, and shows no signs of slowing down.

In the past, self-injected medicine was mainly insulin, injected by those with diabetes, along with anti-coagulants for those at high risk of blood clots, said Eric J. Topol, MD, editor-in-chief of Medscape (WebMD’s sister publication for health care professionals), a professor of molecular medicine, and executive vice president of Scripps Research in La Jolla, CA.

“Fast forward,” Topol said. “Now we have all these autoimmune disease drugs [that can be self-injected]. We have these anti-obesity, anti-diabetes drugs, we have the powerful low-cholesterol agents, the drugs like Repatha [evolocumab]. We have people taking two or three different injectable drugs every other week.”

All this, he said, comes after many people, just 2 years ago, claimed they had “needle phobia” when offered a COVID-19 vaccine. In one U.K. study, researchers who polled more than 15,000 adults and matched them to a general population sample concluded that about 10% of vaccine hesitancy was due to fear of blood, needles, or invasive medical procedures.

“And now we are in a world where we are training the public to inject themselves,” Topol said.

The market for self-injected drugs is increasing, with no signs of slowing down, according to analysts’ reports. While estimates range greatly, one analysis estimated that the global self-injection devices market size was $6.6 billion in 2021 and would grow nearly 6% a year from 2022 to 2030.

Self-injected devices include prefilled syringes or pens and auto-injectors. As of August 2021, according to a market review, nearly 80 auto-injectors have been developed by more than 20 drug companies. When researchers evaluated 2,964 shots given from the auto-injectors, just 12 device malfunctions occurred, for a failure rate of 0.40%.

Chances are, someone you know self-injects a medication, such as Humira (adalimumab) for arthritis, Repatha (evolocumab) to manage cholesterol, Dupixent (dupilumab) for asthma or, yes, Ozempic (semaglutide) for diabetes control or Wegovy (semaglutide) for weight loss.

Three key things are driving this trend, according to George I’ons, head of product strategy for Owen Mumford Ltd. in Oxford, U.K., which designs, develops, and makes injectable drug delivery systems for drug, biotech, and generics industries. These include:

  • Staff shortages at medical clinics and hospitals
  • Financial pressures on health care systems
  • A growing aging population, likely to need more medications on a regular basis

Having patients give themselves shots, when possible, not only saves clinic time and expense, but also spares the patients a trip to the clinic, of course, and often a copay. “The more people can do for themselves, the less you need to occupy staff time,” I’ons said. That means more time staff can spend on areas that really need attention. That 20 or 30 minutes of clinic time that don’t need to be spent giving someone medicine can be put to valuable use, he said.

Improved Devices, Needles

While the needle phobics may shudder at the self-injector trend, ongoing device improvements are aimed at comfort. For instance, I’ons said, “a lot of auto-injectors hide the needle before and after use.” The user feels just a piece of plastic against the skin.

Needles have often gotten so thin, that at least with some devices, “you could quite easily not even feel the thing going in,” he said. For insulin delivery, I’ons said, the needles have gotten thinner and shorter over the years.

But not all medicines delivered by self-injector can use the smallest needle, he said. Some drugs, because of their viscosity, or thickness, may need bigger needles.

When people complain of discomfort as the medication is injected, they could be feeling not the tiny needle, but the drug itself, or one of its inactive ingredients, I’ons said. He cited the case of drug maker AbbVie removing the buffer, citrate, from Humira (adalimumab) and offering a citrate-free version in 2018 because the citrate was linked to pain where people got the shot.

Companies said they are focused on technology advances to make self-injection less unpleasant. “Significant advances in technology, as well as our investments in R&D, have allowed Lilly to explore a variety of different injection methods over the years,” Nadia Ahmad, MD, associate vice president and medical director of obesity clinical development for Eli Lilly & Company, said in a statement.

Some people prefer the shots over pills, she said, because “in some cases, it may lead to higher adherence and better efficacy through consistent use.”

At Amgen, an executive said demand is growing from patients and providers “to have flexibility when it comes to administration of our medicines.” Jyothis George, vice president and global medical therapeutic area head in general medicine at Amgen, said in a statement that for Repatha, for example, grew 32% in the first quarter of this year.  In February, the FDA approved self-administration of Tezspire (Tezepelumab-ekko), developed by Amgen and AstraZeneca, for patients with severe asthma.

Education Helps Self-Injection Skills

Introducing patients to self-injections is part of the day’s work for Amy Hess-Fischl, a certified diabetes educator and registered dietitian who works as a diabetes educator at the University of Chicago. “As they sit down, I hand them a needle, a syringe, and say, ‘Go ahead and inject.’ Once they do that, they say, ‘Oh my God, it’s so small.’” It gets the anxiety of the unknown out of the way, she said.

She’s talking about insulin injections. “When it comes to these other injectables, with so many, you don’t even see the needle.”

She reminds patients that the needles are decreasing in size, in general, in both the length and the thickness, or gauge. Some needles are now so short and so small, they can be compared to an eyelash, she said.

She reminds patients, too, that self-injecting can be empowering. “It’s about patient-centered care. I think this new revolution in injectables is going to improve patient-centered care and reduce anxiety.”

Support and education are important, she said. While there are online resources for self-injecting, the human touch remains important, she said. Any health care providers prescribing a self-injected medication, Hess-Fischl said, “needs to have a plan about where to send this patient to be successful.” If the health care provider doesn’t come through, she suggests patients call the drugmaker, and staff there should be able to give instruction, or tell them where to get the instruction.

The Next Market?

While many drugs can be self-injected, not all can. Many patients with chronic diseases depend on drugs that must be delivered with an IV, which means spending hours in a clinic or other facility.

One barrier is the high viscosity of some of these medicines, making it impossible to make and inject some of the monoclonal antibodies at the small volumes needed for shots under the skin.

Science could change that, said Jeffrey Hackman, CEO and chairman of Comera Life Sciences, who has come up with ways to change some biologics into forms that could be given under the skin and self-injected by the patient at home.

“I don’t think we can ever get out of IV medicines [entirely],” he said. But he has hopes that some biologics now given via IV at clinics will be self-injected at home within the next 5 to 7 years, and much more quickly than the process now requires.

SOURCES:

Heather, former Ozempic user, Southern California.

Eric J. Topol, MD, editor-in-chief, Medscape; professor of molecular medicine and executive vice president, Scripps Research, La Jolla, CA.

George I’ons, head of product strategy, Owen Mumford Ltd., Oxford, U.K.

Medical Device and Diagnostic Industry: “An expert look at issues driving up the demand for self-administration drug-delivery devices that combine pre-filled safety-engineered aspects.”

Psychology of Medicine: “Injection fears and COVID-19 vaccine hesitancy.”

Journal of Pharmaceutical Sciences: “Caffeine as a Viscosity Reducer for Highly Concentrated Monoclonal Antibody Solutions.”

Grandview Research: “Self-Injection Devices Market Size, Share & Trends Analysis Report by Product (Autoinjectors, Needle-free Injectors), By Usability (Disposable, Reusable), By Application (Cancer, Pain Management), By Region, And Segment Forecasts, 2022-2030.”

Nadia Ahmad, MD, associate vice president, medical director of obesity clinical development, Eli Lilly & Co., Indianapolis.

Amy Hess-Fischl, diabetes educator, University of Chicago.

AbbVie: “Getting to Know Humira (adalimumab) Citrate-Free.”

Jeffrey Hackman, CEO, chairman, Comera Life Sciences, Woburn, MA.

Jyothis George, vice president, global medical therapeutic area head, general medicine, Amgen.

AI in Medicine: ‘Give It a Try, Take It For a Ride’

/0 Comments/in /by

In this exclusive video, Harlan Krumholz, MD, SM, of the Yale School of Medicine and Yale New Haven Hospital in Connecticut, discusses uses of large language models like ChatGPT in healthcare settings and how to use new artificial intelligence (AI) technology responsibly.

Krumholz is the director of the Center for Outcomes Research and Evaluation, the Harold H. Hines Jr. Professor of Medicine, and a professor in the Institute for Social and Policy Studies, Investigative Medicine and of Public Health.

The following is a transcript of his remarks:

I’m always surprised that so many people have heard of ChatGPTopens in a new tab or window and other AI platforms but there are still a lot of people who haven’t tried it yet, so they really don’t know what the experience is like and maybe they’re not really familiar or clear about it.

Hi, I’m Harlan Krumholz from the Yale School of Medicine, and I just wanted to take a few minutes to talk about these new models and to provide a little context in case you’re one of those who hasn’t had a chance to really try them out yet.

These AI models, like ChatGPT, are called large language models. Sometimes you hear people offhand saying LLMs — large language models — it makes you sound like you’re in the know if you say that. Well, these are foundation models that are trained on massive, diverse, large datasets and can be applied for numerous downstream tasks.

For medicine, these can be used as chatbots for patients. What are chatbots? Chatbots are automated tools that can interact with patients to elicit information and even give advice without the need for a human being involved. They can be used for interactive note-taking or they can augment the performance of people doing procedures. They can generate reports like radiology reports, they’re helping basic scientists identify targets for drug development, they can be used for bedside decision support.

Sound too good to be true? Well, at least at this stage, it is a bit too good to be true. I mean, it’s a remarkable tool. I think we’re at a juncture in history; it’s a step function with what these are able to achieve compared with what I was seeing was able to be achieved with AI before this. Now, this is about taking unstructured data — not data that fits into a case report form or into a given field — but take unstructured data like notes and texts and be able to make sense of it and then be able to feed it back appropriately when people are asking questions.

Now, you may know that there are a lot of people who are raising warnings about this AI. They’re thinking that we’re moving too fast. There are even some people who think this could be the end of humanity. Now, lest you think that this is only about people who are untethered to the reality of the world, these are actually very smart people, very well-steeped in AI that are expressing concerns, and governments are stepping forward and wondering who should really be able to control these kind of tools and how they might be applied.

There’s another feature to these — well, let me say, it’s both a feature and a bug — that is, these models are capable of creativity. So you could say, “I want to write a note to someone and I want it to be done in the form of a Shakespearean sonnet.” Well, it can actually produce that, or in the style of anyone that you can think of. That’s creativity.

But every once in a while you’ll be asking it a question about reality — and believe it or not, these are called hallucinations of the AI — that is, it can provide an answer that may even seem reasonable, but actually it’s made up. This happened to a lawyer who was using it to develop references for a court caseopens in a new tab or window, and it turned out that some of the references were actually made-up references, quite to the embarrassment of the individual and perhaps to some professional harm.

So there’s a lot to sort out with these, and there are a range of possibilities. Like I said, it’s a juncture in history, but I urge you to give it a try. For example, in clinic this weekend — I do a clinic with medical students — we were taking some of the more perplexing patients and putting their symptoms into this. By the way, you just put in, “I have a patient with these symptoms.” You want to be careful by the way, this isn’t mostly HIPAA [Health Insurance Portability and Accountability Act] overseen, so we were being vague but still put in the symptoms. It generated a pretty good differential diagnosis.

This can be used for a wide variety of teaching, but you do need some expertise to know whether or not what it’s giving you is real and whether you can trust it and rely on it.

A recent New York Times articleopens in a new tab or window came out and I was quoted as saying, “You’d be crazy not to try this.” And I’ll say this, too, I really urge clinicians and healthcare professionals to become familiar with this kind of technology. Give it a try, take it for a ride. Get familiar with what’s coming out, because I think on the horizon you’re going to see this in medicine and you’re going to see this being applied in a wide variety of ways.

You’re already seeing Epic making an agreementopens in a new tab or window with OpenAI who developed this platform, ChatGPT, to be able to integrate it into Epic for many of the tedious tasks that need to be done — report generation and so forth — that that could actually make lives better for physicians and make the chart more complete.

Now, we talk a lot about ChatGPT, but just by the way, there are a lot of these large language models out there. ChatGPT is just one of them. And many people are suggesting that in future generations, these are only going to get more powerful and there will be competition among the tech companies and other newly emerging companies that are going to try to leverage the rapid advances. In the last 6 months, again by the way, people have said that there’s been more advances in the field of AI than they’d seen in a decade.

So, I think we’re on the cusp of a different moment in history. This issue in medicine is going to be very important. Also, what needs to be regulated? What is it that can come into medicine that doesn’t need to be regulated? And what can we really trust? As clinicians, we don’t really need to understand exactly how it works, but we need to know whether we can trust it. That’s going to take some additional time and testing. We’re not quite sure how it’s going to fit, but I’m sure in the end this will help transform medicine, hopefully for the betterment of patients. We need to be involved to ensure that there’s not unintended harm that occurs as new technology gets introduced.

But I’m optimistic about the possibilities and, again, I urge you to give them a try.