Urology health policy in 2025: Big wins, ongoing battles, and what comes next

In this interview, Mara R. Holton, MD, highlights a year of notable advocacy achievements for LUGPA amid substantial regulatory flux driven by a new administration. The organization secured a major legislative victory with an across-the-board 2.5% increase to the Medicare Physician Fee Schedule conversion factor, championed by Rep. Greg Murphy, MD (R-NC). LUGPA also advanced its in-office dispensing (IOD) bill through the House, and although it stalled in the Senate, momentum continues. Bipartisan efforts on pharmacy benefit manager (PBM) reform and 340B program oversight progressed as well, with expectations for increased PBM transparency by late 2025.

A central policy priority this year has been promoting site-neutral payments. Holton notes growing recognition in Congress and the Centers for Medicare & Medicaid Services (CMS) that independent practices often deliver care at lower cost than hospital outpatient departments. CMS’s recent equalization of J-code reimbursement for drug administration marks an incremental but meaningful step toward broader site-neutrality efforts aimed at supporting Medicare’s long-term solvency.

Telehealth remains essential for follow-up care and rural access, yet long-term stability requires a permanent legislative fix. Holton stresses that sustainable telehealth reimbursement must acknowledge the infrastructure investments required and maintain parity with in-person payment.

She also underscores persistent coverage disparities in advanced diagnostic testing, such as molecular and PCR-based urinary tract infection (UTI) diagnostics and genomic prostate cancer assays. Advocacy is needed to align payers with evolving evidence and ensure consistent nationwide access. Prostate-specific antigen (PSA) screening policy continues to challenge early detection, with regional variations in coverage and slow CMS adaptation to new testing technologies.

Access to advanced prostate cancer therapies—especially oral oncolytics—remains constrained by restrictions on mailing medications from in-office dispensaries, creating burdens for rural patients. Holton emphasizes urgent reform to preserve timely, affordable treatment in community settings.

Finally, effective advocacy requires stronger collaboration among physicians, industry, and patient groups. CMS’s proposed 2026 Hospital Outpatient Prospective Payment System (OPPS) rule, eliminating the inpatient-only list and expanding ambulatory surgical center (ASC)-eligible procedures, reflects a shift toward delivering equivalent care in lower-cost settings—a trend Holton views as both timely and essential. Holton is the founder and director of the Women’s Wellness Center at Anne Arundel Urology, is chair of LUGPA’s Health Policy Committee, and serves on the LUGPA Board of Directors.

Could you briefly summarize some of the key policy and advocacy wins for LUGPA in 2025?

2025 was certainly an interesting year for LUGPA, particularly with the administration change. There has been tremendous movement in all the regulatory agencies, and a lot of uncertainty. LUGPA has remained very active legislatively over the past year. We’ve also engaged with the new department heads that are most pertinent to us, such as Medicare and CMS. As far as policy wins, the single biggest win, which I would attribute to Representative [Greg] Murphy[, MD], from North Carolina, [is the roughly] 2.5% increase to the conversion factor that all physicians receive across the board for the physician fee schedule. We've had tremendous legislative momentum this year, with LUGPA’s advocacy resulting in a very successful IOD [in-office dispensing] bill, which passed the House and was advanced to the Senate. It did not go beyond the Senate because of specific Senate Finance Committee issues but is continuing to be worked on, and there is a letter circulating. I would put that in the “big wins” category.

Additionally, as it pertains to pharmacy benefit manager reform as well as 340B, we've seen bipartisan, bicameral support for those initiatives, and LUGPA has been at the forefront of many of those initiatives and continues to be a valuable asset to Congress as they consider how to do those. There is a 340B study underway this year, and we are very hopeful that we may see some PBM transparency legislation by the end of 2025. We're getting there.

There's ongoing debate around site-neutral payments and flexibility and reimbursement across care settings. How do these policies affect patient access and the viability of independent urology practices compared with hospital-owned groups?

Site neutrality is a pivotal issue for all independent practices, and really, it's a pivotal issue for all Americans because it affects both the global cost of care as well as the acceleration and the cost of care. There is broad recognition—again, I would say at least partially due to LUPGA and other independent organizations’ efforts to educate Congress—about the fact that in the case of equivalent delivery of care, an independent practice is almost always a lower cost setting. That does not mean that all care should or can be delivered in an independent setting. But when those are equivalent sites of care, generally speaking, that will be the lower-cost site of delivery. Excitingly, this year, in the Medicare Physician Fee Schedule, this issue was specifically addressed with J-code reimbursement for drug administration. They equilibrated this across sites, essentially identifying that the resources needed to administer drugs in a hospital or an HOPD [hospital outpatient department] setting vs those in an independent setting were equivalent. You're talking about IV tubing and IV equipment, not an IV pole. Those don't all cost massively more in a hospital setting, so although this is a baby step toward site neutrality, the regulators also indicated their interest in other site-neutral initiatives. There is significant interest and broad recognition that site neutrality is a massive opportunity to give Medicare some solvency into the future. Absent this, there is a lot of pessimism that Medicare will be able to pay the bills going forward.

Telehealth has become a vital component of urologic care, especially for follow up and patients in rural areas. How do current reimbursement policies support or limit telehealth and urology, and what changes are needed to make telehealth a sustainable part of care delivery?

We need a definitive legislative fix for telehealth that exists beyond continuing resolutions. Physicians’ offices need to know year to year that they will continue to be able to deliver telehealth with the flexibilities that CMS and Congress have defined at this point statutorily. We need a statute fix. As far as reimbursement goes, we need a formalized recognition that delivery of telehealth services requires infrastructure, which, although different from that in person, is nonetheless capital intensive, including HIPAA-[compliant] phone systems, remote monitoring systems, and that reimbursement needs to remain, at the very least, on par with in-person reimbursement. We need stronger governance and guidance about that.

Advanced molecular and PCR testing for UTIs has shown clinical utility but faces reimbursement and coverage challenges. What role should advocacy pay play in aligning payers and policy makers with the clinical evidence supporting these tests?

This is a really important issue, both as it pertains to prostate cancer testing, UTI testing and testing as it advances. There is certainly a balance between novel testing being perhaps over utilized, and the advantages that novel testing can [bring] to patients. What I am concerned about, in particular as it pertains to UTI and PCR testing, is that there are significant disparities in coverage across the country, such that patients in one region are able to avail themselves of a clinically effective, very valuable technology, and perhaps in other regions are not. The goal, particularly for Medicare, is that there be equivalent access to care across geographic regions. As far as advocacy, it is always important that we remain available and conscientious in educating the perhaps slower-to-adapt government infrastructure to the value that these new tests are bringing to our patients on the front lines. I really think of independent practices as the incubators for innovation, and that can be done on a very small scale. It's a small ship, and you can turn it quickly. I think that patients really see the benefit of that as far as efficacy and expediency, as well as cost control. We are responsible for educating legislators both at the state and federal level, as well as regulators at the state and federal level, about how we're deploying these tests to the betterment of our patients in our practices, and obviously globally, as an organization, LUPGA advocacy seeks to do that.

PSA testing remains a cornerstone of early prostate cancer detection but continues to face shifting policy and coverage dynamics. What’s needed to ensure that evidence-based screening remains accessible and reimbursed appropriately?

First of all, within the urologic community, there is large consensus that the PSA guidelines, as they were changed by the USPSTF, were inadequate and that unfortunately, we've seen increased incidence in presentation of advanced prostate cancer as a result of this. As it pertains to PSA, there have been efforts at many state levels to ensure that there are protections for men for this type of testing, which I hope at least make it equivalent in its recognition of importance as perhaps mammography for women. As far as advanced genetic testing for prostate cancer, this gets us right back to that innovative, novel, impactful level of advanced testing and payment disparities across regions where one patient in one location may be able to get a customized cancer therapy based on molecular testing, and a patient in another region may not. I have serious concerns about the ability of CMS to adapt to testing as quickly as it's happening to ensure that patients can get these lifesaving, life-extending tests, which affect the delivery of, in particular, chemotherapy, as well as some hormonal therapies.

Access to advanced prostate cancer therapies under Medicare Parts B and D remains a concern, particularly for oral oncolytics. What reforms or advocacy efforts do you think are most urgent to ensure patients can receive timely and affordable treatment?

As I [touched on earlier], in-office dispensing is a crisis. Rural health care is a crisis, and that's not news to anyone who's been involved in health care in the past several years. Independent practices form a critical or provide a critical service to patients in the community in the access of these advanced, life extending, lifesaving modalities that can be safely delivered in those settings. Now that we have gone to in-office dispensing being precluded from mailing or delivering patients their medications, patients are forced to travel to and from physicians’ offices to receive these prescriptions. These are patients who are being seen quite frequently anyway, but who may be coming several hours, requiring cost and logistics associated with that. It is 100% the goal of the LUGPA community to ensure that patients who are receiving comprehensive care for their advanced disease in an outpatient setting can continue to do so in a way that is accessible, efficient, and affordable.

Advocacy in health policy often requires alignment between physicians, industry, and patient advocacy groups. What does effective collaboration look like in urology?

I have been galvanized by the pharmaceutical industry in the past 5 years or so with the advent of the newest modalities, in particular APC [advanced prostate cancer], but also for bladder cancer. Pharma has really taken a lead in educating. Although I recognize that this is not a totally altruistic interest, as care becomes more complicated, as care becomes more effective, this is more critical than ever in the community. The average urologist is probably 55+. He or she may have almost no familiarity with this in the community, and so those are our frontline people to make sure that patients who are not perhaps interfacing with a large hospital system are aware of the most up-to-date treatments. I would say pharma interfacing on an educational basis with LUGPA and LUGPA-type practices is really a tremendous benefit to both of us.

As far as patient organizations, I think there are challenges there. I don't think that physician groups and community or public advocacy groups have historically interfaced terribly effectively. I do think that there's a lot of work to be done there to ensure that we promote our patients’ interests at the legislative level, because I think that we're both doing advocacy alongside each other, and I would really hope that we can bring those 2 messages in together and deliver them in tandem more.

What are the key takeaways for urologists from the 2026 OPPS proposed rule?

The CMS OPPS rule, as proposed, [would] eliminate the inpatient-only list. The inpatient-only list is an anachronism of a time when the kind of advanced procedures we're doing now in an outpatient setting couldn't be done. I was thrilled to see that go, and then hand in glove with that is the covered procedure list, expanding the kinds of procedures that are covered in an ASC outpatient setting. Those are 2 things in the OPPS that indicate that CMS is identifying that we really do want to migrate procedures into the lowest-cost sites of service for equivalent care.