Health Policy and Payment Update

• HHS announced that drug companies will begin removing certain Black Box warning labels from hormone replacement therapy (HRT) products for use in menopause.
• The Centers for Medicare and Medicaid Services (CMS) released more information about upcoming new prior authorization requirements in fee-for-service (FFS) Medicare, known as the WISeR model, which AUGS members should prepare for.
• CMS finalized the calendar year (CY) 2026 Medicare Physician Fee Schedule (PFS), with one modification AUGS advocated for.
• The federal government shutdown ended, and there are implications for Medicare telehealth claims.
• AUGS members should consider joining the AUGS Advocacy Network to amplify our priorities.

HHS Announced Removal of Black Box Warnings on HRT Products

What this means for you: Label change will increase access to hormone therapy and decrease barriers to use of low-dose vaginal estrogen.

HHS announced that the FDA is initiating the removal of certain Black Box warnings on HRT products for use in menopause. The agency stated that the application of warnings, following the Women's Health Initiative study, has decreased women's use of HRT products for treatment of menopausal symptoms. Over the next several months, companies offering HRT products for menopause will begin removing Black Box language referencing risks of cardiovascular disease, breast cancer, and probable dementia, but warnings for endometrial cancer for systemic estrogen-alone products will remain. The FDA is also recommending that women start HRT within 10 years of menopause onset or before 60 years of age for systemic HRT.

AUGS submitted comments supporting the modification of Black Box warnings for low-dose topical vaginal estrogen products stating:

"Low-dose topical vaginal estrogen therapies are safe and effective treatments for genitourinary syndrome of menopause, recurrent urinary tract infections, and other gynecologic conditions. The current Black Box warning misrepresents the risk profile of these products by attributing adverse effects to these medications when such risks have not been substantiated in formulations with minimal systemic absorption."

Links of Interest:

• FDA literature review and expert panel
• FDA stakeholder call (recording available here); several AUGS leaders, including AUGS President Dr. Ferzandi, were in attendance.

AUGS Members Should Prepare for Prior Authorization in FFS Medicare for Select Items and Services

What this means for you: Starting January 2026, AUGS members in Arizona, New Jersey, Ohio, Oklahoma, Texas, and Washington should be prepared to submit prior authorization requests, or face pre-payment review, for selected FFS Medicare items and services.

Announced in June 2025, the Wasteful and Inappropriate Services Reduction (WISeR) model partners CMS with third-party technology vendors that have experience using artificial intelligence, machine learning, and automated decision logic to manage prior authorization processes for other payers, including Medicare Advantage plans. At launch, the model applies only to claims for selected items/services submitted by providers in the six states above.

For AUGS members, the services most relevant under the WISeR Model include:

• Incontinence control devices (excluding collagen bulking) - NCD 230.10
• Sacral nerve stimulation for urinary incontinence - NCD 230.18

CMS released an operational guide specifying services subject to prior authorization (HCPCS/CPT details in appendices A-C) and the required documentation. Review these materials now to prepare for January 2026, and watch for additional guidance from CMS, participating vendors, and your MAC.

CMS Finalized CY 2026 Medicare Physician Payment Policies

What this means for you: While CMS adopted a suggestion by AUGS, CMS also finalized policies that will harm physician practices. AUGS will continue to work with similarly aligned stakeholders to assess next steps and continue our ongoing advocacy to improve Medicare physician payment stability.

On October 31, CMS released the CY 2026 Medicare PFS final rule. Below are some key finalized policies and how they compare with AUGS' comments.

• Conversion Factor (CF): CMS finalized a +3.77% CF increase for advanced alternative payment model (APM) participants and 3.26% for other clinicians, reflecting: an annual statutory update (+0.75% APM / +0.25% non-APM) provided under MACRA, a one-time +2.5% add-on from the One Big Beautiful Bill Act, and a +0.49% budget-neutrality adjustment tied to efficiency adjustment savings. While welcome, the bump leans heavily on the one-time 2.5% add-on. Absent Congressional relief for 2027, the CF reverts toward MACRA's modest base updates. AUGS will continue urging CMS and Congress to secure permanent, meaningful CF updates, modernize budget neutrality, and ensure a stable, predictable payment system.
• Efficiency Adjustment: CMS finalized a policy that will reduce work RVUs by 2.5% in CY 2026 and additional amounts every three years thereafter. This "efficiency adjustment" impacts most surgical and procedural specialties by reducing their overall payments. AUGS strongly opposed this approach, which is based on flawed assumptions about efficiency and physician work. We will continue urging lawmakers in Congress to stop this harmful policy from taking effect on January 1.  
• Practice Expense (PE) Methodology: CMS finalized a change that cuts the indirect PE allocated to facility-based services to 50% of the amount allocated to non-facility (office) services. The agency's aim is to curb what it views as duplicative payment when services are furnished in hospitals or ASCs. This is one of the most significant changes to the PFS methodology in over 20 years and will shift PE-related spending from facility settings to office-based care. AUGS strongly opposed the change, noting that urogynecologists still carry meaningful overhead, even when working in a facility.  
• Teaching Physician Virtual: In the proposed rule, CMS would have limited the permanent virtual-presence policy to resident telehealth services in rural (non-MSA) sites only. AUGS opposed this, urging CMS to keep virtual supervision available in all training locations to support women's health workforce development. In the final rule, CMS reversed course: starting January 1, 2026, teaching physicians may use real-time two-way audio/video to meet the presence requirement for resident-furnished Medicare telehealth visits in any location (i.e., three-way telehealth with the patient, resident, and teaching physician in separate locations). This preserves flexible subspecialty supervision for consults, post-op follow-ups, and complex pelvic floor disorder management across systems with multiple locations and is an important win for urogynecology training and patient access.

Read more from our McDermott+ consultants here.

Federal Government Shutdown Ends

What this means for you: Due to the shutdown, the NIH did not review grant applications, and Medicare telehealth flexibilities expired, both of which continue to have implications for AUGS members. AUGS will update members with developments.

The federal government shutdown, from October 1 - November 12, was the longest lasting shutdown. At the core of the debate was the looming expiration of the enhanced advanced premium tax credits (APTCs) for the Affordable Care Act Marketplace.

Along with the government shutdown, a FFS Medicare policy allowing patients to receive non-behavioral health telehealth in their home and outside of rural areas expired on September 30. CMS issued guidance multiple times during the lapse in authority, including providing an update on November 6 that MACs would return all held telehealth claims to providers and providers should not submit claims for unallowable telehealth services until the government shutdown ends. After the end of the shutdown, on November 20, CMS issued FAQs and provided an update on Medicare telehealth flexibilities noting that telehealth flexibilities will now expire January 30, 2026, in line with the government funding package. Additionally, the package retroactively restored telehealth flexibilities to October 1, 2025 when they first lapsed. With this update, providers may resubmit returned claims to CMS, as well as submit any other telehealth claims held in anticipation of possible Congressional action. Clinicians are also encouraged to identify which beneficiaries were charged for telehealth services with dates of service on or after October 1, 2025, that are retroactively payable and instead submit claims to Medicare, refunding any overpayment to beneficiaries.

Without congressional funding, the NIH stated that no new grants would be reviewed or awarded during the shutdown. The agency stated that awards granted prior to the shutdown would be able to draw down funding, and that all pending awards would be sent once the shutdown ended. The NIH also did not conduct its October review cycle. AUGS members who submitted grant applications during the shutdown should consider resubmitting them.

Join the AUGS Urogyn Advocacy Network

AUGS members should consider signing up for the Urogyn Advocacy Network, which is open to all AUGS members with an interest in supporting AUGS advocacy efforts. Members can sign up and/or remove themselves at any time. By signing up, you'll stay connected to timely opportunities where your voice can make a real difference-whether that's contacting legislators, participating in virtual or in person Hill Days, or lending your expertise to specific advocacy efforts.

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