Comments to CMS on Quality Measures and ADAP 340B Calculation in the CY2027 Physician Fee Schedule
Administrator
Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
7500 Security Boulevard
Baltimore MD 21244
Submitted electronically via www.regulations.gov
Re: Comments on CY 2027 Payment Policies under the Medicare Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program (CMS-1848-P)
Dear Administrator Oz:
The HIV+Hepatitis Policy Institute, a leading national policy organization promoting quality and affordable healthcare for people and communities affected by HIV, viral hepatitis, and other serious and chronic health conditions, thanks the Centers for Medicare and Medicaid Services (CMS) for the opportunity to provide comments on the Quality Payment Program (QPP) and the Medicare Prescription Drug Inflation Rebate Program provisions of the CY 2027 Physician Fee Schedule (PFS) proposed rule.
HIV Quality Measures
Quality measurement in HIV care is a critical way to improve outcomes across the healthcare system and support efforts to bring the HIV epidemic to an end. We support CMS’s continued commitment to this area and encourage the agency to sustain and build on this focus in the future. Specifically, we support the following proposals:
- Expanding HIV measures across additional specialties. We support CMS’s proposal to expand the HIV Viral Suppression (Q338) and STI Testing for People with HIV (Q205) measures into the Obstetrics/Gynecology and Preventive Medicine specialty measure sets, as well as the proposed expanded availability of HIV-related measures into the Family and Internal Medicine specialty measure sets. HIV care takes place in a wide range of settings outside infectious disease specialty practices, and these changes recognize the important role primary care and women’s health clinicians can play. Making these measures available in more settings will help ensure that HIV quality is assessed wherever it happens.
- HIV-focused MIPS core measure designations. We support CMS’s proposal to designate Q205 and Q338 as core measures within the “Prevention and Treatment of Infectious Disorders Including Hepatitis C and HIV” MVP. Core measure designation recognizes viral suppression and STI testing as priorities within the MVP most relevant to HIV care and underscores that achieving them is central to high-quality care for people with HIV.
- Continuing the HIV Prevention Improvement Activity. We support CMS’s retention of the “Improving Practice Capacity for HIV Prevention Services” Improvement Activity. This activity promotes evidence-based HIV prevention practices and linkage to care, and its continuation helps to ensure that HIV prevention is an integral part of quality improvement efforts alongside treatment and care.
We urge CMS to improve the HIV screening quality measure in the following ways:
- Designating the HIV screening measure as a core measure within MIPS. We urge CMS to designate the HIV screening measure as a core measure within the Value in Primary Care MVP. Increasing HIV screenings in primary care helps to normalize routine testing and strengthens performance in the settings where most patients encounter the health system and supports national and local efforts to end the HIV epidemic. Screening is the entry point into the entire HIV prevention and care continuum, and giving it core measure status would align incentives with that reality.
- Ensuring that HIV measures reflect current clinical guidelines. We recommend that the HIV screening measure be updated to align with current CDC recommendations and other broadly accepted clinical guidelines, including routine testing at least once for everyone above age 13 and repeat screenings every 3-6 months for those at increased risk. Ensuring that the measure is always aligned with the most recent recommendation incentivizes clinicians to provide testing consistent with the standard of care to the patients who need it the most.
CMS Should Close the Gap for Viral Hepatitis
We appreciate CMS’s proposal to designate Hepatitis C Virus: Sustained Virological Response (Q516) as a core measure within the “Prevention and Treatment of Infectious Disorders Including Hepatitis C and HIV” MVP alongside the proposed HIV-related core measures. We encourage CMS to consider extending core measure recognition to quality measures for other parts of the hepatitis C care continuum, including screening, linkage to care, and treatment initiation. An outcome measure like SVR only recognizes patients who have been diagnosed and started on treatment and does not incentivize screening to identify people who don’t know their HCV status.
We also ask CMS to consider extending comparable recognition to hepatitis B. The only quality measure in the MIPS inventory (Q275) checks HBV status prior to beginning therapy for inflammatory bowel disease, a narrow safety screening within an unrelated therapeutic context. We urge CMS to prioritize the development of quality measures that reflect hepatitis B’s own care continuum, including screening, linkage to care, and treatment.
As we have noted in prior comments to HHS on the importance of viral hepatitis quality measures in Medicaid, CDC estimates that close to half of all people estimated to be living with hepatitis B or C are unaware of their status, which is why CDC now recommends universal screening for HBV and HCV alongside HIV.[1] Without diagnosis, these diseases often progress silently over decades, with far too many people presenting to care only after developing cirrhosis, liver cancer, or the need for a liver transplant. Quality improvement measures that recognize screening, linkage to care, and treatment are essential to catching people earlier in that progression across the health system and save lives as well as lifetime medical costs often borne by public programs.
AIDS Drug Assistance Program (ADAP) 340B Claims
The Inflation Reduction Act requires drug manufacturers to pay Medicare Part D inflation rebates when drug prices rise faster than inflation, but medications purchased through the 340B Program must be excluded from that calculation. Because state AIDS Drug Assistance Programs rely heavily on 340B pricing and rebates to sustain access to antiretroviral therapy for their low-income clients, it is important to accurately exclude ADAP 340B claims from the inflation rebate calculation. Doing so requires a dedicated methodology to identify or estimate ADAP 340B claims, one that necessarily diverges from the prescriber- and pharmacy-based methodology CMS finalized in the CY 2026 PFS final rule, since ADAPs do not fit that model.
State AIDS Drug Assistance Programs (ADAPs) are payers, and as such are fundamentally different from other 340B Covered Entities, such as hospitals and clinics, which prescribe 340B drugs directly, dispensed through contract pharmacies. This distinction means ADAP 340B claims cannot be identified or treated the same way as those of other covered entities.
We support CMS’ updated proposal to account for ADAP 340B claims in the Medicare Part D inflation rebate calculation. The accurate identification of these claims ensures that inflation rebates required by the Inflation Reduction Act reflect true net drug costs.
For the same reason, we urge CMS to confirm that ADAPs will not be required to submit 340B claims data to a repository. If CMS determines that such submission is necessary, we ask that CMS ensure that ADAPs are afforded flexibility with regards to submission timelines and required data elements that ADAPs, unlike other covered entities, may have difficulty providing.
If you have any questions, comments, or would like to discuss these issues further, please contact Carl Schmid, Executive Director, HIV+Hepatitis Policy Institute, at cschmid@hivhep.org or (202) 462-3042; or Kevin Herwig, Health Policy Director, HIV+Hepatitis Policy Institute, at kherwig@hivhep.org or (617) 666-6634.
Sincerely,
Carl E. Schmid, II
Executive Director
cc: Heather Hauck, MSW, LICSW, Associate Administrator, HRSA HIV/AIDS Bureau
Robyn Neblett Fanfair, MD, MPH, Director, Division of HIV Prevention, CDC NCHHSTP
Carolyn Wester, MD, MPH, Director, Division of Viral Hepatitis, CDC NCHHSTP
[1] https://hivhep.org/testimony-comments-letters/public-comments-on-potential-viral-hepatitis-quality-measures-in-medicaid/