Comment on Proposed Measures for the 2025 Measure Set Review (MSR) Cycle

June 26, 2025

Nicole Brennan, MPH, DrPH

Executive Director

Partnership for Quality Measurement

submitted via https://p4qm.org/2025-MSR-Cycle-Proposed-Measure-Comments

Re: 2025 Measure Set Review Cycle - (00058-01-C-MIPS) Annual Hepatitis C Virus (HCV) Screening for Patients who are Active Injection Drug Users; (00319-01-C-MIPS) Hepatitis C: Screening for Hepatocellular Carcinoma (HCC) in Patients with Cirrhosis; and (00385-01-C-MIPS) Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy.

Dear Dr. Brennan,

We would like to thank Battelle and the Partnership for Quality Measurement for its ongoing engagement with stakeholders towards an informed and thoughtful quality measure review process.

The American Gastroenterological Association (AGA) represents and supports approximately 16,000 providers and requests the following measures:  (00058-01-C-MIPS) Annual Hepatitis C Virus (HCV) Screening for Patients who are Active Injection Drug Users (QID 387); (00319-01-C-MIPS) Hepatitis C: Screening for Hepatocellular Carcinoma (HCC) in Patients with Cirrhosis (QID 401); and (00385-01-C-MIPS) Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy (QID 275) remain in the Quality Payment Program (QPP) as these measures continue to promote high value care for gastroenterologists and other specialties. These are a few measures that specifically address patient safety among high-risk populations. 

(00058-01-C-MIPS) Annual Hepatitis C Virus (HCV) Screening for Patients who are Active Injection Drug Users (QID 387)

The goal of QID 387 is to improve HCV screening rates among patients who are at high risk of contracting HCV as compared to the general population.  Unlike the general population that is recommended for one-time screening as outlined in QID 400 - One-Time Screening for Hepatitis C Virus (HCV) and Treatment Initiation, QID 387 ensures that patients who have ongoing IV drug use have annual HCV screening due to their ongoing exposure to contracting this virus.  Of the estimated 3.5 million people living in the United States with HCV, only 49-75% have been tested for HCV and are aware of their status[1]. Reported cases of HCV have increased (approximately 20% per year) between 2010 - 2016 which is partially due to improved case detection and more likely due to rising rates of injection drug use[2]^,[3],[4]. Additionally, only one third have been referred for HCV care and only 5.6% receive recommended treatment. HCV is highly prevalent among patients with IV drug use and individuals with early-stage HCV often have no symptoms. In a recent analysis of data from a national health survey, 67.9% of persons ever infected with HCV reported an exposure risk (e.g., injection drug use, having sexual contact with suspected/confirmed HCV+ patient), 2 weeks to 6 months prior to symptom onset, and the remaining 32.1% reported no known exposure risk.[5]^,[6] Current testing strategies have had limited success, as evidenced by the substantial number of HCV-infected persons who remain unaware of their HCV status and this measure intends to improve this success rate. Hepatitis C, if left untreated, leads to poor outcomes including the development of chronic liver disease (cirrhosis), liver cancer (hepatocellular carcinoma), and deaths, along with high rates of transmission to others that could have been otherwise preventable. 

(00319-01-C-MIPS) Hepatitis C: Screening for Hepatocellular Carcinoma (HCC) in Patients with Cirrhosis (QID 401)

The goal of QID 401 is to prevent liver cancer related mortality among HCV patients through regular HCC screening intervals. HCC is a primary tumor of the liver and constitutes more than 90% of liver tumors. HCC occurs in approximately 85% of patients diagnosed with cirrhosis[7] and HCC is now the fifth most common cause of cancer worldwide.[8]  A recent study found that being up to date with screening for at least 50% of time during the 4 years preceding HCC diagnosis was associated with improved overall survival (log-rank test of equality over strata P = 0.002). In multivariate analysis, each 10% increase in follow-up time consistent with up to date with screening was associated with a 3.2% decrease in the hazard of death (hazard ratio, 0.97; 95% CI, 0.95-0.99).  And each 10% of time spent up to date with screening was associated with a 10.1% increased likelihood of diagnosis with early-stage HCC (95% CI, 6.3%-14.0%) and a 6.8% increased likelihood of curative treatment (95% CI, 2.8%-11.0%).[9]^,[10]   This measure ensures that patients with HCV related cirrhosis are screened for HCC at regular intervals to reduce liver cancer mortality among this high risk population. Importantly, this measure is directly reflective of the guidelines by the American Association for the Study of Liver Diseases (AASLD), which emphasizes the evidence and best-practice behind this critical measure[11].

(00385-01-C-MIPS) Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy (QID 275)

The goal of QID 275 is to reduce patient safety risks before initiating biologic anti-TNF therapy for patients with IBD and is the only measure specific to IBD patients available in the QPP. It is essential to screen the patient for HBV, as research has documented reactivation of HBV after initiation of anti-TNF therapy.  Tumor necrosis factor (TNF) alpha antagonists are potent immunosuppressive drugs that are first-line treatments for many autoimmune diseases, including IBD. Because TNF-alpha plays an important role in the host defense against many infections, patients treated with anti-TNFs are at higher risk for severe infections and reactivation of chronic infections, including HBV. A recent study involving a cohort of 8,887 patients found a HBV reactivation rate of 39%  underscoring the importance of screening for HBV before initiating anti-TNF therapy.[12]  This measure ensures that patients do not have unintended consequences of activated HBV after starting ant-TNF therapy and reactivation of HBV in the setting of immunosuppression in IBD can lead to acute liver failure and increased mortality rate

Core Quality Measures Collaborative (CQMC) Gastroenterology & HIV/HCV Measures Sets

QID 387, QID 401 and QID 275 are included in the updated 2025 Core Quality Measures Collaborative (CQMC) Gastroenterology (GI) Measures Set, QID 401 is included in the HIV/HCV measure set and QID 387 has been recommended to be included in this measure set.  The measures included in these measure sets involved input and direction from the Partnership for Quality Measurement (PQM) and Centers for Medicare & Medicaid Services (CMS). All three measures were voted by the collaborative to continue in the GI Measures Set for 2025[13]^,[14].

The CQMC was initially created in 2015 as a “broad-based coalition of healthcare leaders working to facilitate cross-payer measure alignment through the development of core sets of measures to assess the quality of healthcare in the United States” with the aims of:

• Identifying high-value, high-impact, evidence-based measures that promote better patient outcomes, and provide useful information for improvement, decision-making and payment.
• Aligning measures across public and private payers to achieve congruence in the measures being used for quality improvement, transparency, and payment purposes.
• Reducing the burden of measurement by eliminating low-value metrics, redundancies, and inconsistencies in measure specifications and quality measure reporting requirements across payers. (https://p4qm.org/CQMC)

The CQMC has described maintenance process considerations to include measures that no longer have an opportunity for improvement, no longer align with clinical guidelines, or have implementation challenges. None of these scenarios apply to these measures.

Since the initial development of the GI Measures Set, QID 401 and QID 275 was determined by multiple stakeholders, including CMS, commercial payers, and other experts, to be of high value and important to drive improvement in priority areas. QID 401 has been in the HIV/HCV measure set since initial development and in 2025, QID 387 was voted to be added to the GI measure set following a full collaborative vote in early 2025. Removal of these measures does not align with expert consensus and multi-stakeholder input.

MVP ID: M1422: Gastroenterology Care MIPS Value Pathway (MVP)

QID 401 and QID 275 are included in the 2025 Gastroenterology Care MIPS Value Pathway (MVP ID: M1422)[15].  Due to the limited number of gastroenterology specific quality measures available in the QPP, any reduction in measures will significantly impact our specialty’s ability to participate in MIPS in both traditional MIPS and MVP reporting mechanisms.

AGA strongly encourages Battelle and the Partnership for Quality Measurement to exclude (00058-01-C-MIPS) Annual Hepatitis C Virus (HCV) Screening for Patients who are Active Injection Drug Users; (00319-01-C-MIPS) Hepatitis C: Screening for Hepatocellular Carcinoma (HCC) in Patients with Cirrhosis; and (00385-01-C-MIPS) Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy from the 2025 Measure Set Review Cycle as they continue to be meaningful and feasible measures that have been vetted by multiple stakeholders for inclusion in a variety of national reporting programs, are designed specifically for clinicians providing treatment for digestive and liver related conditions and are three of 7 gastroenterology-specific measures available in MIPS outside of a Qualified Clinical Data Registry (QCDR). Removal of these measures would significantly impact gastroenterologists’ ability to meaningfully participate in the MIPS program.

We appreciate the opportunity to provide comments on the 2025 MSR Cycle. If you have any questions about our feedback or if we may provide any additional information, please contact  Kathleen Teixeira, at AGA ([email protected]).

Sincerely,

Lawrence Kim, MD, AGAF

President, American Gastroenterological Association

[1] Yehia BR, Schranz AJ, Umscheid CA, Lo Re V 3rd. The treatment cascade for chronic hepatitis C virus infection in the United States: a systematic review and meta-analysis. PLoS One. 2014 Jul 2;9(7):e101554. doi: 10.1371/journal.pone.0101554. PMID: 24988388; PMCID: PMC4079454.

[2] Park D, Oh S, Cano M, Salas-Wright CP, Vaughn MG. Trends and distinct profiles of persons who inject drugs in the United States, 2015-2019. Prev Med. 2022 Nov;164:107289. doi: 10.1016/j.ypmed.2022.107289. Epub 2022 Oct 6. PMID: 36209817.

[3] Marks LR, Nolan NS, Liang SY, Durkin MJ, Weimer MB. Infectious Complications of Injection Drug Use. Med Clin North Am. 2022 Jan;106(1):187-200. doi: 10.1016/j.mcna.2021.08.006. PMID: 34823730.

[4] Hall EW, Rosenberg ES, Jones CM, Asher A, Valverde E, Bradley H. Estimated number of injection-involved drug overdose deaths, United States, 2000 - 2018. Drug Alcohol Depend. 2022 May 1;234:109428. doi: 10.1016/j.drugalcdep.2022.109428. Epub 2022 Mar 26. PMID: 35364419.

[5] Tsang CA, Tonzel J, Symum H, et al. State-Specific Hepatitis C Virus Clearance Cascades — United States, 2013–2022. MMWR Morb Mortal Wkly Rep 2024;73:495–500. DOI: http://dx.doi.org/10.15585/mmwr.mm7321a4

[6] Liu CH, Kao JH. Acute hepatitis C virus infection: clinical update and remaining challenges. Clin Mol Hepatol. 2023 Jul;29(3):623-642. doi: 10.3350/cmh.2022.0349. Epub 2023 Feb 20. PMID: 36800699; PMCID: PMC10366792.

[7] oannou GN, Splan MF, Weiss NS, McDonald GB, Beretta L, Lee SP. Incidence and predictors of hepatocellular carcinoma in patients with cirrhosis. Clin Gastroenterol Hepatol. 2007 Aug;5(8):938-45, 945.e1-4.

[8] Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 01;136(5):E359-86.

[9] Mezzacappa C, Kim NJ, Vutien P, Kaplan DE, Ioannou GN, Taddei TH. Screening for Hepatocellular Carcinoma and Survival in Patients With Cirrhosis After Hepatitis C Virus Cure. JAMA Netw Open. 2024 Jul 1;7(7):e2420963. doi: 10.1001/jamanetworkopen.2024.20963. PMID: 38985470; PMCID: PMC11238019.

[10] Asafo-Agyei KO, Samant H. Hepatocellular Carcinoma. [Updated 2023 Jun 12]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK559177/

[11] Singal, Amit G.1; Llovet, Josep M.2,3,4; Yarchoan, Mark5; Mehta, Neil6; Heimbach, Julie K.7; Dawson, Laura A.8; Jou, Janice H.9; Kulik, Laura M.10; Agopian, Vatche G.11; Marrero, Jorge A.12; Mendiratta-Lala, Mishal13; Brown, Daniel B.14; Rilling, William S.15; Goyal, Lipika16; Wei, Alice C.17; Taddei, Tamar H.18,19. AASLD Practice Guidance on prevention, diagnosis, and treatment of hepatocellular carcinoma. Hepatology 78(6):p 1922-1965, December 2023. | DOI: 10.1097/HEP.0000000000000466

[12] Incidence of Hepatitis B Virus Reactivation and Hepatotoxicity in Patients Receiving Long-term Treatment With Tumor Necrosis Factor Antagonists Pauly, Mary Patricia et al. Clinical Gastroenterology and Hepatology, Volume 16, Issue 12, 1964 - 1973.e1

[13] https://p4qm.org/sites/default/files/2025-05/CQMC-Gastroenterology-Core…

[14] https://p4qm.org/sites/default/files/2025-03/CQMC-HIV-Hepatitis-C-Core-…

[15] https://qpp.cms.gov/mips/explore-mips-value-pathways/2025/M1422

June 26, 2025

Nicole Brennan, MPH, DrPH

Executive Director

Partnership for Quality Measurement

submitted via https://p4qm.org/2025-MSR-Cycle-Proposed-Measure-Comments

Re: 2025 Measure Set Review Cycle - (00058-01-C-MIPS) Annual Hepatitis C Virus (HCV) Screening for Patients who are Active Injection Drug Users; (00319-01-C-MIPS) Hepatitis C: Screening for Hepatocellular Carcinoma (HCC) in Patients with Cirrhosis; and (00385-01-C-MIPS) Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy.

Dear Dr. Brennan,

We would like to thank Battelle and the Partnership for Quality Measurement for its ongoing engagement with stakeholders towards an informed and thoughtful quality measure review process.

The American Gastroenterological Association (AGA) represents and supports approximately 16,000 providers and requests the following measures:  (00058-01-C-MIPS) Annual Hepatitis C Virus (HCV) Screening for Patients who are Active Injection Drug Users (QID 387); (00319-01-C-MIPS) Hepatitis C: Screening for Hepatocellular Carcinoma (HCC) in Patients with Cirrhosis (QID 401); and (00385-01-C-MIPS) Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy (QID 275) remain in the Quality Payment Program (QPP) as these measures continue to promote high value care for gastroenterologists and other specialties. These are a few measures that specifically address patient safety among high-risk populations. 

(00058-01-C-MIPS) Annual Hepatitis C Virus (HCV) Screening for Patients who are Active Injection Drug Users (QID 387)

The goal of QID 387 is to improve HCV screening rates among patients who are at high risk of contracting HCV as compared to the general population.  Unlike the general population that is recommended for one-time screening as outlined in QID 400 - One-Time Screening for Hepatitis C Virus (HCV) and Treatment Initiation, QID 387 ensures that patients who have ongoing IV drug use have annual HCV screening due to their ongoing exposure to contracting this virus.  Of the estimated 3.5 million people living in the United States with HCV, only 49-75% have been tested for HCV and are aware of their status[1]. Reported cases of HCV have increased (approximately 20% per year) between 2010 - 2016 which is partially due to improved case detection and more likely due to rising rates of injection drug use[2]^,[3],[4]. Additionally, only one third have been referred for HCV care and only 5.6% receive recommended treatment. HCV is highly prevalent among patients with IV drug use and individuals with early-stage HCV often have no symptoms. In a recent analysis of data from a national health survey, 67.9% of persons ever infected with HCV reported an exposure risk (e.g., injection drug use, having sexual contact with suspected/confirmed HCV+ patient), 2 weeks to 6 months prior to symptom onset, and the remaining 32.1% reported no known exposure risk.[5]^,[6] Current testing strategies have had limited success, as evidenced by the substantial number of HCV-infected persons who remain unaware of their HCV status and this measure intends to improve this success rate. Hepatitis C, if left untreated, leads to poor outcomes including the development of chronic liver disease (cirrhosis), liver cancer (hepatocellular carcinoma), and deaths, along with high rates of transmission to others that could have been otherwise preventable. 

(00319-01-C-MIPS) Hepatitis C: Screening for Hepatocellular Carcinoma (HCC) in Patients with Cirrhosis (QID 401)

The goal of QID 401 is to prevent liver cancer related mortality among HCV patients through regular HCC screening intervals. HCC is a primary tumor of the liver and constitutes more than 90% of liver tumors. HCC occurs in approximately 85% of patients diagnosed with cirrhosis[7] and HCC is now the fifth most common cause of cancer worldwide.[8]  A recent study found that being up to date with screening for at least 50% of time during the 4 years preceding HCC diagnosis was associated with improved overall survival (log-rank test of equality over strata P = 0.002). In multivariate analysis, each 10% increase in follow-up time consistent with up to date with screening was associated with a 3.2% decrease in the hazard of death (hazard ratio, 0.97; 95% CI, 0.95-0.99).  And each 10% of time spent up to date with screening was associated with a 10.1% increased likelihood of diagnosis with early-stage HCC (95% CI, 6.3%-14.0%) and a 6.8% increased likelihood of curative treatment (95% CI, 2.8%-11.0%).[9]^,[10]   This measure ensures that patients with HCV related cirrhosis are screened for HCC at regular intervals to reduce liver cancer mortality among this high risk population. Importantly, this measure is directly reflective of the guidelines by the American Association for the Study of Liver Diseases (AASLD), which emphasizes the evidence and best-practice behind this critical measure[11].

(00385-01-C-MIPS) Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy (QID 275)

The goal of QID 275 is to reduce patient safety risks before initiating biologic anti-TNF therapy for patients with IBD and is the only measure specific to IBD patients available in the QPP. It is essential to screen the patient for HBV, as research has documented reactivation of HBV after initiation of anti-TNF therapy.  Tumor necrosis factor (TNF) alpha antagonists are potent immunosuppressive drugs that are first-line treatments for many autoimmune diseases, including IBD. Because TNF-alpha plays an important role in the host defense against many infections, patients treated with anti-TNFs are at higher risk for severe infections and reactivation of chronic infections, including HBV. A recent study involving a cohort of 8,887 patients found a HBV reactivation rate of 39%  underscoring the importance of screening for HBV before initiating anti-TNF therapy.[12]  This measure ensures that patients do not have unintended consequences of activated HBV after starting ant-TNF therapy and reactivation of HBV in the setting of immunosuppression in IBD can lead to acute liver failure and increased mortality rate

Core Quality Measures Collaborative (CQMC) Gastroenterology & HIV/HCV Measures Sets

QID 387, QID 401 and QID 275 are included in the updated 2025 Core Quality Measures Collaborative (CQMC) Gastroenterology (GI) Measures Set, QID 401 is included in the HIV/HCV measure set and QID 387 has been recommended to be included in this measure set.  The measures included in these measure sets involved input and direction from the Partnership for Quality Measurement (PQM) and Centers for Medicare & Medicaid Services (CMS). All three measures were voted by the collaborative to continue in the GI Measures Set for 2025[13]^,[14].

The CQMC was initially created in 2015 as a “broad-based coalition of healthcare leaders working to facilitate cross-payer measure alignment through the development of core sets of measures to assess the quality of healthcare in the United States” with the aims of:

• Identifying high-value, high-impact, evidence-based measures that promote better patient outcomes, and provide useful information for improvement, decision-making and payment.
• Aligning measures across public and private payers to achieve congruence in the measures being used for quality improvement, transparency, and payment purposes.
• Reducing the burden of measurement by eliminating low-value metrics, redundancies, and inconsistencies in measure specifications and quality measure reporting requirements across payers. (https://p4qm.org/CQMC)

The CQMC has described maintenance process considerations to include measures that no longer have an opportunity for improvement, no longer align with clinical guidelines, or have implementation challenges. None of these scenarios apply to these measures.

Since the initial development of the GI Measures Set, QID 401 and QID 275 was determined by multiple stakeholders, including CMS, commercial payers, and other experts, to be of high value and important to drive improvement in priority areas. QID 401 has been in the HIV/HCV measure set since initial development and in 2025, QID 387 was voted to be added to the GI measure set following a full collaborative vote in early 2025. Removal of these measures does not align with expert consensus and multi-stakeholder input.

MVP ID: M1422: Gastroenterology Care MIPS Value Pathway (MVP)

QID 401 and QID 275 are included in the 2025 Gastroenterology Care MIPS Value Pathway (MVP ID: M1422)[15].  Due to the limited number of gastroenterology specific quality measures available in the QPP, any reduction in measures will significantly impact our specialty’s ability to participate in MIPS in both traditional MIPS and MVP reporting mechanisms.

AGA strongly encourages Battelle and the Partnership for Quality Measurement to exclude (00058-01-C-MIPS) Annual Hepatitis C Virus (HCV) Screening for Patients who are Active Injection Drug Users; (00319-01-C-MIPS) Hepatitis C: Screening for Hepatocellular Carcinoma (HCC) in Patients with Cirrhosis; and (00385-01-C-MIPS) Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy from the 2025 Measure Set Review Cycle as they continue to be meaningful and feasible measures that have been vetted by multiple stakeholders for inclusion in a variety of national reporting programs, are designed specifically for clinicians providing treatment for digestive and liver related conditions and are three of 7 gastroenterology-specific measures available in MIPS outside of a Qualified Clinical Data Registry (QCDR). Removal of these measures would significantly impact gastroenterologists’ ability to meaningfully participate in the MIPS program.

We appreciate the opportunity to provide comments on the 2025 MSR Cycle. If you have any questions about our feedback or if we may provide any additional information, please contact  Kathleen Teixeira, at AGA ([email protected]).

Sincerely,

Lawrence Kim, MD, AGAF

President, American Gastroenterological Association

[1] Yehia BR, Schranz AJ, Umscheid CA, Lo Re V 3rd. The treatment cascade for chronic hepatitis C virus infection in the United States: a systematic review and meta-analysis. PLoS One. 2014 Jul 2;9(7):e101554. doi: 10.1371/journal.pone.0101554. PMID: 24988388; PMCID: PMC4079454.

[2] Park D, Oh S, Cano M, Salas-Wright CP, Vaughn MG. Trends and distinct profiles of persons who inject drugs in the United States, 2015-2019. Prev Med. 2022 Nov;164:107289. doi: 10.1016/j.ypmed.2022.107289. Epub 2022 Oct 6. PMID: 36209817.

[3] Marks LR, Nolan NS, Liang SY, Durkin MJ, Weimer MB. Infectious Complications of Injection Drug Use. Med Clin North Am. 2022 Jan;106(1):187-200. doi: 10.1016/j.mcna.2021.08.006. PMID: 34823730.

[4] Hall EW, Rosenberg ES, Jones CM, Asher A, Valverde E, Bradley H. Estimated number of injection-involved drug overdose deaths, United States, 2000 - 2018. Drug Alcohol Depend. 2022 May 1;234:109428. doi: 10.1016/j.drugalcdep.2022.109428. Epub 2022 Mar 26. PMID: 35364419.

[5] Tsang CA, Tonzel J, Symum H, et al. State-Specific Hepatitis C Virus Clearance Cascades — United States, 2013–2022. MMWR Morb Mortal Wkly Rep 2024;73:495–500. DOI: http://dx.doi.org/10.15585/mmwr.mm7321a4

[6] Liu CH, Kao JH. Acute hepatitis C virus infection: clinical update and remaining challenges. Clin Mol Hepatol. 2023 Jul;29(3):623-642. doi: 10.3350/cmh.2022.0349. Epub 2023 Feb 20. PMID: 36800699; PMCID: PMC10366792.

[7] oannou GN, Splan MF, Weiss NS, McDonald GB, Beretta L, Lee SP. Incidence and predictors of hepatocellular carcinoma in patients with cirrhosis. Clin Gastroenterol Hepatol. 2007 Aug;5(8):938-45, 945.e1-4.

[8] Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 01;136(5):E359-86.

[9] Mezzacappa C, Kim NJ, Vutien P, Kaplan DE, Ioannou GN, Taddei TH. Screening for Hepatocellular Carcinoma and Survival in Patients With Cirrhosis After Hepatitis C Virus Cure. JAMA Netw Open. 2024 Jul 1;7(7):e2420963. doi: 10.1001/jamanetworkopen.2024.20963. PMID: 38985470; PMCID: PMC11238019.

[10] Asafo-Agyei KO, Samant H. Hepatocellular Carcinoma. [Updated 2023 Jun 12]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK559177/

[11] Singal, Amit G.1; Llovet, Josep M.2,3,4; Yarchoan, Mark5; Mehta, Neil6; Heimbach, Julie K.7; Dawson, Laura A.8; Jou, Janice H.9; Kulik, Laura M.10; Agopian, Vatche G.11; Marrero, Jorge A.12; Mendiratta-Lala, Mishal13; Brown, Daniel B.14; Rilling, William S.15; Goyal, Lipika16; Wei, Alice C.17; Taddei, Tamar H.18,19. AASLD Practice Guidance on prevention, diagnosis, and treatment of hepatocellular carcinoma. Hepatology 78(6):p 1922-1965, December 2023. | DOI: 10.1097/HEP.0000000000000466

[12] Incidence of Hepatitis B Virus Reactivation and Hepatotoxicity in Patients Receiving Long-term Treatment With Tumor Necrosis Factor Antagonists Pauly, Mary Patricia et al. Clinical Gastroenterology and Hepatology, Volume 16, Issue 12, 1964 - 1973.e1

[13] https://p4qm.org/sites/default/files/2025-05/CQMC-Gastroenterology-Core…

[14] https://p4qm.org/sites/default/files/2025-03/CQMC-HIV-Hepatitis-C-Core-…

[15] https://qpp.cms.gov/mips/explore-mips-value-pathways/2025/M1422

June 26, 2025

Nicole Brennan, MPH, DrPH

Executive Director

Partnership for Quality Measurement

submitted via https://p4qm.org/2025-MSR-Cycle-Proposed-Measure-Comments

Re: 2025 Measure Set Review Cycle - (00058-01-C-MIPS) Annual Hepatitis C Virus (HCV) Screening for Patients who are Active Injection Drug Users; (00319-01-C-MIPS) Hepatitis C: Screening for Hepatocellular Carcinoma (HCC) in Patients with Cirrhosis; and (00385-01-C-MIPS) Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy.

Dear Dr. Brennan,

We would like to thank Battelle and the Partnership for Quality Measurement for its ongoing engagement with stakeholders towards an informed and thoughtful quality measure review process.

The American Gastroenterological Association (AGA) represents and supports approximately 16,000 providers and requests the following measures:  (00058-01-C-MIPS) Annual Hepatitis C Virus (HCV) Screening for Patients who are Active Injection Drug Users (QID 387); (00319-01-C-MIPS) Hepatitis C: Screening for Hepatocellular Carcinoma (HCC) in Patients with Cirrhosis (QID 401); and (00385-01-C-MIPS) Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy (QID 275) remain in the Quality Payment Program (QPP) as these measures continue to promote high value care for gastroenterologists and other specialties. These are a few measures that specifically address patient safety among high-risk populations. 

(00058-01-C-MIPS) Annual Hepatitis C Virus (HCV) Screening for Patients who are Active Injection Drug Users (QID 387)

The goal of QID 387 is to improve HCV screening rates among patients who are at high risk of contracting HCV as compared to the general population.  Unlike the general population that is recommended for one-time screening as outlined in QID 400 - One-Time Screening for Hepatitis C Virus (HCV) and Treatment Initiation, QID 387 ensures that patients who have ongoing IV drug use have annual HCV screening due to their ongoing exposure to contracting this virus.  Of the estimated 3.5 million people living in the United States with HCV, only 49-75% have been tested for HCV and are aware of their status[1]. Reported cases of HCV have increased (approximately 20% per year) between 2010 - 2016 which is partially due to improved case detection and more likely due to rising rates of injection drug use[2]^,[3],[4]. Additionally, only one third have been referred for HCV care and only 5.6% receive recommended treatment. HCV is highly prevalent among patients with IV drug use and individuals with early-stage HCV often have no symptoms. In a recent analysis of data from a national health survey, 67.9% of persons ever infected with HCV reported an exposure risk (e.g., injection drug use, having sexual contact with suspected/confirmed HCV+ patient), 2 weeks to 6 months prior to symptom onset, and the remaining 32.1% reported no known exposure risk.[5]^,[6] Current testing strategies have had limited success, as evidenced by the substantial number of HCV-infected persons who remain unaware of their HCV status and this measure intends to improve this success rate. Hepatitis C, if left untreated, leads to poor outcomes including the development of chronic liver disease (cirrhosis), liver cancer (hepatocellular carcinoma), and deaths, along with high rates of transmission to others that could have been otherwise preventable. 

(00319-01-C-MIPS) Hepatitis C: Screening for Hepatocellular Carcinoma (HCC) in Patients with Cirrhosis (QID 401)

The goal of QID 401 is to prevent liver cancer related mortality among HCV patients through regular HCC screening intervals. HCC is a primary tumor of the liver and constitutes more than 90% of liver tumors. HCC occurs in approximately 85% of patients diagnosed with cirrhosis[7] and HCC is now the fifth most common cause of cancer worldwide.[8]  A recent study found that being up to date with screening for at least 50% of time during the 4 years preceding HCC diagnosis was associated with improved overall survival (log-rank test of equality over strata P = 0.002). In multivariate analysis, each 10% increase in follow-up time consistent with up to date with screening was associated with a 3.2% decrease in the hazard of death (hazard ratio, 0.97; 95% CI, 0.95-0.99).  And each 10% of time spent up to date with screening was associated with a 10.1% increased likelihood of diagnosis with early-stage HCC (95% CI, 6.3%-14.0%) and a 6.8% increased likelihood of curative treatment (95% CI, 2.8%-11.0%).[9]^,[10]   This measure ensures that patients with HCV related cirrhosis are screened for HCC at regular intervals to reduce liver cancer mortality among this high risk population. Importantly, this measure is directly reflective of the guidelines by the American Association for the Study of Liver Diseases (AASLD), which emphasizes the evidence and best-practice behind this critical measure[11].

(00385-01-C-MIPS) Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy (QID 275)

The goal of QID 275 is to reduce patient safety risks before initiating biologic anti-TNF therapy for patients with IBD and is the only measure specific to IBD patients available in the QPP. It is essential to screen the patient for HBV, as research has documented reactivation of HBV after initiation of anti-TNF therapy.  Tumor necrosis factor (TNF) alpha antagonists are potent immunosuppressive drugs that are first-line treatments for many autoimmune diseases, including IBD. Because TNF-alpha plays an important role in the host defense against many infections, patients treated with anti-TNFs are at higher risk for severe infections and reactivation of chronic infections, including HBV. A recent study involving a cohort of 8,887 patients found a HBV reactivation rate of 39%  underscoring the importance of screening for HBV before initiating anti-TNF therapy.[12]  This measure ensures that patients do not have unintended consequences of activated HBV after starting ant-TNF therapy and reactivation of HBV in the setting of immunosuppression in IBD can lead to acute liver failure and increased mortality rate

Core Quality Measures Collaborative (CQMC) Gastroenterology & HIV/HCV Measures Sets

QID 387, QID 401 and QID 275 are included in the updated 2025 Core Quality Measures Collaborative (CQMC) Gastroenterology (GI) Measures Set, QID 401 is included in the HIV/HCV measure set and QID 387 has been recommended to be included in this measure set.  The measures included in these measure sets involved input and direction from the Partnership for Quality Measurement (PQM) and Centers for Medicare & Medicaid Services (CMS). All three measures were voted by the collaborative to continue in the GI Measures Set for 2025[13]^,[14].

The CQMC was initially created in 2015 as a “broad-based coalition of healthcare leaders working to facilitate cross-payer measure alignment through the development of core sets of measures to assess the quality of healthcare in the United States” with the aims of:

• Identifying high-value, high-impact, evidence-based measures that promote better patient outcomes, and provide useful information for improvement, decision-making and payment.
• Aligning measures across public and private payers to achieve congruence in the measures being used for quality improvement, transparency, and payment purposes.
• Reducing the burden of measurement by eliminating low-value metrics, redundancies, and inconsistencies in measure specifications and quality measure reporting requirements across payers. (https://p4qm.org/CQMC)

The CQMC has described maintenance process considerations to include measures that no longer have an opportunity for improvement, no longer align with clinical guidelines, or have implementation challenges. None of these scenarios apply to these measures.

Since the initial development of the GI Measures Set, QID 401 and QID 275 was determined by multiple stakeholders, including CMS, commercial payers, and other experts, to be of high value and important to drive improvement in priority areas. QID 401 has been in the HIV/HCV measure set since initial development and in 2025, QID 387 was voted to be added to the GI measure set following a full collaborative vote in early 2025. Removal of these measures does not align with expert consensus and multi-stakeholder input.

MVP ID: M1422: Gastroenterology Care MIPS Value Pathway (MVP)

QID 401 and QID 275 are included in the 2025 Gastroenterology Care MIPS Value Pathway (MVP ID: M1422)[15].  Due to the limited number of gastroenterology specific quality measures available in the QPP, any reduction in measures will significantly impact our specialty’s ability to participate in MIPS in both traditional MIPS and MVP reporting mechanisms.

AGA strongly encourages Battelle and the Partnership for Quality Measurement to exclude (00058-01-C-MIPS) Annual Hepatitis C Virus (HCV) Screening for Patients who are Active Injection Drug Users; (00319-01-C-MIPS) Hepatitis C: Screening for Hepatocellular Carcinoma (HCC) in Patients with Cirrhosis; and (00385-01-C-MIPS) Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy from the 2025 Measure Set Review Cycle as they continue to be meaningful and feasible measures that have been vetted by multiple stakeholders for inclusion in a variety of national reporting programs, are designed specifically for clinicians providing treatment for digestive and liver related conditions and are three of 7 gastroenterology-specific measures available in MIPS outside of a Qualified Clinical Data Registry (QCDR). Removal of these measures would significantly impact gastroenterologists’ ability to meaningfully participate in the MIPS program.

We appreciate the opportunity to provide comments on the 2025 MSR Cycle. If you have any questions about our feedback or if we may provide any additional information, please contact  Kathleen Teixeira, at AGA ([email protected]).

Sincerely,

Lawrence Kim, MD, AGAF

President, American Gastroenterological Association

[1] Yehia BR, Schranz AJ, Umscheid CA, Lo Re V 3rd. The treatment cascade for chronic hepatitis C virus infection in the United States: a systematic review and meta-analysis. PLoS One. 2014 Jul 2;9(7):e101554. doi: 10.1371/journal.pone.0101554. PMID: 24988388; PMCID: PMC4079454.

[2] Park D, Oh S, Cano M, Salas-Wright CP, Vaughn MG. Trends and distinct profiles of persons who inject drugs in the United States, 2015-2019. Prev Med. 2022 Nov;164:107289. doi: 10.1016/j.ypmed.2022.107289. Epub 2022 Oct 6. PMID: 36209817.

[3] Marks LR, Nolan NS, Liang SY, Durkin MJ, Weimer MB. Infectious Complications of Injection Drug Use. Med Clin North Am. 2022 Jan;106(1):187-200. doi: 10.1016/j.mcna.2021.08.006. PMID: 34823730.

[4] Hall EW, Rosenberg ES, Jones CM, Asher A, Valverde E, Bradley H. Estimated number of injection-involved drug overdose deaths, United States, 2000 - 2018. Drug Alcohol Depend. 2022 May 1;234:109428. doi: 10.1016/j.drugalcdep.2022.109428. Epub 2022 Mar 26. PMID: 35364419.

[5] Tsang CA, Tonzel J, Symum H, et al. State-Specific Hepatitis C Virus Clearance Cascades — United States, 2013–2022. MMWR Morb Mortal Wkly Rep 2024;73:495–500. DOI: http://dx.doi.org/10.15585/mmwr.mm7321a4

[6] Liu CH, Kao JH. Acute hepatitis C virus infection: clinical update and remaining challenges. Clin Mol Hepatol. 2023 Jul;29(3):623-642. doi: 10.3350/cmh.2022.0349. Epub 2023 Feb 20. PMID: 36800699; PMCID: PMC10366792.

[7] oannou GN, Splan MF, Weiss NS, McDonald GB, Beretta L, Lee SP. Incidence and predictors of hepatocellular carcinoma in patients with cirrhosis. Clin Gastroenterol Hepatol. 2007 Aug;5(8):938-45, 945.e1-4.

[8] Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 01;136(5):E359-86.

[9] Mezzacappa C, Kim NJ, Vutien P, Kaplan DE, Ioannou GN, Taddei TH. Screening for Hepatocellular Carcinoma and Survival in Patients With Cirrhosis After Hepatitis C Virus Cure. JAMA Netw Open. 2024 Jul 1;7(7):e2420963. doi: 10.1001/jamanetworkopen.2024.20963. PMID: 38985470; PMCID: PMC11238019.

[10] Asafo-Agyei KO, Samant H. Hepatocellular Carcinoma. [Updated 2023 Jun 12]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK559177/

[11] Singal, Amit G.1; Llovet, Josep M.2,3,4; Yarchoan, Mark5; Mehta, Neil6; Heimbach, Julie K.7; Dawson, Laura A.8; Jou, Janice H.9; Kulik, Laura M.10; Agopian, Vatche G.11; Marrero, Jorge A.12; Mendiratta-Lala, Mishal13; Brown, Daniel B.14; Rilling, William S.15; Goyal, Lipika16; Wei, Alice C.17; Taddei, Tamar H.18,19. AASLD Practice Guidance on prevention, diagnosis, and treatment of hepatocellular carcinoma. Hepatology 78(6):p 1922-1965, December 2023. | DOI: 10.1097/HEP.0000000000000466

[12] Incidence of Hepatitis B Virus Reactivation and Hepatotoxicity in Patients Receiving Long-term Treatment With Tumor Necrosis Factor Antagonists Pauly, Mary Patricia et al. Clinical Gastroenterology and Hepatology, Volume 16, Issue 12, 1964 - 1973.e1

[13] https://p4qm.org/sites/default/files/2025-05/CQMC-Gastroenterology-Core…

[14] https://p4qm.org/sites/default/files/2025-03/CQMC-HIV-Hepatitis-C-Core-…

[15] https://qpp.cms.gov/mips/explore-mips-value-pathways/2025/M1422

ASCO recommends against prioritizing the Plan of Care for Pain and Pain Intensity Quantified Measures in the 2025 MSR cycle.  Consistent with our comments on the 2025 Quality Payment Program (QPP) Proposed Rule, ASCO continues to strongly opposes the removal of 00473-01-C-MIPS Oncology: Medical and Radiation – Plan of Care for Pain from the MIPS Program, and believes the availability of both measures should be maintained in MIPS.  Rather than being duplicative, the Plan of Care for Pain measure is intended to be paired with 00474-07-C-MIPS Oncology: Medical and Radiation – Pain Intensity Quantified.  These measures are intended to be implemented sequentially to achieve a comprehensive clinical quality outcome, with the pain intensity quantified measure confirming that the patient's pain was evaluated, and the plan of care measure validating that a patient care plan for pain was developed based on assessment and pain quantification.  ASCO’s intent is for eligible clinicians to report on both measures as a unit, while maintaining independent performance scores on each measure for quality improvement purposes.

Additionally, both measures were recently re-endorsed by the CMS-certified consensus-based entity, Battelle, as part of its fall 2023 Endorsement and Maintenance cycle.  During the re-endorsement evaluation, ASCO received feedback from the patient/caregiver representatives on Battelle’s Advanced Illness and Post-Acute Care Committee that the Plan of Care for Pain measure is very important.  This sentiment is consistent with a 2022 study evaluating patient and caregiver perspectives on cancer-related quality measures, in which pain management and improvement remained priorities for health system implementation, and patients and caregivers emphasized the importance of routine pain screening, management, and follow-up¹. 

Especially because both the pain intensity quantified and plan of care for pain measures are included as high priority measures in the Advancing Cancer Care MVP, ASCO continues to recommend maintaining the use of both measures in MIPS as we undertake work to develop a patient-reported outcome performance measure (PRO-PM) for cancer-related pain, scheduled to begin in 2025.  We feel it is imperative to maintain the availability of these measures in MIPS to enable assessment of appropriate quantification and care for cancer-related pain, and to maintain stability in measure offerings until a new measure is ready for deployment.

¹ O'Hanlon, C. E., Giannitrapani, K. F., Lindvall, C., Gamboa, R. C., Canning, M., Asch, S. M., Garrido, M. M., ImPACS Patient and Caregiver Panel, Walling, A. M., & Lorenz, K. A. (2022). Patient and Caregiver Prioritization of Palliative and End-of-Life Cancer Care Quality Measures. Journal of General Internal Medicine, 37(6), 1429–1435. https://doi.org/10.1007/s11606-021-07041-8

ASCO recommends against prioritizing the Plan of Care for Pain and Pain Intensity Quantified Measures in the 2025 MSR cycle.  Consistent with our comments on the 2025 Quality Payment Program (QPP) Proposed Rule, ASCO continues to strongly opposes the removal of 00473-01-C-MIPS Oncology: Medical and Radiation – Plan of Care for Pain from the MIPS Program, and believes the availability of both measures should be maintained in MIPS.  Rather than being duplicative, the Plan of Care for Pain measure is intended to be paired with 00474-07-C-MIPS Oncology: Medical and Radiation – Pain Intensity Quantified.  These measures are intended to be implemented sequentially to achieve a comprehensive clinical quality outcome, with the pain intensity quantified measure confirming that the patient's pain was evaluated, and the plan of care measure validating that a patient care plan for pain was developed based on assessment and pain quantification.  ASCO’s intent is for eligible clinicians to report on both measures as a unit, while maintaining independent performance scores on each measure for quality improvement purposes.

Additionally, both measures were recently re-endorsed by the CMS-certified consensus-based entity, Battelle, as part of its fall 2023 Endorsement and Maintenance cycle.  During the re-endorsement evaluation, ASCO received feedback from the patient/caregiver representatives on Battelle’s Advanced Illness and Post-Acute Care Committee that the Plan of Care for Pain measure is very important.  This sentiment is consistent with a 2022 study evaluating patient and caregiver perspectives on cancer-related quality measures, in which pain management and improvement remained priorities for health system implementation, and patients and caregivers emphasized the importance of routine pain screening, management, and follow-up¹. 

Especially because both the pain intensity quantified and plan of care for pain measures are included as high priority measures in the Advancing Cancer Care MVP, ASCO continues to recommend maintaining the use of both measures in MIPS as we undertake work to develop a patient-reported outcome performance measure (PRO-PM) for cancer-related pain, scheduled to begin in 2025.  We feel it is imperative to maintain the availability of these measures in MIPS to enable assessment of appropriate quantification and care for cancer-related pain, and to maintain stability in measure offerings until a new measure is ready for deployment.

¹ O'Hanlon, C. E., Giannitrapani, K. F., Lindvall, C., Gamboa, R. C., Canning, M., Asch, S. M., Garrido, M. M., ImPACS Patient and Caregiver Panel, Walling, A. M., & Lorenz, K. A. (2022). Patient and Caregiver Prioritization of Palliative and End-of-Life Cancer Care Quality Measures. Journal of General Internal Medicine, 37(6), 1429–1435. https://doi.org/10.1007/s11606-021-07041-8

ASCO recommends against prioritizing 00628-01-C-MIPS RAS (KRAS and NRAS) Gene Mutation Testing Performed for Patients with Metastatic Colorectal Cancer who Receive Anti-epidermal Growth Factor Receptor (EGFR) in the 2025 MSR cycle, and believes the measure should be retained in MIPS and the Advancing Cancer Care MVP.  We speculate that this measure does not have a historical benchmark due to a relatively small annual number of newly diagnosed metastatic colorectal cancer patients (estimated at 20 percent of all newly diagnosed colorectal cancers, or some 30,000 patients annually), but we nevertheless continue to believe this is a meaningful measure to assess biomarker concordant care in the era of personalized medicine and precision oncology. 

The Society for Immunotherapy of Cancer (SITC) is providing comment recommending against the inclusion of 01651-01-C-MIPS: Appropriate intervention of immune-related diarrhea and/or colitis in patients treated with immune checkpoint inhibitors in the Measures Set Review (MSR). This measure addresses a critical and growing aspect of cancer patient care, aligns with the needs of the MIPS program, and carries a minimal data burden relative to its potential benefit. 

Critical Need: 

Checkpoint inhibitor therapies continue to be one of the fastest-growing modalities in oncology, including increased use as first-line treatments across multiple disease types. With over 128 immune checkpoint inhibitors (ICIs) approved in the United States¹, the use of these therapies is expanding rapidly, making the proper management of immune related adverse events (irAEs) critically important to patient outcomes. 

As stated within the measure description: 

“The occurrence of diarrhea and colitis can be a normal and treatable toxicity (and is many times not immune-related), but if it is immune-related, it can become life-threatening if not addressed in a timely manner. Diarrhea and colitis are the second-most commonly reported AEs (adverse events) with ICIs (immune checkpoint inhibitors), and symptoms typically develop within 6 to 8 weeks of starting treatment. Preventing diarrhea includes early recognition of symptoms. Proper grading of diarrhea is essential for proper management. Regardless of immunotherapy agent used, effective colitis and diarrhea management is accomplished by early intervention.” 

This justification has continued to be an emphasis across SITC’s membership, specifically on how important it is for patients on immunotherapies to be treated for these common and life-threatening adverse events. It is important to note that the treatment of these adverse events differs from those associated with other oncology modalities. As the use of ICIs continues to grow, ensuring appropriate and timely treatment remains a critical need for the field. 

Alignment with MIPS:  

This measure continues to fill an unmet need within the MIPS quality program by specifically addressing irAEs. Currently, no other measures in the program focus on this critical issue. Its inclusion in the MIPS Measure Value Pathway on Advancing Cancer Care highlights its relevance and underscores the essential role it plays in the treatment and management of cancer care. Throughout the review process of these measures, it was emphasized that as the utilization of immunotherapy continues to grow, it will be critical to maintain measures within the program that address these novel therapies. 

Data Burden:  

As previously noted, this measure continues to address a critical need and provides meaningful value to the MIPS program. As outlined in the original submission materials, the data burden associated with this measure is minimal. Therefore, its removal would offer little reduction in reporting burden while eliminating a valuable opportunity to support a key quality metric in cancer care. 

Based on the critical need, the alignment and value provided to the MIPS Program, and the limited data burden, we recommend that this measure is not included within the MSR for this year. Based on feedback from the field, there is interest and value in utilization of this measure, and over time we believe its utility and impact will grow. Please let us know if there are any questions and we would be happy to answer them and serve as a resource in any way.  

[1] https://www.cancerresearch.org/regulatory-approval-timeline-of-active-i…;

SITC is in agreement with ASCO and recommends against prioritizing 00628-01-C-MIPS RAS (KRAS and NRAS) Gene Mutation Testing Performed for Patients with Metastatic Colorectal Cancer who Receive Anti-epidermal Growth Factor Receptor (EGFR) in the 2025 MSR cycle. While this is a limited patient population, the measure is an important quality metric and should continue to be included within the MIPS program as well as the Advancing Cancer Care MVP. Personalized medicine and precision medicine are growing areas of the field, and this measure works to ensure proper utilization and implementation of novel biomarker technology. 

The American Society of Clinical Oncology (ASCO) concurs with the position of the Society for Immunotherapy of Cancer (SITC) regarding the inclusion of 01651-01-C-MIPS: Appropriate intervention of immune-related diarrhea and/or colitis in patients treated with immune checkpoint inhibitors in the Measures Set Review (MSR). This measure addresses a critical and growing aspect of cancer patient care, aligns with the needs of the MIPS program, carries a minimal data burden relative to its potential benefit, and stakeholders feel that over time, the utility and impact of the measure will grow with continued use.

Because of critical need, limited data burden, and the alignment and value provided to the MIPS Program from the continued inclusion of this measure, ASCO recommends 01651-01-C-MIPS is not prioritized for inclusion in the 2025 MSR.  Please see below for additional details supporting these comments:

Critical Need:

Checkpoint inhibitor therapies continue to be one of the fastest-growing modalities in oncology, including increased use as first-line treatments across multiple disease types. With over 128 immune checkpoint inhibitors (ICIs) approved in the United States (source), the use of these therapies is expanding rapidly, making the proper management of immune related adverse events (irAEs) critically important to patient outcomes.

As stated within the measure description:

“The occurrence of diarrhea and colitis can be a normal and treatable toxicity (and is many times not immune-related), but if it is immune-related, it can become life-threatening if not addressed in a timely manner. Diarrhea and colitis are the second-most commonly reported AEs (adverse events) with ICIs (immune checkpoint inhibitors), and symptoms typically develop within 6 to 8 weeks of starting treatment. Preventing diarrhea includes early recognition of symptoms. Proper grading of diarrhea is essential for proper management. Regardless of immunotherapy agent used, effective colitis and diarrhea management is accomplished by early intervention.”

This justification has continued to be an emphasis across SITC’s membership, specifically on how important it is for patients on immunotherapies to be treated for these common and life-threatening adverse events. It is important to note that the treatment of these adverse events differs from those associated with other oncology modalities. As the use of ICIs continues to grow, ensuring appropriate and timely treatment remains a critical need for the field.

Alignment with MIPS: 

This measure continues to fill an unmet need within the MIPS quality program by specifically addressing irAEs. Currently, no other measures in the program focus on this critical issue. Its inclusion in the MIPS Measure Value Pathway on Advancing Cancer Care highlights its relevance and underscores the essential role it plays in the treatment and management of cancer care. Throughout the review process of these measures, it was emphasized that as the utilization of immunotherapy continues to grow, it will be critical to maintain measures within the program that address these novel therapies.

Data Burden: 

As previously noted, this measure continues to address a critical need and provides meaningful value to the MIPS program. As outlined in the original submission materials, the data burden associated with this measure is minimal. Therefore, its removal would offer little reduction in reporting burden while eliminating a valuable opportunity to support a key quality metric in cancer care.

June 30, 2025

Nicole Brennan, MPH, DrPH

Executive Director

Partnership for Quality Measurement 

RE: Proposed Measures for the 2025 Measure Set Review (MSR) Cycle

Submitted via https://p4qm.org/2025-MSR-Cycle-Proposed-Measure-Comments

Dear Dr. Brennan:

On behalf of the members of the American Podiatric Medical Association (APMA), the national organization representing the vast majority of the nation’s estimated 15,000 doctors of podiatric medicine (DPMs), also known as podiatric physicians and surgeons, we thank you for the opportunity to comment on the proposed measures for the 2025 measure set review cycle. APMA requests that measures (00199-01-C-MIPS) Diabetes Mellitus: Diabetic Foot and Ankle Care, Peripheral Neuropathy - Neurological Evaluation and (00200-01-C-MIPS) Diabetes Mellitus: Diabetic Foot and Ankle Care, Ulcer Prevention - Evaluation of Footwear not be prioritized for review. APMA requests that these measures remain in the Quality Payment Program (QPP) as they continue to promote high value care for patients with diabetes and are meaningful measures for podiatrists and other eligible clinicians. 

Diabetes affects nearly 12% of the U.S. population and almost 1/3 of those aged 65 and older.[1] People with diabetes experience complications, such as neuropathy (loss of sensation in their lower extremities), foot deformity, and skin breakdown (diabetic foot ulcer). Shoe trauma, in concert with loss of protective sensation and concomitant foot deformity, is the leading event precipitating foot ulceration in persons with diabetes. The lifetime risk of a person with diabetes developing a foot ulcer may be as high as 25%.[2] And, nearly 85% of amputations are precipitated by foot ulcers among people with diabetes, making foot ulceration is the most common single precursor to lower extremity amputations among people with diabetes.[3] From a study back in 2014, diabetic foot ulcers were found to impose substantial burden on payers, ranging from $9-13 billion in addition to the costs associated with diabetes itself.[4]

As one of Dr. Oz’s top priorities is to shift the paradigm for health care from a system that focuses on sick care to one that fosters prevention, wellness, and chronic disease management, maintaining these two measures in QPP aligns with that goal. A 2011 study found that care provided by podiatrists, such as care that is outlined in these two quality measures, can reduce the disease and economic burdens of diabetes.[5] Patients under the care of a podiatric physician had significantly lower rates of amputation and significantly lower costs.⁵

In addition to providing limb- and life-saving quality care to people with diabetes, it is critical to maintain (00199-01-C-MIPS) Diabetes Mellitus: Diabetic Foot and Ankle Care, Peripheral Neuropathy - Neurological Evaluation and (00200-01-C-MIPS) Diabetes Mellitus: Diabetic Foot and Ankle Care, Ulcer Prevention - Evaluation of Footwear given the small number of podiatry-specific measures in the QPP. The removal of these measures would result in there being no measures related to diabetic foot care and fewer relevant, meaningful quality measures for podiatrists and other eligible clinicians who care for people with diabetes. 

APMA is currently working with CMS and Acumen to develop a Non-Pressure Ulcer episode-based cost measure. One of the goals of this effort is to ensure there is a cost measure to populate a future MIPS Value Pathway (MVP) that is relevant to podiatrists since no such MVP currently exists. The diabetic foot quality measures are currently the most relevant quality measures to pair with this cost measure in a future MVP.

Thank you for the opportunity to offer comments on the proposed measures for the 2025 MSR cycle. APMA requests that measures 00199-01-C-MIPS and 00200-01-C-MIPS not be prioritized for review and remain in the QPP. Please contact Dyane Tower, DPM, MPH, MS, CAE, Vice President, Clinical Affairs and Medical at [email protected] or (301) 581-9250, for further inquiries or discussion.

Sincerely, 

Brooke Bisbee, DPM 

President

[1] National Diabetes Statistics Report. https://www.cdc.gov/diabetes/php/data-research/index.html#:~:text=Total…

[2] Boulton AJ, Armstrong DG, Albert SF, Frykberg RG, Hellman R, Kirkman MS, Lavery LA, LeMaster JW, Mills JL Sr, Mueller MJ, Sheehan P, Wukich DK; Task Force of the Foot Care Interest Group of the American Diabetes Association. Comprehensive foot examination and risk assessment. Endocr Pract. 2008 Jul-Aug;14(5):576-83. doi: 10.4158/EP.14.5.576. PMID: 18753100.

[3] Sloan FA, Feinglos MN, Grossman DS. Receipt of care and reduction of lower extremity amputations in a nationally representative sample of U.S. Elderly. Health Serv Res. 2010 Dec;45(6 Pt 1):1740-62. doi: 10.1111/j.1475-6773.2010.01157.x. Epub 2010 Aug 16. PMID: 20722748; PMCID: PMC3026956.

[4] Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for medicare and private insurers. Diabetes Care. 2014;37(3):651-8. doi: 10.2337/dc13-2176. Epub 2013 Nov 1. Erratum in: Diabetes Care. 2014 Sep;37(9):2660. PMID: 24186882.

[5] Carls GS, Gibson TB, Driver VR, Wrobel JS, Garoufalis MG, Defrancis RR, Wang S, Bagalman JE, Christina JR. The economic value of specialized lower-extremity medical care by podiatric physicians in the treatment of diabetic foot ulcers. J Am Podiatr Med Assoc. 2011 Mar-Apr;101(2):93-115. doi: 10.7547/1010093. PMID: 21406693.

June 30, 2025

Nicole Brennan, MPH, DrPH

Executive Director

Partnership for Quality Measurement 

RE: Proposed Measures for the 2025 Measure Set Review (MSR) Cycle

Submitted via https://p4qm.org/2025-MSR-Cycle-Proposed-Measure-Comments

Dear Dr. Brennan:

On behalf of the members of the American Podiatric Medical Association (APMA), the national organization representing the vast majority of the nation’s estimated 15,000 doctors of podiatric medicine (DPMs), also known as podiatric physicians and surgeons, we thank you for the opportunity to comment on the proposed measures for the 2025 measure set review cycle. APMA requests that measures (00199-01-C-MIPS) Diabetes Mellitus: Diabetic Foot and Ankle Care, Peripheral Neuropathy - Neurological Evaluation and (00200-01-C-MIPS) Diabetes Mellitus: Diabetic Foot and Ankle Care, Ulcer Prevention - Evaluation of Footwear not be prioritized for review. APMA requests that these measures remain in the Quality Payment Program (QPP) as they continue to promote high value care for patients with diabetes and are meaningful measures for podiatrists and other eligible clinicians. 

Diabetes affects nearly 12% of the U.S. population and almost 1/3 of those aged 65 and older.[1] People with diabetes experience complications, such as neuropathy (loss of sensation in their lower extremities), foot deformity, and skin breakdown (diabetic foot ulcer). Shoe trauma, in concert with loss of protective sensation and concomitant foot deformity, is the leading event precipitating foot ulceration in persons with diabetes. The lifetime risk of a person with diabetes developing a foot ulcer may be as high as 25%.[2] And, nearly 85% of amputations are precipitated by foot ulcers among people with diabetes, making foot ulceration is the most common single precursor to lower extremity amputations among people with diabetes.[3] From a study back in 2014, diabetic foot ulcers were found to impose substantial burden on payers, ranging from $9-13 billion in addition to the costs associated with diabetes itself.[4]

As one of Dr. Oz’s top priorities is to shift the paradigm for health care from a system that focuses on sick care to one that fosters prevention, wellness, and chronic disease management, maintaining these two measures in QPP aligns with that goal. A 2011 study found that care provided by podiatrists, such as care that is outlined in these two quality measures, can reduce the disease and economic burdens of diabetes.[5] Patients under the care of a podiatric physician had significantly lower rates of amputation and significantly lower costs.⁵

In addition to providing limb- and life-saving quality care to people with diabetes, it is critical to maintain (00199-01-C-MIPS) Diabetes Mellitus: Diabetic Foot and Ankle Care, Peripheral Neuropathy - Neurological Evaluation and (00200-01-C-MIPS) Diabetes Mellitus: Diabetic Foot and Ankle Care, Ulcer Prevention - Evaluation of Footwear given the small number of podiatry-specific measures in the QPP. The removal of these measures would result in there being no measures related to diabetic foot care and fewer relevant, meaningful quality measures for podiatrists and other eligible clinicians who care for people with diabetes. 

APMA is currently working with CMS and Acumen to develop a Non-Pressure Ulcer episode-based cost measure. One of the goals of this effort is to ensure there is a cost measure to populate a future MIPS Value Pathway (MVP) that is relevant to podiatrists since no such MVP currently exists. The diabetic foot quality measures are currently the most relevant quality measures to pair with this cost measure in a future MVP.

Thank you for the opportunity to offer comments on the proposed measures for the 2025 MSR cycle. APMA requests that measures 00199-01-C-MIPS and 00200-01-C-MIPS not be prioritized for review and remain in the QPP. Please contact Dyane Tower, DPM, MPH, MS, CAE, Vice President, Clinical Affairs and Medical at [email protected] or (301) 581-9250, for further inquiries or discussion.

Sincerely,

Brooke Bisbee, DPM 

President

[1] National Diabetes Statistics Report. https://www.cdc.gov/diabetes/php/data-research/index.html#:~:text=Total…

[2] Boulton AJ, Armstrong DG, Albert SF, Frykberg RG, Hellman R, Kirkman MS, Lavery LA, LeMaster JW, Mills JL Sr, Mueller MJ, Sheehan P, Wukich DK; Task Force of the Foot Care Interest Group of the American Diabetes Association. Comprehensive foot examination and risk assessment. Endocr Pract. 2008 Jul-Aug;14(5):576-83. doi: 10.4158/EP.14.5.576. PMID: 18753100.

[3] Sloan FA, Feinglos MN, Grossman DS. Receipt of care and reduction of lower extremity amputations in a nationally representative sample of U.S. Elderly. Health Serv Res. 2010 Dec;45(6 Pt 1):1740-62. doi: 10.1111/j.1475-6773.2010.01157.x. Epub 2010 Aug 16. PMID: 20722748; PMCID: PMC3026956.

[4] Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for medicare and private insurers. Diabetes Care. 2014;37(3):651-8. doi: 10.2337/dc13-2176. Epub 2013 Nov 1. Erratum in: Diabetes Care. 2014 Sep;37(9):2660. PMID: 24186882.

[5] Carls GS, Gibson TB, Driver VR, Wrobel JS, Garoufalis MG, Defrancis RR, Wang S, Bagalman JE, Christina JR. The economic value of specialized lower-extremity medical care by podiatric physicians in the treatment of diabetic foot ulcers. J Am Podiatr Med Assoc. 2011 Mar-Apr;101(2):93-115. doi: 10.7547/1010093. PMID: 21406693.

See attached

See attached

Please see attached. 

The American College of Surgeons (ACS) appreciates the opportunity to submit comments to the Measure Set Review (MSR) process facilitated by Battelle. Our comments focus on measure 00502-01-C-MIPS, Patient-Centered Surgical Risk Assessment and Communication. This measure evaluates “the percentage of patients who underwent a non-emergency surgery who had their personalized risks of postoperative complications assessed by their surgical team prior to surgery using a clinical data-based, patient-specific risk calculator and who received personal discussion for those risks with their surgeon.” The ACS supports the inclusion of this measure in the Merit-based Incentive Payment System (MIPS) because assessing preoperative risk and communicating that risk in a way that a patient understands gives the patient agency and facilitates shared decision making with identification of patient goals. 

Formal and comprehensive goals of care discussions and advanced care planning are critical for all patients. A systematic review found that only 2-29% of older patients had discussed long term care goals and end of life wishes with their physicians despite the fact that between 61-91% reported feeling that this was an important issue.(1) Shared decision-making (SDM) with patients hinges upon high-quality communication, empowering patients to reflect upon and identify personal health goals.(2) Most healthcare professionals understand the implicit trade-offs required in achieving treatment goals (i.e., most patients will want all of the above, while healthcare providers may recognize that the certain treatments may not maintain the patient’s function or independence, or may be accompanied by bothersome symptoms). These trade-offs should be explicitly addressed with patients so they may better understand the potential outcomes of their health goal. Using a surgical risk calculator allows surgeons to assess risk in a validated way by applying the most recent and relevant surgical outcomes data, while also reducing their cognitive load. There are multiple examples of validated tools, such as the National Surgical Quality Improvement Program (NSQIP) Surgical Risk Calculator and Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Risk Calculator, that can be used to support risk assessments and SDM conversations. Because shared decision-making is a critical element of patient-centered care and leveraging a surgical risk calculator supports surgeons in these conversations, this measure should not be considered for review at this time. 

In addition, while we presume that the rationale for review of the Patient-Centered Surgical Risk Assessment and Communication measure is due to its “topped out” status, it is the only measure in the MIPS inventory that incentivizes shared decision-making conversations prior to surgical care. There are several reasons why we disagree with this rationale. First, because MIPS measures are self-selected and self-reported, clinicians who have SDM discussions about the decision to operate are more likely to report this measure. Yet all surgical teams should facilitate these discussions, therefore we ask CMS—what percentage of surgeons are not having SDM discussions with their patients?  Second, this measure is included in the Surgical Care MIPS Value Pathways (MVP), which will further incentivize SDM across surgery. As more physicians transition into using MVPs, more MIPS-eligible clinicians might begin to report this measure, which could impact the benchmarks. CMS should not remove this measure from MIPS until it has more accurate data on whether the measure should be considered topped out. Third, the current MIPS framework does not look at the whole program of surgical care, instead the measures are unaligned with team-based care delivery and focus on specific actions or events. When CMS thinks of surgical quality it must be considered through the lens of quality programs that assess structures, processes, and outcomes within a service line, drive connection between members of the care team, and incorporate the patient’s goals and preferences in decisions for treatment. Shared decision making is a critical piece of the surgical care journey. Until this can be achieved, it is important that measures that incentivize components of quality programs, including shared decision making, are maintained in MIPS. 

For these reasons, the Patient-Centered Surgical Risk Assessment and Communication measure should not be prioritized for review under the 2025 MSR process. CMS must continue to explore quality frameworks that incentivize programmatic, team-based surgical care for a condition, which includes shared decision making as a foundational component. 

1. Sharp T, Moran E, Kuhn I, Barclay S. Do the elderly have a voice? Advance care planning discussions with frail and older individuals: a systematic literature review and narrative synthesis. Br J Gen Pract. Oct 2013;63(615):e657-68. doi:10.3399/bjgp13X673667
2. Hanson LC, Winzelberg G. Research priorities for geriatric palliative care: Goals, values, and preferences. J Palliat Med. 2013;16(10):1175-1179.

The American Society of Plastic Surgeons (ASPS) appreciates the opportunity to submit comments to the Measure Set Review (MSR) process facilitated by Battelle. Our comments focus on measure 00502-01-C-MIPS, Patient-Centered Surgical Risk Assessment and Communication. This measure evaluates “the percentage of patients who underwent a non-emergency surgery who had their personalized risks of postoperative complications assessed by their surgical team prior to surgery using a clinical data-based, patient-specific risk calculator and who received personal discussion for those risks with their surgeon.” The ASPS supports the inclusion of this measure in the Merit-based Incentive Payment System (MIPS) because assessing preoperative risk and communicating that risk in a way that a plastic surgery patient understands gives the patient agency and facilitates shared decision making with identification of patient goals. 

Formal and comprehensive goals of care discussions and advanced care planning are critical for all patients. A systematic review found that only 2-29% of older patients had discussed long term care goals and end of life wishes with their physicians despite the fact that between 61-91% reported feeling that this was an important issue.(1) Shared decision-making (SDM) with patients hinges upon high-quality communication, empowering patients to reflect upon and identify personal health goals.(2) Most healthcare professionals understand the implicit trade-offs required in achieving treatment goals (i.e., most patients will want all of the above, while healthcare providers may recognize that the life-prolonging treatment may not maintain the patient’s function or independence, or may be accompanied by bothersome symptoms). These trade-offs should be explicitly addressed with patients so they may better understand the potential outcomes of their health goal. Using a surgical risk calculator allows surgeons to assess risk in a validated way by applying the most recent and relevant surgical outcomes data, while also reducing their cognitive load. The National Surgical Quality Improvement Program (NSQIP) Surgical Risk Calculator is an example of a validated tool that plastic surgeons can use to support risk assessments and shared decision-making conversations. Because shared decision-making is a critical element of patient-centered care and leveraging a surgical risk calculator relevant to plastic surgery supports surgeons in these conversations, this measure should not be considered for review at this time. 

As shared with us by our colleagues and measure stewards, the American College of Surgeons, we presume that the rationale for review of the Patient-Centered Surgical Risk Assessment and Communication measure is due to its “topped out” status. However, this is the only measure in the MIPS inventory that incentivizes shared decision-making conversations prior to surgical care. There are several reasons why we, like ACS, disagree with this rationale. First, because MIPS measures are self-selected and self-reported, clinicians who have SDM discussions about the decision to operate are more likely to report this measure. Yet all surgical teams should facilitate these discussions, therefore we ask CMS—what percentage of surgeons are not having SDM discussions with their patients? Second, this measure is included in the Surgical Care MIPS Value Pathways (MVP), which will further incentivize SDM across surgery. As more physicians transition into using MVPs, more MIPS-eligible clinicians might begin to report this measure, which could impact the benchmarks and result in a measure that is no longer topped out. Third, the current MIPS framework does not look at the whole program of care, instead the measures are unaligned with team-based care delivery and focus on specific actions or events. When CMS thinks of surgical quality it must be considered through the lens of quality programs that assess structures, processes, and outcomes within a service line, drive connection between members of the care team, and incorporate the patient’s goals and preferences in decisions for treatment. Until this can be achieved, it is important that measures that incentivize components of quality programs, such as shared decision making, are maintained in MIPS. 

For these reasons, ASPS believes that the Patient-Centered Surgical Risk Assessment and Communication measure should not be prioritized for review under the 2025 MSR process. CMS must continue to explore quality frameworks that incentivize programmatic, team-based surgical care for a condition, which includes shared decision making as a foundational component. 

1. Sharp T, Moran E, Kuhn I, Barclay S. Do the elderly have a voice? Advance care planning discussions with frail and older individuals: a systematic literature review and narrative synthesis. Br J Gen Pract. Oct 2013;63(615):e657-68. doi:10.3399/bjgp13X673667
2. Hanson LC, Winzelberg G. Research priorities for geriatric palliative care: Goals, values, and preferences. J Palliat Med. 2013;16(10):1175-1179.

Please see attached comments. 

Please see attached comments