{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T21:02:05Z","timestamp":1791406925496,"version":"4.3.3"},"reference-count":32,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"20","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["JAHA"],"published-print":{"date-parts":[[2025,10,21]]},"abstract":"<jats:sec xml:lang=\"en\">\n                    <jats:title>Background<\/jats:title>\n                    <jats:p xml:lang=\"en\">Patients with heart failure (HF) often have difficulty obtaining life\u2010saving medications due to coverage barriers, such as prior authorizations and high out\u2010of\u2010pocket costs. To promote better coverage for high value therapies and inform policymakers about cost effectiveness, the American Heart Association\/American College of Cardiology\/Heart Failure Society of America added Value Statements to HF guidelines. We assessed whether these guidelines influenced Medicare drug coverage policies for 2 life\u2010saving, costly HF medications: angiotensin receptor neprilysin inhibitors (ARNI\u2013guideline \u201chigh value\u201d) and sodium glucose cotransporter\u20102 inhibitors (SGLT2i\u2013guideline \u201cintermediate value\u201d).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p xml:lang=\"en\">We performed an observational study using Medicare prescription drug plan formulary files from April 2020 to April 2023 to separately assess for changes in coverage barriers to ARNI and SGLT2i after Value Statement publication (April 2022), and subsequent Medicare plan online update (October 2022). The primary outcome was the percentage of plans each month with any barrier to drug coverage (prior authorizations, tier \u22653 out\u2010of\u2010pocket cost\u2010sharing, step therapy, or no coverage). Analyses used interrupted time series and difference\u2010in\u2010differences approaches. Difference\u2010in\u2010differences analyses used direct oral anticoagulants as a control due to their comparable cost and use as ARNI and SGLT2i, but without a Value Statement.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p xml:lang=\"en\">Among 7396 Medicare drug plans, monthly rates of any coverage barrier ranged from 94.3% to 97.4% for ARNI and 93.2% to 96.6% for SGLT2i. Most barriers were due to tier \u22653 out\u2010of\u2010pocket cost\u2010sharing requirements (ARNI: 94.3%\u201395.8%; SGLT2i: 93.2%\u201395.6%). Coverage barriers remained stable in April 2022 and declined slightly in October 2022. In difference\u2010in\u2010differences analyses, the presence of a Value Statement was associated with a ~1 percentage point decline in coverage barriers for both ARNI (difference\u2010in\u2010differences estimate, \u22121.07% [95% CI, \u22121.44% to \u22120.70%]) and SGLT2i (\u22121.32% [95% CI, \u22121.63% to \u22121.00%]).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec xml:lang=\"en\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p xml:lang=\"en\">Coverage barriers to ARNI and SGLT2i were common and changed only slightly after publication of Value Statements in HF guidelines. There is a critical need for robust strategies to improve access to life\u2010saving HF medications.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/jaha.125.043610","type":"journal-article","created":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T12:11:27Z","timestamp":1760011887000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Impact of Heart Failure Guideline Publication on Medicare Drug Coverage Policies: A Quasi\u2010Experimental Analysis"],"prefix":"10.1161","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7768-459X","authenticated-orcid":false,"given":"Amrita","family":"Mukhopadhyay","sequence":"first","affiliation":[{"name":"NYU Grossman School of Medicine","place":["New York, USA"]},{"name":"NYU Grossman School of Medicine","place":["New York, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathalia","family":"Ladino","sequence":"additional","affiliation":[{"name":"NYU Grossman School of Medicine","place":["New York, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9305-1859","authenticated-orcid":false,"given":"Tyrel","family":"Stokes","sequence":"additional","affiliation":[{"name":"NYU Grossman School of Medicine","place":["New York, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0986-9004","authenticated-orcid":false,"given":"Aparna","family":"Narendrula","sequence":"additional","affiliation":[{"name":"NYU Grossman School of Medicine","place":["New York, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2340-2021","authenticated-orcid":false,"given":"Stuart D.","family":"Katz","sequence":"additional","affiliation":[{"name":"NYU Grossman School of Medicine","place":["New York, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0284-0655","authenticated-orcid":false,"given":"Harmony R.","family":"Reynolds","sequence":"additional","affiliation":[{"name":"NYU Grossman School of Medicine","place":["New York, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5238-2122","authenticated-orcid":false,"given":"Allison P.","family":"Squires","sequence":"additional","affiliation":[{"name":"NYU Rory Meyers College of Nursing","place":["New York, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1089-3896","authenticated-orcid":false,"given":"Rishi K.","family":"Wadhera","sequence":"additional","affiliation":[{"name":"Richard A. and Susan F. Smith Center for Outcomes Research at Beth Israel Deaconess Medical Center","place":["Boston, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5225-4721","authenticated-orcid":false,"given":"Donglan Stacy","family":"Zhang","sequence":"additional","affiliation":[{"name":"NYU Grossman School of Medicine","place":["New York, USA"]},{"name":"NYU Grossman Long Island School of Medicine","place":["Mineola, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9954-5999","authenticated-orcid":false,"given":"Samrachana","family":"Adhikari","sequence":"additional","affiliation":[{"name":"NYU Grossman School of Medicine","place":["New York, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4460-1046","authenticated-orcid":false,"given":"Saul","family":"Blecker","sequence":"additional","affiliation":[{"name":"NYU Grossman School of Medicine","place":["New York, USA"]},{"name":"NYU Grossman School of Medicine","place":["New York, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_1_2_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1409077"},{"key":"e_1_3_1_3_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1911303"},{"key":"e_1_3_1_4_2","doi-asserted-by":"publisher","DOI":"10.1161\/circulationaha.120.051783"},{"key":"e_1_3_1_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2018.04.070"},{"key":"e_1_3_1_6_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12872-022-02734-2"},{"key":"e_1_3_1_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cardfail.2021.03.012"},{"key":"e_1_3_1_8_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2023.16290"},{"key":"e_1_3_1_9_2","doi-asserted-by":"publisher","DOI":"10.1161\/JAHA.122.027662"},{"key":"e_1_3_1_10_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0000000000000042"},{"key":"e_1_3_1_11_2","doi-asserted-by":"publisher","DOI":"10.1161\/cir.0000000000001063"},{"key":"e_1_3_1_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2013.10.008"},{"key":"e_1_3_1_13_2","doi-asserted-by":"publisher","DOI":"10.18553\/jmcp.2023.29.5.582"},{"key":"e_1_3_1_14_2","doi-asserted-by":"publisher","DOI":"10.18553\/jmcp.2023.29.3.257"},{"key":"e_1_3_1_15_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.119.040580"},{"key":"e_1_3_1_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2016.10.053"},{"key":"e_1_3_1_17_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0000000000000665"},{"key":"e_1_3_1_18_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1107039"},{"key":"e_1_3_1_19_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0905561"},{"key":"e_1_3_1_20_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1009638"},{"key":"e_1_3_1_21_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1310907"},{"key":"e_1_3_1_22_2","unstructured":"Cubanski JD Damico A Neuman T. How Medicare\u2019s new drug price negotiation program could expand access to selected drugs. 2023 https:\/\/www.kff.org\/medicare\/issue\u2010brief\/how\u2010medicares\u2010new\u2010drug\u2010price\u2010negotiation\u2010program\u2010could\u2010expand\u2010access\u2010to\u2010selected\u2010drugs\/."},{"key":"e_1_3_1_23_2","unstructured":"Services CfMaM . Medicare drug price negotiation program: negotiated prics for initial price applicability year 2026. 2024. https:\/\/www.cms.gov\/files\/document\/fact\u2010sheet\u2010negotiated\u2010prices\u2010initial\u2010price\u2010applicability\u2010year\u20102026.pdf."},{"key":"e_1_3_1_24_2","first-page":"2020","volume-title":"Bootstrapping Differences\u2010in\u2010Differences Estimates","author":"Hounkannounon B","year":"2011","unstructured":"Hounkannounon B. Bootstrapping Differences\u2010in\u2010Differences Estimates. Vol 24. CIREQ, Universite de Montreal, https:\/\/www.rbnz.govt.nz, Eri\u015fim Tarihi; 2011:2020."},{"key":"e_1_3_1_25_2","doi-asserted-by":"publisher","DOI":"10.1161\/circoutcomes.122.009179"},{"key":"e_1_3_1_26_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2021.6139"},{"key":"e_1_3_1_27_2","doi-asserted-by":"publisher","DOI":"10.18553\/jmcp.2019.25.12.1319"},{"key":"e_1_3_1_28_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2013.02.011"},{"key":"e_1_3_1_29_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2009.1409"},{"key":"e_1_3_1_30_2","doi-asserted-by":"publisher","DOI":"10.2337\/cd18-0105"},{"key":"e_1_3_1_31_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.kint.2020.06.019"},{"key":"e_1_3_1_32_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.kint.2022.06.008"},{"key":"e_1_3_1_33_2","doi-asserted-by":"publisher","DOI":"10.2337\/dci22-0027"}],"container-title":["Journal of the American Heart Association"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ahajournals.org\/doi\/full\/10.1161\/JAHA.125.043610","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,19]],"date-time":"2025-11-19T11:21:28Z","timestamp":1763551288000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ahajournals.org\/doi\/10.1161\/JAHA.125.043610"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,21]]},"references-count":32,"journal-issue":{"issue":"20","published-print":{"date-parts":[[2025,10,21]]}},"alternative-id":["10.1161\/JAHA.125.043610"],"URL":"https:\/\/doi.org\/10.1161\/jaha.125.043610","relation":{},"ISSN":["2047-9980"],"issn-type":[{"value":"2047-9980","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,21]]},"assertion":[{"value":"2025-06-11","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-08-08","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-09","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e043610"}}