Statement to the
Centers for Medicare & Medicaid Services’ (CMS’) First Biannual 2023 Healthcare
Common Procedure Coding System (HCPCS) Public Meeting
May 31, 2023
Re: Self-Measured Blood Pressure Devices – IHC221222X2AHC
The National Forum for Heart Disease & Stroke Prevention supports the American Heart Association (AHA) and American Medical Association’s (AMA’s) request to the Centers for Medicare & Medicaid Services (CMS) for a Benefit Category Determination that self-measured blood pressure (SMBP) devices are durable medical equipment (DME).
As CMS’ Agenda states, “Hypertension is the number one chronic condition of Medicare beneficiaries.”1 There is strong evidence that SMBP improves hypertension control, which will reduce the incidence of myocardial infarction, stroke, and heart failure.
CMS based its preliminary decision that SMBP devices do not qualify as DME on its interpretation that “SMBP devices are generally not used by the patient to self-manage hypertension, but rather require clinical intervention to manage their medical condition.”1 The National Forum is pleased that CMS seeks additional information to inform its final decision.
The evidence shows that SMBP devices are used for both patient self-management and obtaining data to share with clinicians.
- The 2020 Surgeon General’s Call to Action to Control Hypertension reported that SMBP involves a clinician/patient “feedback loop [that] enhances patient engagement in care and provides timely information to the clinical team to improve care.2 (emphasis added)
- A Community Preventive Services Task Force systematic review of evidence found, “as patients become more aware of their blood pressure readings, they may also become more motivated to improve other lifestyle behaviors such as healthful eating, physical activity, and smoking cessation.”3
- Clinical guidelines recommend using SMBP home monitoring devices, which are widely utilized. For example, Kaiser Permanente, which provides healthcare for 12.6 million members nationally, has a remote patient monitoring program for diabetes and hypertension.4 This program empowers KP members with diabetes and hypertension to better manage chronic conditions by monitoring blood pressure or blood sugar levels from their homes and making self-directed behavior modifications.
- The TASMIN-R trial showed that “among patients with hypertension at high risk of cardiovascular disease, self-monitoring with self-titration of antihypertensive medication compared with usual care resulted in lower systolic blood pressure at 12 months.”5
Besides the clear beneficial effect on improving hypertension control, a recently published study modeled data from the 2019 Behavioral Risk Factor Surveillance System and the published literature. It showed that compared to usual care, adopting SMBP was estimated to reduce myocardial infarction cases by 4.9 percent and stroke cases by 3.8 percent, saving an average of $7,794 in healthcare costs per person over 20 years.6
In light of the evidence that SMBP devices are used for patient self-management and clinical care, the National Forum strongly urges CMS to classify SMBP devices as DME.
1. Centers for Medicare & Medicaid Services (CMS) Centers for Medicare & Medicaid Services’ (CMS’) First Biannual 2022 Healthcare Common Procedure Coding System (HCPCS) Public Meeting Agenda. https://www.cms.gov/files/document/hcpcs-public-meeting-agenda-non-drug-and-non-biological-items-and-services-may-31-2023-updated-05/16.pdf , accessed 5/22/2023, pp. 3-4.
2. U.S. Department of Health and Human Services. The Surgeon General’s Call to Action to Control Hypertension. Washington, DC: U.S. Department of Health and Human Services, Office of the Surgeon General; 2020, p. 24.
3. Community Preventive Services Task Force. Heart Disease and Stroke Prevention: Self-Measured Blood Pressure Monitoring Interventions for Improved Blood Pressure Control. Task Force Finding and Rationale Statement. July 5, 2016 update. https://www.thecommunityguide.org/media/pdf/HDSP-Self-Measured-Blood-Pressure-508.pdf, accessed 5/22/2023, pp.5-6
4. Managing diabetes and hypertension from home. August 5, 2020. https://about.kaiserpermanente.org/health-and-wellness/our-care/managing-chronic-health-conditions-from-home , accessed 5/22/2023. pp. 5-6.
5. McManus RJ, Mant J, Haque MS, Bray EP, Bryan S, Greenfield SM, Jones MI, Jowett. S, Little P, Penaloza C, Schwartz C, Shackleford H, Shovelton C, Varghese J, Williams B, Hobbs FD, Gooding T, Morrey I, Fisher C, Buckley D. Effect of self-monitoring and medication self-titration on systolic blood pressure in hypertensive patients at high risk of cardiovascular disease: the TASMIN-SR randomized clinical trial. JAMA. 2014 Aug 27;312(8):799-808.
6. Li Y, Zhang D, Li W, Chen Z, Thapa J, Mu L, Zhu H, Dong Y, Pagán JA. The Health and Economic Impact of Expanding Home Blood Pressure Monitoring. Am J Prev Med. 2023 May 13;S0749-3797(23)00232-5. doi: 10.1016/j.amepre.2023.05.010.