Ambulatory Blood Pressure Monitoring (ABPM)

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The Connected Health Initiative (CHI) appreciates the opportunity to provide input on the Centers for Medicare & Medicaid Services’ (CMS) Proposed Decision Memo for Ambulatory Blood Pressure Monitoring (ABPM) (CAG-00067R2) dated April 9, 2019.¹

CHI is the leading effort by stakeholders across the connected health ecosystem to responsibly advance the use of digital health innovations in the prevention and treatment of disease, supporting an environment in which patients and consumers can see improvements in their health. We seek essential policy changes that will help all Americans benefit from an information and communications technology-enabled healthcare system. For more information, see www.connectedhi.com.

CHI is a longtime active global advocate for the increased use of new and innovative digital health tools in both the prevention and treatment of disease, particularly for chronic conditions such as high blood pressure. Additionally, CHI is an appointed member of the American Medical Association’s (AMA) Digital Medicine Payment Advisory Group, an initiative bringing together a diverse cross-section of 15 nationally recognized experts that identifies barriers to digital medicine adoption and proposes comprehensive solutions revolving around coding, payment, coverage, and more.² CHI is also a board member of Xcertia, a collaborative effort to develop and disseminate mHealth app guidelines that can drive the value digital health products bring to the market and the confidence that physicians and consumers can have in health apps and their ability to help people achieve their health and wellness goals.³

In its Proposed Decision Memo, CMS proposes that evidence justifies ambulatory blood pressure monitoring (ABPM) being deemed reasonable and necessary for the diagnosis and management of hypertension in certain Medicare beneficiaries with suspected masked hypertension, to be covered once per year per patient. Supported ABPM devices would be quality-certified and validated for use in the intended patient population, capable of producing standardized plots of blood pressure measurements for 24 hours with daytime and nighttime windows and normal blood pressure bands demarcated, provided to patients with oral and written instructions and a test run in the physician’s office must be performed, and read by the treating physician or treating non-physician practitioner.

CHI generally supports further coverage expansions to help Medicare beneficiaries realize the improved outcomes that remote patient monitoring technology can provide. CHI supports CMS’ proposal to expand coverage for ABPM that tracks patients outside of the doctor’s office, and agrees that such an extension is supported by a strong evidence base. The use of remote patient monitoring tools for Medicare beneficiaries with suspected masked hypertension, in addition to beneficiaries suspected of white coat hypertension, will assist in the detection of high blood pressure that would otherwise be missed, preventing mortality, stroke and cardiovascular disease, kidney disease, and other diseases.

However, the CHI urges CMS to avoid locking in a limited set of technologies for ABPM use through a restrictive definition. Many technologies exist today, and will further be developed in the future, that will enable the reliable tracking of ABPM within the parameters that CMS puts forward. We are concerned that the proposed definition of an eligible ABPM device may be interpreted to include legacy, single-purpose devices to the exclusion of innovative devices that utilize the latest in physiologic sensing, paired with an active internet connectivity-enabled feedback loop, enabling care planning and coordination augmented by predictive analytical technology, and, if necessary, streamlined interventions that save lives. The reliability of an ABPM device is no longer correlated to whether the data it collects is stored locally in the device for later interpretation by a caregiver. CHI further notes that CMS’ analysis and conclusions under its ABPM-specific assessment questions addressing improved outcomes are aligned with this broader vision of eligibility for ABPM devices. CHI therefore requests that CMS clarify in its Determination that it contemplates eligibility for the range of connected devices capable of providing 24 hour measurements of ABPM for transmission, including combination devices enabling reliable ABPM that utilize secure cloud-based storage to provide collected ABPM data to clinicians for review. CMS should delete the requirement for ABPM data to be “stored in the device” from the proposed Item/Service Description in Appendix C.

CHI appreciates the opportunity to submit its comments to CMS. We look forward to assisting CMS in realizing a technology-enabled care continuum that provides maximum value to patients at the lowest costs.

Sincerely,

Brian Scarpelli
Senior Global Policy Counsel
Connected Health Initiative
1401 K St NW (Ste 501)
Washington, DC 20005

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I am writing in support of the AHA/ACA Guidelines recently published regarding ambulatory blood pressure monitoring

• Recommend that CMS revise the clinical circumstances in which ABPM is appropriate and necessary to be consistent with prior guidelines including the 2017 American Heart Association/American College of Cardiology Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults, including:
  • Removal of the requirement of 3 months of lifestyle interventions prior to ABPM use, as there is no empiric evidence to support first proceeding with lifestyle change before obtaining an immediate diagnosis, confirmation, or exclusion of white coat or masked hypertension.
  • Usage of an average office blood pressure of two separate office blood pressure readings
  • Removal of references to out-of-office measurements before a patient is eligible for coverage of ABPM; the proposed NCD’s phrasing suggests that home blood pressure monitoring be done first, while the USPSTF-recommended method for diagnosing hypertension is to use ABPM as the out-of-office blood pressure measurement
  • Addition of the missing diastolic blood pressure range and correction of the systolic range so that it reads “between 120 mm Hg and 129 mm Hg for systolic blood pressure or between 75 mm Hg and 79 mm Hg for diastolic blood pressure.”
• Recommend that CMS specify nocturnal hypertension as an indication for ABPM.
• Recommend that a specific blood pressure device validation protocol rather than referring to a specific website that summarizes whether a device has undergone validation testing, be used.
• Request clarification from CMS regarding the “management” aspect of this proposed coverage determination, given the organizations’ request focused on diagnosis only, and clinical guidelines for management of hypertension differ from the clinical guidelines for diagnosis.

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1. The requirement of 3 months of lifestyle intervention prior to ABPM is not germane to whether a patient has or does not have hypertension, white coat hypertension (WCH) or masked hypertension (MH) as a diagnosis. This should be removed.


2. The requirement of out-of-office measurement BEFORE a patient is eligible for ABPM is illogical and should be removed. ABPM is considered the gold standard for diagnosing hypertension, WCH, and MH. Other methods of out-of-office BP measurement may be used as alternatives for diagnosis, but there is not as strong an evidence base for them.

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Dear Dr. Jensen:

The New York City (NYC) Department of Health and Mental Hygiene (Health Department) submits this comment on the Proposed Decision Memo for Ambulatory Blood Pressure Monitoring (ABPM). As we originally commented on November 8, 2018, we support the extension of Medicare coverage for patients who would benefit from ABPM for diagnostic confirmation or management of hypertension (HTN).

The proposed language for inclusion of ABPM in the Medicare National Coverage Determinations Manual is not fully aligned with the current evidence base and state of professional consensus on the use of ABPM. The circumstances outlined only address uses of ABPM for diagnosis, but not management of hypertension. The current proposal includes two circumstances for which ABPM will be allowed – suspected white coat HTN (WCH) and masked HTN (MH). WCH and MH are typically identified during diagnosis of HTN in patients who are not prescribed antihypertensive medications. While these are both appropriate uses of ABPM, there are other circumstances in which ABPM should be allowed, particularly in the course of HTN management for those who have already been diagnosed with HTN and prescribed medications. One example is in identifying and managing white coat effect, which differs from WCH. White coat effect occurs in patients prescribed antihypertensive medications who have higher readings in the office than out-of-office.^1,2 Patients with white coat effect are susceptible to overtreatment and its related complications because they may appear treatment resistant based on in-office blood pressure measurements.^i,ii Other examples in which ABPM could be used during the course of treatment include assessment of masked uncontrolled HTN, hypotension, nocturnal HTN and monitoring of medication efficacy.^i,ii

Additionally, the current proposal defines WCH and MH as requiring a three-month behavioral intervention trial. This is not consistent with clinical guidelines and professional consensus in the definition of these phenotypes.^i,ii

Recommendations:

• We recommend adding a third circumstance for which ABPM would be allowed so it extends beyond diagnosis and includes those with an existing HTN diagnosis.
• In the definition of WCH and MH, we recommend removing the 3-month behavioral intervention component and clarifying that these definitions are only for diagnosis.
• We also recommend removing the specific blood pressure cutoffs in the definitions. Not all providers, clinical guidelines, and professional societies have adopted the 2017 ACC/AHA cutoffs.^iii,iv,v

Thank you again for the opportunity to submit comments on this important issue.

Sincerely,

Oxiris Barbot, MD
Commissioner
New York City Department of Health and Mental Hygiene

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The Personal Connected Health Alliance (PCHAlliance), a non-profit membership association, appreciates the opportunity to provide comment on the CMS Proposed Decision Memo for Ambulatory Blood Pressure Monitoring (ABPM). Our comment supplements the information we provided to support CMS’ review, analysis and update of its National Coverage Decision (NCD) on Ambulatory Blood Pressure Monitoring on November 8, 2018. We believe that updating the Medicare ABPM National Coverage Decision (NCD) to reflect current evidence-based standards of care and technology is essential to enable providers to deliver effective, efficient and patient centered care to Medicare beneficiaries. Our comments, both in this letter and our 11/8/18 comment submission, focus on updating of both the covered indications and the definition of ABPM to ensure it is technology neutral.

Interoperable, connected health, including blood pressure monitoring, requires a broad ecosystem of shared digital health information. PCHAlliance members span this entire ecosystem including entities that: manufacture the devices patients and providers use to measure biophysical data; provide health insights and increase the usability of clinical decision support; provide care; operate the networks that communicate patient generated data between patients and providers; and represent consumer perspectives on connected health. PCHA’s member list can be found at http://www.pchalliance.org.

We have several brief comments on the proposed national coverage decision on ABPM, and refer CMS back to our 11/8/18 comment letter which included extensive citations:

• We support and appreciate the revised specifications for ABPM devices so that providers may use any quality certified device from which periodic blood pressure measurement data is directly communicated to the cloud and/or to a provider data monitoring platform and/or to the provider maintained electronic health record. We applaud CMS for eliminating the old NCD requirement for a dedicated receiver to be part of a qualified ABPM device. The proposed APBM device specifications are technology neutral as drafted and this allows both innovation and provider choice of device.
• We urge CMS to clarify the relationship between this coverage decision and self-measured blood pressure monitoring. As we noted in our 11/8/18 comments, the AMA’s CPT Editorial Committee has created two new CPT codes on self-measured blood pressure monitoring that align with the evidence base and the USPSTF recommendations for home blood pressure monitoring for diagnosis of hypertension. Today’s technology allows for 24-hour, day and night, blood pressure monitoring to be digitally recorded and shared (OR to be manually recorded and shared), how does this coverage decision relate to the new CPT codes?
• We request CMS provide more direction on the “C. Other Indications” portion of the proposed coverage decision and suggest that CMS list examples of what could be considered but is not currently a listed example of an “other indication.” For example, in our 11/8/19 comment letter, PCHAlliance noted peer reviewed literature (7 citations) and standards of care (1 citation) for use of ABPM for those with spinal cord injury. In our experience, the publication of an NCD leads to use of the specified service/technology ONLY for the specified indications, and a presumption that all other indications are not covered. Without clarity and clear direction on what “other indications” may include, clinically appropriate evidence-based use will be curtailed.
• We note that the specified indications for ABPM are extremely narrow and do not align with the USPSTF recommendations or with the AHA/AMA letter requesting revision of this NCD. This is a concern as it will lead to underuse of APBM compared to the standard of care. We urge CMS to broaden the use of ABPM for the full range of indications supported by the literature OR to clarify that it will cover self-measured home blood pressure monitoring for the full range of indications for which 24-hour blood pressure monitoring is indicated.

We appreciate the opportunity to provide information and are excited that CMS is updating its coverage policy for ABPM. This NCD has the potential to build and advance evidence-based blood pressure monitoring and interoperability. Patients need and expect our health care system to operate with 21st century technology that enables patient-provider electronic communication.

Please contact me if you need any additional information or have questions. The Personal Connected Health Alliance welcomes the opportunity to work with CMS as these and other exciting regulatory and policy changes are under consideration.

Sincerely,

Rob Havasy
Executive Director, Personal Connected Health Alliance

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Dear Ms. Syrek Jensen,

Thank you for the opportunity to respond to the policies included in the Proposed Decision Memo for Ambulatory Blood Pressure Monitoring (ABPM) (CAG-00067R2). Hill-Rom Welch Allyn supports the Centers for Medicare and Medicaid Services’ (CMS) proposed decision to cover ambulatory blood pressure monitoring (ABPM) for the diagnosis and management of hypertension in Medicare beneficiaries under specific circumstances. Hill-Rom appreciates your consideration of our comments below.

Hill-Rom is a leading worldwide manufacturer and provider of medical technologies and related services for the health care industry, including patient support systems, safe mobility and handling solutions, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, surgical products and information technology solutions. Hill-Rom's comprehensive product and service offerings are used by health care providers across the health care continuum and around the world in hospitals, extended care facilities and home care settings to enhance the safety and quality of patient care.

On June 17, 2015, Hill-Rom announced the acquisition of Welch Allyn, a leading global manufacturer of medical diagnostic equipment whose products are utilized in over ninety percent of physician offices in the United States. Welch Allyn has been deeply committed to primary, frontline care for the past 100 years. The combined companies have nearly two centuries of medical device innovation between them and are working together to develop new technologies that make a difference in the lives of Medicare beneficiaries and their caregivers.

Hill-Rom is pleased that the agency is proposing to allow Medicare coverage of ABPM for the diagnosis and management of hypertension in Medicare beneficiaries under specific circumstances, which includes revised guidelines for white coat hypertension (WCH) and expanded coverage for masked hypertension (MH). However, one significant concern is that the “three months of behavioral interventions including diet and exercise modification” may prove to be challenging for patients to fully implement, and for providers to accurately track and document. To wait several visits before activating ABPM to determine whether or not a patient has WCH, due to the required three month period focused on modifying behaviors, is problematic, given the unlikelihood that the targeted patient population will be able to drastically change their lifestyle in this timeframe. Hill-Rom alternatively recommends confirmation of a diagnosis, followed by a treatment recommendation that includes education by the physician. We think in many situations it would be difficult to prove behavior modifications occurred; coupled with likely low compliance, it would contradict the need for expanded ABPM screening for more patients. Not only has this been documented with a number of prevalent hypertensive patients, but consider that 67.2 percent of patients older than 65 years are hypertensive.¹ The issue may be even more problematic for MH patients because “MH is a particularly high risk hypertensive phenotype and should not be left untreated.”² Confirmation of a hypertension diagnosis followed by a treatment recommendation will allow for greater access to ABPM and improved patient outcomes.

Hill-Rom also has concerns with the removal of the 24 hour ABPM monitoring condition. A significant number of MH patients may be missed by not conducting monitoring for a full 24 hours. A recent study highlighted that 24 hour ABPM should be considered in order to provide physicians with a complete record of a patient’s blood pressure.³ Another study that reviewed over ten years of data on 24 hour ABPM monitoring compared to examinations in a clinic also concluded that “ABPM measurements were a stronger predictor of all-cause and cardiovascular mortality than clinic blood-pressure measurements.”⁴ This study, published in the New England Journal of Medicine, determined that WCH “was not benign and masked hypertension was associated with greater risk of death than sustained hypertension.”

Further, we believe it is clinically important that a future coverage determination should highlight specific high-risk patients who need ABPM monitoring for MH and WCH. A systematic review seems to suggest that overweight men greater than 45 years, smokers, pre-hypertensive, and individuals diagnosed with diabetes mellitus may be at greatest risk for MH, and that African American males are also very much at risk.⁵ Additionally, a significant body of literature supports ABPM monitoring “in risk stratification among patients with nondialysis chronic kidney disease (CKD) and kidney transplant” for improved management of various hypertension types.⁶ Focused attention on high-risk patient populations will increase the rate of ABPM monitoring use and improve cardiovascular outcomes in certain patient populations.

Hill-Rom appreciates the opportunity to comment on this Proposed Decision Memo and for the Agency’s consideration of our comments and recommendations. We strongly support the underlying Proposed Decision, but respectfully request consideration of our concerns and recommendations before a final determination is made. Please feel free to contact Thomas Jeffers, Vice President for Government Affairs, at tom.jeffers@hill-rom.com or 812-934-7958 should you have any questions or need additional information.

Sincerely,

Andreas Frank
SVP and President, Front Line Care
Hill-Rom, Inc.

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May 9, 2019

Tamara Syrek Jensen, J.D.
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Dear Ms. Syrek Jensen:

On behalf of Medtronic, I am pleased to respond to the Centers for Medicare & Medicaid Services’ (CMS’s) request for public comment on the proposed National Coverage Determination (NCD) for Ambulatory Blood Pressure Monitoring (ABPM).

Medtronic is the world’s leading medical technology company, specializing in implantable and interventional therapies that alleviate pain, restore health, and extend life. We are committed to the continual research and development necessary to produce high-quality products and to support innovative therapies that improve patients’ lives.

Medtronic appreciates the positive steps CMS takes in the proposed NCD to expand coverage of ABPM to better align with the U.S. Preventive Services Task Force’s Recommendation on Screening for High Blood Pressure (USPSTF) and recent AHA/ACC Hypertension Guidelines.^1,2 We believe the proposed changes will help identify and lead to better management of Medicare beneficiaries with uncontrolled hypertension.

In April 2018, Medtronic received FDA approval for an investigational device exemption (IDE) pivotal trial to evaluate the Symplicity Spyral™ renal denervation system in patients with high blood pressure in the absence of anti-hypertensive drugs.³ In November 2018, Medtronic received FDA approval for a second, randomized, sham-controlled IDE study to evaluate this renal denervation system in patients with high blood pressure who are already prescribed anti-hypertensive drugs.⁴ Because of its precision, reliability, and support from the FDA, an ABPM threshold is used in these studies to identify eligible patients for renal denervation and to evaluate blood pressure reduction following the procedure. Specifically, the primary efficacy endpoint in both studies is blood pressure change from baseline as measured by ABPM.

ABPM measurements have been shown to be a stronger predictor of all-cause and cardiovascular mortality than clinic blood-pressure values. Indeed, at a December 2018 FDA panel meeting evaluating anti-hypertensive devices including renal denervation, the FDA stated, “[T]here was convincing evidence that compared to daytime or office blood pressures, ABPM is a more sensitive and specific method to assess blood pressure, measure cardiovascular risk, and reduce variability due to factors such as white coat hypertension.”⁵

Importantly, ABPM is the only form of blood pressure measurement that can identify diurnal patterns of blood pressure variability including the nighttime “dipping” and “morning surge” that are more closely associated with cardiovascular risk than daytime periods.^6,7 Management of blood pressure is therefore critical during the night. ABPM measurements are important for demonstrating the clinical efficacy of renal denervation as the procedure has been shown in the pilot trials for Symplicity Spyral™ to lower blood pressure over the 24-hour period, including during nighttime and the morning surge periods.^8,9

As new treatments for hypertension, like renal denervation, become available to physicians and patients in the future, the clinical value of ABPM may continue to expand beyond that which is recognized by the proposed NCD in the listed covered indications. It will therefore be important to ensure that there is flexibility for coverage of other uses not explicitly listed in the NCD. To that end, Medtronic strongly supports CMS’s decision to add language leaving coverage of other indications not listed in the NCD at the discretion of the Medicare Administrative Contractors (MACs).

Furthermore, we support the addition of this language given that the USPSTF recommendation and U.S. hypertension guidelines support broader use of ABPM beyond the specific indications covered in the proposed NCD. Specifically, the USPSTF recommends obtaining blood pressure measurements outside of the clinical setting for diagnostic confirmation of hypertension before starting treatment (Grade A) and states that ABPM is the reference standard for confirming the diagnosis of hypertension.¹⁰ The most recent AHA/ACC hypertension guidelines also support out-of-office blood pressure measurement via ABPM or home blood pressure monitoring as a Class 1A recommendation to confirm the diagnosis of hypertension and for titration of blood-pressure lowering medication.¹¹ MACs are well-positioned to review these other uses of ABPM (beyond the indications specified in the proposed NCD) to ensure they are reasonable and necessary based on the clinical circumstances.

Thank you for the opportunity to comment on this proposed NCD. We appreciate CMS’s consideration of our comments. If you have questions or need further information, please feel free to contact me at (763) 526-0963 or bonnie.handke@medtronic.com.

Sincerely,

Bonnie Handke, RN, MBA
Vice President
Health Economics, Policy and Payment
Medtronic

References:

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The American College of Medical Quality is pleased to offer the following public comments to the Centers for Medicare and Medicaid Services regarding Proposed Decision Memo for Ambulatory Blood Pressure Monitoring (ABPM) (CAG-00067R2) as follows:

1. Recommend that CMS revise the clinical circumstances in which ABPM is appropriate and necessary to be consistent with prior guidelines including the 2017 American Heart Association/American College of Cardiology Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults, including:

2. Removal of the requirement of 3 months of lifestyle interventions prior to ABPM use, as there is no empiric evidence to support first proceeding with lifestyle change before obtaining an immediate diagnosis, confirmation, or exclusion of white coat or masked hypertension.

3. Usage of an average office blood pressure of two separate office blood pressure readings

4. Removal of references to out-of-office measurements before a patient is eligible for coverage of ABPM; the proposed NCD’s phrasing suggests that home blood pressure monitoring be done first, while the USPSTF-recommended method for diagnosing hypertension is to use ABPM as the out-of-office blood pressure measurement

5. Addition of the missing diastolic blood pressure range and correction of the systolic range so that it reads “between 120 mm Hg and 129 mm Hg for systolic blood pressure or between 75 mm Hg and 79 mm Hg for diastolic blood pressure.”

6. Recommend that CMS specify nocturnal hypertension as an indication for ABPM.

7. Recommend that a specific blood pressure device validation protocol rather than referring to a specific website that summarizes whether a device has undergone validation testing, be used.

8. Request clarification from CMS regarding the “management” aspect of this proposed coverage determination, given the organizations’ request focused on diagnosis only, and clinical guidelines for management of hypertension differ from the clinical guidelines for diagnosis

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CMS should revise the clinical circumstances in which ABPM is appropriate and necessary to be consistent with the 2017 American Heart Association/American College of Cardiology Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults, including:

(1) Remove the requirement of 3 months of lifestyle interventions prior to ABPM use, as there is no empiric evidence to support first proceeding with lifestyle change before obtaining an immediate diagnosis, confirmation, or exclusion of white coat or masked hypertension.

(2) Use an average office blood pressure of two separate office blood pressure measurements

(3) Remove references to out-of-office BP measurements before a patient is eligible for coverage of ABPM; the proposed NCD’s phrasing suggests that HBPM be done first, while the USPSTF-recommended method for diagnosing hypertension is to use ABPM as the out-of-office BP measurement.

(4) Add the missing diastolic blood pressure range and correct the systolic range so that it reads “between 120 mm Hg and 129 mm Hg for systolic blood pressure or between 75 mm Hg and 79 mm Hg for diastolic blood pressure.”

CMS should specify nocturnal hypertension as an indication for ABPM.

CMS should recommend a specific blood pressure device validation protocol rather than referring to a specific website that summarizes whether a device has undergone validation testing, be used.

CMS should clarify the “management” aspect of this proposed coverage determination, given the fact that clinical guidelines for management of hypertension differ from the clinical guidelines for diagnosis.

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May 9, 2019

Tamara Syrek-Jensen, J.D.
Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Ambulatory Blood Pressure Monitoring (ABPM) National Coverage Determination Proposed Decision Memorandum (CAG-00067R2)

Dear Ms. Syrek-Jensen:

The American College of Cardiology (ACC) appreciates this opportunity to provide input on the proposed national coverage determination (NCD) governing ABPM services provided to Medicare beneficiaries. The ACC envisions a world where innovation and knowledge optimize cardiovascular care and outcomes. As the professional home for the entire cardiovascular care team, the mission of the College and its more than 52,000 members is to transform cardiovascular care and to improve heart health. The ACC bestows credentials upon cardiovascular professionals who meet stringent qualifications and leads in the formation of health policy, standards and guidelines. The College also provides professional medical education, disseminates cardiovascular research through its world-renowned JACC Journals, operates national registries to measure and improve care, and offers cardiovascular accreditation to hospitals and institutions. For more, visit acc.org.

As indicated previously in comments on the national coverage analysis stage, the ACC supports expanded coverage of ABPM services to better define hypertension and blood pressure goals in the care of patients with the most important modifiable risk factor for mortality in the United States. While reports vary widely, in general about 1/3 of patients in studies that evaluated ABPM would be reclassified as masked or white coat hypertension, creating important implications for treatment decisions. Comments below on the proposed NCD focus on clarifying and further improving the indications for coverage CMS proposed, consistent with the 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults¹ which CMS cited in the proposed decision memorandum.

Indications

Management

CMS proposes that ABPM is reasonable and necessary for “diagnosis and management” of hypertension in certain circumstances for beneficiaries with suspected white coat hypertension and suspected masked hypertension. The ACC interprets this to mean that ABPM services would be covered for both patients with undiagnosed hypertension and patients already diagnosed with hypertension. The latter is a key element of care, as patients known to have hypertension still present with white coat or masked hypertension that complicates management. It would be helpful for CMS to confirm coverage in those instances and ensure that the resulting claims processing change request allows claims for patients already diagnosed with hypertension to be managed using ABPM. This would align with CMS’s summary of a European Society of Hypertension working group that recommends repeating ABPM annually or biennially in some patients and more frequently in others.²

Masked Hypertension

The ACC generally supports the proposed expansion to include suspected masked hypertension, though suggests some improvements to the proposed definition masked hypertension. CMS defines this as “office blood pressure between 120 and 130/80 mm Hg on at least two separate clinic/office visits with two separate measurements made at each visit after 3 months of behavioral interventions including diet and exercise modification and at least two blood pressure measurements taken outside the office which are ≥130/80 mm Hg.” This definition—and resulting coverage—would be improved and consistent with guidelines if it instead read, “average office blood pressure ≥120 mm Hg and < 130 mm Hg for systolic blood pressure or ≥75 mm Hg and < 80 mm Hg for diastolic blood pressure on at least two separate clinic/office visits.”

This revision correctly captures patients with only elevated systolic, only elevated diastolic blood pressure, or both elevated systolic and diastolic blood pressure, and incorporates the recommended standard that the relevant blood pressure is derived from an average of at least two measurements.

This revision would also remove a requirement for, “3 months of behavioral interventions including diet and exercise modification” that are discussed as nonpharmaceutical interventions in the guideline but are not actually recommended as a condition of diagnosis. A conservative approach for patients to attempt lifestyle modifications will be part of any course of care but including behavioral intervention and a 3-month delay as a condition of care could prove problematic in several ways. First, if, as ACC already stated it believes, the draft NCD is meant to cover both undiagnosed hypertensive patients as well as already diagnosed hypertensive patients, the latter group would have already attempted these modifications. Second, such a requirement creates a documentation and compliance issue that may hinder care—some clinicians will be uncertain how to correctly document whether the patient successfully attempted lifestyle modifications. Third, clinicians may be hesitant to proceed to ABPM if they are unable to confirm attempts at lifestyle modifications. This is an instance where guideline care recommendations do not translate well into coverage indications.

Finally, this revision would also remove the requirement for two additional blood pressure measurements taken outside the office setting. The guideline discusses a role for home blood pressure monitoring (HBPM) to diagnose masked hypertension that is equal to ABPM, not supplementary. Later comments address HBPM further.

The ACC generally supports the thresholds in the definition for suspected white coat hypertension. However, CMS inadvertently again packaged systolic and diastolic blood pressures together when both can be indicative independently. This definition would be improved if it read, “average office blood pressure >130 mm Hg and <160 mm Hg for systolic blood pressure or >80 mm Hg and <100 mm Hg for diastolic blood pressure on at least two separate clinic/office visits.” This revision again incorporates the role for an average of at least two measurements.

The same rationale to remove a requirement for 3 months of behavioral interventions and two additional blood pressure measurements taken outside the office setting discussed in reference to masked hypertension also apply for white coat hypertension.

Home blood pressure monitoring (HBPM) is recommended in the 2017 guideline as an equal option for diagnosis of adults with suspected white coat hypertension or masked hypertension, as well as for management of adults diagnosed with white coat hypertension. Specific procedures for collection of HBPM data are shared in Table 10 of the guideline.

The AMA CPT Editorial Panel indicated in its summary of panel actions from the September 2018 meeting that two new codes were created to report self-measured blood pressure monitoring. Self-measured blood pressure monitoring is simply another name for HBPM. While not addressed in coverage section of the proposed NCD, CMS should consider whether incorporation of HBPM into care of hypertensive patients would warrant an additional NCD, could be incorporated into an amended version of this NCD, or is simply going to be added to the physician fee schedule without any coverage policy from CMS, leaving coverage of these services to contractor discretion. The ACC recommends CMS incorporate HBPM into this revised ABPM NCD to provide patients and caregivers an additional option for diagnosing and managing hypertension.

Thank you for considering this feedback regarding Medicare coverage of ABPM and HBPM. Please contact James Vavricek at jvavricek@acc.org if you need additional information from the College.

Sincerely,

Richard Kovacs, MD, FACC
President

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Division of Nephrology
777 Welch Road, Suite DE
Stanford University School of Medicine
Stanford, CA 94304-5114
(650) 498-4809

May 8, 2019

Public Comment to CMS re: Proposed Decision Memo for Ambulatory Blood Pressure Monitoring (CAG-00067R2)

We are pleased to see that CMS has proposed a new guideline (A) for coverage of 24-hour ambulatory blood pressure monitoring (ABPM) to diagnose masked hypertension, in addition to existing coverage for white coat hypertension. The circumstances outlined in the proposal are reasonable. Coverage for this condition will lead to novel and real-world insights into masked hypertension. We welcome this proposal and the benefits that will ensue. Expanding Medicare coverage of ABPM will advance the field of hypertension care for the following reasons:

In part (B) of the proposal, the recommendation for “other indications” is still somewhat vague and may lead to inequities in coverage. Respectfully, we would propose that in (B), CMS specifies additional conditions for which ABPM may be considered for coverage. These would include: suspected nocturnal hypertension and paroxysmal hypertension.

We are encouraged by this new CMS proposal. We would simply request that in part (B), conditions for use of ABPM be more specifically defined as these are the likely reasons why it may be prescribed, and additional details may help insurers and providers to be more precise about the use of this important technology.

Thank you for your time and attention.

Vivek Bhalla, MD, FASN, FAHA
Director, Stanford Hypertension Center
Stanford University School of Medicine
vbhalla@stanford.edu
@Stanford_HTN

Tara I. Chang, MD, MS, FASN
Associate Professor of Medicine
Director, Clinical Research
Division of Nephrology
Stanford University School of Medicine
@taraichang

Robert T. Isom, MD
Clinical Associate Professor
Co-Director, Stanford Hypertension Center
Stanford University School of Medicine
risom@stanford.edu

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As a nephrologist with a major clinical focus in the care of complex hypertension and research focus surrounding hypertension measurement, I share the concerns expressed by the AMA and AHA regarding the proposed CMS coverage. I strongly urge CMS to reconsider the clinical circumstances around which ABPM is covered, in order to be consistent with current guidelines. Specifically, I am not aware of any evidence that three months of lifestyle modifications are appropriate prior to screening for masked or white coat hypertension, nor that home blood pressure monitoring is necessary or appropriate prior to ABPM (alternatively, evidence suggests at this time that home blood pressure monitoring should only be used for diagnosis of masked or white coat hypertension when ABPM is not available, and that ABPM and home blood pressure monitoring can be highly discrepant). Particularly, home blood pressure cannot capture non-dipping and reverse dipping, which are of substantial prognostic significance and may be missed under the proposed coverage scheme if a patient’s self-monitored home blood pressure seems to be at goal. Accordingly, evaluation for nocturnal hypertension should be included as an indication for ABPM, given robust evidence of cardiovascular the risk of non-dipping.

Additionally, I am concerned about the coverage document’s repeated references to dableducational’s website, as this site is outdated and inaccurate/biased in several instances. Please see our recent publication in Hypertension (Cohen JB et al. Hypertension. 2019 Feb;73(2):258-264. doi: 10.1161/HYPERTENSIONAHA.118.11990) for further details regarding this concern. I urge CMS to recommend that devices be validated using the AAMI/ISO protocol rather than referring individuals to this website.

Furthermore, I agree with the AHA and AMA that there needs to be greater clarification regarding coverage for individuals who are already receiving management for known hypertension, as these individuals also stand to benefit a great deal from coverage of ABPM.

I hope that CMS will reconsider the wording of the current proposed coverage. Thank you for considering our comments during this time.

Regards,

Jordana Cohen, MD, MSCE

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Consistent with AHA & AMA, PCNA, recommends that CMS revise the clinical circumstances in which ABPM is appropriate and necessary to be in line with prior guidelines including the 2017 AHA/ACC Guidelines for Prevention, Detection, Evaluation & Management of High Blood Pressure in Adults.

Specifically, consistent with AHA & AMA's recommendation, PCNA recommends removal of the 3 month requirement of lifestyle intervention prior to ABPM use because of lack of evidence supporting this statement/recommendation. In addition, we recommend removal of reference to out-of-office measurements before a patient is eligible for coverage of ABPM . We also recommend that CMS specify nocturnal hypertension as an indication for ABPM and that a specific BP device validation protocol rather than reference to a website be used. Finally PCNA also recommends clarification from CMS regarding "management" aspect of the proposed coverage determination - given the organizations' request focused on diagnosis only and clinical guidelines for management of hypertension differ from the guidelines for diagnosis

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Recommend that CMS revise the clinical circumstances in which ABPM is appropriate and necessary to be consistent with prior guidelines including the 2017 American Heart Association/American College of Cardiology Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults, including:

• Removal of the requirement of 3 months of lifestyle interventions prior to ABPM use, as there is no empiric evidence to support first proceeding with lifestyle change before obtaining an immediate diagnosis, confirmation, or exclusion of white coat or masked hypertension.
• Usage of an average office blood pressure of two separate office blood pressure readings
• Removal of references to out-of-office measurements before a patient is eligible for coverage of ABPM; the proposed NCD’s phrasing suggests that home blood pressure monitoring be done first, while the USPSTF-recommended method for diagnosing hypertension is to use ABPM as the out-of-office blood pressure measurement
• Addition of the missing diastolic blood pressure range and correction of the systolic range so that it reads “between 120 mm Hg and 129 mm Hg for systolic blood pressure or between 75 mm Hg and 79 mm Hg for diastolic blood pressure.”
• Recommend that CMS specify nocturnal hypertension as an indication for ABPM.
• Recommend that a specific blood pressure device validation protocol rather than referring to a specific website that summarizes whether a device has undergone validation testing, be used.
• Request clarification from CMS regarding the “management” aspect of this proposed coverage determination, given the organizations’ request focused on diagnosis only, and clinical guidelines for management of hypertension differ from the clinical guidelines for diagnosis.

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May 7, 2019

Tamara Syrek Jensen, J.D.
Director
Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare and Medicaid Services
Baltimore, MD 21244

Re: Proposed National Coverage Decision for Ambulatory Blood Pressure Monitoring (ABPM) (CAG-00067R2)

Dear Director Jensen:

On behalf of Ochsner Health System, I am writing to express our appreciation for the opportunity to comment on the Proposed National Coverage Determination for Ambulatory Blood Pressure Monitoring (ABPM). We commend leaders of the Centers for Medicare and Medicaid Services (CMS) for this proposed decision that could expand the use of out-of-office tools and devices to diagnose and treat the widespread prevalence of hypertension among Medicare beneficiaries.

As you have emphasized in the proposed decision memo, the prevalence of hypertension in the United States is 30.5% according to the Centers for Disease Control and Prevention (CDC), and the rate of uncontrolled hypertensives was 55.4%. In addition, and among Medicare eligible beneficiaries, 67.4% of women between the ages of 65 and 74 have hypertension, rising to a rate of 78.7% for women 75 years of age and older. Among men, the prevalence of hypertension was 61.1% and 67.4% for these respective age groups. Further, the proposed decision memo thoroughly describes the major population-based risks of hypertension that can lead to cardiovascular disease, heart attack, stroke, kidney disease, vision loss, chronic heart failure, and other disabling and serious medical conditions, which will accelerate as the population ages and Medicare eligibility and enrollment continue to grow.

We commend CMS for recognizing and addressing this important area of care management and offering new ways to identify and treat people with hypertension and help these patients manage their disease while preventing and reducing these dangerous health conditions and associated cost. Ochsner generally supports the Proposed National Coverage Decision for ABPM and stands ready to work with you and the agency to improve the nation’s efforts to prevent and control high blood pressure and its complications.

Overview of Ochsner Health System

Ochsner, one of the nation’s leading health systems, is headquartered in New Orleans and provides a comprehensive range of services through its network of more than 30 owned, managed, or affiliated hospitals, and 110 total sites of care, including its health centers and urgent care clinics, which are located throughout Louisiana and Mississippi. Ochsner offers a wide array of specialized and nationally ranked services with its 3,600 affiliated physicians, including 1,300 employed physicians practicing in more than 90 specialties and subspecialties, and more than 25,000 employees. Each year Ochsner and its hospital and physician partners serve over 1 million individual patients who come from every state in the nation and more than 60 countries across the world. Finally, Ochsner is one of the nation’s largest independent academic medical centers with nearly 300 full-time residents and fellows participating in 27 ACGME accredited programs and four additional specialty programs; a global medical school in partnership with The University of Queensland School of Medicine based in Brisbane, Australia; and, programs of biomedical research.

Comments on the Proposed National Coverage Determination for Ambulatory Blood Pressure Monitoring

Ochsner strongly supports the proposed decision by CMS stating there is sufficient evidence to determine that ABPM is reasonable for the diagnoses and management of hypertension for Medicare beneficiaries with suspected white coat hypertension and suspected masked hypertension, which is a major risk factor for adverse outcomes. We agree with the proposed clinical guidelines for the use of ABPM and the assessment that the use of ABPM will improve health outcomes in patients with suspected white coat hypertension and patients with suspected masked hypertension.

Ochsner also believes that it is important to have standards governing ABPM devices, and agrees with the four major criteria that have been proposed, including:

• Quality-certified and validated for use in the intended patient population by the dabl Educational Trust Ltd. or by a similar blood pressure monitoring device quality control organization;
• Capable of producing standardized plots of blood pressure measurements for 24 hours with daytime and night-time windows and normal blood pressure bands demarcated;
• Provided to patients with oral and written instructions and a test run in the physician’s office must be performed; and
• Read by the treating physician or treating non-physician practitioner.

Ochsner Hypertension Digital Medicine Program: A New Model of Care

As the agency considers new policies, payments, and programs to improve hypertension diagnosis and treatment, we respectfully wish to restate and share with you the approach and results of our Hypertension Digital Medicine program. Ochsner has been actively engaged in the development of digital medicine programs for the treatment of chronic disease, and one such model is our innovative and nationally recognized Hypertension Digital Medicine program.

In contrast to traditional models of care, which are based on episodic data points and physician visits, our Hypertension Digital Medicine program offers a continuous care model, where – through the use of connected devices – blood pressure data is automatically sent to their electronic medical record where it is monitored remotely by a dedicated care team that provides proactive, preventive interventions. Patients enrolled in the program take their blood pressure weekly using a wireless, at-home blood pressure cuff. The results are directly transmitted to their care team, who are able to see the trends in each patient’s blood pressure measurements and make changes to their treatment as needed.

This innovative approach allows more frequent data and a more meaningful feedback loop between patients and the care team, instead of relying on only a handful of readings each year during in-office visits. Office visit readings, due to “White Coat Hypertension,” often can be inaccurate. Data directly from home can identify both white coat hypertension as well as masked hypertension accurately. Using real-time information and trend data from patient’s readings in their home, we can provide patients timely and tailored feedback, such as medication adjustments, healthy eating tips, and exercise goals. Patients and their physicians receive monthly reports to track progress.

Results of the program show it is an effective means of achieving and maintaining blood pressure control. More than 71% of patients, who were previously out of control, achieved control within 90 days of entering the program, compared to 31% percent of patients following the traditional care model.^*1

Through its intentional focus on patient engagement, Ochsner’s Hypertension Digital Medicine program has also helped to increase medication adherence by 7.5%, compared with a 2.5% lower adherence in the usual care control group.

For patients, lower blood pressure means a lower likelihood of heart attack, stroke, and kidney failure. In turn, these changes in patient risk factors for numerous chronic diseases will reduce costs and improve patient quality of life.

Conclusion

Once again, on behalf of Ochsner Health System, please accept our thanks for your thoughtful consideration of these comments. Ochsner has a long-standing commitment to innovation in the diagnosis and management of chronic disease and we are eager to be a resource for you and your colleagues on these and other important policy and payment issues. We welcome the opportunity to partner with you and the agency to consider other ways in which the Medicare program can support the deployment of innovative, convenient, and affordable models of care that extend the positive impact of digital medicine platforms and capabilities to the benefit of patients, providers, and the Medicare Trust Fund.

Sincerely,

Philip M. Oravetz, MD, MPH, MBA
Chief Population Health Officer
Ochsner Health System
1514 Jefferson Highway
New Orleans, LA 70121

Endnote: *1 Milani RV, et al., Improving Hypertension Control and Engagement Using Digital Tools, Am J Medicine 2017;130:14-20.

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To: Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services

From: American Society of Pediatric Nephrology

re: Proposed Decision Memo for Ambulatory Blood Pressure Monitoring (ABPM) (CAG-00067R2)

The American Society of Pediatric Nephrology (ASPN) is pleased to offer comments on the proposed decision memo for ambulatory blood pressure monitoring (ABPM).

Founded in 1969, ASPN is a professional society composed of pediatric nephrologists whose goal is to promote optimal care for children with kidney disease and to disseminate advances in the clinical practice and basic science of pediatric nephrology. ASPN currently has over 700 members, making it the primary representative of the Pediatric Nephrology community in North America.

As the voice for pediatric kidney disease, ASPN strives to ensure that infants, children, adolescents and young adults with kidney disease receive appropriate and quality care. As such, we offer the following comments to the proposed decision memo.

We previously submitted comments in November 2018 on CMS’ request for reconsideration of an existing National Coverage Determination (NCD) on ABPM and we are pleased that CMS expanded this coverage for beneficiaries with suspected white coat hypertension and suspected masked hypertension. While we support these changes in the proposed decision memo, several areas of concern remain that, if implemented as written, would hinder access to critical care for children with chronic kidney disease (CKD) and other high-risk patients.

ASPN continues to recommend that CMS include pediatric kidney disease patients in the population covered by the ABPM decision memo. Pediatric ESRD patients are unique in that they are eligible for Medicare coverage and there are well-established links between childhood hypertension (HTN) and CKD. Among children and adolescents with CKD, approximately 50 percent are known to be hypertensive.¹ In children and adolescents with end-stage renal disease (either those on dialysis or after transplant), between 48 percent to 79 percent are hypertensive, with 20 percent to 70 percent having uncontrolled HTN.² Almost 20% of pediatric HTN may be attributable to CKD.³

The American Academy of Pediatrics’ (AAP) 2017 Clinical Practice Guidelines for Screening and Management of High Blood Pressure in Children and Adolescents include specific key action statements regarding use of ABPM in children and adolescents that we have included for your reference below.

• ABPM should be performed for confirmation of hypertension in children and adolescents with office BP measurements in the elevated BP category for 1 year or more or with stage 1 hypertension over 3 clinic visits.
• Routine performance of ABPM should be strongly considered in children and adolescents with high-risk conditions (secondary hypertension, chronic kidney disease, diabetes, solid organ transplant, obesity, obstructive sleep apnea, aortic coarctation, genetic syndromes associated with hypertension, treated hypertensive patients, history of premature birth) to assess hypertension severity and determine if abnormal circadian BP patterns are present, which may indicate increased risk for target organ damage.
• Children and adolescents who have undergone coarctation repair should undergo ABPM for the detection of hypertension.
• ABPM may be used to assess treatment effectiveness in children and adolescents with hypertension, especially when clinic and/or home BP measurements indicate insufficient BP response to treatment. ⁴

ASPN also recommends that CMS recognize the unique needs of patients with high-risk conditions such as kidney disease, diabetes, and those who have received transplants in this coverage policy. According to the AAP’s 2017 Clinical Practice Guideline, “the routine performance of ABPM should be strongly considered in children and adolescents with high-risk conditions (see Table 12 below) to assess HTN severity and determine if abnormal circadian BP patterns are present, which may indicate increased risk for target organ damage (grade B, moderate recommendation).”⁵

ASPN is also concerned that the proposed NCD includes a requirement that three-months of behavioral interventions including diet and exercise modification take place before ABPM is covered again for a patient. For pediatric patients with CKD, behavioral modifications are not first line therapy for hypertension given the association between hypertension and progression of CKD, and the fact that behavioral modifications do not address the underlying cause of hypertension, namely kidney disease. While behavioral modifications are still important, the 2017 AAP Guidelines recommend that children with ‘any stage of hypertension associated with CKD or diabetes mellitus therapy should be initiated with a single medication’ for management of hypertension, rather than a trial of lifestyle modifications. In addition, since many children with CKD have masked hypertension, ABPM may be the best tool for monitoring effectiveness of therapy.

We appreciate the opportunity to offer comments to CMS. Please contact our Washington representative, Erika Miller, at (202) 484-1100 or emiller@dc-crd.com if we can provide additional information or clarification regarding ASPN’s comments.

Sincerely,

Patrick Brophy, MD, MHCDS
President

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May 9, 2019

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services

Dear Ms. Syrek,

On behalf of the National Association of Community Health Centers, we are pleased to provide comments in response to CMS' Proposed Decision Memo for Ambulatory Blood Pressure Monitoring (ABPM) (CAG-00067R2).

NACHC is the national membership organization for federally qualified health centers (FQHCs or "health centers"). With over 1400 organizations and 11,000 delivery sites nationwide, health centers are non-profit, community-directed providers that serve as the primary medical home for 28 million patients, including 1 in 6 Medicaid beneficiaries. Health centers serve as the largest primary care network in the country, providing comprehensive services in all 50 states and U.S. Territories. For more detail on health centers, please see Attachment A.

NACHC appreciates the CMS' efforts to improve patient access to ambulatory blood pressure monitoring. We would specifically like to offer the following comments as CMS works to finalize this memo.

• We recommend that CMS revise the clinical circumstances in which ABPM is appropriate and necessary to be consistent with prior guidelines including the 2017 American Heart Association/American College of Cardiology Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults, including:
  • Removal of the requirement of 3 months of lifestyle interventions prior to ABPM use, as there is no empiric evidence to support first proceeding with lifestyle change before obtaining an immediate diagnosis, confirmation, or exclusion of white coat or masked hypertension.
  • Usage of an average office blood pressure of two separate office blood pressure readings
  • Removal of references to out-of-office measurements before a patient is eligible for coverage of ABPM; the proposed NCD's phrasing suggests that home blood pressure monitoring be done first, while the USPSTF-recommended method for diagnosing hypertension is to use ABPM as the out-of-office blood pressure measurement
  • Addition of the missing diastolic blood pressure range and correction of the systolic range so that it reads "between 120 mm Hg and 129 mm Hg for systolic blood pressure or between 75 mm Hg and 79 mm Hg for diastolic blood pressure."
• We recommend that CMS specify nocturnal hypertension as an indication for ABPM.
• Recommend that a specific blood pressure device validation protocol rather than referring to a specific website that summarizes whether a device has undergone validation testing, be used.
• Request clarification from CMS regarding the "management" aspect of this proposed coverage determination, given the organizations' request focused on diagnosis only, and clinical guidelines for management of hypertension differ from the clinical guidelines for diagnosis.

Health centers appreciate CMS's work to improve access to patient care. Thank you for the opportunity to comment on this draft decision memo. NACHC and its member organizations are willing to provide clarification or answer any follow up information on our comments, please contact Meg Meador at mmeador@nachc.org.

Sincerely,

Ron Yee, MD, MBA, FAAFP
Chief Medical Officer
National Association of Community Health Centers

For over 50 years, health centers have provided access to quality and affordable primary and preventive healthcare services to millions of uninsured and medically underserved people nationwide, regardless of their ability to pay. At present there are almost 1,400 health centers with more than 11,000 sites. Together, they serve over 28 million patients, including 8.4 million children and more than 1 in 6 Medicaid beneficiaries.

Health centers provide care to all individuals, regardless of their ability to pay. All health centers provide a full range of primary and preventive services, as well as services that enable patients to access health care appropriately (e.g., translation, health education, transportation). A growing number of Health Centers also provide dental, behavioral health, pharmacy, and other important supplemental services.

To be approved by the Federal government as a Health Center, an organization must meet requirements outlined in Section 330 of the Public Health Service Act. These requirements include, but are not limited to:

• Serve a federally-designated medically underserved area or a medically underserved population. Some Health Centers serve an entire community, while other target specific populations, such as persons experiencing homelessness or migrant farmworkers.
• Offer services to all persons, regardless of the person's ability to pay.
• Charge no more than a nominal fee to patients whose incomes are at or below the Federal Poverty Level (FPL).
• Charge persons whose incomes are between 101% and 200% FPL based on a sliding fee scale.
• Be governed by a board of directors, of whom a majority of members must be patients of the health center.

Most Section 330 health centers receive Federal grants from the Bureau of Primary Health Care (BPHC) within HRSA. BPHC's grants are intended to provide funds to assist health centers in covering the otherwise uncompensated costs of providing care to uninsured and underinsured indigent patients, as well as to maintain the health center's infrastructure. Patients who are not indigent or who have insurance, whether public or private, are expected to pay for the services rendered. In 2017, on average, the insurance status of Health Center patients is as follows:

• 49% are Medicaid recipients
• 23% are uninsured
• 18% are privately insured
• 9% are Medicare recipients

No two health centers are identical, but they all share one common purpose: to provide primary health care services that are coordinated, culturally and linguistically competent, and community-directed, to uninsured and medically underserved people.

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ABPM in the diagnosis and management of hypertension is a vital tool for patients and clinicians. Indications for its use are clearly delineated by the American College of Cardiology and American Heart Association. Given this, the proposed changes should consider further alignment with the 2017 ACC/AHA guidelines on hypertension. Specifically, consideration should be given to removing the requirement for 3 months of lifestyle intervention prior to ABPM use, as evidence is lacking to support this 3 month time frame. Second, when considering the office BP cutoffs, an average office BP threshold over 2 separate visits should be utilized. Next, elevated diastolic BP readings in the range of 75 mmHg to 79 mmHg should be included as a criteria for ABPM use.

The USPSTF also provides guidance on ABPM use. CMS should consider aligning with the USPSTF in recommending the use of ABPM for the use of diagnosing elevated out of office hypertension, rather than relying on home BP monitoring and then using ABPM as a confirmation.

Finally, given that ABPM is the only manner currently available to easily diagnosis nocturnal hypertension, a well documented cardiovascular risk, nocturnal hypertension should be added as an indication for ABPM use. Thank you.

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May 8, 2019

Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: CAG00067R2
Proposed Decision Memo for Ambulatory Blood Pressure Monitoring

Dear Sir/Madam,

On behalf of the National Association of Chronic Disease Directors (NACDD), we appreciate the opportunity to submit a comment on CMS’ proposed National Coverage Determination for Ambulatory Blood Pressure Monitoring (ABPM).

Given its mission to improve the health of the public by strengthening state-based leadership and expertise for chronic disease prevention and control, NACDD is a critical stakeholder in improving the health of the nation. For the past 30 years, NACDD has provided training and technical assistance opportunities to build state, local, and territorial health department capacity, such as national and state-specific chronic disease academies designed to support the core work of health departments, webinars, communities of practice, as well as peer exchange related to health systems, policy development, epidemiology, and evaluation. In addition, NACDD has developed toolkits, websites, issue briefs, white papers, success stories, translation materials, and other resources to guide states and partners in carrying out evidence-based work of chronic disease prevention and health promotion, often specific to high-burden populations, including those who have less access to health care and/or poorer quality of care.

With nearly 75 million Americans with hypertension and only half of these with controlled disease,¹ not to mention cardiovascular disease-specific healthcare costs of roughly $316 billion annually,² cardiovascular health promotion and disease prevention has been a priority for NACDD since 1998. Additionally, given the increased risk for heart attack, stroke, chronic heart failure, and kidney disease associated with hypertension,³ many of these efforts have concentrated on improving hypertension management and control, in alignment with the priorities of the Centers for Disease Control and Prevention’s Division for Heart Disease and Stroke Prevention. Yet there is still considerable room for improvement in cardiovascular care, and we advocate for providing patients with as many effective and economical opportunities to manage their disease as possible. With the benefit of this breadth and depth of experience, we submit the following comment for your consideration.

As detailed in your Proposed Decision Memo, there is a considerable body of evidence supporting the procurement of blood pressure readings outside the clinical setting. Per the American College of Cardiology/American Heart Association Task Force on Clinical Practice 2017 hypertension guideline, ABPM is considered the gold standard in out-of-office blood pressure readings given its condensed record of readings at regular intervals over a 24-hour period. ⁴ However, this guideline further notes Home Blood Pressure Monitoring (HBPM), also known as Self-Measured Blood Pressure (SMBP) monitoring, may be the more practical approach to collecting non-clinical blood pressure readings when employed with a validated device and via proper protocols. ⁴ As a result, we recommend including SMBP as an affordable and accessible alternative to ABPM for diagnosis confirmation and ongoing hypertensive patient management as part of your decision on ABPM coverage. The inclusion of SMBP with additional supports is directly aligned with the 2019 US Preventive Services Task Force Final Recommendation Statement on High Blood Pressure in Adults, where it is noted, “In addition to office blood pressure measurement, ABPM and HBPM may be used to confirm a diagnosis of hypertension after initial screening.” ⁵

SMBP trains patients to use validated blood pressure measurement devices on a regular basis in settings with which they are familiar, such as their homes. Patients’ blood pressure readings are then shared with their providers in-person during clinical appointments, via phone, or electronically. This approach, therefore, addresses industry-wide concerns of misdiagnosis and mis-management as a result of white coat hypertension, and provides multiple data points on which clinicians can assess patient severity and degree of disease control. Further, the volume and consistency of readings provided via SMBP, coupled with regular provider touch-points and support, has been shown to increase controlled patient engagement and investment in their care, leading to sustained blood pressure control and hypertension management. ⁶ Given the opportunity to access SMBP devices with clinical supports, this same effect may likely be seen in people with uncontrolled hypertension.

In addition, when employed with web or phone-based support from health care providers or as part of a team-based care model, SMBP has been found to be a cost-effective management tool among the uncontrolled hypertensive population. ⁷ The clinical supports noted above, such as training on BP monitor use, validation of device, data capture, etc., can be provided by a variety of professionals beyond licensed clinicians, thereby further decreasing costs. Community-based organizations such as YMCAs, senior centers, etc., are also excellent possible partners in providing supports to SMBP patients, potentially reducing the clinical burden of patient management, while improving overall hypertension management.

As healthcare continues to move towards a holistic value-based care model, SMBP with additional supports should be a central component of hypertension management. We wholeheartedly support its coverage by CMS.

Thank you again for your consideration of our comments.

Sincerely,

John Robitscher
Chief Executive Officer
National Assocition of Chronic Disease Directors

CC: NACDD 2019 Board of Directors
NACDD Cardiovascular Health Council

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I am a pediatric nephrologist, and as such provide ESRD care for some of the youngest beneficiaries of Medicare. I have multiple concerns about the current proposed policy.

1) The inclusion of only absolute BP thresholds to qualify for payment. In a young child, these values well exceed stage 1 and potentially even stage 2 hypertension thresholds, such that they would be inappropriate if applied to the pediatric population, and may well exclude from coverage our patients, even when concern for either masked or white coat HTN is present. Please consider inclusion of percentiles based thresholds/definitions for children.

2) It is entirely possible for a pediatric CKD patientwho is high risk for long term cardiovascular sequelae of HTNto have masked hypertension that is isolated to sleep hours. This is well documented in several publications from the Chronic Kidney Disease in Children (aka CKiD) study. It is impractical to require families of these patients to take blood pressures at night and document those to be abnormal for a patient to be considered "at risk" for masked hypertension. I would therefore respectfully submit that known high risk conditions (i.e. chronic kidney disease, solid organ transplant, sickle cell disease, and other) be exempted from the requirement to document abnormally elevated BPs out of office prior to allowing coverage for ABPM.

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May 9, 2019

Tamara Syrek Jensen, J.D.
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: CAG-00067R2 Proposed National Coverage Determination for Ambulatory Blood Pressure Monitoring

Dear Ms. Syrek Jensen:

On behalf of the American Heart Association and the American Medical Association, we would like to thank the Centers for Medicare and Medicaid Services (CMS) for responding to our request for a reconsideration of the Ambulatory Blood Pressure Monitoring (ABPM) National Coverage Determination (NCD) by proposing to expand coverage and issuing a revised coverage determination.

We are pleased that CMS has proposed expanding the covered indications for ABPM to include masked hypertension, as well as making Medicare’s ABPM coverage policy consistent with recent changes to the thresholds used for diagnosing hypertension. There are several areas, however, where we believe modifications and corrections are necessary to ensure coverage and use of ABPM that is consistent with published clinical guidelines. Recognizing that office based blood pressure determinations lack the precision needed and reproducibility over multiple office measurements to make an accurate diagnosis of hypertension, it is imperative that the NCD be structured such that it supports the use of ABPM to achieve its fullest potential to reduce the harms caused by hypertension among Medicare beneficiaries as described and given an ‘A’ rating by the U.S. Preventive Services Task Force (USPSTF)¹.

Specifically, we recommend that CMS:

• Revise the clinical circumstances in which ABPM is appropriate and necessary to be consistent with prior guidelines including the 2017 American Heart Association/American College of Cardiology Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults (referred to as “2017 AHA/ACC guideline”²).
• Specify nocturnal hypertension as an indication for ABPM. Nocturnal hypertension can only be diagnosed precisely by ABPM and is common in morbid conditions such as chronic kidney disease, diabetes mellitus, systolic hypertension in older persons, and neurodegenerative diseases.
• Recommend a specific blood pressure device validation protocol rather than referring to a specific website that summarizes whether a device has undergone validation testing.
• Request clarification from CMS regarding the “management” aspect of this proposed coverage determination, given the organizations’ request focused on diagnosis.

We expand upon these recommendations below.

In the proposed coverage determination, CMS describes the two circumstances in which it has determined ambulatory blood pressure monitoring is reasonable and necessary, as follows:

1. For beneficiaries with suspected white coat hypertension, which is defined as office blood pressure ≥130/80 mm Hg and < 160/100 mm Hg on at least two separate clinic/office visits with two separate measurements made at each visit after 3 months of behavioral interventions including diet and exercise modification and with at least two blood pressure measurements taken outside the office which are < 130/80 mm Hg;


2. For beneficiaries with suspected masked hypertension, which is defined as office blood pressure between 120 and 130/80 mm Hg on at least two separate clinic/office visits with two separate measurements made at each visit after 3 months of behavioral interventions including diet and exercise modification and at least two blood pressure measurements taken outside the office which are ≥130/80 mm Hg.

We recommend that the following revisions be made to these conditions to ensure their consistency with previously published definitions and blood pressure thresholds.

First, in both circumstances as proposed in the coverage determination, “3 months of behavioral interventions including diet and exercise modification” would be required before beneficiaries are eligible for ABPM. Lifestyle interventions, as described in the proposed coverage determination, are not an essential criterion since there is no empiric evidence to support first proceeding with lifestyle change before obtaining an immediate diagnosis, confirmation, or exclusion of white coat or masked hypertension. For example, the USPSTF has not required that lifestyle change be conducted first before a diagnosis of hypertension be made using office blood pressure and out-of-office blood pressure. Therefore, we recommend strongly that this portion of the condition be removed.

Second, according to the 2017 AHA/ACC guideline, “an average of ≥2 readings obtained on ≥2 occasions [be used] to estimate the individual’s level of office blood pressure.” Accordingly, we recommend that the language be revised to indicate an average office blood pressure, not simply two separate office blood pressure readings. Averaging multiple readings is important because it provides a more stable estimate of blood pressure than using one reading.

Third, we request that references to out-of-office measurements before a patient is eligible for coverage of ABPM be removed. As currently written, the phrasing (“blood pressure measurements taken outside the office”) suggests that home blood pressure monitoring be done first before ABPM should be done. The USPSTF-recommended method for diagnosing hypertension is to use ABPM as the out-of-office blood pressure measurement, and when not available, the next recommendation is home blood pressure monitoring as the alternative approach that “may be acceptable.” Home blood pressure monitoring is not currently covered or reimbursed for Medicare patients, and so we are concerned that including this step not only does not align with the USPSTF recommendations or clinical guidelines, but will also confuse practitioners and deter use of ABPM since there is no coverage for delivering the necessitated previous step. Additionally, it is not clear how patients would obtain a monitor in these circumstances, suggesting that the burden would be on the patient to purchase a monitor, in the absence of coverage. Therefore, we recommend that this requirement be removed.

Lastly, the masked hypertension circumstance appears to be missing a diastolic blood pressure range and the systolic range is incorrect. According to the 2017 ACC/AHA guideline, the threshold should be “between 120 mm Hg and 129 mm Hg for systolic blood pressure or between 75 mm Hg and 79 mm Hg for diastolic blood pressure.”

Based on these recommendations, we propose the revised circumstances read as follows:

1. For beneficiaries with suspected white coat hypertension, which is defined as an average office blood pressure of SBP greater than 130 mm Hg but less than 160 mm Hg or DBP greater than 80 mm Hg but less than 100 mm Hg on two separate clinic/office visits with at least two separate measurements made at each visit.


2. For beneficiaries with suspected masked hypertension, which is defined as average office blood pressure between 120 mm Hg and 129 mm Hg for SBP or between 75 mm Hg and 79 mm Hg for DBP on at two separate clinic/office visits with at least two separate measurements made at each visit.

Using previously published nighttime blood pressure thresholds (nighttime systolic blood pressure ≥120 mmHg or nighttime diastolic blood pressure ≥70 mmHg,^3,4 ) the prevalence of nocturnal hypertension is estimated to be 20-60%⁵ with a very high prevalence being reported among African Americans.⁶ Nocturnal hypertension is defined by the 2017 AHA/ACC 2017 guideline to be a nighttime systolic blood pressure ≥110 mmHg or nighttime diastolic blood pressure ≥65 mmHg. The prevalence of nocturnal hypertension is likely to be higher using these lower nighttime blood pressure thresholds. Data described in several studies suggest that nighttime blood pressure is a stronger predictor of outcomes compared with daytime blood pressure.^7,8,9,10 Guidelines, including those of the European Society of Hypertension and European Society of Cardiology consider the definition of masked hypertension be based not only on daytime blood pressure but also nighttime blood pressure. The proposed definition of masked hypertension, however, would not specifically identify nocturnal hypertension and so we are recommending that an indication be added to enable the use of ABPM to detect cases of suspected nocturnal hypertension.

In the proposed coverage determination, CMS proposes a list of requirements for ABPM devices, including that they be “quality-certified and validated for use in the intended patient population by the dabl Educational Trust Ltd. or by a similar blood pressure monitoring device quality control organization.” While we recognize CMS provides leeway for other organizations that reference blood pressure devices that meet quality requirements, we believe that rather than specifying a particular website (whose accuracy cannot be confirmed or lifespan of webhosting is not reported), CMS should specify which validation protocol, such as those developed by the International Organization for Standardization (ISO) and the Association for the Advancement of Medical Instrumentation (AAMI), should be used.

Our initial coverage determination request focused on the use of ABPM for diagnosis of hypertension to match the USPSTF guidance and A rating for “obtaining measurements outside of the clinical setting for diagnostic confirmation before starting treatment.” The proposed coverage determination allows for ABPM for diagnosis “and management.” We were pleased to see that CMS recognizes the role for ABPM in the management of hypertension, but our organizations would also appreciate if CMS could provide some additional clarification about the “management” aspect of this Medicare coverage policy.

In closing, we reiterate the American Heart Association and the American Medical Association appreciation of CMS’s proposed expansion of its National Coverage Determination and encourage CMS to incorporate our proposed revisions. If you or your staff have any questions or would like to discuss our comments further, please do not hesitate to contact Madeleine Konig at madeleine.konig@heart.org or 202-785-7930.

Sincerely,

Ivor J. Benjamin, MD, FAHA
President
American Heart Association

James L. Madara, MD
Executive Vice President, CEO
American Medical Association

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If you can’t measure it, you can’t understand it. If you can’t understand it, you can’t control it. If you can’t control it, you can’t improve it. Having an understanding of vascular health is vital for long-term health and provides critical information that can help physicians and payors identify problems before they become dangerous and life-threatening.

Expanding ABPM Improves Quality & Value-Based Outcomes

Identify hypertension -
Helps identify & stratify those who have undiagnosed or unmanaged hypertension and refer them for further treatment.
Reduce sick days & costs -
Prevent major cardiovascular events among at-risk patients and manage costs in sick days, absenteeism and other related costs.
Aid patient compliance -
A patient-friendly ABPM Health Screening report helps patients to understand their program of management and greatly aids medication compliance.
Here’s a quick of review of some big picture numbers from the NIH, CDC & CMS. Cardiovascular disease will account for $656,000,000,000 in costs on the U.S. healthcare system. Over 50% involve high blood pressure as a risk factor. How much of the Medicare budget this year will be eaten up by these expenses? This quarter? This week? These costs are on the rise.
As significant as hypertension medication costs can be, they pale in comparison to hospitalization costs from a stroke or heart attack resulting from individuals not taking their medication as prescribed. Studies have shown that clinical, economic, and quality-of-life outcomes improve when routine ABPM screening for blood pressure control and medication adherence are part of the treatment plan.6

Direct and indirect financial benefits are profound:

• health care cost savings
• health risk reduction
• disability claims reduction/management
• reduced sick days
• productivity improvements
• reduced presenteeism
• improved patient satisfaction
• improved awareness

I strongly urge CMS to expand the ABPM ICD-10 codes to include the following:

• Z13.6 Screening for cardiovascular disorder

If you, as CMS are able to properly identify high blood pressure and associated cardiovascular disease stemming from high blood pressure, doctors can start managing a nationwide epidemic.

Thank you for considering our comments on this important policy change for ABPM. In reading through the considerations it is clear that are a number of deviations from a clear recommendation from experts and groups. ABPM is appropriate and necessary and should be consistent with prior guidelines including the 2017 American Heart Association/American College of Cardiology Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults. To restore that consistency, we recommend the following 6 changes:
1. Add in that CMS specify nocturnal hypertension as an indication for ABPM
2. Delete the requirement of 3 months of lifestyle interventions prior to ABPM – this does not help the 27% of masked HTN patients.
3. Removal of references to out-of-office measurements before a patient is eligible for coverage of ABPM – patent compliance is a significant problem in obtaining out of office.
4. Usage of an average office blood pressure of two separate office blood pressure readings. The readings vary by day.
5. Recommend that a specific blood pressure device validation protocol rather than referring to a specific commercial website that summarizes whether a device has undergone validation testing, be used.
6. Regarding 5, above. DABL is a commercial enterprise and is one of many performing similar services. To prevent charges of preferential treatment over its competitors, Its name should be stricken from the policy (in favor of 5 – above) as a matter of ethical accountability.
7. Request clarification from CMS regarding the “management” aspect of this proposed coverage determination, given the organizations’ request, focused on diagnosis only, and clinical guidelines for the management of hypertension differ from the clinical guidelines for the diagnosis.

I learned early this morning that DABL is a shakedown and front organization owned by Spacelabs and Omron and uses AAMI and ESH testing results to protect pump and cuff devices against the inevitable innovation of a century-old technology. I learned that Healthstats was asked to pay $100,000 for an acceptable listing on this rather dubious “educational organization” website.

Compare the opaqueness http://www.dableducational.org/aims_obj.html &
NOW TRANSPARENCY
https://www.eshonline.org/about-esh/scientific-council/
https://www.aami.org/membershipcommunity/content.aspx?ItemNumber=1298&navItemNumber=4603
I struggle to believe that CMS would rely on the recommendation of an obscure and dubious Irish 'educational trust' sponsored by our competitors and not US organizations like FDA, AAMI, and others who have all approved BPro.
Even in UK & Ireland, while we are not endorsed by DABL, BPro is listed on the British and Irish Hypertension Society's website (they are the trusted authority, not (DABL). Furthermore, the National Health Service (NHS) is using our device.
For whatever reason, DABL has taken the stance that cuff based ABPM is better than wrist-based (although they haven't published any data or done any studies to support that). We haven't been very concerned by this because only the Irish market seems to care about DABL, until now.

Thank you,

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We are very glad to learn that the CMS has proposed expanding the coverage of ambulatory blood pressure monitoring (ABPM) from the previous policy of identifying white-coat hypertension (WCH) only to also identifying masked hypertension (MH). We thank the authors for basing their support for such proposal on the evidence provided by some of our studies (Spanish ABPM registry and ENRICA cohorts), among other published literature. We hereby comment on some specific aspects of the proposal to further contribute to the debate on the value of ABPM in clinical practice.

MH (high blood pressure [BP] only out of the clinic or office) is a highly dangerous condition. Not only it is probably the type of hypertension with the highest or almost the highest morbidity/mortality risk but it can also be considered a double-silent killer for being both asymptomatic and undetectable in the office. The latest American hypertension guidelines (ACC/AHA; Whelton et al, 2017) and the European ones (ESC/ESH; Williams et al, 2018) have many parallels and they both highlight the importance of identifying this specific BP condition. Nevertheless, there are some differences worth mentioning here. The American guidelines (which algorithms for detecting MH were used by CMS for its proposal) lowered the office BP threshold for defining hypertension from 140/90 to 130/80. Thus, the guidelines recommend ABPM (or home BP monitoring) for office BP in the 120-9/< 80 range (after 3 mo trial of lifestyle modification) to screen for MH. This is important since MH prevalence within this BP range is not negligible and the related mortality risk is higher compared to lower office and out-of-office BPs (Asayama et al, PLoS Med 2014;11:e1001591; Banegas & Ruilope, unpublished data). In contrast, under the current European guidelines these MH cases may be missed unless the patients present with hypertension-mediated organ damage or high cardiovascular risk. Still, the European guidelines provide an extensive list of indications for ABPM or home BP monitoring, including the further examination of conditions in which MH is more common (high-normal BP in European terms, i.e., office BP 130-9/85-9). In any case, as professor Eoin O´Brien usually forewarns, ABPM underuse could have medicolegal consequences due to a failure to provide a technology recommended by all international medical societies and, thus, a failure to uncover a potentially lethal but detectable and treatable condition.

Probably due to practical reasons, the ACC/AHA guidelines recommend daytime ambulatory (or home) BP monitoring in the algorithm for MH detection. Still, CMS considers 24-h performance as a mandatory characteristic of ABPM devices, which offers the additional assessment of nighttime BP values and the possibility of detecting nocturnal hypertension which has substantial mortality and morbidity risk. Morbidity is important for Medicare beneficiaries >65 years, as professor Bakris mentioned in a previous comment (10/11/2018). Supporting other authors, we found that geriatric morbidities (e.g., frailty and disability) were associated with higher nighttime systolic BP in older Spanish adults (Gijón-Conde et al, J Am Med Dir Assoc 2018;19:433).

Regarding WCH, as professor Mancia has repeatedly stated, there may be low-risk and high-risk types of this phenotype (Mancia & Grassi, J Am Coll Cardiol 2016;68:2044). Thus, the importance of identifying WCH does not only reside in avoiding overtreatment of the, probably more numerous, low-risk cases but also in not neglecting the high-risk ones. The latter probably present more often with cardiometabolic factors, including metabolic syndrome (Cuspidi et al, J Hypertens 2018;36:1833), organ damage, no treatment, or stable WCH over time, but more research is needed.

ABPM is well-accepted by most patients and, for diagnostic purposes, it is effective and more cost-effective than office and home BP measurement (Beyhaghi & Viera, Hypertension 2019;73:121). ABPM´s accessibility and affordability are increasing but it still remains unavailable for many patients in the US and other countries (Martín-Rioboó et al, J Hypertens 2018;36:1051). The devices´ prices are decreasing, but they should be further reduced while in-progress, simpler cuff-less technologies should be fully developed and validated. In Spain, we have made an appeal for the expansion of ABPM in clinical practice especially to general practitioners (GPs) and nurses. Further, concurring with the U.S. Preventive Services Task Force we are now encouraging Spaniard GPs to look beyond the logistic difficulties and develop programs and protocols for ABPM. As ABPM information is still relatively scarce worldwide, we also join Dr. Townsend´s call for an ABPM registry in the U.S. (Townsend, N Engl J Med 2018;378:1555) and other countries as needed.

Finally, based on the importance of MH and WCH, it seems reasonable that ABPM were used not only for confirming a diagnosis of hypertension (sustained hypertension) but also to identify masked- and white-coat-hypertension, a task that the CMS has now endorsed. Thank you.

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Hello,

I have the following comments regarding the proposed decision:

• Recommend that CMS revise the clinical circumstances in which ABPM is appropriate and necessary to be consistent with prior guidelines including the 2017 American Heart Association/American College of Cardiology Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults, including:
  • Removal of the requirement of 3 months of lifestyle interventions prior to ABPM use, as there is no empiric evidence to support first proceeding with lifestyle change before obtaining an immediate diagnosis, confirmation, or exclusion of white coat or masked hypertension.
  • Usage of an average office blood pressure of two separate office blood pressure readings
  • Removal of references to out-of-office measurements before a patient is eligible for coverage of ABPM; the proposed NCD’s phrasing suggests that home blood pressure monitoring be done first, while the USPSTF-recommended method for diagnosing hypertension is to use ABPM as the out-of-office blood pressure measurement
  • Addition of the missing diastolic blood pressure range and correction of the systolic range so that it reads “between 120 mm Hg and 129 mm Hg for systolic blood pressure or between 75 mm Hg and 79 mm Hg for diastolic blood pressure.”
• Recommend that CMS specify nocturnal hypertension as an indication for ABPM.
• Recommend that a specific blood pressure device validation protocol rather than referring to a particular website that summarizes whether a device has undergone validation testing, be used.
• Request clarification from CMS regarding the “management” aspect of this proposed coverage determination, given the organizations’ request focused on diagnosis only, and clinical guidelines for management of hypertension differ from the clinical guidelines for diagnosis.

Thank you,
Sarang Baman, MD

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Thank for considering our comments on this important policy change for ABPM.

In reading through the considerations it is clear that are a number of deviations from clear recommendation from experts and groups. ABPM is appropriate and necessary, and should be consistent with prior guidelines including the 2017 American Heart Association/American College of Cardiology Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults.

To restore that consistency, we recommend the following 6 changes:

1. Add in that CMS specify nocturnal hypertension as an indication for ABPM
2. Delete the requirement of 3 months of lifestyle interventions prior to ABPM – this does not help the 27% of masked HTN patents.
3. Removal of references to out-of-office measurements before a patient is eligible for coverage of ABPM – patent compliance is a significant problem in obtaining out of office.
4. Usage of an average office blood pressure of two separate office blood pressure readings. The readings vary by day.
5. Recommend that a specific blood pressure device validation protocol rather than referring to a specific commercial website that summarizes whether a device has undergone validation testing, be used.
6. Regarding 5, above. DABL is a commercial enterprise, and is one of many preforming similar services. To prevent charges of preferential treatment over it’s competitors, It’s name should be stricken from the policy (in favor of 5 – above) as a matter of ethical accountability .
7. Request clarification from CMS regarding the “management” aspect of this proposed coverage determination, given the organizations’ request focused on diagnosis only, and clinical guidelines for management of hypertension differ from the clinical guidelines for diagnosis.

Thank you,

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To Whom it May Concern,

As a tenured nurse and current CNO/COO of a hospital in Northwest Arkansas, I would like to recommend that CMS revise the clinical circumstances in which ABPM is appropriate and necessary to be consistent with prior guidelines including the 2017 American Heart Association/American College of Cardiology Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults, including:

• Removal of the requirement of 3 months of lifestyle interventions prior to ABPM use, as there is no empiric evidence to support first proceeding with lifestyle change before obtaining an immediate diagnosis, confirmation, or exclusion of white coat or masked hypertension.
• Usage of an average office blood pressure of two separate office blood pressure readings
• Removal of references to out-of-office measurements before a patient is eligible for coverage of ABPM; the proposed NCD’s phrasing suggests that home blood pressure monitoring be done first, while the USPSTF-recommended method for diagnosing hypertension is to use ABPM as the out-of-office blood pressure measurement
• Addition of the missing diastolic blood pressure range and correction of the systolic range so that it reads “between 120 mm Hg and 129 mm Hg for systolic blood pressure or between 75 mm Hg and 79 mm Hg for diastolic blood pressure.”

In addition, I would like to recommend a specific blood pressure device validation protocol rather than referring to a specific website that summarizes whether a device has undergone validation testing, be used.

I would also like to request clarification from CMS regarding the “management” aspect of this proposed coverage determination, given the organizations’ request focused on diagnosis only, and clinical guidelines for management of hypertension differ from the clinical guidelines for diagnosis.

Thank you,

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We recommend that CMS revise the clinical circumstances in which ABPM is appropriate and necessary to be consistent with prior guidelines including the 2017 American Heart Association/American College of Cardiology Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults, including:

• Removal of the requirement of 3 months of lifestyle interventions prior to ABPM use, as there is no empiric evidence to support first proceeding with lifestyle change before obtaining an immediate diagnosis, confirmation, or exclusion of white coat or masked hypertension.
• Usage of an average office blood pressure of two separate office blood pressure readings
• Removal of references to out-of-office measurements before a patient is eligible for coverage of ABPM; the proposed NCD’s phrasing suggests that home blood pressure monitoring be done first, while the USPSTF-recommended method for diagnosing hypertension is to use ABPM as the out-of-office blood pressure measurement
• Addition of the missing diastolic blood pressure range and correction of the systolic range so that it reads “between 120 mm Hg and 129 mm Hg for systolic blood pressure or between 75 mm Hg and 79 mm Hg for diastolic blood pressure.”

We recommend that CMS specify nocturnal hypertension as an indication for ABPM.

We recommend that a specific blood pressure device validation protocol rather than referring to a specific website that summarizes whether a device has undergone validation testing, be used.

We request clarification from CMS regarding the “management” aspect of this proposed coverage determination, given the organizations’ request focused on diagnosis only, and clinical guidelines for management of hypertension differ from the clinical guidelines for diagnosis.

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Recommend that CMS revise the clinical circumstances in which ABPM is appropriate and necessary to be consistent with prior guidelines including the 2017 American Heart Association/American College of Cardiology Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults, including: ?Removal of the requirement of 3 months of lifestyle interventions prior to ABPM use, as there is no empiric evidence to support first proceeding with lifestyle change before obtaining an immediate diagnosis, confirmation, or exclusion of white coat or masked hypertension.

• Usage of an average office blood pressure of two separate office blood pressure readings
• Removal of references to out-of-office measurements before a patient is eligible for coverage of ABPM; the proposed NCD’s phrasing suggests that home blood pressure monitoring be done first, while the USPSTF-recommended method for diagnosing hypertension is to use ABPM as the out-of-office blood pressure measurement
• Addition of the missing diastolic blood pressure range and correction of the systolic range so that it reads “between 120 mm Hg and 129 mm Hg for systolic blood pressure or between 75 mm Hg and 79 mm Hg for diastolic blood pressure.”
• Recommend that CMS specify nocturnal hypertension as an indication for ABPM.
• Recommend that a specific blood pressure device validation protocol rather than referring to a particular website that summarizes whether a device has undergone validation testing, be used.
• Request clarification from CMS regarding the “management” aspect of this proposed coverage determination, given the organizations’ request focused on diagnosis only, and clinical guidelines for management of hypertension differ from the clinical guidelines for diagnosis.

Strongly recommend advice on correct cuff size since we have many large people in our country and a cuff that is too small will read a falsely elevated BP.

Thank you, Ann Dodge

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I recommend that CMS revise the clinical circumstances in which ABPM is appropriate and necessary to be consistent with prior guidelines including the 2017 American Heart Association/American College of Cardiology Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults, including:

Removal of the requirement of 3 months of lifestyle interventions prior to ABPM use, as there is no empiric evidence to support first proceeding with lifestyle change before obtaining an immediate diagnosis, confirmation, or exclusion of white coat or masked hypertension.

Usage of an average office blood pressure of two separate office blood pressure readings

Removal of references to out-of-office measurements before a patient is eligible for coverage of ABPM; the proposed NCD’s phrasing suggests that home blood pressure monitoring be done first, while the USPSTF-recommended method for diagnosing hypertension is to use ABPM as the out-of-office blood pressure measurement

Addition of the missing diastolic blood pressure range and correction of the systolic range so that it reads “between 120 mm Hg and 129 mm Hg for systolic blood pressure or between 75 mm Hg and 79 mm Hg for diastolic blood pressure.”

Recommend that CMS specify nocturnal hypertension as an indication for ABPM.

Recommend that a specific blood pressure device validation protocol rather than referring to a particular website that summarizes whether a device has undergone validation testing, be used.

Request clarification from CMS regarding the “management” aspect of this proposed coverage determination, given the organizations’ request focused on diagnosis only, and clinical guidelines for management of hypertension differ from the clinical guidelines for diagnosis.

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I am a Internal Medicine physician and Hypertension Specialist I have been performing ABPM since the 1980's and found the procedure clinically incredibly useful I applaud the expansion of this underused device

As a practicing PCP, I find the proposed requirement of 3 months of lifestyle modification ridiculous Firstly, most practices are not capable of instruction nor monitoring/documentation. Secondly, waiting for 3 months practically just means that most of these patients suspected of having a known life-threatening disease, will be lost to follow-up. This has been proven in research. Third, there is no research showing this approach to be effective.

The requirement to have out of office readings is also not practical, nor according to published national and international guidelines. Many patients do not have an accurate home BP monitor nor known how to properly use it. This is a costly major hurdle which will strongly discourage usage of ABPM
Payment should be expanded to patients being treated for resistant hypertension or have unexplained LVH during treatment, hypotension or syncopal episodes, or suspected nocturnal hypertension.

Using http://www.dableducational.org/ for assuring validation also does not make sense. I understand this is no longer funded nor updated. The AMA is proposing a VDL site, which would be more appropriate for a CMS guideline

ABPM is vastly underutilized. It is essential to make an accurate first time diagnosis of hypertension and masked hypertension. This is especially true as it is a life-long treatable diagnosis whose benefits of treatment have been well established by evidence based guidelines and is cost-effective. Blood pressure is variable throughout 24 hours (i.e. 60mmHg systolic in normotensives) making numerous readings a requirement. ABPM does this

A concern of CMS is expansion of a payment that maybe abused. I would be happy with reimbursement for this low-cost procedure every 2-3 years, rather than yearly, with less restrictions and documentations. ABPM is less costly than Bone Density testing and certainly sleep apnea screening. Please reconsider the excessive requirements this proposal mandates. Thank you

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re: CMS Proposed Decision Memo for Ambulatory Blood Pressure Monitoring (ABPM) (CAG-00067R2)

To whom it concerns
I am submitting public comment on behalf of myself, Beverly B Green MD, MPH as a physician and senior investigator whose area of research includes blood pressure (BP) measurement.
I am in agreement with the American Heart Association and American Medical Association recommendations that are being submitted with some modifications.

• Recommend that CMS revise the clinical circumstances in which ABPM is appropriate and necessary to be consistent with prior guidelines including the 2017 American Heart Association/American College of Cardiology Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults, including:
  • Removal of the requirement of 3 months of lifestyle interventions prior to ABPM use, as there is no empiric evidence to support first proceeding with lifestyle change before obtaining an immediate diagnosis, confirmation, or exclusion of white coat or masked hypertension.
  • Usage of an average office blood pressure of two separate office blood pressure readings
  • Removal of references to out-of-office measurements before a patient is eligible for coverage of ABPM; the proposed NCD's phrasing suggests that home blood pressure monitoring be done first, while the USPSTF-recommended method for diagnosing hypertension is to use ABPM as the out-of-office blood pressure measurement
  • Addition of the missing diastolic blood pressure range and correction of the systolic range so that it reads "between 120 mm Hg and 129 mm Hg for systolic blood pressure or between 75 mm Hg and 79 mm Hg for diastolic blood pressure."
• Recommend that a specific blood pressure device validation protocol rather than referring to a specific website that summarizes whether a device has undergone validation testing, be used.
• Request clarification from CMS regarding the "management" aspect of this proposed coverage determination, given the organizations' request focused on diagnosis only, and clinical guidelines for management of hypertension differ from the clinical guidelines for diagnosis.
• Request coverage of ABPM for hypertension management - for patients with uncontrolled clinic BP (average of 2 BPs on at least 2 occasions of ?130/80) and on 3 or more anti-hypertensive medications (resistant hypertension)
• Request coverage of ABPM for hypertension management - for patients with uncontrolled clinic BP (average of 2 BPs on at least 2 occasions of ?130/80) and on less than 3 medications and symptoms suggestive of overtreatment of hypertension (e.g., dizziness, fatigue, falling)

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I am pleased to see increased focus on ABPM and increasing coverage, as this is an important tool for clinicians treating hypertension.

I recommend that the guidelines follow the 2017 ACC/AHA hypertension guideline. Clinicians should not be discouraged from using ABPMs by requiring 3 months of "lifestyle intervention" first. All clinicians should be discussing lifestyle interventions regardless of ABPM decisions. Including this rewuirement will likely decrease utilization without improving health.

Also, ABPM should be an option regardless of out of office BP measurement - many patients cannot afford home monitors or don't know how to use them properly.
Please also cover suspected nocturnal hypertension as an indication for ABPM: this is critical as it is very underdiagnosed and likely more common in african american communities.

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I would advocate for several changes to CMS proposed changes for Medicare coverage for ABPM:

1. For masked hypertension, ABPM testing should be available for office BP 120-139/80-89.
   Rationale: While the current guidelines are based on cutpoints recommended by the 2017 AHA/ACC BP guidelines, the 2 leading primary care societies (AAFP, ACP) did not accept these cutpoints, and generally still follow JNC 7 but using a cutpoint of 140/90.


2. Removal of the requirement of 3 months of lifestyle interventions prior to ABPM use, as there is no empiric evidence to support first proceeding with lifestyle change before obtaining an immediate diagnosis, confirmation, or exclusion of white coat or masked hypertension.


3. Usage of an average office blood pressure of two separate office blood pressure readings


4. Removal of references to out-of-office measurements before a patient is eligible for coverage of ABPM; the proposed NCD’s phrasing suggests that home blood pressure monitoring be done first, while the USPSTF-recommended method for diagnosing hypertension is to use ABPM as the out-of-office blood pressure measurement


5. Recommend that CMS specify nocturnal hypertension as an indication for ABPM.


6. Recommend that a specific blood pressure device validation protocol rather than referring to a specific website that summarizes whether a device has undergone validation testing, be used.


7. Request clarification from CMS regarding the “management” aspect of this proposed coverage determination, given the organizations’ request focused on diagnosis only, and clinical guidelines for management of hypertension differ from the clinical guidelines for diagnosis. Ideally, ABPM would be covered to looked for masked and white coat effect among those already on medication treatment, not just in the context of diagnosis.

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I think this is an important step to the successful implementation of ambulatory blood pressure monitoring (ABPM), an evidence-based method for assessing out-of-office blood pressure (BP). Given that several US (2017 AHA/ACC guideline and USPSTF) and international guidelines endorses ABPM for the diagnosis and management of high BP, it is imperative that the CMS revise the circumstances for which ABPM is appropriate and necessary.

I have read the decision summary and I have several major concerns.

First, office BP should be based on an average of 2 or more readings across 2 visits (this is stated in the 2017 AHA/ACC guideline).

Second, the office BP ranges for suspected masked hypertension are incorrect (these are not the ranges from the 2017 AHA/ACC guideline).

Third, the requirement for ABPM seems to be based on BP measurements taken out of the office. The only other validated method of out-of-office BP measurement is home BP monitoring (HBPM) and it is unclear why HBPM has to be done first before conducting ABPM. Many guidelines and scientific statements say that ABPM is the preferred method with HBPM as an alternative approach particularly for the initial diagnosis of hypertension.

Fourth, I know that the 2017 AHA/ACC guideline suggested that individuals be on 3 months of lifestyle intervention prior to conducting ABPM. However, this is not based on strong empiric data. Currently and in the past, we don’t and have not required 3 months of lifestyle intervention before initially diagnosing hypertension since lifestyle intervention is considered to be a “treatment” of hypertension rather than a criteria for the diagnosis of hypertension. The USPSTF and international guidelines do not require that 3 months of lifestyle intervention be done before ABPM is performed.

Fifth, there is little mention of nocturnal hypertension. The benefit of ABPM is that it can also assess BP during asleep. High BP during sleep (nocturnal hypertension) is very common, and there is evidence to suggest BP during asleep period is a stronger predictor of cardiovascular events than BP during the awake period. Therefore, I think this should be included as an indication.

Finally, I strongly recommend not referencing specific websites like dabl educational for validated devices (the information on this website cannot be confirmed and there is no guarantee this information is free from commercial bias). For validation, I would rather reference specific validation protocols such as AAMI that devices should be validated with.

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Cleveland Clinic is a not-for-profit, integrated healthcare system dedicated to patient-centered care, teaching and research. Our health system is comprised of a main campus, 13 community hospitals, 19 family health centers and 3 wellness centers with over 3,600 salaried physicians and scientists. Last year, our system had over seven million patient visits and more than 229,000 hospital admissions

The following are the comments of Cleveland Clinic in response to the request for public comments for the proposed National Coverage Determination for Ambulatory Blood Pressure Monitoring.

We appreciate the decision by CMS to expand coverage for ambulatory blood pressure monitoring (ABPM) and believe it is an appropriate step in the right direction based on the available evidence. Previously limiting the coverage of ABPM to those with suspected white coat hypertension significantly limited access to technology that provides a wealth of diagnostic and prognostic information. We wholeheartedly agree with the decision’s statement that, “It is an essential tool in managing hypertension to reduced mortality and improve other health outcomes for Medicare beneficiaries.”

However, we are concerned that CMS is requiring two separate office visits “with two separate measurements made at each visit after three months of behavioral interventions including diet and exercise modification and at least two blood pressure measurements taken outside the office” for patients with suspected masked hypertension or suspected white coat hypertension. In both of these cases, we are concerned that requiring patients to complete two office visits and wait a minimum of three months before implementing ambulatory monitoring could put the patient at unnecessary risk. We therefore suggest that if a patient presents with increased blood pressure measured appropriately during a visit, the patient should be able to be sent home with an ambulatory monitoring device so that the physician can begin to proactively manage the patient. This will enable the physician to put a care plan into place immediately once the data from the ABPM becomes available, rather than potentially waiting months both between two office visits and after three months of behavioral interventions. Such waiting could significantly delay treatment for this very serious condition.

Finally, we recommend clarification of the terms “suspected white coat hypertension” and “suspected masked hypertension” to specify that this terminology is inclusive of patients already taking blood pressure lowering medications. As is correctly noted in the full text (Section VIII. CMS Analysis) of the proposed decision memo, “masked hypertension may occur in patients with both untreated and treated for hypertension,” and “there is also a substantial proportion of patients who may appear to be in control or be normotensive, but have masked hypertension.”

Thank you for conducting a thoughtful process that allows us to provide input on such important issues. Should you need any further information, please don’t hesitate to contact me.

Luke Laffin, MD
Staff Cardiologist, Section of Preventative Cardiology
Cleveland Clinic

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ABPM should be covered for all ABPMs (both for diagnosis and management) on pediatric patients as it has been shown to be superior to clinic blood pressure for diagnosis and management in this population. In particular, masked HTN is prevalent in many populations including children with CKD, ESRD, solid organ transplant, cancer, and sickle cell disease. (see studies cited below)

1: Shah S, Swartz S, Campbell J, Srivaths PR. Ambulatory blood pressures and central blood pressures are associated with cardiovascular morbidity in adolescent and young adult patients receiving chronic hemodialysis. Pediatr Nephrol. 2019 Feb 18. doi: 10.1007/s00467-019-04208-8. [Epub ahead of print] PubMed PMID: 30778828.

2: Grisaru S, Yue M, Samuel SM, Chaput KH, Hamiwka LA. Blood pressure in children with attention deficit/hyperactivity disorder. Paediatr Child Health. 2018 Sep;23(6):e102-e108. doi: 10.1093/pch/pxx207. Epub 2018 Mar 5. PubMed PMID: 30455580; PubMed Central PMCID: PMC6234428.

3: Zambaiti E, Sergio M, Baldanza F, Corrado C, Di Pace MR, Cimador M. Correlation between hypertrophy and risk of hypertension in congenital solitary functioning kidney. Pediatr Surg Int. 2019 Jan;35(1):167-174. doi: 10.1007/s00383-018-4389-z. Epub 2018 Oct 29. PubMed PMID: 30374633.

4: Iturzaeta A, Pompozzi L, Casas Rey C, Passarelli I, Torres F. Prevalence of masked hypertension among children with risk factors for arterial hypertension. Arch Argent Pediatr. 2018 Oct 1;116(5):328-332. doi: 10.5546/aap.2018.eng.328. English, Spanish. PubMed PMID: 30204983.

5: McMahon KR, Harel-Sterling M, Pizzi M, Huynh L, Hessey E, Zappitelli M. Long-term renal follow-up of children treated with cisplatin, carboplatin, or ifosfamide: a pilot study. Pediatr Nephrol. 2018 Dec;33(12):2311-2320. doi: 10.1007/s00467-018-3976-5. Epub 2018 Sep 14. PubMed PMID: 30218190.

6: Höcker B, Weber LT, John U, Drube J, Fehrenbach H, Klaus G, Pohl M, Seeman T, Fichtner A, Wühl E, Tönshoff B. Steroid withdrawal improves blood pressure control and nocturnal dipping in pediatric renal transplant recipients: analysis of a prospective, randomized, controlled trial. Pediatr Nephrol. 2019 Feb;34(2):341-348. doi: 10.1007/s00467-018-4069-1. Epub 2018 Sep 4. PubMed PMID: 30178240.

7: Moodalbail DG, Falkner B, Keith SW, Mathias RS, Araya CE, Zaritsky JJ, Stuart MJ. Ambulatory hypertension in a pediatric cohort of sickle cell disease. J Am Soc Hypertens. 2018 Jul;12(7):542-550. doi: 10.1016/j.jash.2018.04.005. Epub 2018 May 5. PubMed PMID: 29804939.

8: Massella L, Mekahli D, Paripovic D, Prikhodina L, Godefroid N, Niemirska A, Agbas A, Kalicka K, Jankauskiene A, Mizerska-Wasiak M, Afonso AC, Salomon R, Deschênes G, Ariceta G, Özçakar ZB, Teixeira A, Duzova A, Harambat J, Seeman T, Hrcková G, Lungu AC, Papizh S, Peco-Antic A, De Rechter S, Giordano U, Kirchner M, Lutz T, Schaefer F, Devuyst O, Wühl E, Emma F. Prevalence of Hypertension in Children with Early-Stage ADPKD. Clin J Am Soc Nephrol. 2018 Jun 7;13(6):874-883. doi: 10.2215/CJN.11401017. Epub 2018 Apr 19. PubMed PMID: 29674338; PubMed Central PMCID: PMC5989684.

9: Peterson CG, Miyashita Y. The Use of Ambulatory Blood Pressure Monitoring As Standard of Care in Pediatrics. Front Pediatr. 2017 Jun 30;5:153. doi: 10.3389/fped.2017.00153. eCollection 2017. Review. PubMed PMID: 28713799; PubMed Central PMCID: PMC5492637.

10: Seeman T, Dostálek L, Gilík J. Control of hypertension in treated children and its association with target organ damage. Am J Hypertens. 2012 Mar;25(3):389-95. doi: 10.1038/ajh.2011.218. Epub 2011 Nov 17. PubMed PMID: 22089110.

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White coat hypertension is not an either/or diagnosis with true hypertension. In my experience, many patients have both. For patients with both problems, several ambulatory blood pressure monitor cycles in close, but not immediate, succession are needed to optimize antihypertensive management as a drug and dose is started. The response to that therapy needs to be gauged for further drug and dose adjustments to be made appropriately. With the new policy, ambulatory blood-pressure monitoring can only be obtained once annually. The new policy seems to be encouraging me to adjust my patients’ blood pressure medications only once annually. That’s fine when only small changes need to be made after years on a stable drug regimen, but the new policy still short-changes patients at initial diagnosis of hypertension their needed access to ambulatory blood-pressure monitoring. How about allowing up to six cycles of ambulatory blood-pressure monitoring in the first two years after diagnosis of hypertension, followed thereafter by allowing only one cycle of ambulatory blood-pressure monitoring annually?

I also would like to echo the comments of others that children should be allowed access to ambulatory blood-pressure monitoring. Certainly, the use of ambulatory blood-pressure monitoring among children is demanded under guidelines from the American Academy of Pediatrics—both at initial diagnosis of hypertension and during active medication titration.

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I do agree with this non-invasive diagnostic proposal for tracking of the blood pressure of patients who have been identified as hypertensive. However, I would suggest that the monitoring of blood pressure should include guidelines for the patient to follow. The instructions must be clear and simple enough that patients with various literacy level can understand. The design and complexity of the blood pressure apparatus must be also considered. Measurement of the blood pressure is a non-invasive procedure. Many blood pressure apparatuses require patients to be still, sit with arms and back supported and feet placed flat on the floor (Bruce, 2019). If this is required by this device, the instructions must be very clear.

Since the blood pressure of the patient is critical for optimal disease control, the standardization of the ambulatory blood pressure monitoring devices will be essential. At present, many patients purchase their blood pressure devices from various pharmacies or stores. Providers have to trust that the patients are monitoring their blood pressure as instructed by the manufacture of the device. Therefore, having a standardized blood pressure monitoring device will eliminate any inaccurate readings of the blood pressure. I support this initiative and I think it will benefit all of our patients.

References
Bruce, A. (2019) Validation of the Welch Allyn home blood pressure monitor with professional SureBP algorithm with a special feature of accuracy during involuntary (tremor) patient movement. Blood Pressure Monitoring 24(2) 89-92 doi:10.1097/MBP.0000000000000365

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USPSTF recommends obtaining BP outside of the clinical setting for CONFIRMATION OF DIAGNOSIS in every subject older than 18 who has been screened for high blood pressure. The proposed rule falls severely short of this recommendation

The major reason for USPSTF's recommendation is that office BPs are recognized as being inaccurate, and misclassify subjects in both directions (as hypertensive when actually normotensive and viceversa) in about 15-20% of cases. Furthermore, nocturnal hypertension cannot be detected by any other means than by ABPM, a particularly important issue since it carries a specific detrimental prognosis.

For the specific (and thus inadequate) cases contemplated by the proposed rule (white coat and masked hypertension), there are also problems:
a) the requirement of out of office values to suspect either diagnosis builds-in an issue of feasibility (cost of monitors, education, etc) that shifts the burden from the public health arena to the patients
b) the required three month interval of behavior modification flies in the face of other current recommendations. For example, for many subjects in whom a diagnosis of white coat syndrome will be excluded or for many in whom a diagnosis of masked hypertension will be established, the magnitude of BP elevation may require immediate pharmacological therapy, with one or sometimes two drugs. It is well known (e.g., VALUE trial) that the earlier the initiation and escalation of antihypertensive therapy, the faster and, most importantly, THE MORE SUSTAINED the blood pressure effect is. So this aspect of the proposed rule builds-in a component of potentially harmful mandatory neglect for a substantial number of subjects.
c) the proposed limitation of once-a-year coverage for the procedure does not allow for assessment of the results of an intervention (for example the response to therapy in subjects with masked hypertension)

In brief, I was disappointed by reading the proposed rule and believe that every effort should be made to modify it in such a way that aligns it with the intended purpose of the USPSTF recommendation.

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I am pleased the policy includes reference, though brief, to the evaluation of children with elevated blood pressure.

I would like to see that expanded as there is reasonably good evidence that ABPM reduces cost of evaluation, diagnostics, and treatment of elevated BP in children. Also good evidence that it provides information that is unique to ABPM and associated with cardiovascular disease in at risk populations (like with CKD).

It would be very useful for the guidelines to specifically say that the definition of elevated BP in children varies by age, sex, and height and perhaps provide the brief table from the reference that defines approximate cutoffs. Currently, in the course of clinical care and billing, it is common for the lack of such specific statement to result in administrative requests for clarification about need for ABPM (for example a 9 year old child's BP might seem "normal" on the adult scale but be very high). Putting this clarifying information in the policy itself could lead to less administrative burden on CMS, private insurers, and health care systems.

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To whom it may concern:

I strongly support the proposal to expand coverage of ABPM. Having worked on an AHRQ-funded national initiative on cardiovascular quality improvement (EvidenceNow), it repeatedly came to my attention that insurance companies were not covering these devices. Additionally, it was noted that low cost devices available from pharmacies were not reliable.

The inability to monitor BP between office visits became a significant barrier to identifying accurate readings and acting on them, as advised by the evidence base. In order to improve outcomes in hypertension, a goal aligned with CMS focus on value-based care and high priority chronic conditions, these devices are critical. Please consider any available levers to push Medicaid and private insurance plans to follow the lead.

Sam Ross
Center for Health Information Partnerships
Feinberg School of Medicine
Northwestern University

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