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1、The Future of Remote Patient MonitoringJanuary 20242HEALTH PROGRAMUnder the leadership of former Senate Majority Leaders Tom Daschle and Bill Frist,M.D.,the Bipartisan Policy Centers Health Program develops bipartisan policy recommendations that will improve health care,lower costs,and enhance cover

2、age and delivery.The program focuses on coverage and access to care,delivery system reform,cost containment,chronic and long-term care,and rural and behavioral health.ACKNOWLEDGMENTSBPC would like to thank the Peterson Center on Healthcare for its generous support of BPCs Digital Health work.BPC ack

3、nowledges former staff member Sabah Bhatnagar for her contributions to this work.DISCLAIMERThe findings and recommendations expressed herein do not necessarily represent the views or opinions of BPCs founders,its funders,or its board of directors.Julia HarrisAssociate Director Mikayla CurtisProject

4、Associate Maya SandalowSenior Policy AnalystG.William HoaglandSenior Vice PresidentMarilyn SerafiniExecutive Director AUTHORSCONSULTANTCara TenenbaumFounder,Strathmore Health Strategy LLC 3Table of Contents4 EXECUTIVE SUMMARY7 OVERVIEW 16 POLICY RECOMMENDATIONS16 Ensuring Appropriate Service Coverag

5、e 21 Improving Equity 26 Ensuring Data Security and Privacy 30 CONCLUSION34 GLOSSARY OF ACRONYMS35 ENDNOTES4Executive Summary Digital health advocates believe remote monitoringthe use of digital technologies to collect and relay patient data to health care professionalshas the potential to transform

6、 disease management,health outcomes,and patient care,especially for individuals with multiple chronic conditions who lack convenient access to providers.Medicare,most state Medicaid agencies,and many private health insurance plans cover remote monitoring services.For the purposes of this report,we d

7、efine remote monitoring as an umbrella term for remote physiologic monitoring(RPM)and remote therapeutic monitoring(RTM).RPM refers to the monitoring of physiologic datasuch as weight,blood glucose,or blood pressurewhile RTM refers to the monitoring of patients self-reported nonphysiologic data,such

8、 as pain levels or medication adherence.Currently,the Centers for Medicare&Medicaid Services(CMS)limits RTM reimbursement to cases involving the respiratory system,musculoskeletal system,and cognitive behavioral therapy.Although the percentage of patients using RPM remains relatively low(594 monthly

9、 claims per 100,000 Medicare enrollees in 2021),the use of RPM increased among Medicare beneficiaries more than sixfold from 2018-2021.1 In part,this increase was due to CMS expanded coverage rules during the COVID-19 public health emergency.Thirty-four state Medicaid programs covered RPM services a

10、s of March 2023;however,many Medicaid programs restrict RPM use in some way.2 RTM uptake has also steadily increased since its introduction in 2022,yet billing and documentation requirements can hinder its widespread adoption.3,4The evidence base on remote monitoring,particularly for RPM tools,is gr

11、owing.Yet some policy experts cite a lack of robust evidence on the optimal use of remote monitoring,including its duration and target patient groups.In the absence of such evidence,these experts question whether we are effectively“rightsizing”the use of these services.Underuse could limit access to

12、 beneficial care,while overuse could unnecessarily increase spending in federal health care programs.Additionally,providers cite the need for toolssuch as generative artificial intelligence(AI)to manage streams of data,otherwise the volume of patient-generated information can become overwhelming and

13、unmanageable.Over the past year,the Bipartisan Policy Center undertook an extensive effort to develop evidence-based,federal policy recommendations for the appropriate use and coverage of remote monitoring services.BPC assessed patients access to and use of remote monitoring technologies and their i

14、mpact on health outcomes and cost.We conducted a series of interviews and hosted a private roundtable with health policy experts,federal officials,technology leaders,5medical providers,payers,consumers,and academics to gain insight into the opportunities and challenges regarding remote monitoring.Th

15、is report looks broadly at ways to improve the use of remote monitoring services,ensure equitable access to these services across populations,and enhance data security and privacy standards.Now is the time for payers and providers to refine their approach and maximize appropriate adoption for patien

16、ts who stand to benefit from remote monitoring.P O L I CY R E C O M M E N DAT I O N SA.Ensuring Appropriate Service CoverageToday,qualified health care providers have wide latitude regarding the provision and billing of remote monitoring services.But more research is needed on how to optimize the us

17、e of remote monitoring,including by disease state and patient group.Clinical guidelines are critical for the provision of these services.CMS should work with medical specialty societies to evaluate the evidence and determine appropriate coverage mechanisms to guide the optimal use of remote monitori

18、ng,including for which patients and over what duration.This work could include collaborating with Medicare Administrative Contractors(MACs)or issuing National Coverage Determinations(NCDs).As more evidence emerges about the appropriate use of remote monitoring devices,the secretary of HHS should use

19、 the departments existing authority to recommend a diverse set of billing codes so providers have more options for the time they spend on the data and the number of minimum days of data required.CMS should further clarify current policies regarding appropriate coding and billing of RPM and RTM.It sh

20、ould also require providers not enrolled in risk-based models to attest to medical necessity for patients continued use of remote monitoringat a frequency deemed appropriate by the HHS secretary and based on condition-specific clinical guidelines.CMS should work with the American Medical Association

21、(AMA)and relevant medical specialty societies to develop additional RTM billing codes to allow for use cases beyond musculoskeletal,respiratory,and cognitive behavioral therapyas the evidence supports.Congress should request the Medicare Payment Advisory Commission(MedPAC)to report on the impact of

22、remote monitoring on clinical outcomes and cost by disease state,and on any new billing thresholds or code durations,at least every three years.6B.Improving Equity To ensure high quality and the equitable provision of remote monitoring servicesincluding for those individuals with poor disease contro

23、l,poor medication adherence,and/or difficulty maintaining regular careproviders and patients need access to comprehensive information on device performance.Additionally,safety-net providers need flexible reimbursement policies.Congress should direct the Food and Drug Administration(FDA)to promulgate

24、 a rule clarifying that remote monitoring device labels should include performance characteristics to support the safe and effective use of these devices.The FDA should develop an easy-to-reference list or notationsimilar to the AI device listfor consumers to search online for legally marketed remot

25、e monitoring devices.CMS should clarify that it allows store-and-forward technologies for billing codes related to remote monitoring and provide guidance on how often patients should transmit data to providers.This will allow flexibility for patients or providers who do not have access to broadband

26、to benefit from and deliver remote monitoring services.Congress should clarify and refine anti-kickback safe harbors related to providing devices to patients.This is especially important for safety-net providers who often lack the resources to cover startup costs for a remote monitoring program.C.En

27、suring Data Security and Privacy Patient privacy and security concerns have increased with the rise of digital technologies and have affected the uptake of remote monitoring by both patients and providers.The HHS Office of Civil Rights should identify whether existing privacy policies adequately pro

28、tect personal health information gathered,stored,and transmitted through remote monitoring.If gaps remain,the office should assess whether it has the authority to close that gap and,if it does not,Congress should do so.HHS should study the use of cybersecurity safe harbor laws to determine their eff

29、ectiveness.HHS,through the Office of the National Coordinator for Health Information Technology,should continue to ensure the existence of appropriate data standards so that remote monitoring devices can be interoperable with electronic health record(EHR)systems.7OverviewDigital health is a rapidly

30、evolving landscape that encompasses an array of devices,software,and delivery modes.Over the past year and a half,BPC homed in on remote monitoring devices and evaluated their impact on equitable access to care,as well as on patient outcomes and cost effectiveness.This report synthesizes findings fr

31、om the available published literature and from in-depth interviews with health policy experts,federal officials,technology leaders,vendors,medical providers,payers,consumers,and academics.DEFINING REMOTE PHYSIOLOGIC AND REMOTE THER APEUTIC MONITORINGFor the purposes of this report,we define remote m

32、onitoring as an umbrella term for remote physiologic monitoring(RPM)and remote therapeutic monitoring(RTM).The main difference between RPM and RTM is the type of data collected.RPM covers only physiologic datasuch as heart rate and blood pressurewhile RTM monitors nonphysiologic data,such as pain le

33、vels and medication adherence.5 For reimbursement,RPM requires the device to automatically record patient data;RTM allows patients self-reported data.6 Additionally,the American Medical Associations Resource-Based Relative Value Scale Update Committee designed RTM codes to be used primarily by physi

34、cal therapists and other providers who cannot bill for emergency and management services,while it designed RPM codes for physicians.7 For a comprehensive overview of the differences between RPM and RTM,seeAppendix A.8CMS introduced the RPM Current Procedural Terminology(CPT)codes in the calendar yea

35、r 2020 CMS Physician Fee Schedule,which included codes for setting up equipment,monitoring the data,and interacting with patients to review the data.8 CMS does not restrict RPM codes to specific conditions.These codes assist with the monitoring of a wide variety of conditions,including diabetes,high

36、 blood pressure,heart conditions,and sleep apnea.CMS introduced RTM CPT codes a few years later in the calendar year 2022 CMS Physician Fee Schedule.9 Although the RTM codes are structured similarly to the RPM codes,they cover a much smaller range of cases and are reimbursed only for“respiratory sys

37、tem status,musculoskeletal system status,therapy adherence,and therapy response”use cases.10 AMA refined these codes to include cognitive behavioral therapy,although current utilization is low.11 Unlike RPM,which has a general billing code and does not restrict coverage to specific conditions,the AM

38、A developed the RTM codes with the intention to expand them and account for other body systems as technology develops.12 For examples of both RPM and RTM devices,see Figure 1.Figure 1.Examples of RPM and RTM Devicesaa CMS reimburses continuous glucose monitoring separately from RPM(see Appendix C fo

39、r CPT codes),yet research often cites it as an example of remote physiologic monitoring.Additionally,RPM and RTM services can utilize Software as a Medical Device.RPM device examplesRTM device examples continuous glucose monitors blood pressure monitors heart monitors virtual physical therapy pain m

40、anagement software digital kneeE V I D E N C E-B AS E D U S E CAS E SResearch is evolving regarding the impact of remote monitoring on patient outcomes and cost.RPMs evidence base is stronger than its newer counterpart,RTM.The following examples,while not exhaustive,highlight the potential for remot

41、e monitoring to improve patient outcomes and realize cost savings.Type 1 Diabetes:Many health care providers believe continuous glucose monitoring should be a part of the standard treatment for Type 1 diabetes.13 One systematic literature review found that continuous glucose monitoring is associated

42、 with improved HbA1c levels,reduced hospitalizations,and reduced instances of diabetic ketoacidosis.14 Yet studies that evaluated the cost effects yielded mixed results,making it difficult to provide a savings estimate.15 9Heart Failure:Numerous systematic reviews demonstrate the clinical benefits o

43、f RPM for treating heart failure.16 One Department of Veterans Affairs(VA)study using RPM and telehealth exemplifies the potential for improved patient outcomes and cost savings.In this study,the VA provided 38 participants with in-home devices to monitor vital signs;nurses called patients weekly re

44、garding changes detected by the device and pharmacists adjusted prescriptions accordingly.Researchers estimated the intervention prevented 26 emergency room visits over five months.17 The outcome demonstrated the potential for significant cost savings,since the VA serves over 300,000 veterans with c

45、hronic heart failure and the average cost of a single heart failure hospital admission is$23,077.18Hypertension:Evidence suggests that remote blood pressure monitoring can improve health outcomes and save money.One meta-analysis concluded that patients using RPM to monitor blood pressure at home had

46、 significantly reduced in-office readings.19 Another study of women with hypertensive disorders in pregnancy found that telehealth combined with remote blood pressure monitoring was associated with a reduction in hospital readmissions.20 One modeling study estimated that home blood pressure monitori

47、ng could save nearly$7,800 in health care costs per person over 20 years,with the greatest potential for savings among racial minorities and people living in rural areas.21 Wound Care:A study of wound therapy RTMnot currently covered by Medicaredemonstrates the potential for cost savings.22 The trea

48、tment combines portable negative pressure wound therapywhich uses suction to promote wound healingwith an integrated RTM device that transmits data for monitoring by virtual specialists.RTM was associated with overall cost savings of$3,753 per patient.23 Another study on negative pressure wound ther

49、apy found that RTM with regular adherence calls was associated with increased therapy adherence in 73%of patients,leading to greater reductions in wound volume and surface area.24C OV E R AG E A N D U T I L I Z AT I O N AC R O S S PAY E R SMedicare,most state Medicaid agencies,and many private insur

50、ance agencies cover remote monitoring.Medicaid and private insurance offer broader coverage for RPM than for RTM,possibly due to the more recent introduction of the RTM CPT codes.MedicareThe Medicare program covers both RPM and RTM.Medicare reimburses providers for device supply,device setup,time sp

51、ent analyzing patient data,and 10time spent interacting with patients to adjust treatment.25,26 For a list of remote monitoring CPT codes and their reimbursement rates,see Appendix B.Before the COVID-19 public health emergency and the addition of RTM codes,CMS set a variety of requirements for RPM r

52、eimbursement,including but not limited to:27 Patients must have a pre-existing relationship with the provider.Providers must be eligible to furnish evaluation and management services.Services must monitor acute care or chronic conditions.The device must meet the definition of a medical device,as def

53、ined by the FDA.The device must electronically collect and automatically upload data to a secure location for interpretation by the billing provider.The device must collect data for at least 16 out of 30 days.bDuring the COVID public health emergency,Medicare permitted providers to bill for RPM serv

54、ices furnished to new patients and reduced the 16-day reporting requirement to two days.28 Once the public health emergency ended,Medicare reinstated the pre-pandemic rules,requiring established patient-provider relationships and 16 days of reporting.In 2022,CMS introduced RTM payment policies for t

55、he monitoring of respiratory system status,musculoskeletal system status,therapy adherence,and therapy response.29 Although most requirements mirror those of RPM,the following distinctions exist:A wider array of providersincluding physical therapists,occupational therapists,and physiatristscan use R

56、TM codes,whereas only physicians,nurse practitioners,and physician assistants eligible to bill for evaluation and management services can use RPM.c Patients can self-report RTM data,while RPM data requires automatic uploading.30 Providers cannot bill both RPM and RTM for the same patient in a single

57、 month.31Medicare spending on remote monitoring is increasing rapidly,likely due to a combination of increased usage,widespread adoption of telehealth during the pandemic,and the establishment of permanent RPM and RTM codes.An b In the 2024 Physician Fee Schedule,CMS clarifies that this 16-day requi

58、rement does not apply to treatment codes.See:https:/www.federalregister.gov/public-inspection/2023-24184/medicare-and-medicaid-programs-calendar-year-2024-payment-policies-under-the-physician-fee-schedule.Also see Appendix B for more details.c Physiatrists are physicians who specialize in physical m

59、edicine and rehabilitation.See:https:/www.hopkinsmedicine.org/health/treatment-tests-and-therapies/physiatrist 11analysis of RPM spending for Medicare enrollees showed an increase from$5.5 million in 2019 to$101 million in 2021.32 Despite the large increase,this growth still represents only 594 mont

60、hly claims per 100,000 enrollees.A separate analysis found that a small group of primary care providers has largely driven the increase in RPM spending.RTM uptake has also steadily increased since its recent introduction,yet billing and documentation requirements can hinder widespread adoption.33,34

61、Despite increasing usage,remote monitoring tools are likely underutilized in some areas.Experts we spoke with indicated that access to remote monitoring is more a function of where a patient lives and who their provider is,rather than their medical condition and if they would benefit from remote mon

62、itoring.A 2022 survey found that only one-quarter of medical practices offered remote monitoring.35,36Lawmakers have expressed concerns about the misuse of remote monitoring codes in Medicare.In the 2015 Medicare Reauthorization Act,Congress directed the Government Accountability Office to complete

63、a report on the use of telehealth and RPM in the private insurance market.37 The report called attention to the absence of originating site codes in billing records,a potential indication of improper billing.38 A report on remote monitoring by the HHS Office of Inspector General,scheduled for releas

64、e in 2024,will provide new information on the evolution of remote monitoring;the characteristics of Medicare patients and providers using these services;and the potential for fraud,waste,and abuse.39 MedicaidCurrently,37 state Medicaid programs reimburse for RPM;requirements for coverage vary signif

65、icantly by state,however.40 Many state Medicaid programs that offer remote monitoring reimbursement have restrictions associated with its use.Common restrictions include limiting reimbursement to only home health agencies,specifying which conditions qualify for monitoring,and setting criteria for ac

66、ceptable monitoring devices and data collection.41 Medicaid coverage of RTM has much less clarity than RPM:West Virgina released a bulletin in 2022 announcing the new RTM codes,but it is unclear whether other states have released similar guidance.42 Private PayersA variety of major private insurers

67、cover RPM,including Humana,Aetna,Cigna,UnitedHealthcare,and some branches of BlueCross BlueShield.43 Several follow CMS guidelines when determining which RPM devices and services to cover,while other private plans offer different coverage.44 Private insurers are less likely to cover RTM.Cigna,for ex

68、ample,issued a medical coverage policy in May 2023 explaining its decision to cover RPM services but not RTM,citing RTMs lack of peer-reviewed evidence.45 On the other hand,Anthem Blue Cross Blue Shield began covering RTM in 2023.46 An August 2023 AMA report 12on commercial payer coverage of digital

69、 technologies notes that the lack of coverage alignment between payers and the inconsistent levels of transparency on coding guidelines,can limit the uptake of these technologies.47F DA R E G U L AT I O N CMS payment policies require that remote monitoring devices meet the FDAs definition of a medic

70、al device.Section 201(h)of the Food,Drug,and Cosmetic Act states that devices must either be recognized in the official National Formulary;intended for use in the diagnosis,cure,mitigation,treatment,or prevention of a disease or condition;or“intended to affect the structure or any function of the bo

71、dy.”48 The FDA considers software to be a medical devicetermed Software as a Medical Deviceif it meets this same definition.To ensure safety and effectiveness,the FDA regulates remote monitoring medical devices and provides guidance to manufacturers on their design,testing,and labeling.Devices have

72、three major pathways to market depending on their risk classification.49 High risk devices must go through premarket approval,a review process that requires results from clinical trials.Most moderate risk devices undergo premarket notification(510(k)review,which often does not require clinical trial

73、s and focuses on establishing similarity to an already cleared device.50 Manufacturers must register and list low risk devices.Many available remote monitoring tools are classified as moderate risk;however,some could be high or low risk.The FDA also requires device manufacturers to comply with post-

74、market requirements,such as reporting adverse events,monitoring device performance,and adjusting the device or its labeling to address safety or effectiveness concerns.51 The FDA has also taken steps in recent years to address Software as a Medical Device.In 2019,the agency proposed a regulatory fra

75、mework for modifications to AI machine learning-based software as a medical device.The FDA introduced the concept of a predetermined change control plan(PCCP),which would allow for certain modifications to occur without the need for a renewed premarket review.The Food and Drug Omnibus Reform Act of

76、2022 added Section 515C to give the FDA express authority to accept PCCPs.The FDA has now begun to accept PCCPs and to establish standards for devices that rely on adaptive algorithms.52,53,54,55 The agency has also taken steps to harmonize its approach with the U.K.and Canadian health authorities.5

77、6 However,the FDA provides limited and sometimes differing information on the performance of the devices,and there is no easy way to compare two similar devices.Researchers have raised concerns about the limits of the FDAs regulatory authority over remote monitoring devices,including the agencys abi

78、lity to mitigate risks of fraudulent devices,ensure patient privacy,and address device safety and accuracy issues.57 13The FDA launched the Patient Monitoring and Control Program in 2021 to address regulatory science gaps,including:58 lack of clear guidelines on testing with patient monitoring datas

79、ets,which limits the utility of this type of least burdensome testing and often results in the collection of new data or a reanalysis of existing information;limited availability of test methods and comprehensive information required to enable medical devices and systems to communicate(i.e.,interope

80、rability);and,lack of a way to evaluate a product over numerous iterations,including updates to algorithms.The Biden administrations October 2023 Executive Order on AI calls on HHS to develop an AI assurance policy to evaluate and monitor AI-enabled health care tools.59 FDA oversight of medical devi

81、ces is likely to be a part of this policy.EQ U IT Y I M P L I CAT I O N SRemote monitoring services have myriad health equity implications.Remote monitoring can expand access to health services for populations facing barriers to care,including people with mobility issues,residents of rural areas,ind

82、ividuals without access to transportation,and people with lower incomes.60,61,62,63 Individual companies and institutions tout the potential for remote monitoring to increase access to care.64,65 However,without proactive measures,remote patient monitoring could perpetuate or even exacerbate pre-exi

83、sting disparities in access to and quality of care.Before 2024,safety-net providers faced unique financial barriers to starting and maintaining remote monitoring because they could not bill for these programs.66 CMS pays federally qualified health centers(FQHCs)and rural health clinics(RHCs)an all-i

84、nclusive rate for each patient visit,and providers cannot bill separately for most individual services.67 Healthcare Common Procedure Coding System code G0511 for general care management is one of the few separate billing options,and it covers services typically performed outside of face-to-face vis

85、its,such as chronic care management.In the 2024 Physician Fee Schedule,CMS finalized its proposal to include remote monitoring services in Healthcare Common Procedure Coding System code G0511 and allow safety-net providers to bill code G0511 multiple times per month.68 As such,safety-net providers c

86、an now receive separate reimbursement for RPM and RTM.Broadband issues can inhibit patients use of remote monitoring services.Many Americans grapple with limited broadband,including 46 million individuals living in rural and frontier communities.69 A study comparing rural hospitals to their urban an

87、d suburban counterparts found that patients using rural remote 14monitoring programs reported more concerns regarding privacy,ability to pay,and lack of strong cell service.70 Data show that the digital divide affects the use of health IT,despite the fact that the majority of Americans want access t

88、o digital health data.71,72Providers and older adults,non-native speakers,racial minorities,and individuals unfamiliar with digital tools might face unique barriers to adopting and reaping the benefits of remote monitoring services.73,74,75 Among these challenges are the algorithmic biases present i

89、n some medical devices.The following example illustrates this challenge and highlights the importance of centering equity considerations:Providers utilizing remote monitoring note that the volume of patient-generated information can become unmanageable.Automation systemsincluding ones that incorpora

90、te AIcould help providers to manage streams of data by sending alerts when values are out of range and conducting additional analyses to inform disease management protocols.Yet AI algorithms,reliant on vast amounts of data for training,can inadvertently exacerbate biases present in the data.Research

91、 has uncovered racial biases in medical devices,including ones used for remote monitoring.76 For example,pulse-oximeters consistently yield unreliable results for people of color,and AI tools that used data from these devices to guide treatment decisions during the pandemic may have exacerbated this

92、 existing bias.77,78,79 Any AI-integrated automation systems would need to include safeguards to protect against these and other risks.As policymakers prepare for the future of remote monitoring,they will need to be mindful of these inequities to fully realize the benefits of remote monitoring.DATA

93、S E C U R IT Y A N D P R I VACY The United States has no single overarching privacy law,and privacy regulations may not fully cover data from home-monitoring technologies.80Regulatory bodies have enforced the Health Insurance Portability and Accountability Act of 1996(HIPAA)and the Health Breach Not

94、ification Rule in actions against remote monitoring and digital health companies.HIPAA is the main health-related privacy statute,and it protects patient information when held by certain covered entities,including health providers,health insurers,and the business associates of those individuals or o

95、rganizations.81,82 Yet HIPAA might not apply to user-generated data or data generated by remote monitoring devices before those data are sent to 15the doctor.83,84,85 RPM device and software firms are unlikely to be business associates under the definition in 45 CFR 160.103.86,87 HIPAA might not app

96、ropriately protect information collected by telehealth companies because these companies typically connect patients with providers,rather than provide care themselves.88,89The Federal Trade Commission(FTC)enforces the prohibition of unfair or deceptive acts or practices and has promulgated the Healt

97、h Breach Notification Rule,which requires a company to notify the public when it has had a data breach.90,91 The FTC recently began enforcing this rule,notably with a$1.5 million settlement with GoodRx.92 In June 2023,the commission published a Notice of Proposed Rulemaking regarding updates to the

98、Health Breach Notification Rule.93 The proposed rule would add wellness productssuch as sexual health,sleep,and diet appsto the definition of health care services or supplies.It also requires third-party service providers to vendors of personal health records to provide notification to these vendors

99、 following the discovery of a breach.There are numerous additional cybersecurity requirements and standards for health data.FDA-reviewed devices must adhere to a level of cybersecurity that provides reasonable assurance of security for users.The Consolidated Appropriations Act of 2023 granted the FD

100、A authority to refuse to accept any premarket submission that did not meet its cybersecurity requirements,and in April 2023 the agency sent a letter to health care providers regarding cybersecurity vulnerabilities in a genetic sequencing device.94,95,96,97 There are also voluntary frameworks,such as

101、 the Health Information Trust Alliance common standards and the framework from the National Institute of Standards and Technology,as well as interoperability standards,such as the Fast Healthcare Interoperability Standards.98,99,100Yet cybersecurity gaps likely remain.Many legally marketed devices f

102、all within the category of devices for which the FDA is exercising enforcement discretion,and they might not meet the FDA standards for cybersecurity.More than 70%of surveyed telehealth providers report using legacy operating systems,which can pose risks to security because they often cannot be patc

103、hed or updated.101 Additionally,patients who are monitored or managed at home likely do not have the same privacy and cybersecurity safeguards as a hospital setting.Patients without cybersecurity safeguards might also spread malware to their providers.10216Policy Recommendations A.Service Coverage C

104、MS should work with medical specialty societies to evaluate the evidence and determine appropriate coverage mechanisms to guide the optimal use of remote monitoring,including for which patients and over what duration.This work could include collaborating with Medicare Administrative Contractors(MACs

105、)or issuing National Coverage Determinations(NCDs).Medicare providers have wide discretion to determine whether remote monitoring services are“reasonable and necessary”for their patients.103 Research shows significant differences in the use of remote monitoring technology for patients with similar d

106、iagnoses.Studies also do not show substantial targeting of the technology on people with more serious or poorly controlled diseases.104,105At the same time,remote monitoring CPT code requirements limit the extent to which providers can tailor their approach to service delivery by patient or conditio

107、n.For example,some remote monitoring CPT codes require providers to interact with patients for a minimum of 20 minutes to receive reimbursement.In 2023,the Patient Safety Network of the Agency for Healthcare Research and Quality released a report emphasizing the need for“robust processes and clear g

108、uidelines”to help providers identify appropriate patients and optimally use these services.The cost effectiveness of remote monitoring can vary by type of 17service,diseases monitored,and the setting in which monitoring is occurring,according to the report.106 In February 2023,Medicare Administrativ

109、e Contractors held a multijurisdictional Contractor Advisory Committee meeting to review the strength of the clinical evidence for RPM and RTM.Several experts voiced concerns about restricting coveragesuch as through Local Coverage Determinationswhile research is ongoing.Following this meeting,MACs

110、decided not to develop Local Coverage Determinations for remote monitoring.107 CMS should continue to monitor the evidence and use its existing authorities to craft appropriate coverage mechanisms that guide the optimal use of remote monitoring tools.Based on the evidence,CMS could work with MACs to

111、 address local needs or issue NCDs to establish a uniform,nationwide approach.The coverage mechanisms should at minimum specify conditions,target populations,measure(s)to monitor,measurement frequency,and recommended measurement duration.They could also offer guidance on how frequently providers nee

112、d to review the data.Some health conditions might require daily review of data,whereas others might only need review weekly or monthly.CMS should partner with medical specialty societies and other external experts through existing pathways,including the Medicare Evidence Development and Coverage Adv

113、isory Committee and the Agency for Healthcare Research and Quality Technology Assessments.CMS also references practice guidelines and compendiasuch as those developed by the American Diabetes Associationwhen it makes national coverage determinations.108,109 For example,the agency covers cancer treat

114、ments included in practice guidelines.110 These existing pathways and processes will help to clarify the appropriate use of remote tools,both encouraging their use when there is evidence of benefit and discouraging their use when there is not.As more evidence emerges about the appropriate use of rem

115、ote monitoring devices,the secretary of HHS should use the departments existing authority to recommend a diverse set of billing codes so providers have more options for the time they spend on the data and the number of minimum days of data required.To bill Medicare for remote monitoring devices,a pr

116、ovider must monitor a patient for at least 16 days of a 30-day period;to bill Medicare for treatment or data interpretation,a provider must spend at least 20 minutes of time on these services per month.During the COVID-19 public health emergency,Medicare reduced the 16 reporting days to two days;onc

117、e the public health emergency ended,Medicare reinstated the pre-pandemic rules.111The 16-day data collection and 20-minute interaction limits might not be appropriate for every clinical situation.For example,providers might only 18need a few days of foot temperature data for diabetic patients at ris

118、k of developing foot ulcers.And a provider might find that less than 20 minutes of care management and interaction is sufficient for medication titration in certainconditions.As more evidence becomes available about the best uses of remote monitoring devices,CMS should use its existing authority to

119、create multiple billing thresholds so there are more options for the minimum days of data required and for the time a provider spends on treatment or interpreting data.A bipartisan bill introduced in 2021 by Reps.Troy Balderson(R-OH)and Katie Porter(D-CA)would extend the lower two-day billing thresh

120、old until two years after the public health emergency and would require the HHS secretary to report on appropriate long-term billing thresholds.112 As evidence develops,RTM and RPM might be able to use the same CPT codes,and the nuances of provider time could be captured similarly for both technolog

121、ies.Most stakeholders agree,however,that for now,the separation of the two is important to maintain.CMS should further clarify current policies regarding appropriate coding and billing of RPM and RTM.It should also require providers not enrolled in risk-based models to attest to medical necessity fo

122、r patients continued use of remote monitoringat a frequency deemed appropriate by the HHS secretary and based on condition-specific clinical guidelines.Providers use of remote monitoring billing codes varies widelysome use the codes for monitoring patient physiological data,others use remote monitor

123、ing data as an impetus to bring patients in for an office or virtual visit,while yet others do both simultaneously.113CMS has taken steps to clarify policies in recent years.In 2021,CMS said that the 20 minutes of intraservice work associated with the treatment codes for remote monitoring includes“a

124、 practitioners time engaged in interactive communication as well as time engaged in non-face-to-face care management services during a calendar month.”114 Additionally,the CMS 2023 Physician Fee Schedule highlighted rules to protect against the double billing of codes for chronic pain management and

125、 remote monitoring,and the 2024 Physician Fee Schedule clarified which specific remote monitoring codes must adhere to the 16-day data collection requirement.115,116 CMS should provide further guidance to providers on how and when to use remote monitoring billing codes via one or more of the followi

126、ng regulatory and communications avenues:CMS could provide clarity through the Physician Fee Schedule,which lists the fees CMS pays providers for specific work.117 19 In the fiscal year 2023 omnibus,Congress directed CMS to share information with states on ways to leverage telehealth and remote moni

127、toring to reach people experiencing homelessness.118 As part of this communication,CMS could include language about when to use remote monitoring codes and which codes should not be billed together.CMS could publish a bulletin or FAQ explaining the codes and when to use them.A bulletin is considered

128、 subregulatory guidance and provides the agencys thinking on an issue.119 CMS could partner with providers professional societies and expert groups to provide continuing medical education on remote monitoring and include accurate information about billing.CMS could also provide non-continuing medica

129、l education courses online.120 If data emerge around billing confusion for any particular disease state,CMS could work with the specialty societies representing these providers to provide additional education.Last,and likely most easily,CMS could clarify billing requirements through communications c

130、hannels,such as officials speeches or the CMS blog.121Additionally,CMS should require providers not enrolled in risk-based models to attest to medical necessity for patients continued use of remote monitoring technologyat a frequency deemed appropriate by the HHS secretary and based on condition-spe

131、cific clinical guidelines.Today,providers qualified to bill for remote monitoring services have wide latitude to choose which patients receive remote monitoring services and for how long.Yet ongoing monitoring of controlled disease sometimes provides limited utility.For example,one study found that

132、most hypertension medication adjustments occurred within the first four months of starting RPM.122 Beyond this period,the frequency of medication adjustment aligned with rates observed before RPM use.In a fee-for-service reimbursement environment,providers can have strong incentive to increase the u

133、tilization of RPM,potentially beyond its period of clinical benefit.Third-party remote monitoring vendors could further incentivize uptake by reducing the costs for providers to scale their services,including by supplying monitoring devices and conducting patient onboarding.123To help ensure the app

134、ropriate use of remote monitoring,CMS should require providers to attest to the clinical necessity of a patients continued use of the services.Until clinical guidelines are established,attestations allow providers a relatively simple way to ensure they are thoughtful about monitoring usage and to cu

135、rb ongoing remote monitoring applications that provide little to no clinical value.124 Numerous health programs,including some Medicaid programs,have successfully used provider attestation.125 They have also used attestation to address other Medicare requirements,such as interoperability.126 Similar

136、 requirements have worked to curb inappropriate antibiotic usage.127 20CMS should exempt providers participating in risk-based models from an attestation requirement.Value-based models already incentivize providers to adopt higher-value,cost-effective uses in their practices.CMS could also consider

137、additional flexibility for providers participating in risk-based models,such as reconsidering restrictions that limit remote monitoring use to one provider per patient in a 30-day period,even when a patient uses more than one device.This restriction disproportionally affects Medicare beneficiaries w

138、ith multiple chronic conditions who may need various specialists along with a primary care provider to manage their care.Regardless of a formal attestation requirement,the authorizing provider should re-evaluate the necessity of the service regularly,at a frequency that aligns with clinical guidelin

139、es.This would verify that a patients data continues to be important to monitor and provides clinical value.CMS should work with the American Medical Association(AMA)and relevant medical specialty societies to develop additional RTM billing codes to allow for use cases beyond musculoskeletal,respirat

140、ory,and cognitive behavioral therapyas the evidence supports.Currently,RTM billing codes exist only for three body systems:musculoskeletal,respiratory,and cognitive behavioral therapy.Industry and other stakeholders have requested that CMS develop a generic RTM device code,but it has not created one

141、.Before any expansion of RTM service codes,it is important to consider the implications on patient health outcomes and costs.Evidence-based tools may exist in the market today that are not related to musculoskeletal,respiratory,or cognitive behavioral therapy.For example,one manufacturer published d

142、ata demonstrating positive outcomes and cost savings when patients use its wound care system.Yet providers cannot bill for this system because it does not fit in the existing allowable RTM categories.128Experts we talked to said that CMS current RTM coverage policies largely relate to which manufact

143、urers were actively involved in submission processes.Limits on RTM codes might artificially constrict the market of available tools and have a chilling effect on innovation.CMS should work with the AMA to evaluate the evidence base that could support additional RTM billing codes to allow for use bey

144、ond those cases currently available.Sufficient evidence does not yet exist to support a recommendation consolidating remote physiologic and remote therapeutic monitoring into a single set of payment codes.However,it is important to note that in both cases,CMS is paying for the providers time reviewi

145、ng the patients data.In the future,21MedPAC could review emerging data to recommend consolidation,or CMS could consider rulemaking on the matter.Congress should request the Medicare Payment Advisory Commission(MedPAC)to report on the impact of remote monitoring on clinical outcomes and cost by disea

146、se state,and on any new billing thresholds or code durations,at least every three years.The best-use cases for remote monitoringbased on disease,device,patient,time frame for monitoring,risk factors,and other parametersare still unclear.At a Medicare Administrative Contractor advisory meeting in ear

147、ly 2023,many attendees provided mixed evidence on the clinical effectiveness of remote monitoring.129 One attendee noted that any changes to coverage or reimbursement during the evidence-gathering phase could harm the uptake of remote monitoring.130 Another attendee conceded that“the widespread adop

148、tion and data generation on specific clinical applications for remote patient monitoring wont really mature for another couple of years.”131 In May 2023,the contractors announced they would not be making changes to RPMcoverage.132 Further evidence will help Medicare determine the clinical utility of

149、 remote monitoring,including how often it informs clinical decisions and promotes positive patient outcomes.133 Congress should request that MedPAC gather and analyze the existing data on remote monitoring and report at least every three years on its findings.The MedPAC report should provide an anal

150、ysis or meta-analysis of studies by disease state and include information about device type,patient characteristics,and length of monitoring.B.Improving Equity Congress should direct the FDA to promulgate a rule clarifying that remote monitoring device labels should include performance characteristi

151、cs to support the safe and effective use of these devices.CMS reimbursement policies require that remote monitoring devices meet the definition of a legal device.Yet FDA-approved or-cleared devices do not always share sufficient performance information to allow providers and patients to understand t

152、he clinical utility of the data.And limited information on performance characteristics can make it difficult for patients to avoid counterfeit devices.FDA-regulated devices,including remote monitoring devices,are not always accurate and do not consistently perform the same across demographic groups.

153、134 For example,FDA-regulated blood pressure cuffs have produced inaccurate at-home readings,despite regulations requiring regular calibration.135,136,137,138 Research has also shown that pulse oximeters can be less 22accurate on people with darker skin.139 This bias has prompted FDA advisory commit

154、tee meetings and calls from state attorneys general for clearer labeling and rigorous device testing.140 In 2018,the FDA published guidance for industry on reporting age,race,and ethnicity data for medical devices.However,it focused on devices for which there are clinical studies,and many devices do

155、 not undergo clinical trials before coming to market.141 In 2022,the FDA approved only 22 devices through the premarket approval process and more than 3,000 devices through the 510(k)pathway,the majority of which did not undergo clinical trials.142,143 The FDA should support the safe and effective u

156、se of remote monitoring devices by promulgating a rule clarifying that device labels should include performance characteristics.Transparency is particularly important with monitoring devices increasingly incorporating automation systems and AI.Performance characteristics should include,but not be li

157、mited to,the analytical performance of the device,the error rate,and the relevant population on which the device has been tested,and how it performs across races,ethnicities,and sexes.144 Information should also address performance drift by indicating the time frame over which devices“without the ne

158、ed for calibration”are accurate.145 The In Vitro Diagnostics Rulewhich mandates the disclosure of performance characteristics,opening instructions,and calibration proceduresoffers a model for transparent device labeling.146 The FDA should develop an easy to reference list or notationsimilar to the A

159、I device listfor consumers to search online for legally marketed remote monitoring devices.The FDA operates a number of databases where the public can search for medical devices,but no single database is dedicated to remote patient monitoring devices.147 It can be difficult,as a result,to find accur

160、ate information about the status and proper utilization of these devices.There are separate databases for each of the review mechanisms(de novo,510k,premarket approval),a registration and listing database,and a general devices database.148,149,150,151 Remote monitoring devices can go through any of

161、these mechanisms,and no centralized database compiles them at this time.An FDA webpage on emergency use authorizations for remote or wearable patient monitoring devices provided information about devices authorized for use during the COVID-19 public health emergency,when the FDA promulgated an enfor

162、cement discretion policy.152,153 Yet the site does not include any remote devices approved,cleared,or granted marketing authorization outside of the emergency use authorization process.Relabeling by distributors might further complicate efforts to find information about a remote monitoring device.BP

163、C found one such example of a program that distributed glucometers to help recipients control their blood glucose.The 23specific glucometer does not appear in the FDA databases because the company,which is not the original manufacturer,relabeled the product.The agency often keeps this information as

164、 a trade secret.However,it is key to evaluating a devices performance,and the FDA should make it public.Ultimately,patients and providers have no simple way to find out whether a remote monitoring device is FDA cleared or approved.There is no list of cleared or approved remote monitoring devices and

165、 no denotation in the databases to easily find which devices are remote monitoring.As such,manufacturers may face difficulties complying with CMS requirements for FDA review,and patients and providers may not be able to locate accurate information about the status and proper utilization of their dev

166、ices.The FDA should create a list of legally marketed remote monitoring devices,as it does for artificial intelligence devices,although that list is not comprehensive.154 It could also create other ways to search for these products in its numerous databases or across the databases,including by label

167、ing remote monitoring devices.Many legally marketed devices are not FDA reviewed due to enforcement discretion,so this list would be incomplete.Nonetheless,it would be a helpful resource.CMS should clarify that it allows store-and-forward technologies for billing codes related to remote monitoring a

168、nd provide guidance on how often patients should transmit data to providers.This would allow flexibility for patients or providers who do not have access to broadband to benefit from and deliver remote monitoring services.Individuals living in areas without broadband technology face significant barr

169、iers in receiving remote monitoring services.Currently,about 42 million Americans lack access to broadband.155 Remote monitoring devices transmit data through cellular or broadband.Cellular remote monitoring devices use the same network as cellphones to transmit data,while Bluetooth-enabled remote m

170、onitoring devices use wireless communication and require an internet connection.While remote monitoring devices currently do not send large amounts of data,not all devices can connect to a cellphones hot spot or send data directly through cellular platforms.There is confusion about to how often devi

171、ces and/or patients must transmit data to a provider to qualify for remote monitoring reimbursement.If data are not recorded and transmitted in real time,some experts said providers might not be able to bill for remote monitoring services.CMS could address this confusion and facilitate access to rem

172、ote monitoring by clarifying that it reimburses for store-and-forward technology.Store-and-forward,also called asynchronous technologies,allows for the electronic transmission of medical information to a practitioner at a distant site for 24use outside of a live patient interaction.CMS should allow

173、store-and-forward technology for remote monitoring billing codes and provide guidance on how often devices and/or patients must transmit data to a provider.For example,requiring data uploads at least weekly could be an appropriate safeguard.To the extent possible,this frequency should be based on di

174、sease-specific evidence.As federal agencies work to expand broadband,clarification from CMS regarding store-and-forward for remote monitoring services would facilitate access to care for patients who lack broadband access.156 Congress should clarify and refine anti-kickback safe harbors related to p

175、roviding devices to patients.This is especially important for safety-net providers who often lack the resources to cover startup costs for a remote monitoringprogram.The dynamics of acquiring remote monitoring devices differ widely,influenced by such factors as medical necessity,where an individual

176、lives,and a providers financial models.Some patients own their devices outright,while others rely on short-term rentals,in which providers purchase or lease the device and supply it to the patient.CMS has a billing code for the provision of a remote monitoring device,but anti-kickback statutes can m

177、ake it difficult for medical providers to offer devices to patients.The anti-kickback statute penalizes individuals or entities for financial transactions intended to influence referrals to federal health care services.Providers and payers face a fine of$100,000,a prison term of 10 years,or both for

178、:knowingly and willfully offering or paying directly or indirectly,overtly or covertly,in cash or in kind to anypersonto induce suchpersonto purchase,lease,order,or arrange for or recommend purchasing,leasing,or ordering any good,facility,service,or item for which payment may be made in whole or in

179、part under afederal health care program.157 Some providers find financial sources outside of Medicare to avoid anti-kickback penalties and to ensure patient access to remote monitoring.158 Yet many medical practices cannot supply devices to their patients without coverage for the device itself.Witho

180、ut provider involvement,some patients might not be able to afford beneficial remote monitoring services.In recent years,the HHS Office of the Inspector General(OIG)has taken several steps to refine and clarify anti-kickback safe harbors and expand access to remote monitoring,including:In 2019,OIG pu

181、blished an advisory opinion allowing a pharmaceutical company to loan smartphones to financially constrained patients“to receive adherence data from a sensor embedded in prescribed antipsychotic medication.”159 25 In 2020,OIG published an anti-kickback final rule,which notes that remote monitoring c

182、ould fit under the safe harbor exception under certain circumstances.160 The final rule aims to protect“certain value-based arrangements that would improve quality,outcomes,and efficiency with an aim to support innovative methods and novel arrangements,including the use of digital health technology

183、such as remote patient monitoring and telehealth.”161 The rule grants safe harbor protection for the exchange of digital health tools by medical device manufacturers,but it excludes physician-owned distributorships from this protection.OIG outlined the following example of a qualifying agreement:A“t

184、echnology company could provide the physician group with necessary digital health technology that improves the physician groups ability to observe recovery and intervene,asnecessary.”162 In 2022,OIG published another advisory opinion allowing a medical provider to lend limited-use smartphones to“cer

185、tain existing patients to facilitate access to telehealth services.”163 The office noted that under some circumstances,this agreement would violate the anti-kickback statute,but that it would not take action against the provider.OIG cautioned that the“opinion may not be relied on by any person other

186、 than Requestor.”164 In 2023,OIG provided an advisory opinion allowing a manufacturer of an FDA-approved noninvasive colon cancer test to provide a$75 Mastercard gift card to some beneficiaries for returning the sample.165 Although this approach would typically breach the anti-kickback statute,OIG c

187、hose not to enforce any administrative penalties.Although OIGs actions have been critical,Congress should clarify and create safeguards to eliminate the necessity for advisory opinions such as the ones outlined above.Any legislation should clarify which types of remote monitoring agreements and equi

188、pment are not subject to anti-kickback penalties and should specify lawful practices under the existing billing codes.Congress has attempted to address anti-kickback safe harbors in several bipartisan bills introduced in the 118th Congress.The DIVERSE Trials Act(S.2706/H.R.5030)would allow clinical

189、trial sponsors to provide participants with digital health technologies that would facilitate their participation in the trial.These actions would not violate the anti-kickback statute.166 The CONNECT for Health Act(S.2016/H.R.4189)would clarify fraud and abuse laws regarding a medical provider furn

190、ishing remote monitoring-related technologies.167 26C.Data Security and Privacy The HHS Office of Civil Rights should identify whether existing privacy policies adequately protect personal health information gathered,stored,and transmitted through remote monitoring.If gaps remain,the office should a

191、ssess whether it has the authority to close that gap and,if it does not,Congress should do so.Some regulatory experts argue that there are few gaps in the regulation of personal health information,but others disagree.168,169 One witness at a Senate hearing highlighted concerns about“an increasing am

192、ount of personal health information that is circulated and not regulated,”noting wearable technology home medical devices.170 And existing privacy and cybersecurity protections have not fully protected consumers from ransomware attacks on hospitals and other companies that retain sensitive informati

193、on.171 At the same time,it is important that unfounded concerns regarding patient privacy do not hinder the appropriate use of medically necessary technology.The HHS Office of Civil Rights(OCR)should determine whether existing privacy policies adequately protect personal health information gathered,

194、stored,and transmitted through remote monitoring.OCR could start by reviewing FDA cybersecurity policies,HIPAA,and the FTCs Health Breach Notification Rule.FDA cybersecurity policies:Medicare only covers remote monitoring services that meet the FDAs definition of a medical device,and FDA-reviewed de

195、vices must adhere to a level of cybersecurity that provides reasonable assurance of security for users.In 2023,the agency gained authority to refuse to accept any premarket submission that did not meet its cybersecurity requirements;it also alerted health care providers to cybersecurity vulnerabilit

196、ies in a genetic sequencing device.172,173,174,175 Yet many legally marketed devices fall within the category of devices for which the FDA is exercising enforcement discretion,and therefore they might not meet the FDA standards for cybersecurity.HIPAA:CMS-covered remote monitoring devices must also

197、adhere to HIPAA privacy standards.Yetas outlined in the“Cybersecurity is Patient Safety”report by the office of Sen.Mark Warner(D-VA)HIPAA focuses on data in a provider or payer setting,and the act does not cover many types of data and actors,such as apps and consumer devices.176 Although HIPAA appl

198、ies to data gathered via CMS-covered remote monitoring devices once those data reach the health care provider,confusion remains as to whether the act applies to data generated before reaching the provider.177 FTCs Health Breach Notification Rule:Many entities that are not subject to HIPAA are subjec

199、t to the FTCs Health Breach Notification Rule,which requires companies to share a notification publicly after a data breach.178 27BPC supports proposed changes to the Health Breach Notification Rule to further safeguard personal health information by encompassing a wider range of data and entities.S

200、ome provisions of the rule would also address the perceived regulation of personal health information and ensure that all stakeholders are aware of their responsibilities with respect to those data.If OCR determines there is no gap in privacy protections,it should make that finding clear through sub

201、regulatory means,such as blogs,speeches,and other communications.If OCR determines there is a gap in privacy protections,it should assess whether it has the authority to close that gap and then do so,if possible.If it does not have the authority,the agency should call on Congress to do so.Congress h

202、as already considered the need for additional privacy laws.The bipartisan American Data Privacy and Protection Act(H.R.8152)was introduced in the House of Representatives in 2022 to create a comprehensive federal consumer privacy framework.179 The House Energy and Commerce Committee,in its report on

203、 the act,expressed that the sector-by-sector privacy laws were insufficient;that the state patchwork of laws was confusing for both consumers and businesses,leaving gaps and making compliance difficult;and that a national privacy law would provide more consistency and the appropriate level of oversi

204、ght.180 HHS should study the use of cybersecurity safe harbor laws to determine their effectiveness.Cybersecurity safe harbor provisions exist at the state and federal level to protect companies that experience cybersecurity breaches despite complying with industry-recognized cybersecurity standards

205、.Both Utah and Ohio have safe harbor laws.181,182 Other federal laws,such as those protecting childrens privacy,have safe harbor provisions.183 HHS recently received authority from Congress to consider a companys use of industry-standard security practices when making decisions about HIPAA violation

206、s.184 It remains to be seen if this change is effective.HHS should study the use of cybersecurity safe harbor laws to determine their effectiveness and whether additional laws are needed.Congress proposed other studies on cybersecurity safe harbor provisions in the American Data Privacy and Protecti

207、on Act,introduced in 2022.185 The bill directs the FTC to analyze safe harbor provisions related to childrens online privacy and provide regular recommendations regarding policy changes to improve the effectiveness of these provisions.HHS should also continue to enhance the ability of the HHS chief

208、information officer to address cybersecurity concerns,as highlighted by Sen.Warners(D-VA)2022 Request for Information and an anticipated OIG report.The chief information officer is responsible for all information technology efforts within the department,including cybersecurity.186 Sen.Warners“Cybers

209、ecurity is 28Patient Safety”report outlines the need to ensure the officer is adequately equipped to lead HHS work on cybersecurity in health care,including by advocating for necessary resources,coordinating with other agencies,and outlining expectations of external stakeholders.187 An OIG report ex

210、pected in 2025 will evaluate HHS governance over programs and assess whether appropriate minimum safeguards are in place to prevent,detect,and recover from cyberattacks.188HHS,through the Office of the National Coordinator for Health Information Technology,should continue to ensure the existence of

211、appropriate data standards so that remote monitoring devices can be interoperable with Electronic Health Record(EHR)systems.Interoperability facilitates seamless sharing of patient data across various systems.In remote monitoring,interoperability enables devices and EHRs to share information.Such in

212、tegration streamlines provider workflows and offers a central home for patients health data.Research links the interoperability of remote monitoring to patient satisfaction,engagement,and safety.189 Nearly 90%of providers use EHRs,and the percentage of hospitals that have some level of interoperabil

213、ity in their health records is rising.190,191 Yet integrating data from remote monitoring with existing EHRs has been a challenge.192 CMS requires that remote monitoring devices be able to transmit data electronically.However,there is no requirement regarding interoperability for a provider to recei

214、ve reimbursement.193Many EHRs were designed for episodic care,rather than regular monitoring.194 And some providers have invested in new or updated EHR systems that might not be compatible with remote monitoring devices.Providers,as a result,must either manually enter remote monitoring data into the

215、ir EHRs or rely on third-party vendor software to link remote monitoring data with EHR systems.195 Stakeholders BPC spoke with expressed concern about situations in which a single provider or practice has patients with different remote monitoring devices,potentially leading to inconsistencies in dat

216、a retrieval across those devices.In recent years,Congress and federal agencies have taken many steps to facilitate health data exchange and interoperability.In the 21st Century Cures Act,Congress directed HHS to establish the Trusted Exchange Framework and Common Agreement(TEFCA),which HHS released

217、in January 2022.TEFCA“describes a common set of nonbinding,foundational principles for trust policies and practices that can help facilitate exchange”among health information networks.196,197 HHS has announced that it approved six health information networks to adopt TEFCA by the end of 2023.198 The

218、 success of TEFCA hinges on widespread adoption.199 29Stakeholders within Congress,federal agencies,and the private sector recognize the importance of interoperability between medical devices and EHR systems.Academic experts urge the FDA to form a public-private partnership to support the interopera

219、bility of medical devices.200 The Better Interoperability for Devices Act(H.R.1557),introduced in March 2023 and supported by industry stakeholders,would require an FDA study of medical device interoperability.201,202 And the FDA is researching and testing standards to promote interoperable medical

220、devices.203 HHS should build on this work and collaborate with stakeholders across the public and private sectors to ensure appropriate data standards so that remote monitoring devices are interoperable with EHR systems.30ConclusionRemote monitoring devices have the potential to revolutionize clinic

221、al treatment and bridge gaps in care for hard-to-reach populations.Some policy and medical experts,however,voice concern about a lack of robust evidence on the optimal use of remote monitoring and question whether we are effectively“rightsizing”the use of these services,ensuring access for patients

222、who need it most,and spending health care dollars in effective ways.Additionally,many disagree on the extent to which existing privacy policies adequately protect patient health information.Adoption of remote monitoring is increasing rapidly and likely to continue to increase as technology improves,

223、providers establish manageable workflows,and patients become more familiar with its use.Now is the time for policymakers,payers,and providers to refine their approach to this technology to maximize safe,appropriate adoption for patients who stand to benefit.BPCs recommendations are evidence-based,vi

224、able solutions to help guide policymakers forward.This report synthesizes findings from across the available published literature,as well as from in-depth conversations with health policy experts,federal officials,technology leaders,vendors,medical providers,payers,consumers,and academics.BPCs work

225、can inform policies to fully realize the promise of remote monitoring by fine-tuning coverage,ensuring equitable access to the technology,and prioritizing patient security.31Appendix A:Differences Between Remote Physiologic Monitoring and Remote Therapeutic Monitoring204Remote Physiologic Monitoring

226、Remote Therapeutic MonitoringCodesCPT Codes 99091,99453,99454,99457,and 99458 CPT Codes 98975,98976,98977,98978,98980,and 98981 ServicesEvaluation and managementGeneral medicineBilling ProviderPhysicians and nonphysician practitioner who can bill for evaluation and management services,as well as cer

227、tain clinical staff under the general supervision of the physician Providers eligible to bill general medicine codesData TypesPhysiologic data is not yet defined by CMS or the AMA,but illustrative examples provided by the RPM code descriptors include weight,blood pressure,pulse oximetry,and respirat

228、ory flow rate Nonphysiologic data,including respiratory system status,musculoskeletal system status,therapy adherence in cognitive behavior therapy,and therapy response for cognitive behavior therapy Clinical Use CasesThe RPMdevice supply code(99454)is not restrictedto data related tospecific biolog

229、icalsystems The device supply codes are limited to respiratory system data(98976),musculoskeletal system data(98977),and cognitive behavioral therapy data(98978)Data CollectionFDA-approved medical device mustdigitally(i.e.,automatically)record and uploadpatient physiologic data Requires the use of a

230、n FDA-approved device,but data may be digitally uploadedormanually self-reportedSource:Nancy Halstead,Lauren Bentlage,and Sebnem Dugmeoglu,“MACs Consider Guidance on Remote Patient Monitoring Amid Exploding Utilization,”Reed Smith,March 17,2023.Available at:https:/ B:CPT Code Descriptions and CY2023

231、 Reimbursement Rates for Remote Physiologic Monitoring and Remote Therapeutic Monitoring205,206,207Remote Physiological MonitoringCodeDescriptionReimbursement RateFrequencyCPT 99453Initial setup and patient training on the use of equipment$19Billed once per device CPT 99454Supply of device and colle

232、ction of data$50Billed once per 30 days if the patient takes at least 16 daily readingsCPT 99457First 20 minutes of patient interaction to adjust treatment based on RPM recordings$48Billed once per 30 daysCPT 99458Second(and third)20 minutes of patient interaction to adjust treatment based on RPM re

233、cordings$39Can be billed multiple times in a 30-day periodCPT 99091Time spent by provider to interpret information received from an RPM device(at least 30 minutes)$54Billed once per 30 daysRemote Therapeutic MonitoringCodeDescriptionReimbursement RateFrequencyCPT 98975Initial setup and patient train

234、ing on the use of equipment$19Billed once per deviceCPT 98976Supply of device with scheduled recording and/or programmed alert(s)transmission to monitor respiratory system$50Billed once per 30 days if the patient takes at least 16 daily readingsCPT 98977Supply of device with scheduled recording and/

235、or programmed alert(s)transmission to monitor musculoskeletal system$50Billed once per 30 days if the patient takes at least 16 daily readingsCPT 98978Remote therapeutic monitoring(e.g.,therapy adherence,therapy response);device(s)supply with scheduled(eg,daily)recording(s)and/or programmed alert(s)

236、transmission to monitor cognitive behavioral therapyCode is contractor priced;no national data available Billed once per 30 days if the patient takes at least 16 daily readingsCPT 98980Time spent by provider to perform treatment or interpret data;requires patient interaction,first 20 minutes$49Bille

237、d once per 30 days 33CPT 98981Time spent by provider to perform treatment or interpret data;requires patient interaction,each additional 20 minutes$39Can be billed multiple times in a 30-day periodContinuous Glucose MonitoringCPT 95249Patient-provided equipment,sensor placement,hookup,calibration of

238、 monitor,patient training,and printout of recording$62Billed once per deviceCPT 95250Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours;physician or other qualified health care professional(office)provided equipment,sensor placem

239、ent,hookup,calibration of monitor,patient training,removal of sensor,and printout of recording$147Billed once per 30 daysCPT 95251Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours;analysis,interpretation,and report$35Billed once

240、 per 30 daysNote:In the 2024 Physician Fee Schedule,CMS provides conflicting information regarding the 16-day data collection requirement for remote monitoring.Page 78883 lists RPM and RTM supply codes,RPM setup code,and RTM treatment codes:“only one practitioner can bill CPT codes 99453 and 99454,o

241、r CPT codes 98976,98977,98980,and 98981,during a 30-day period,and only when at least 16 days of data have been collected.”Yet on page 78884,CMS explicitly states that the requirement does not apply to RPM and RTM treatment management codes 99457,99458,98980,and 98981,emphasizing that these codes ac

242、count for provider time spent in a calendar month and do not require 16 days of data collection in a 30-day period.Sources:RPM and RTM:PrescribeFIT,“2023 Updates to Remote Monitoring CPT Codes&Reimbursements,”2023.Available at:https:/ glucose monitoring:American Association for Family Physicians,“Co

243、ding for Remote Patient Monitoring and Continuous Glucose Monitoring,”2023.Available at:https:/www.aafp.org/family-physician/practice-and-career/getting-paid/coding/coding-remote-patient-monitoring-continuous-glucose-monitoring.html.Reimbursement Rates:Centers for Medicare&Medicaid Services,“Search

244、the Physician Fee Schedule,”October 1,2023.Available at:https:/www.cms.gov/medicare/physician-fee-schedule/search.34Glossary of AcronymsAMA American Medical AssociationCMS Centers for Medicare&Medicaid ServicesCPT Current Procedural TerminologyEHR Electronic Health RecordFDA Food and Drug Administra

245、tionFTC Federal Trade CommissionFQHC Federally Qualified Health CenterHHS Department of Health and Human ServicesHIPAA Health Insurance Portability and Accountability ActMedPAC Medicare Payment Advisory CommissionOIG Office of the Inspector GeneralPCCP Predetermined Change Control PlanRHC Rural Heal

246、th ClinicRPM Remote Physiologic MonitoringRTM Remote Therapeutic MonitoringTEFCA Trusted Exchange Framework and Common Agreement 35Endnotes1 Mitchell Tang,Carter H.Nakamoto,and Ariel D.Stern,“Trends in Remote Patient Monitoring Use in Traditional Medicare,”JAMA Internal Medicine,182(9):1005-10006,20

247、22.Available at:https:/ Center for Connected Health Policy,“Telehealth Policy Summary Report:Insights Into State-Level Trends from CCHP,”May 16,2023.Available at:https:/mailchi.mp/cchpca/just-released-telehealth-policy-summary-report-insights-into-state-level-trends-from-cchp-spring-2023-edition.3 S

248、teven Driver,Di Jiang,et al.,“The Implication for Remote Physiologic Monitoring and Remote Therapeutic Monitoring Reimbursement in Private and Public Insurance in the United States,”Digital Therapeutics Alliance,November 15,2022.Available at:https:/dtxalliance.org/2022/11/15/rpm-and-rtm-reimbursemen

249、t-implications-in-u-s-private-and-public-insurance/.4 Obinna Ekekezie,George Luke Hartstein,and John Torus,“Expanding Mental Health Care AccessRemote Therapeutic Monitoring for Cognitive Behavioral Therapy,”JAMA Health Forum,4(9):e232954,2023.Available at:https:/ Department of Health and Human Servi

250、ces,“Telehealth for Physical Therapy,”2023.Available at:https:/telehealth.hhs.gov/providers/best-practice-guides/telehealth-for-physical-therapy/physical-therapy-and-remote-patient-monitoring#:text=The%20main%20difference%20between%20RPM,%E2%80%9D%20and%20%E2%80%9Cmedication%20adherence.%E2%80%9D.6

251、Nathaniel M.Lacktman and Thomas B.Ferrante,“CMS Proposes New Remote Therapeutic Monitoring Codes:What You Need to Know,”Foley&Lardner,July 15,2021.Available at:https:/ Centers for Medicare&Medicaid Services,“CY 2022 Payment Policies Under the Physician Feed Schedule and Other Changes to Part B Payme

252、nt Policies,”Federal Register,86(221):64996-66031,November 19,2021.Available at:https:/www.federalregister.gov/documents/2021/11/19/2021-23972/medicare-program-cy-2022-payment-policies-under-the-physician-fee-schedule-and-other-changes-to-part.8 Centers for Medicare&Medicaid Services,“CY 2020 Revisi

253、ons to Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies,”Federal Register,84(221):62568-63563,November 15,2019.Available at:https:/www.federalregister.gov/documents/2019/11/15/2019-24086/medicare-program-cy-2020-revisions-to-payment-policies-under-the-ph

254、ysician-fee-schedule-and-other.9 Centers for Medicare&Medicaid Services,“Pub 100-04 Medicare Claims Processing,Transmittal 11118,”CMS Manual System,November 10,2021.Available at:https:/www.cms.gov/files/document/r11118cp.pdf.10 Ibid.11 Obinna Ekekezie,George Luke Hartstein,and John Torus,“Expanding

255、Mental Health Care AccessRemote Therapeutic Monitoring for Cognitive Behavioral Therapy,”JAMA Health Forum,4(9):e232954,2023.Available at:https:/ Andis Robeznieks,“As remote patient monitoring expands,so does CPT to describe it,”American Medical Association,April 15,2022.Available at:https:/www.ama-

256、assn.org/practice-management/cpt/remote-patient-monitoring-expands-so-does-cpt-describe-it.3613 John B.Welsh and Roy Thomas,“Continuous Glucose Monitoring:An Emerging Standard of Care,”Evidence Based Diabetes Management,25(4):n.p.,March 31,2019.Available at:https:/ Aditi Aggarwal,Smit Pathak,and Ric

257、ha Goyal,“Clinical and economic outcomes of continuous glucose monitoring system(CGMS)in patients with diabetes mellitus:A systematic literature review,”Diabetes Research and Clinical Practice,186:109825,March 9,2022.Available at:https:/ Ibid.16 Nazli Bashin,Mohanraj Karunanithi,et al.,“Remote Monit

258、oring of Patients With Heart Failure:An Overview of Systematic Reviews,”Journal of Medical Internet Research,19(1):e18,2017.Available at:https:/pubmed.ncbi.nlm.nih.gov/28108430/.17 Kimberly A.Lynch,David A.Ganz,et al.,“Improving heart failure and guideline-directed medical therapy through proactive

259、remote patient monitoring-home telehealth and pharmacy integration,”BJM Open Quality,11:e001901,2022.Available at:https:/www.ncbi.nlm.nih.gov/pmc/articles/PMC9341192/pdf/bmjoq-.pdf.18 Peter W.Groeneveld,Elina L.Medvedeva,and Lorrie Walker,“Outcomes of Care for Ischemic Heart Disease and C

260、hronic Health Failure in the Veterans Health Administration,”JAMA Cardiology,3(7):563-571,July 2018.Available at:https:/ Sang-Hyun Park,Jong-Ho Shin,et al.,“An Updated Meta-Analysis of Remote Blood Pressure Monitoring in Urban-Dwelling Patients with Hypertension,”International Journal of Environment

261、al Research and Public Health,18:10583,2021.Available at:https:/pubmed.ncbi.nlm.nih.gov/34682329/.20 Kara Kjertsten Hoppe,Nicole Thomas,et al.,“Telehealth with remote blood pressure monitoring compared with standard care for postpartum hypertension,”American Journal of Obstetrics and Gynecology,223(

262、4):585-588,October 2020.Available at:https:/www.ajog.org/article/S0002-9378(20)30554-8/fulltext.21 Yan Li,Donglan Zhang,et al.,“The Health and Economic Impact of Expanding Home Blood Pressure Monitoring,”American Journal of Preventative Medicine,65(5):775-782,2023.Available at:https:/ Leah P.Griffin

263、 and Mikaela M.Sifuentes,“Remote Monitoring Saves Costs in Outpatient Negative Pressure Wound Therapy,”American Journal of Managed Care 28(2):n.p.,August 30,2021.Available at:https:/ Ibid.24 Leah Griffin and Laura M.Leyva Casillas,“A patient-center remote therapy monitoring program focusing on incre

264、ased adherence to wound therapy:a large cohort study,”Wounds:a Compendium of Clinical Research and Practice,30(8):81-83,August 1,2018.Available at:https:/europepmc.org/article/med/30212369.25 AAMC Regulatory Resource,“2021 Medicare Coverage of Remote Physiologic Monitoring(RPM).”Available at:https:/

265、www.aamc.org/media/55306/download.26 Centers for Medicare&Medicaid Services,“Pub 100-04 Medicare Claims Processing,Transmittal 11118,”CMS Manual System,November 10,2021.Available at:https:/www.cms.gov/files/document/r11118cp.pdf.27 Health and Human Services,“Telehealth and remote patient monitoring,

266、”2023.Available at:https:/telehealth.hhs.gov/providers/preparing-patients-for-telehealth/telehealth-and-remote-patient-monitoring.3728 Centers for Medicare&Medicaid Services,“Physicians and Other Clinicians:CMS Flexibilities to Fight COVID-19,”July 20,2023.Available at:https:/www.cms.gov/files/docum

267、ent/physicians-and-other-clinicians-cms-flexibilities-fight-covid-19.pdf.29 Centers for Medicare&Medicaid Services,“Pub 100-04 Medicare Claims Processing,Transmittal 11118,”CMS Manual System,November 10,2021.Available at:https:/www.cms.gov/files/document/r11118cp.pdf.30 Nancy Halstead,Lauren Bentlag

268、e,and Sebnem Dugmeoglu,“MACs Consider Guidance on Remote Patient Monitoring Amid Exploding Utilization,”Reed Smith,March 17,2023.Available at:https:/ Centers for Medicare&Medicaid Services,“Pub 100-04 Medicare Claims Processing,Transmittal 11118,”CMS Manual System,November 10,2021.Available at:https

269、:/www.cms.gov/files/document/r11118cp.pdf.32 Jeffrey R.Curtis and James Willig,“Uptake of Remote Physiologic Monitoring in the US Medicare Program:A Serial Cross-sectional Analysis,”JMIR Mhealth Uhealth,11:e46046,2023.Available at:https:/www.ncbi.nlm.nih.gov/pmc/articles/PMC10186184/.33 Steven Drive

270、r,Di Jiang,et al.,“The Implication for Remote Physiologic Monitoring and Remote Therapeutic Monitoring Reimbursement in Private and Public Insurance in the United States,”Digital Therapeutics Alliance,November 15,2022.Available at:https:/dtxalliance.org/2022/11/15/rpm-and-rtm-reimbursement-implicati

271、ons-in-u-s-private-and-public-insurance/.34 Obinna Ekekezie,George Luke Hartstein,and John Torous,“Expanding Mental Health Care AccessRemote Therapeutic Monitoring for Cognitive Behavioral Therapy,”JAMA Health Forum,4(9):e232954,September 15,2023.Available at:https:/ Ibid.36 Christian Green,“Despite

272、 the rise in telehealth during the pandemic,remote patient monitoring lags,”Medical Group Management Association STAT,June 16,2022.Available at:https:/ H.R.2Medicare Access and CHIP Reauthorization Act of 2015,114th Congress(2015-2016).Available at:https:/www.congress.gov/bill/114th-congress/house-b

273、ill/2/text.38 Government Accountability Office,Health Care:Telehealth and Remote Patient Monitoring Use in Medicare and Selected Federal Programs,GAO-17-365,April 14,2017.Available at:https:/www.gao.gov/products/gao-17-365.39 Department of Health and Human Services,Office of Inspector General,“Use o

274、f Remote Patient Monitoring Services in Medicare,”April 2023.Available at:https:/oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000766.asp.40 Center for Connected Health Policy,“Remote Patient Monitoring,”2023.Available at:https:/www.cchpca.org/topic/remote-patient-monitoring/.41

275、Center for Connected Health Policy,“Policy trend maps,”2023.Available at:https:/www.cchpca.org/policy-trends/.42 Center for Connected Health Policy,“State Telehealth Laws and Reimbursement Policies Report,Fall 2023,”October 2023.Available at:https:/www.cchpca.org/resources/state-telehealth-laws-and-

276、reimbursement-policies-report-fall-2023-2/.43 HealthArc,“Remote Care Reimbursements With Commercial Insurance,”2023.Available at:https:/www.healtharc.io/blogs/remote-care-reimbursements-with-commercial-insurance/.44 Lighthouse Healthcare Advisors LLC,Remote Patient Monitoring Regulations and Reimbur

277、sement Guide,May 7,2020.Available at:https:/ Cigna,“Medical Coverage Policy Remote Patient Monitoring(RPM)and Remote Therapeutic Monitoring(RTM),”May 11,2023.Available at:https:/ Anthem,“Remote Therapeutic and Physiologic Monitoring Services,”Clinical UM Guideline#CG-MED-91,September 27,2023.Availab

278、le at:https:/ American Medical Association,Future of Health:Commercial Payer Coverage for Digital Medicine Codes,August 31,2023.Available at:https:/www.ama-assn.org/system/files/issue-brief-commercial-payer-coverage-digital-care.pdf.48 Food and Drug Administration,“How to Determine if Your Product i

279、s a Medical Device,”September 29,2022.Available at:https:/www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device.49 Food and Drug Administration,“Overview of Device Regulation,”September 4,2020.Available at:https:/www.fda.gov/medical-devices/device-advi

280、ce-comprehensive-regulatory-assistance/overview-device-regulation.50 Food and Drug Administration,“Information Sheet Guidance For IRBs,Clinical Investigators,and Sponsors:Frequently Asked Questions About Medical Devices,”January 2006.Available at:https:/www.fda.gov/files/about%20fda/published/Freque

281、ntly-Asked-Questions-About-Medical-Devices-Information-Sheet.pdf.51 Food and Drug Administration,“Postmarket Surveillance Under Section 522 of the Federal Food,Drug,and Cosmetic Act,”October 7,2022.Available at:https:/www.fda.gov/media/81015/download.52 Food and Drug Administration,“Artificial Intel

282、ligence and Machine Learning Software as a Medical Device,”January 2021.Available at:https:/www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device.53 H.R.2617Consolidated Appropriations Act of 2023,117th Congress(2021-2022).Avail

283、able at:https:/www.congress.gov/117/bills/hr2617/BILLS-117hr2617enr.pdf.54 Food and Drug Administration,“CDHR Issues Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning,”March 2023.Available at:https:/www.fda.gov/medical-devices/medical-devices-news-and-

284、events/cdrh-issues-draft-guidance-predetermined-change-control-plans-artificial-intelligencemachine.55 Food and Drug Administration,“Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring,”October 19,2023.Available at:https:/www.fda.gov/media/136290/download

285、.56 Food and Drug Administration,“Artificial Intelligence and Machine Learning Discussion Paper.”Available at:https:/www.fda.gov/files/medical%20devices/published/US-FDA-Artificial-Intelligence-and-Machine-Learning-Discussion-Paper.pdf.57 Sara Gerke,Carmel Shachar,et al.,“Regulatory,safety,and priva

286、cy concerns of home monitoring technologies during COVID-19,”Nature Medicine,26:1176-1182,2020.Available at:https:/ Food and Drug Administration,“Patient Monitoring and Control Program:Research on Patient Monitoring and Control Devices,”March 24,2021.Available at:https:/www.fda.gov/medical-devices/m

287、edical-device-regulatory-science-research-programs-conducted-osel/patient-monitoring-and-control-program-research-patient-monitoring-and-control-devices.59 The White House,“Executive Order on the Safe,Secure,and Trustworthy Development and Use of Artificial Intelligence,”October 30,2023.Available at

288、:https:/www.whitehouse.gov/briefing-room/presidential-actions/2023/10/30/executive-order-on-the-safe-secure-and-trustworthy-development-and-use-of-artificial-intelligence/.60 Bill Murray and Jessica Nadler,“Can digital tech and regulators help improve health equity?”Deloitte,January 31,2023.Availabl

289、e at:https:/ Alaina J.Kessler,Melanie Besculides,et al.,“Promoting digital health equity through remote patient monitoring:A feasibility study,”Journal of Clinical Oncology,40(28):441,October 1,2022.Available at:https:/ascopubs.org/doi/abs/10.1200/JCO.2022.40.28_suppl.441.62 Brian W.Anthony,“How Pat

290、ient Monitoring Is Poised to Revolutionize Healthcare,”MedCityNews,February 27,2023.Available at:https:/ Novitas Solutions,“Multi-Jurisdictional Contractor Advisory Committee(CAC)Meeting,”February 28,2023.Available at:https:/www.novitas- Bill Siwicki,“At Mount Sinai,RPM provides more equal access to

291、 cancer care,”Healthcare IT News,July 6,2021.Available at:https:/ mHealth Intelligence,“Keep Health Equity Top-of-Mind in Remote Patient Monitoring Programs,”February 10,2022.Available at:https:/ Andrew Broderick,Valerie Steinmetz,et al.,“Remote Patient Monitoring in the Safety Net:What Payers and P

292、roviders Need to Know,”California Health Care Foundation,July 9,2021.Available at:https:/www.chcf.org/publication/remote-patient-monitoring-safety-net-payers-providers-need-know/#related-links-and-downloads.67 Department of Health and Human Services,“Billing Medicare as a safety-net provider,”July 1

293、4,2023.Available at:https:/telehealth.hhs.gov/providers/billing-and-reimbursement/billing-medicare-as-a-safety-net-provider.68 Centers for Medicare&Medicaid Services,“CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies,”Federal Register

294、,88(220):78818-80047,November 16,2023.Available at:https:/www.federalregister.gov/public-inspection/2023-24184/medicare-and-medicaid-programs-calendar-year-2024-payment-policies-under-the-physician-fee-schedule.69 Inter-American Development Bank,“At least 77 million rural inhabitants have no access

295、to high-quality internet services,”October 29,2020.Available at:https:/www.iadb.org/en/news/least-77-million-rural-inhabitants-have-no-access-high-quality-internet-services#:text=Of%20the%20total%20amount%20of,rural%20areas%20of%20the%20Americas.70 David Penberthy,Caroline Offit,et al.,“Differences

296、in perceptions and use of remote patient monitoring technology in rural cancer programs,”Journal of Clinical Oncology,41(16):1582,2023.Available at:https:/ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.1582.71 Sara Heath,“Patient Portal Use in Mental Health Is Up,But Digital Literacy Key,”Patient

297、 Engagement Hit,September 29,2022.Available at:https:/ Pew Charitable Trusts,Most Americans Want to Share and Access More Digital Health Data,July 27,2021.Available at:https:/www.pewtrusts.org/en/research-and-analysis/issue-briefs/2021/07/most-americans-want-to-share-and-access-more-digital-health-d

298、ata.73 Samantha Gonzalez,Ami B.Bhatt,and Jaclyn A.Pagliaro,“Optimizing Telehealth for Special Populations and Closing the Digital Divide:Addressing Social Determinants of Health in Virtual Care,”in Healthcare Information Technology for Cardiovascular Medicine,ed.Ami B.Bhatt(Springer Cham:2021).Avail

299、able at:https:/ Anu-Marja Kaihlanen,Lotta Virtanen,et al.,“Towards digital health equity a qualitative study of the challenges experienced by vulnerable groups in using digital health services in the COVID-19 era,”BMC Health Services Research,22:188,2022.Available at:https:/ Andis Robeznieks,“For gr

300、owing number of doctors,life in medicine extends into 70s,”American Medical Association,October 7,2019.Available at:https:/www.ama-assn.org/delivering-care/health-equity/growing-number-doctors-life-medicine-extends-70s.4076 Kara Hartnett,“Racially biased medical device results raise patient safety c

301、oncerns,”Modern Healthcare,September 26,2022.Available at:https:/ Usha Lee McFarling,“Pulse oximeters and their inaccuracies will get FDA scrutiny.What took so long?”STAT News,November 1,2022.Available at:https:/ Ahmed Alboksmatty,Thomas Beaney,et al.,“Effectiveness and safety of pulse oximetry in r

302、emote patient monitoring of patients with COVID-19:a systematic review,”Lancet Digital Health,4:279-289,April 2022.Available at:https:/ Sylvia E Sudat,Paul Wesson,et al.,“Racial Disparities in Pulse Oximeter Device Inaccuracy and Estimated Clinical Impact on COVID-19 Treatment Course,”American Journ

303、al of Epidemiology,192(5):703-713,May 5,2023.Available at:https:/pubmed.ncbi.nlm.nih.gov/36173743/80 Sara Gerke,Carmel Shachar,et al.,“Regulatory,safety,and privacy concerns of home monitoring technologies during COVID-19,”Nature Medicine,26:1176-1182,August 7,2020.Available at:https:/ Department of

304、 Health and Human Services,Office for Civil Rights,“HIPAA Administrative Simplification,”March 2013.Available at:https:/www.hhs.gov/sites/default/files/ocr/privacy/hipaa/administrative/combined/hipaa-simplification-201303.pdf.82 Department of Health and Human Services,“Covered Entities and Business

305、Associates,”June 16,2017.Available at:https:/www.hhs.gov/hipaa/for-professionals/covered-entities/index.html.83 American Medical Association,Remote Patient Monitoring Playbook,2022.Available at:https:/www.ama-assn.org/system/files/ama-remote-patient-monitoring-playbook.pdf.84 Kim Theodos and Scott S

306、ittig,“Health Information privacy Laws in the Digital Age:HIPAA Doesnt Apply,”Perspectives in Health Information Management,18(Winter),2021.Available at:https:/www.ncbi.nlm.nih.gov/pmc/articles/PMC7883355/#B30.85 Erin Brodwin and Tina Reed,“Privacy is at risk as HIPAA fails to keep pace with digital

307、 health,”Axios,April 6,2023.Available at:https:/ Department of Health and Human Services,“Business Associates,”April 3,2003.Available at:https:/www.hhs.gov/hipaa/for-professionals/privacy/guidance/business-associates/index.html.87 45 CFR 160.103.Available at:https:/www.govinfo.gov/content/pkg/CFR-20

308、13-title45-vol1/pdf/CFR-2013-title45-vol1-sec160-103.pdf.88 Katie Palmer,Todd Feathers,and Simon Fondrie-Teitler,“Out of control:Dozens of telehealth startups sent sensitive health information to big tech companies,”STAT News,December 13,2022.Available at:https:/ Ibid.90 Cornell Law School,15 U.S.Co

309、de 45-Unfair methods of competition unlawful,prevention by Commission.Available at:https:/www.law.cornell.edu/uscode/text/15/45.91 Federal Register,16 CF 318 Health Breach Notification Rule.Available at:https:/www.ecfr.gov/current/title-16/chapter-I/subchapter-C/part-318.92 Federal Trade Commission,

310、“FTC Enforcement Action to Bar GoodRx from Sharing Consumers Sensitive Health Info for Advertising,”February 1,2023.Available at:https:/www.ftc.gov/news-events/news/press-releases/2023/02/ftc-enforcement-action-bar-goodrx-sharing-consumers-sensitive-health-info-advertising.93 Federal Trade Commissio

311、n,“FTC Proposes Amendments to Strengthen and Modernize the Health Breach Notification Rule,”May 18,2023.Available at:https:/www.ftc.gov/news-events/news/press-releases/2023/05/ftc-proposes-amendments-strengthen-modernize-health-breach-notification-rule.4194 Food and Drug Administration,“Illumina Cyb

312、ersecurity Vulnerability Affecting the Universal Copy Service Software May Present Risks for Patient Results and Customer Networks:Letter to Health Care Providers,”July 7,2023.Available at:https:/www.fda.gov/medical-devices/letters-health-care-providers/illumina-cybersecurity-vulnerability-affecting

313、-universal-copy-service-software-may-present-risks.95 Food and Drug Administration,“Cybersecurity,”May 1,2023.Available at:https:/www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity.96 Food and Drug Administration,“Cybersecurity in Medical Devices Frequently Asked Questions(FA

314、Qs),”March 29.2023.Available at https:/www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity-medical-devices-frequently-asked-questions-faqs.97 Food and Drug Administration,“Cybersecurity in Medical Devices:Refuse to Accept Policy for Cyber Devices and Related Systems Under Sect

315、ion 524B of the FD&C Act;Guidance for Industry and Food and Drug Administration Staff,”March 30,2023.Available at:https:/www.federalregister.gov/documents/2023/03/30/2023-06646/cybersecurity-in-medical-devices-refuse-to-accept-policy-for-cyber-devices-and-related-systems-under.98 Microsoft Ignite,“H

316、ealth Information Trust Alliance(HITRUST)Common Security Framework(CSF),”March 16,2023.Available at:https:/ Electronic Clinical Quality Improvement Resource Center,“FHIR Fast Healthcare Interoperability Resources,”2023.Available at:https:/ecqi.healthit.gov/fhir.100 National Institute of Standards an

317、d Technology,“Cybersecurity Framework.”Available at:https:/www.nist.gov/cyberframework.101 Jill McKeon,“81%of Telehealth Providers Are Concerned About Data Leakage,”Health IT Security,December 6,2021.Available at:https:/ Bill Siwicki,“Is remote patient monitoring the new cybercrime target?”Healthcar

318、eITNews,March 21,2022.Available at:https:/ Guidelines,”Novitas Solutions,November 10,2019.Available at:https:/www.novitas- Mitchell Tang,Ateev Mehrotra,and Ariel D.Stern,“Rapid Growth Of Remote Patient Monitoring Is Driven By A Small Number Of Primary Care Providers,”Health Affairs(Millwood),41(9):1

319、248-1254,2022.Available at:https:/pubmed.ncbi.nlm.nih.gov/36067430/.105 Palmetto GBA,“Multi-Jurisdictional RPM/RTM for Non-Implantable Devices Contractor Advisory Committee Meeting:February 28,2023.”Available at:https:/ Patient Safety Network,“Remote Patient Monitoring,”March 15,2023.Available at:ht

320、tps:/psnet.ahrq.gov/perspective/remote-patient-monitoring.107 Caroline Reignley,Deborah R.Godes,et al.,“Remote Monitoring Services Under Review:Update on Potential Medicare Coverage Policies,”May 2023.Available at:https:/ Nuha A.ElSayed,Grazia Aleppo,et al.,“Introduction and Methodology:Standards of

321、 Care in Diabetes-2023,”Diabetes Care,46(Suppl.1):S1-S4,2023.Available at:https:/diabetesjournals.org/care/article/46/Supplement_1/S1/148054/Introduction-and-Methodology-Standards-of-Care-in.109 1861 of the Social Security Act(the Social Security Act),42 U.S.C.1395(t).Available at:https:/www.ssa.gov

322、/OP_Home/ssact/title18/1861.htm.110 Ibid.42111 Centers for Medicare and Medicaid Services,“Physicians and Other Clinicians:CMS Flexibilities to Fight COVID-19,”July 20,2023.Available at:https:/www.cms.gov/files/document/physicians-and-other-clinicians-cms-flexibilities-fight-covid-19.pdf112 Office o

323、f Congressman Troy Balderson,“Balderson,Porter Introduce Bill Embracing the Benefits of Remote Patient Monitoring Technology,”July 2,2021.Available at:https:/balderson.house.gov/news/documentsingle.aspx?DocumentID=2154.113 R.Hailu,J Sousa,et al.,“Challenges and Facilitators in Implementing Remote Pa

324、tient Monitoring Programs in Primary Care,”Journal of General Internal Medicine(in press).114 Centers for Medicare&Medicaid Services,“CY 2021 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies,”Federal Register,86(11):5020-5022,January 19,2021.Available at

325、:https:/www.federalregister.gov/documents/2021/01/19/2021-00805/medicare-program-cy-2021-payment-policies-under-the-physician-fee-schedule-and-other-changes-to-part.115 Centers for Medicare&Medicaid Services,“CY 2023 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payme

326、nt and Coverage Policies,”Federal Register,87(222):69538,November 18,2022.Available at:https:/www.govinfo.gov/content/pkg/FR-2022-11-18/pdf/2022-23873.pdf.116 Centers for Medicare&Medicaid Services,“CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Cov

327、erage Policies,”Federal Register,88(150):52262-53197.Available at:https:/www.federalregister.gov/documents/2023/08/07/2023-14624/medicare-and-medicaid-programs-cy-2024-payment-policies-under-the-physician-fee-schedule-and-other.117 Center for Medicare&Medicaid Services,“Fee Schedules-General Informa

328、tion,”November 15,2022.Available at:https:/www.cms.gov/medicare/medicare-fee-for-service-payment/feeschedulegeninfo.118 U.S.House of Representatives,Departments of Labor,Health and Human Services,and Education,and Related Agencies Appropriations Act,2022.Available at:https:/docs.house.gov/billsthisw

329、eek/20220307/BILLS-117RCP35-JES-DIVISION-H_Part1.pdf.119 Centers for Medicare&Medicaid Services,“Go-to-Info|Information Bulletins,”December 19,2022.Available at:https:/www.cms.gov/regulations-and-guidance/administrative-simplification/subregulatory-guidance/go-to-info-information-bulletins.120 Cente

330、rs for Medicare&Medicaid Services,“MLN Web-Based Training,”July 5,2023.Available at:https:/www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnproducts/webbasedtraining.121 Centers for Medicare&Medicaid Services,“CMS Blog,”n.d.Available at:https:/www.cms.gov/blog.122 Mitchell Tang,Ca

331、rter H.Nakamoto,et al.,“Effects of Remote Patient Monitoring Use on Care Outcomes Among Medicare Patients with Hypertension:An Observation Study,”Annals of Internal Medicine,November 7,2023.Available at:https:/pubmed.ncbi.nlm.nih.gov/37931262/.123 Mitchell Tang,Ateev Mehrotra,and Ariel D.Stern,“Rapi

332、d Growth Of Remote Patient Monitoring Is Driven By A Small Number Of Primary Care Providers,”Health Affairs(Millwood),41(9):1248-1254,2022.Available at:https:/pubmed.ncbi.nlm.nih.gov/36067430/.124 Monica OReilly-Jacob,Penny Mohret al.,“Digital Health&Low-Value Care,”Healthcare(Amsterdam,Netherlands)

333、,9(2):100533,June 2021.Available at:https:/www.ncbi.nlm.nih.gov/pmc/articles/PMC9342901/.125 South Carolina Department of Health and Human Services,“Why is this provider attestation form needed?”Available at:https:/www.scdhhs.gov/sites/default/files/Provider%20Attestation%20Form%20User%20Guide%20v1.2.pdf.126 Centers for Medicare&Medicaid Services,”Registration and Attestation,”December 14,2022.Ava