Input:
	Background

		Medicare’s Physician Fee Schedule

CMS uses the Medicare Physician Fee Schedule to pay physicians and  other providers for services delivered to beneficiaries. Physicians and  other providers bill Medicare for their services using various five-digit  billing codes based in part on codes developed by an AMA panel. Each  year, the panel receives proposals from provider groups and others to  revise existing billing codes or create new codes. The panel requires  those who submit proposals to develop a clinical vignette that describes  the typical patient who would receive the service, the diagnosis and  relevant conditions, and estimates of time that physicians might spend in  providing the service for the typical patient. The panel applies several  criteria in reviewing these proposals. For example, a new code  should represent a unique, well-defined procedure or service clearly  identified and distinguished from existing procedures and services;  should not fragment an existing procedure or service represented by  one or more existing codes;  should reflect the typical (not extraordinary) circumstances related to  the delivery of the service;  should be performed by many physicians or other qualified health  care professionals across the United States; and  should be consistent with current medical practice.
CMS pays providers a fixed amount known as the Medicare fee for each  code. The fees are based on relative values—estimates of resources for  the physician’s work (time, skill, and level of training), and practice  expenses (the costs of running a practice such as salaries of non- physician employees, rent, and overhead) required to provide a service  relative to all other services. In setting fees, CMS also does not allow  certain codes to be billed together if it deems that payment for one code  is already included in another. CMS establishes and updates relative  values annually. By law, the effect of any changes to its payment rates  generally must be budget neutral. That is, if total spending increases by  more than $20 million each year, including due to the creation of new  billing codes, fees for all services would have to be reduced accordingly.
Services billed under the physician fee schedule may be provided in a  variety of settings, including physicians’ offices and institutional settings  such as hospitals, skilled nursing facilities and hospices. Non-physicians  may also bill or be reimbursed by Medicare for services under certain  circumstances. For example, some types of non-physicians practicing  independently—such as physician assistants and nurse practitioners— may bill Medicare for certain services that they are legally authorized to  perform under their respective state laws. In other instances, physicians  may bill as if they had furnished services that were provided by non- physician staff that they employ or with whom they have a contractual  relationship as long as the physician has an established relationship with  the beneficiary, and is on the premises to provide supervision if  necessary.

		Care Planning Services in Medicare

Providers and other stakeholders have noted that they care for an elderly  population with increasingly complex medical conditions who receive care  from multiple providers across different sites of care including physicians’  offices, hospitals, nursing homes, and hospices. As such, the focus of  primary care has shifted from treating specific medical conditions to  increased care coordination and planning. CMS also noted that a new  trend in care planning is the use of shared care plans between the  beneficiary and the provider rather than those created solely by the  provider. These jointly developed care plans can be particularly important  to improving overall beneficiary outcomes for beneficiaries with serious  illnesses and also allow other providers involved in the beneficiary’s care  access to timely information that supports planned care.
However, stakeholders have suggested that Medicare’s payment system  does not fully reimburse providers for such care planning services. For  example, some note that the E/M billing codes that primary care  physicians generally use to bill for their services were developed at a time  when care coordination and planning was not part of the standard  practice of medicine; as such, these codes do not reflect time spent on  activities that do not require a face-to-face encounter with the beneficiary,  including medical conferences with other physicians, or telephone calls to  coordinate care with other providers. Some primary care physicians have  requested that CMS conduct a comprehensive review of existing E/M  codes to ensure they account for time spent on these services, or develop  new codes that primary care physicians may exclusively use to bill for  these services. However, others have noted that E/M codes have been  reviewed and valued by the AMA, and the codes account for the time  spent on these services. Moreover, they have stated that care  coordination and planning services are delivered by multiple specialties,  not just primary care physicians.

	Medicare’s Physician Fee Schedule Contains at Least 58 Billing Codes That Providers May Use to Bill for LCCP-Type Services

Our analysis identified at least 58 Medicare Physician Fee Schedule  billing codes that providers may use to bill for LCCP-type services.  These 58 billing codes generally contain components we determined to  be equivalent to the five key components of the LCCP service as defined  in the 2018 BBA. For example, all 58 codes included a provision for the  development of a care plan that addresses the beneficiary’s goals,  values, and preferences, and a provision for coordination with other  providers, which is equivalent to the LCCP component related to  interdisciplinary care. Providers may choose a single code or a  combination of these codes to account for the time, skill, and resources  needed to deliver the service based on the unique health needs of each  patient. (See app. IV for more information on the 58 codes and the LCCP  components they contain as defined in the 2018 BBA.)
The 58 billing codes for LCCP-type services include 45 longstanding,  broadly-defined codes and 13 narrowly-defined codes that were more  recently introduced starting in 2013.
Broadly-defined codes. Of the 45 broadly-defined codes, 39 are E/M  codes that have existed for decades. E/M codes are broadly defined to  include services provided to treat a variety of illnesses (for example,  treatment of a particular medical complaint), but they may also be used to  bill for LCCP-type services. In general, the E/M codes range in complexity  from low to high depending on the amount of time the provider spends  with a patient as well as the complexity of the medical condition(s) being  treated. E/M codes may also be billed if more than 50 percent of the time  allotted for the service is spent on counseling and care coordination—for  example, explaining treatment options and ways to mitigate the patient’s  health risks—which are key components of the LCCP service as defined  in the 2018 BBA.
The E/M codes we identified as representing LCCP-type services were  the more complex codes that had estimates of time that may be spent  providing the service to a typical patient ranging from 30 to 120 minutes  of physician time and 3 to 71 minutes of non-physician time. While the  majority of E/M codes have existed for decades, CMS added six new E/M  codes starting in 2008—referred to as “prolonged” E/M codes—allowing  payment for additional time for care planning and care management  services for complex conditions.
Narrowly-defined codes. Starting in 2013, CMS added 13 narrowly- defined LCCP-type codes to better account for the time spent  coordinating care for patients with complex treatment needs. CMS  implemented these more narrowly-defined care planning codes largely in  response to provider complaints that E/M codes did not sufficiently  account for extensive care management/coordination of care that was  required across multiple providers and settings. Unlike broadly-defined  codes, these narrowly-defined codes can only be used for LCCP-type  services.
The 13 narrowly-defined LCCP-type codes fall into four types: transitional  care management (TCM), chronic care management (CCM), advance  care planning (ACP), and behavioral health integration (BHI). (See table  1.) While some pertain to patients with specific types of health conditions  or in certain settings, others are more general and may be used for a  range of health conditions.
The estimates of physician and non-physician time that may be spent on  the broadly-defined and narrowly-defined codes vary, as does Medicare’s  2019 fees for these billing codes—see examples of commonly used  LCCP-type billing codes in table 2 and see appendix IV for related  information on all 58 LCCP-type billing codes. For example, some  stakeholders told us they might bill a complex E/M code (99214) along  with a CCM code (99487). As our analysis shows, this combination could  result in the provider spending 66 minutes of physician time and 113  minutes of non-physician time for a typical beneficiary, and receiving total  Medicare fees of about $203 in 2019.

	Medicare Spending Increased for All LCCP-Type Services and Increased More Rapidly for New Narrowly-Defined Services That Were Furnished to More Beneficiaries by More Providers

		Medicare Spending on All LCCP-Type Services Increased by 11 Percent from 2013 through 2017, While Spending on Narrowly-Defined Services Grew More Rapidly

Overall Medicare spending on LCCP-type services represented by the 58  billing codes we identified increased from $26 billion in 2013 to $29 billion  in 2017, an 11 percent increase. The vast majority of this spending— about $28.3 billion in 2017—was on services represented by the 45  broadly-defined codes we identified earlier (henceforth we refer to these  services as “broadly-defined services.”) By comparison, Medicare  spending on LCCP-type services represented by the 13 narrowly-defined  codes (henceforth referred to as “narrowly-defined services”) was about  $467 million in 2017.
Though smaller in terms of total dollars, spending on narrowly-defined  services grew at a higher rate than spending on broadly-defined services,  from about $2 per beneficiary in 2013 to $14 per beneficiary in 2017. This  higher rate in growth can mostly be attributed to these four new types of  services being introduced during this 4 year period. For example, as  Table 1 shows, two TCM codes were introduced in 2013 and four CCM  codes were introduced from 2015 to 2017. In contrast, spending growth for broadly-defined services was much smaller, increasing from about  $785 per beneficiary in 2013 to $844 per beneficiary in 2017. For all other  Medicare Physician Fee Schedule services combined, per-beneficiary  spending decreased from about $1,488 in 2013 to $1,426 in 2017.
Spending on CCM and TCM services accounted for most of the total  spending on narrowly-defined LCCP-type services from 2013 to 2017.  (See fig. 1.) For example, in 2017, TCM services accounted for almost  half ($213 million of the total spending of $467 million), while spending on  CCM services accounted for over a third ($162 million of the $467  million).
The growth in spending on narrowly-defined services was driven by  increased utilization—that can be attributed in part to the development of  new codes for these services—rather than increases in Medicare fees for  these services. Specifically, utilization of narrowly-defined services  increased from about 9 services per 1,000 beneficiaries in 2013 to about  177 services per 1,000 beneficiaries in 2017. Average Medicare fees for  these services remained flat during this period.

		More Beneficiaries Received and More Providers Billed for Narrowly-Defined LCCP- Type Services, with a Small Share of Beneficiaries and Providers Accounting for Most of the Services

The number of beneficiaries receiving narrowly-defined LCCP-type  services increased substantially from 2013 to 2017, as more of these  Medicare billing codes were added and began to be utilized during this  time. Specifically, in 2017, about 2.5 million beneficiaries received  narrowly-defined LCCP-type services, representing an 839 percent  increase from about 267,000 beneficiaries in 2013. (See fig. 2.)
While the overall number of beneficiaries receiving narrowly-defined  services increased, these services were concentrated among a relatively  small share of Medicare beneficiaries. Specifically, one-quarter of  beneficiaries who received any of the narrowly-defined services in 2017  received 62 percent of the approximately 6 million services that were  provided that year. (See fig. 3.)
In 2017, of the total 2.5 million beneficiaries that received narrowly- defined services, 90 percent received only one type of narrowly-defined  LCCP-type service. (See fig. 4.) In contrast, only 10 percent of  beneficiaries received multiple types of narrowly-defined LCCP-type  services, the most common combination being CCM and ACP.
Mirroring beneficiary trends, the number of Medicare providers billing for  narrowly-defined LCCP-type services also increased significantly from  2013 through 2017, as these Medicare billing codes were established and  began to be utilized during this time. In 2017, a total of about 100,000  providers billed for narrowly-defined services, representing a 227 percent  increase from about 31,000 providers in 2013. (See fig. 5.)
As with beneficiary trends, while the overall number of providers billing  narrowly-defined services grew from 2013 to 2017, billing for these  services was also increasingly concentrated among a small share of  providers. Specifically, in 2017, 10 percent of providers who billed for any  narrowly-defined services billed about 76 percent of the approximately 6  million services that were provided in that year. (See fig. 6.)
Each year from 2013 through 2017, physicians specializing in internal  medicine accounted for the largest share of spending on narrowly-defined  LCCP-type services. In 2017, internal medicine accounted for 45 percent  of the $467 million in total Medicare spending on narrowly-defined  services. (See fig. 7.) Family practice and nurse practitioners were the  other specialties accounting for the greatest shares of spending.
In terms of the setting in which narrowly-defined LCCP-type services  were provided, the majority were provided in nonfacility settings such as  physicians’ offices. Specifically, in 2017, 94 percent of narrowly-defined  services were provided in nonfacility settings. This trend was consistent  over each of the 5 years from 2013 to 2017.

	Stakeholders Had Mixed Views on Whether a New Billing Code for an LCCP Service Is Needed

		Six Stakeholders Did Not Support Creating a New Billing Code for an LCCP Service

Six of the 19 stakeholders we interviewed did not support the creation of  a new billing code for an LCCP service as defined in the 2018 BBA. Two  of these—representing physician specialties that together accounted for  almost one-fifth of total spending on LCCP-type services in 2017—stated  that the existing billing codes were sufficient for them to provide and bill  for the full range of the LCCP service. They stated that billing either a  single code or a combination of an E/M code and one or more of the 13  narrowly-defined LCCP-type codes we identified allowed them to account  for the full range of the LCCP service as defined in the BBA. As such, the  two stakeholders said, there was no need for a new billing code.
The remaining four stakeholders expressed concerns about creating a  new billing code for an LCCP service. These concerns included the  following:
Overlap with existing codes that require the development of care  plans: While not explicitly stating that existing codes were sufficient,  some stakeholders said that if a new billing code were created for the  LCCP service as defined in the 2018 BBA, it would overlap with or  duplicate existing billing codes. For example, three stakeholders  noted potential overlap with existing billing codes, such as the ACP  and CCM. Three stakeholders said that the care plan that would be  required under the new LCCP code would duplicate existing care  plans that are required by law for beneficiaries in hospices or skilled  nursing facilities. In addition, two stakeholders noted that providers  in their specialty already prepare detailed care plans as a standard  practice of care when evaluating their patients and billing for these  services using existing E/M billing codes. They stated that these care  plans exceed the components of the care plan specified in the 2018  BBA. Stakeholders noted that the existence of multiple overlapping  codes that include the development of a care plan could create  confusion for providers in choosing the most appropriate billing code.
Concerns about code proliferation or code fragmentation: Several  stakeholders were concerned that adding another code to Medicare’s  billing system could result in increased Medicare spending and less,  rather than more, care coordination. Specifically, two stakeholders  stated that having multiple billing codes for care planning and care  management, respectively, would have the potential to increase  spending because multiple providers could start billing the new codes  even though one provider may have primary responsibility for the  beneficiary. (In contrast, under the existing billing codes a single  code that encompassed both types of services could be billed.) For  example, one of these stakeholders said that primary care physicians  generally referred beneficiaries with complex treatment needs to a  surgeon or specialist who then both planned and managed the  beneficiary’s care, yet the primary care physician might also bill the  care planning billing code. In addition to the potential for increased  Medicare spending, three stakeholders said that code  fragmentation—splitting existing billing codes into multiple codes for  services that were previously bundled together—was contrary to the  comprehensive patient-centered model of care that Medicare was  moving towards. Specifically, one provider stated that under such a  model, rather than billing multiple different codes for care planning  and coordination, a primary care practice is paid a monthly  management fee to (among other things) improve care coordination  for patients who receive most of their primary care services from that  practice.

		Thirteen Stakeholders Stated That a New LCCP Code Could Address Concerns Regarding Interdisciplinary Care Reimbursement and Other Limitations They Identified in Existing Billing Codes

While six of the stakeholders we interviewed did not support creating a  new LCCP code, the remaining 13 stakeholders told us that such a billing  code is needed. According to the stakeholders, a new LCCP code as  defined in the 2018 BBA could address several concerns they identified in  Medicare’s existing billing codes related to the provision of the LCCP  service. However, some of these concerns could be addressed under the  current Medicare billing framework, as shown by our analysis of available  data. For example, stakeholders identified the following limitations that  could be addressed by a new LCCP code:  Inadequate reimbursement for time spent on interdisciplinary care:  The 13 stakeholders stated that Medicare’s existing billing codes  either did not require or did not sufficiently reimburse them for the time  spent on interdisciplinary care. They stated there should be a  separate code to reimburse this type of care. However, stakeholders  representing two specialties told us they had proposed such a code to  the AMA but the AMA had rejected their proposals because  interdisciplinary care is already accounted for in the existing billing  codes. Moreover, as our analysis of the 58 billing codes shows, the  majority of these codes include a provision for consultation and  coordination among providers that is equivalent to input from an  interdisciplinary team. With regard to inadequate reimbursement, as  another stakeholder noted, providers may bill a complex E/M service  along with a narrowly-defined LCCP-type service such as CCM. The  total reimbursement for such a combination of codes would be about  $203 as of 2019. (See table 2.)
Insufficient physician time for care planning: Six stakeholders  representing a mix of primary care and medical specialties stated the  existing billing codes (including the more complex E/M codes) had  insufficient physician time to provide both care planning and care  management, which they maintained are separate and distinct  activities. They stated a new code could include the appropriate time  needed. One stakeholder said that care planning requires at least 30  minutes of time, and the complex E/M codes do not allow providers to  bill for the time it takes to provide both the care management of a  complex patient as well as care planning for the patient. According to  the stakeholder, for example, if a provider bills a complex E/M code  that allows for 40 minutes of physician time, that is insufficient to  provide both types of services. While CMS has recently established  new prolonged E/M codes (which allow for an additional 60 minutes of  time), the stakeholder noted that they do not address the problem of  insufficient time because a prolonged E/M code may only be billed  with a companion E/M code, and the threshold of time needed to bill  the two codes together is now too high—specifically 40 minutes for  the complex E/M code plus 60 minutes for the prolonged E/M code.  However, our review of CMS guidance on billing of prolonged E/M  codes shows that providers do not have to meet the full 60 minutes of  time in order to bill a prolonged E/M code; they may bill it as long as  the total time spent on the visit exceeds the typical time for the E/M  visit plus 30 minutes.
Documentation requirements: Three stakeholders, largely  representing primary care and medical specialties, stated that  burdensome documentation requirements for the more complex E/M  codes hampered their ability to bill these codes. They suggested  that a new billing code could be structured similar to the new ACP or  CCM codes which do not have the same documentation  requirements. While these stakeholders expressed concern regarding  documentation as a discouraging factor, our analysis of 2017  Medicare claims data showed that certain specialties, including some  that had expressed this concern, billed the more complex codes at a  significantly higher rate than the average across all specialties. This  may indicate that these documentation requirements do not  necessarily preclude providers from billing these codes. For example,  83 percent of all the E/M new patient visits billed by geriatricians in  2017 were billed using the more complex E/M codes, compared to 48  percent on average. Similarly, 80 percent of all the E/M established  patient visits billed by clinical psychologists in 2017 were billed using  the more complex E/M codes compared to 50 percent on average.  See appendix V for details on billing patterns for all medical  specialties.
Inability of non-physician staff to independently bill for care planning:  Seven stakeholders expressed concerns that non-physician staff such  as nurses and social workers cannot independently bill the existing  Medicare billing codes that we identified as being LCCP-type  services. As one stakeholder explained, non-physician staff may  spend time providing coordination and care planning services  separately rather than concurrently with the physician, but they cannot  bill for this time independently because the physician was not present.  These stakeholders stated that a new LCCP code that could be billed  by physicians and non-physicians that participated in the care  planning process could address this issue. However, other  stakeholders expressed concerns about the effect on Medicare  spending if multiple providers billed for an LCCP service. Moreover,  reimbursement for non-physicians is built into Medicare fees.  Specifically, Medicare’s fee for each billing code includes  reimbursement for physician’s time as well as their practice expenses  (which cover the costs of non-physician staff), and when the AMA  panel develops resources estimates for each billing code (upon which  Medicare fees are based), it considers the amount of non-physician  time spent on that code. Certain non-physician practitioners, such as  nurse practitioners and physician assistants, may also independently  bill services under the Medicare Physician Fee Schedule subject to  certain requirements, and as specified in their scope of practice under  state law.
Stakeholders generally concurred that if a new LCCP code were  implemented, the definition of interdisciplinary care should be flexible and  not require a social worker. Currently, the LCCP billing code as defined in  the 2018 BBA requires that the interdisciplinary team providing care  planning services include a social worker. However, 13 stakeholders  stated that a typical practice did not include a social worker, but rather  included a nurse who might perform the functions of a social worker. They  stated that smaller office-based medical practices could not afford to hire  a social worker. The stakeholders concurred that social workers were  generally available in larger integrated practices (such as a single or  multiple groups aligning with each other or with a larger hospital system)  and in facility settings such as hospitals or skilled nursing facilities.  (Stakeholders also provided other comments on the structure of a  potential new billing code for the LCCP service should such a code be  established by CMS, which we summarize in app. VI.)

	Agency Comments

We provided a draft of this report to HHS for review and comment. HHS  provided technical comments, which we incorporated as appropriate.
We are sending copies of this report to the appropriate congressional  committees, the Secretary of Health and Human Services, and other  interested parties. In addition, the report is available at no charge on the  GAO website at http://www.gao.gov.
If you or your staff have any questions about this report, please contact  me at (202) 512-7114 or farbj@gao.gov. Contact points for our Offices of  Congressional Relations and Public Affairs may be found on the last page  of this report. GAO staff who made major contributions to this report are  listed in appendix VII.

Appendix I: Example of an American Medical Association Vignette

Appendix II: Longitudinal Comprehensive Care Planning Service Components in the Balanced Budget Act of 2018

Appendix II: Longitudinal Comprehensive Care  Planning Service Components in the Balanced  Budget Act of 2018 Pub. L. No. 115-123, § 50342(c)(4), 132 Stat. 211.

Appendix III: Stakeholder Groups Interviewed by GAO

Appendix IV: Medicare Physician Fee Schedule Billing Codes for Longitudinal Comprehensive Care Planning (LCCP)-Type Services

We identified 58 billing codes in Medicare’s physician fee schedule that  may be used to bill for LCCP-type services as defined in the Balanced  Budget Act of 2018 (2018 BBA). Figure 9 shows relevant information on  these billing codes including the short descriptor, beneficiary eligibility  criteria, our analysis of whether the billing code’s components are  equivalent to the components of an LCCP service as defined in the 2018  BBA, and Medicare’s 2019 fee.

Appendix V: Specialty Billing of Complex Evaluation and Management Codes in 2017

Medicare’s physician fee schedule contains evaluation and management  (E/M) codes that providers may use to bill for face-to-face visits in their  offices or other settings such as hospitals. These codes range in  complexity from low to high depending on the amount of time the provider  spends with a patient as well as the complexity of the medical decision-  making and the medical condition(s) being treated. Table 4 shows the  percentage of each specialty’s E/M visits that were billed as complex  visits (moderate or high complexity). In general, primary care and medical  sub-specialties tended to bill complex visits at a higher rate than the all- specialty average, while surgical specialties tended to bill complex visits  at a lower rate than the all-specialty average.

Appendix VI: Longitudinal Comprehensive Care Planning (LCCP) Services: Stakeholder Perspectives on Potential New Billing Code

We interviewed 19 stakeholders including national umbrella groups of  physicians and other providers to obtain their perspectives on the  structure of a new billing code for LCCP-type services as defined in the  Balanced Budget Act of 2018 (2018 BBA), regardless of whether they  supported the creation of a new code. Stakeholders were generally in  agreement that a new billing code for LCCP-type services as defined in  the 2018 BBA, if implemented, should be broadly defined. Specifically,  stakeholders stated that it should not be tied to a specific condition,  should allow for both in-person and non-face-to-face services performed  when the beneficiary was not present, should be billable more than once,  should be available for billing by both primary care physicians and  specialists, and should have restrictions to avoid duplicative billing with  existing billing that provided overlapping services. However,  stakeholders had more mixed views about what these specific restrictions  should be. Stakeholder views about the various structural components or  restrictions included the following:
Applicable medical conditions: The majority of stakeholders (13 of the  17 who responded to this question) stated that the new code should  be broadly defined although they differed in their opinions of what  broadly-defined meant; one stakeholder cautioned against an overly  broad definition, and one suggested pilot testing with a discrete list of  conditions.
Of the 13 stakeholders in favor of a broad definition, 12 stated that  the new billing code should not be tied to any particular specific  illness or medical condition but should be flexible in structure.  Three stakeholders stated that the extent of beneficiaries’ daily  functioning or quality of life should also be considered when  defining applicable medical conditions. For example, a beneficiary  who is not necessarily suffering from a life-threatening illness but  is unable to perform the functions of daily living (such as bathing  and eating) needs extensive care planning and should therefore  be covered under the new LCCP-type service. Three stakeholders  stated that the new code should be billable if a beneficiary’s  existing diagnosis of a serious illness changed. Three  stakeholders stated that a potential new code could be modeled  along the lines of existing billing codes—specifically the advance  care planning (ACP) or chronic care management (CCM) codes— which do not specify any particular medical condition.
Two stakeholders said that a new code should not be so broad  that it could apply to a vast majority of beneficiaries. For example,  one stakeholder stated that the American Medical Association  would likely not approve a code for a generic serious condition  because it would be difficult to differentiate that code from an  existing billing code, such as an evaluation and management  (E/M) code, which may be used for any medical condition  including serious, life-threatening conditions.
One stakeholder suggested pilot testing the code with a discrete  list of conditions, with the intention of expanding the list  afterwards.
In-person or non-face-to-face: The majority of stakeholders (12 of the  15 that responded to this question) stated that a potential new code  should allow for both in-person and non-face-to-face activities (such  as virtual or telehealth—providing clinical care remotely by two-way  video, phone calls with the beneficiary or to arrange referrals or  coordinate care with other providers when the beneficiary was not  present); three said it should only include face-to-face activities.
Twelve stakeholders stated that the visit should include both types  of activities. For example, one stakeholder said the initial visit for  LCCP-type services should be in-person, and follow up activities  such as updating a care plan or remote patient monitoring  (monitoring of patients outside of conventional settings) could be  non-face-to-face.
Three stakeholders said it should only include face-to-face  activities either because of concerns about the potential for  overbilling if the new code included non-face-to-face activities  which might be difficult to verify or because other existing codes,  such as CCM, already cover non-face-to-face activities.
Frequency of billing: All of the 16 stakeholders responding to this  question concurred that the new code should be billable more  frequently than on a one-time basis, although opinions varied on the  exact frequency.
Nine stakeholders said the code should be billable on an ongoing  basis as the beneficiary’s condition changes. For example, one  said that the new code should be on-going because the care  planning and treatment would continue to evolve over time as the  beneficiary’s condition changes.
Seven other stakeholders said that while it should not be an  ongoing service, it should be billable more frequently than once.  For example, one stakeholder specified that it could be billed once  per month or over every three months, but that a target end date  must be specified; otherwise, it would be too similar to existing  billing codes such as the CCM code that may be billed monthly.  Two other stakeholders said it could be billed up to 4-5 times a  year.
Other billing restrictions: All 12 stakeholders responding to this  question indicated that restrictions would be necessary to avoid  overlap with existing billing codes. For example, three stakeholders  suggested that the new code could be billed along with an E/M code  for additional services not covered by the E/M code as long as it does  not overlap with other existing codes that account for additional time  beyond an E/M visit (such as the prolonged E/M visit billing codes).  One suggested that it should not be billed along with any of the  existing narrowly-defined LCCP-type codes, including CCM,  transitional care management, or the ACP codes. One did not specify  any particular code with which the new code should not be billed, but  cautioned that care should be taken to ensure that time spent with the  beneficiary was reported only once.
Providers eligible to bill the code: The majority of stakeholders (13 of  the 15 that responded to this question) stated that both primary care  physicians and specialists should be eligible to bill the new code. Two  of these stakeholders said that there should also be a requirement  that the billing physician has an established relationship with the  beneficiary. Two stakeholders said that only specialists should bill  since they are generally the ones attending to the beneficiary’s  serious illness. Two stakeholders stated that non-physicians  (including social workers) should also be able to bill the code as long  as they are currently allowed to bill separately under the Medicare  Physician Fee Schedule.

Appendix VII: GAO Contact and Staff Acknowledgments

	GAO Contact

	Staff Acknowledgments

In addition to the contact named above, Karen Doran, Assistant Director;  Iola D’Souza, Analyst-in-Charge; Sarah Belford; Krister Friday; John  Lalomio; and Daniel Ries made key contributions to this report. Also  contributing were George Bogart and Muriel Brown.


Input:
	Introduction

Fully autonomous vehicles, which would carry out many or all of their functions without the intervention of a driver, may someday bring sweeping social and economic changes and "lead to breakthrough gains in transportation safety." Motor vehicle crashes caused an estimated 36,560 fatalities in 2018; a study by the National Highway Traffic Safety Administration (NHTSA) has shown that 94% of crashes are due to human errors.
Legislation that would encourage development and testing of autonomous vehicles has faced controversy in Congress. In the 115 th Congress, the House of Representatives passed an autonomous vehicle bill, H.R. 3388 , by voice vote in September 2017. The Senate Committee on Commerce, Science, and Transportation reported a different bill, S. 1885 , in November 2017, but after some Senators raised concerns about the preemption of state laws and the possibility of large numbers of vehicles being exempted from some Federal Motor Vehicle Safety Standards, the Senate bill did not reach the floor. No further action was taken on either bill before the 115 th Congress adjourned.
Although some Members of Congress remain interested in autonomous vehicles, no legislative proposals have become law. Several fatal accidents involving autonomous vehicles raised new questions about how federal and state governments should regulate vehicle testing and the introduction of new technologies into vehicles offered for sale. A pedestrian was killed in Arizona by an autonomous vehicle operated by Uber on March 18, 2018, and three Tesla drivers died when they failed to respond to hazards not recognized by the vehicles. These accidents suggest that the challenge of producing fully autonomous vehicles that can operate safely on public roads may be greater than developers had envisioned, a new outlook voiced by several executives, including the Ford Motor Co. CEO. However, with the authorization of federal highway and public transportation programs set to expire at the end of FY2020, a surface transportation reauthorization bill could become a focus of efforts to also enact autonomous vehicle legislation.

	Advances in Vehicle Technology

While fully autonomous vehicles may lie well in the future, a range of new technologies is already improving vehicle performance and safety while bringing automation to vehicular functions once performed only by the driver. The technologies involved are very different from the predominantly mechanical, driver-controlled technology of the 1960s, when the first federal vehicle safety laws were enacted. These new features automate lighting and braking, connect the car and driver to the Global Positioning System (GPS) and smartphones, and keep the vehicle in the correct lane. Three forces are driving these innovations:
technological advances enabled by new materials and more powerful, compact electronics; consumer demand for telecommunications connectivity and new types of vehicle ownership and ridesharing; and regulatory mandates pertaining to emissions, fuel efficiency, and safety.
Manufacturers are combining these innovations to produce vehicles with higher levels of automation. Vehicles do not fall neatly into the categories of "automated" or "nonautomated," because all new motor vehicles have some element of automation.
The Society of Automotive Engineers International (SAE), an international standards-setting organization, has developed six categories of vehicle automationâranging from a human driver doing everything to fully autonomous systems performing all the tasks once performed by a driver. This classification system ( Table 1 ) has been adopted by the U.S. Department of Transportation (DOT) to foster standardized nomenclature to aid clarity and consistency in discussions about vehicle automation and safety.
Vehicles sold today are in levels 1 and 2 of SAE's automation rating system. Although some experts forecast market-ready autonomous vehicles at level 3 will be available in a few years, deployment of fully autonomous vehicles in all parts of the country at level 5 appears to be more distant, except perhaps within closed systems that allow fully autonomous vehicles to operate without encountering other types of vehicles. Testing and development of autonomous vehicles continue in many states and cities.
Technologies that could guide an autonomous vehicle ( Figure 1 ) include a wide variety of electronic sensors that would determine the distance between the vehicle and obstacles; park the vehicle; use GPS, inertial navigation, and a system of built-in maps to guide the vehicle's direction and location; and employ cameras that provide 360-degree views around the vehicle. To successfully navigate roadways, an autonomous vehicle's computers, sensors and cameras will need to accomplish four tasks that a human driver undertakes automatically: detect objects in the vehicle's path; classify those objects as to their likely makeup (e.g., plastic bag in the wind, a pedestrian or a moving bicycle); predict the likely path of the object; and plan an appropriate response. Most autonomous vehicles use dedicated short-range communication (DSRC) to monitor road conditions, congestion, crashes, and possible rerouting. As 5G wireless communications infrastructure is installed more widely, DSRC may evolve and become integrated with it, enabling vehicles to offer greater interoperability, bandwidth, and cybersecurity. Some versions of these autonomous vehicle technologies, such as GPS and rear-facing cameras, are being offered on vehicles currently on the market, while manufacturers are studying how to add others to safely transport passengers without drivers.
Manufacturers of conventional vehicles, such as General Motors and Honda, are competing in this space with autonomous vehicle "developers" such as Alphabet's Waymo. In addition, automakers are aligning themselves with new partners that have experience with ride-sharing and artificial intelligence:
Ford and Volkswagen have announced that they expect to use autonomous vehicle technology in a new ride-sharing service in Pittsburgh, PA, as early as 2021; GM acquired Cruise Automation, a company that is developing self-driving technology for Level 4 and 5 vehicles. GM has also invested $500 million in the Lyft ride-sharing service; Honda, after breaking off talks about partnering with Waymo, purchased a stake in GM's Cruise Automation; Volvo and Daimler have announced partnerships with ride-sharing service Uber; and BMW partnered with the Mobileye division of Intel, a semiconductor manufacturer, to design autonomous vehicle software.

		Cybersecurity and Data Privacy

As vehicle technologies advance, the security of data collected by vehicle computers and the protection of on-board systems against intrusion are becoming more prominent concerns. Many of the sensors and automated components providing functions now handled by the driver will generate large amounts of data about the vehicle, its location at precise moments in time, driver behavior, and vehicle performance. The systems that allow vehicles to communicate with each other, with roadside infrastructure, and with manufacturers seeking to update software will also offer portals for possible unauthorized access to vehicle systems and the data generated by them.
Protecting autonomous vehicles from hackers is of paramount concern to federal and state governments, manufacturers, and service providers. A well-publicized hacking of a conventional vehicle by professionals demonstrated to the public that such disruptions can occur. Hackers could use more than a dozen portals to enter even a conventional vehicle's electronic systems ( Figure 2 ), including seemingly innocuous entry points such as the airbag, the lighting system, and the tire pressure monitoring system (TPMS). Requirements that increasingly automated vehicles accept remote software updates, so that owners do not need to take action each time software is revised, are in part a response to concerns that security weaknesses be rectified as quickly as possible.
To address these concerns, motor vehicle manufacturers established the Automotive Information Sharing and Analysis Center (Auto-ISAC), which released a set of cybersecurity principles in 2016. DOT's autonomous vehicle policies designate Auto-ISAC as a central clearinghouse for manufacturers to share reports of cybersecurity incidents, threats, and violations with others in the vehicle industry.
Aside from hackers, many legitimate entities would like to access vehicle data, including vehicle and component manufacturers, the suppliers providing the technology and sensors, the vehicle owner and occupants, urban planners, insurance companies, law enforcement, and first responders (in case of an accident). Issues pertaining to vehicle data collection include vehicle testing crash data (how is it stored and who gets to access it); data ownership (who owns most of the data collected by vehicle software and computers); and consumer privacy (transparency for consumers and owner access to data). At present, no laws preclude manufacturers and software providers from reselling data about individual vehicles and drivers to third parties.

	Pathways to Autonomous Vehicle Deployment Abroad

Autonomous vehicles are being developed and tested in many countries, including those that produce most of the world's motor vehicles. Several analyses have evaluated the factors that are contributing to the advancement of autonomous vehicles in various countries:
Innovation . Benchmarks in this area include the number and engagement of domestic automakers and technology developers working on automation, the partnerships they forge with academic and related businesses, the prevalence of ride-sharing services, and autonomous vehicle patents issued. V ehicle infrastructure . Autonomous vehicles will need new types of infrastructure support and maintenance, including advanced telecommunications links and near-perfect pavement and signage markings. Planning and implementing these highway improvements may enable autonomous vehicles to be fully functional sooner. In addition, many test vehicles are currently powered by electricity, so the availability of refueling stations could be a factor in their acceptance. Wo rkforce training. The increased reliance on autonomous vehicle technologies may require different workforce skills. Many traditional mechanical parts may disappear, especially if autonomous vehicles operate entirely on battery power, while the arrangement and function of dashboards and seating may be reinvented. Components suppliers that are already addressing this new product demand and reorienting their workforces will assist in the transition to autonomous vehicles. G overnment laws and regulations that encourage development and testing . Fully autonomous vehicles may not have standard features of today's cars, such as steering wheels and brake pedals, as there will not be a driver. By law or regulation, motor vehicles built today are required to have many of these features. Some governments are taking a lead by modifying vehicle requirements for purposes of pilot programs and tests. Permanent changes in standards will most likely be necessary if autonomous vehicle technologies are to be commercialized. L evel of consumer acceptance . Markets are more likely to embrace autonomous vehicles if many residents in cities see autonomous vehicles on the road, a high level of technology is in use (including internet access and mobile broadband), and ride-hailing services are more widely used.
Several surveys have been conducted analyzing many of these factors. For example, a 2018 Harvard University report highlights plans in China, South Korea, Japan, and the United States to "seize the benefits" of autonomous vehicles. In a report on innovation policies in four Asian countries (China, Japan, South Korea, and Singapore), the United Nations Economic and Social Commission for Asia and the Pacific ranked Singapore first in autonomous vehicle readiness because of its policies and new laws governing their deployment and its high consumer acceptance. The report also notes that South Korea's K-City facility is "intended to be the world's largest testbed for self-driving cars."
A more detailed comparison of factors affecting autonomous vehicle development and deployment has been conducted by KPMG International, which has developed an index to measure how 25 countries are guiding autonomous vehicles ( Table 2 ).
The Netherlands ranked first overall in the KPMG report, where it was cited as "an example of how to ready a country for AVs by performing strongly in many areas , " as well as first in infrastructure. Singapore came in first on policy and legislation because it has a single government entity overseeing autonomous vehicle regulations, it is funding autonomous vehicle pilots, and it has enacted a national standard to promote safe deployment. Contributing to its rank was a World Economic Forum (WEF) report that ranked it first among 139 countries in having an effective national legislature and efficient resolution of legal disputes. Singapore also scored first place on the consumer acceptance metric, primarily because its extensive autonomous testing is being conducted throughout the island nation, thereby familiarizing residents with autonomous passenger vehicles and buses.
Two other major auto-producing countriesâGermany and Japanâfall just below the United States on technology and innovation, according to KPMG, while Japan ranks higher on autonomous vehicle infrastructure ( Table 3 ).

	Issues in Federal Safety Regulation

Vehicles operating on public roads are subject to dual regulation by the federal government and the states in which they are registered and driven. Traditionally, NHTSA, within DOT, has regulated auto safety, while states have licensed automobile drivers, established traffic regulations, and regulated automobile insurance. Proponents of autonomous vehicles note that lengthy revisions to current vehicle safety regulations could impede innovation, as the rules could be obsolete by the time they take effect.
In 2016, the Obama Administration issued the first report on federal regulations affecting autonomous vehicles. Since then, DOT has issued two follow-up reports and has said it anticipates issuing annual updates to its regulatory guidance. In addition, the Federal Communications Commission (FCC) is reconsidering the allocation of electromagnetic spectrum currently reserved for motor vehicle communications, and its decisions may affect how autonomous vehicles evolve.

		Obama Administration Policy Direction

DOT's 2016 report proposed federal and state regulatory policies in these areas:
A set of guidelines outlining best practices for autonomous vehicle design, testing, and deployment. DOT identified 15 practices and procedures that it expected manufacturers, suppliers, and service providers (such as ridesharing companies) to follow in testing autonomous vehicles, including data recording, privacy, crashworthiness, and object and event detection and response. These reports, called Safety Assessment Letters, would be voluntary, but the report noted that "they may be made mandatory through a future rulemaking." A m odel s tate p olicy that identifies where new autonomous vehicle-related issues fit in the current federal and state regulatory structures. The model state policy, developed by NHTSA in concert with the American Association of Motor Vehicle Administrators and private-sector organizations, suggests state roles and procedures, including administrative issues (designating a lead state agency for autonomous vehicle testing), an application process for manufacturers that want to test vehicles on state roads, coordination with local law enforcement agencies, changes to vehicle registration and titling, and regulation of motor vehicle liability and insurance. A streamlined review process to issue DOT regulatory interpretations on autonomous vehicle questions within 60 days and on regulatory exemptions within six months. Identification of new tools and regulatory structures for NHTSA that could build its expertise in new vehicle technologies, expand its ability to regulate autonomous vehicle safety, and increase speed of its rulemakings. Two new tools could be expansion of existing exemption authority and premarket testing to assure that autonomous vehicles will be safe. Some of the new regulatory options cited would require new statutory authority, while others could be instituted administratively. The report noted that "DOT does not intend to advocate or oppose any of the tools.â¦ [I]t intends â¦ to solicit input and analysis regarding those potential options from interested parties."

		Trump Administration Policy Guidelines and Proposed SafetyÂ Rules

The two follow-up reports issued by the Trump Administration describe a more limited federal regulatory role in overseeing autonomous passenger vehicle deployment, while also broadening the scope of DOT oversight by addressing the impact of autonomous technology on commercial trucks, public transit, rail, and ports and ships. The policies described in these reports replace those recommended by the Obama Administration in several ways, including the following:
Encouraging integration of automation across all transportation modes , instead of just passenger vehicles. The October 2018 report Automated Vehicles 3.0 outlines how each of DOT's agencies will address autonomous vehicle safety within its purview. Establishing six automation principles that will be applied to DOT's role in overseeing passenger cars, trucks, commercial buses, and other types of vehicles. These include giving priority to safety; remaining technology-neutral; modernizing regulations; encouraging a consistent federal and state regulatory environment; providing guidance, research, and best practices to government and industry partners; and protecting consumers' ability to choose conventional as well as autonomous vehicles. Reiterating the traditional roles of federal and state governments in regulating motor vehicles and motorists, respectively. The reports cite best practices that states should consider implementing, such as minimum requirements for autonomous vehicle test drivers, and discuss how DOT can provide states with technical assistance. Recommending voluntary action in lieu of regulation. This could include suggesting that manufacturers and developers of autonomous driving systems issue and make public voluntary safety self-assessments to demonstrate transparency and increase understanding of the new technologies and industry development of "voluntary technical standards" to "advance the integration of automation technologies into the transportation system." The NHTSA Voluntary Safety Self-Assessment web page lists 17 companies that have filed self-assessment reports, including three major automakers. To provide a perspective, 64 companies have been issued autonomous vehicle testing permits by the State of California alone. Accelerating NHTSA decisions on requests for exemptions from federal safety standards for autonomous vehicle testing. Promoting development of voluntary technical standards by other organizations, such as the Society of Automotive Engineers, the government's National Institute of Standards and Technology, and the International Organization for Standardization.
DOT has indicated that it wants to revise regulations pertinent to autonomous vehicles, such as redefining the terms "driver" and "operator" to indicate that a human being does not always have to be in control of a motor vehicle. It also said it plans to require changes in standards for the inspection, repair, and maintenance of federally regulated commercial trucks and buses. Along these lines, NHTSA issued a Notice of Proposed Rulemaking in May 2019, requesting comments on testing and verifying how autonomous vehicle technologies may comply with existing federal safety standards.

		National Transportation Safety Board Investigation and Recommendations

On November 19, 2019, the National Transportation Safety Board (NTSB) issued its report on the probable cause of a 2018 fatality involving an autonomous vehicle in Tempe, AZ. In that accident, a pedestrian was fatally injured by a test vehicle operated by Uber Technologies with an operator in the driver's seat. The NTSB investigation determined that the probable cause of the crash "was the failure of the vehicle operator to monitor the driving environment and the operation of the ADS [automated driving system] because she was visually distracted throughout the trip by her personal cell phone." Though the vehicle detected the pedestrian 5.6 seconds before the crash, the NTSB reported that "it never accurately classified her as a pedestrian or predicted her path."
Beyond the immediate cause of this accident, NTSB reported that an "inadequate safety culture" at Uber and deficiencies in state and federal regulation contributed to the circumstances that led to the fatal crash. Among the findings were the following:
Uber's internal safety risk-assessment procedures and oversight of the operator were inadequate, and its disabling of the vehicle's forward collision warning and automatic emergency braking systems increased risks. The Arizona Department of Transportation provided insufficient oversight of autonomous vehicle testing in the state. NHTSA provides insufficient guidance to developers and manufacturers on how they should achieve safety goals, has not established a process for evaluating developers' safety self-assessment reports, and does not require such reports to be submitted, leaving their filing as voluntary.
NTSB recommended that Uber, the Arizona Department of Transportation, and NHTSA take specific steps to address the issues it identified. It also recommended that the American Association of Motor Vehicle Administrators inform all states about the circumstances of the Tempe crash, encouraging them to require and evaluate applications by developers before granting testing permits.

	Connected Vehicles and Spectrum Allocation

Federal regulation of the spectrum used in vehicle communications may affect how automation proceeds. Autonomous vehicles, whose artificial intelligence and technology are generally self-contained in each vehicle, are part of a larger category of connected vehicles and infrastructure. Federal, state, and industry research and testing of vehicle-to-vehicle (V2V) and vehicle-to-infrastructure (V2I) communications has been under way since the 1990s. Together, these two sets of technologies, known as V2X, are expected to reduce the number of accidents by improving detection of oncoming vehicles, providing warnings to drivers, and establishing communications infrastructure along roadways that would prevent many vehicles from leaving the road and striking pedestrians. These technologies fall within the broad category of intelligent transportation systems, which have received strong support from Congress due to their potential to improve traffic flow and safety.
For vehicles to communicate wirelessly, they use radio frequencies, or spectrum, which are regulated by the Federal Communications Commission (FCC). In 1999, the FCC allocated the 5.9 gigahertz (GHz) band solely for motor vehicle safety purposes for vehicles using DSRC. Over the past two decades, industry and government agencies have collaborated to develop, test, and deploy DSRC technologies. States have invested in DSRC-based improvements, and this technology is operating in dozens of states and cities.
As industry has continued to explore vehicle automation, an alternative, cellular-based technology has recently emerged, known as C-V2X. In December 2019, the FCC proposed rules that would reallocate the lower 45 MHz of the 5.9 GHz band for unlicensed use (e.g., Wi-Fi), and allocate the remaining 30 MHz for transportation and vehicle-related use. Of the 30 MHz, the FCC proposed to grant C-V2X exclusive use of 20 MHz of the segment. It is seeking comment on whether the remaining 10 MHz should remain dedicated to DSRC or be dedicated to C-V2X. The FCC commissioners noted that DSRC has evolved slowly and has not been widely deployed, and the rules are intended to ensure the spectrum supports its highest and best use. This decision has competitive implications for the automotive, electronics, and telecommunications industries, and may affect the availability of safety technologies and the path toward vehicle automation. DOT has called for retaining the entire 5.9 GHz band for exclusive transportation use.
 Figure 3 shows that these two technologies facilitate somewhat different types of vehicle and infrastructure communications. In light of their different characteristics, the European Commission has approved DSRC use for direct V2V and V2I communications, while endorsing cellular-based technology for vehicle access to the cloud and remote infrastructure.
Industry groups in the United States took varying positions in the FCC proceedings. DSRC advocates argued that this technology has been proven by years of testing and is already deployed in many areas. They generally supported retaining the 5.9 GHz band for exclusive use for DSRC. C-V2X supporters contended that its cellular-based solution is aligned with international telecommunications standards for 5G technologies and should be allowed to use the 5.9 GHz band alongside DSRC. A group of technology companies, including device makers, argued that additional spectrum is needed to accommodate the increasing number of interconnected devices, and that the 5.9GHz band can safely be shared among transportation and non-transportation uses.

	Congressional Action

During the 115 th Congress, committees in the House of Representatives and the Senate held numerous hearings in 2017 on the technology of autonomous vehicles and possible federal issues that could result from their deployment. Initially, bipartisan consensus existed on major issues: H.R. 3388 , the SELF DRIVE Act, was reported unanimously by the House Committee on Energy and Commerce, and on September 6, 2017, the House of Representatives passed it without amendment by voice vote.
A similar bipartisan initiative began in the Senate. Prior to markup in the Committee on Commerce, Science, and Transportation, the then-chairman and ranking member issued a set of principles they viewed as central to new legislation:
prioritize safety , acknowledging that federal standards will eventually be as important for self-driving vehicles as they are for conventional vehicles; promote innovation and address the incompatibility of old regulations written before the advent of self-driving vehicles; remain technology - neutral , not favoring one business model over another; reinforce separate but complementary federal and state regulatory roles ; strengthen cybersecurity so that manufacturers address potential vulnerabilities before occupant safety is compromised; and educate the public through government and industry efforts so that the differences between conventional and self-driving vehicles are understood.
Legislation slightly different from the House-passed bill emerged: S. 1885 , the AV START Act, was reported by the Committee on Commerce, Science, and Transportation on November 28, 2017. It was not scheduled for a floor vote prior to adjournment in December 2018 because of unresolved concerns raised by several Senators. To address some of those concerns, a committee staff draft bill that would have revised S. 1885 was circulated in December 2018 that could form the basis of future legislation.
The House and Senate bills addressed concerns about state action replacing some federal regulation, while also empowering NHTSA to take unique regulatory actions to ensure safety and encouraging innovation in autonomous vehicles. The bills retained the current arrangement of states controlling most driver-related functions and the federal government being responsible for vehicle safety. The House and Senate bills included the following major provisions. Where the December 2018 Commerce Committee staff draft proposed significant changes, they are noted in this analysis.
P reemption of state laws . H.R. 3388 would have barred states from regulating the design, construction, or performance of highly autonomous vehicles, automated driving systems, or their components unless those laws are identical to federal law. The House-passed bill reiterated that vehicle registration, driver licensing, driving education, insurance, law enforcement, and crash investigations should remain under state jurisdiction as long as state laws and regulations do not restrict autonomous-vehicle development. H.R. 3388 provided that nothing in the preemption section should prohibit states from enforcing their laws and regulations on the sale and repair of motor vehicles.
S. 1885 would also have preempted states from adopting laws, regulations, and standards that would regulate many aspects of autonomous vehicles, but would have omitted some of the specific powers reserved to the states under the House-passed bill. States would not have been required to issue drivers licenses for autonomous-vehicle operations, but states that chose to issue such licenses would not have been allowed to discriminate based on a disability. The bill provided that preemption would end when NHTSA establishes standards covering these vehicles.
The Senate staff draft sought to clarify that state and local governments would not lose their traditional authority over traffic laws. It also would have added provisions that state common law and statutory liability would be unaffected by preemption, and would have limited use of arbitration in death or bodily injury cases until new federal safety standards are in effect.
Exemption authority . Both the House and Senate bills would have expanded DOT's ability to issue exemptions from existing safety standards to encourage autonomous-vehicle testing on public roads. To qualify for an autonomous-vehicle exemption, a manufacturer would have had to show that the safety level of the vehicle equaled or exceeded the safety level of each standard for which an exemption was sought. Current law limits exemptions to 2,500 vehicles per manufacturer per year. The House-passed bill would have phased in increases over four years of up to 100,000 vehicles per manufacturer per year; the Senate bill would have permitted up to 80,000 in a similar phase-in.
H.R. 3388 provided constraints on the issuance of exemptions from crashworthiness and occupant protection standards; S. 1885 did not address those two issues. DOT would have been directed to establish a publicly available and searchable database of motor vehicles that have been granted an exemption. Crashes of exempted vehicles would have had to be reported to DOT. The Senate bill would not have required the establishment of a database of exempted vehicles, and reporting of exempt vehicle crashes would not have been required.
The Senate staff draft added a provision to ensure that vehicles exempted from federal standards would have been required to nonetheless maintain the same level of overall safety, occupant protection, and crash avoidance as a traditional vehicle. A DOT review of vehicle exemptions would have been required annually. The draft capped exemptions at no more than five years.
New NHTSA safety rules. The House bill would have required NHTSA to issue a new regulation requiring developers and manufacturers to submit a "safety assessment certification" explaining how safety is being addressed in their autonomous vehicles. The Senate bill included a similar provision requiring a "safety evaluation report," and would have delineated nine areas for inclusion in the reports, including system safety, data recording, cybersecurity risks, and methods of informing the operator about whether the vehicle technology is functioning properly. While manufacturers and developers would be required to submit reports, the legislation did not mandate that NHTSA establish an assessment protocol to ensure that minimum risk conditions are met.
The Senate staff draft would have clarified the process by which federal motor vehicle safety standards would be updated to accommodate new vehicle technologies, providing additional time for new rulemaking. Within six months of enactment, DOT would have been required to develop and publicize a plan for its rulemaking priorities for the safe deployment of autonomous vehicles.
To address concerns that autonomous vehicles might not recognize certain potential hazardsâincluding the presence of bicyclists, pedestrians, and animalsâand hence possibly introduce new vulnerabilities to motor vehicle travel, the Senate staff draft would have clarified that manufacturers must describe how they are addressing the ability of their autonomous vehicles to detect, classify, and respond to these and other road users. Manufacturers and developers would include this analysis in their safety evaluation reports.
Cybersecurity. The House-passed bill provided that no highly autonomous vehicle or vehicle with "partial driving automation" could be sold domestically unless a cybersecurity plan had been developed by the automaker. Such plans would have to have been developed within six months of enactment and would include
a written policy on mitigation of cyberattacks, unauthorized intrusions, and malicious vehicle control commands; a point of contact at the automaker with cybersecurity responsibilities; a process for limiting access to autonomous driving systems; and the manufacturer's plans for employee training and for maintenance of the policies.
The Senate bill would have required written cybersecurity plans to be issued, including a process for identifying and protecting vehicle control systems, detection, and response to cybersecurity incidents, and methods for exchanging cybersecurity information. A cybersecurity point of contact at the manufacturer or vehicle developer would have had to be named. Unlike the House-passed bill, S. 1885 would have directed DOT to create incentives so that vehicle developers would share information about vulnerabilities, and would have specified that all federal research on cybersecurity risks should be coordinated with DOT.
In addition, S. 1885 would have established a Highly Automated Vehicle Data Access Advisory Committee to provide Congress with recommendations on cybersecurity issues. Federal agencies would have been prohibited from issuing regulations pertaining to the access or ownership of data stored in autonomous vehicles until the advisory committee's report was submitted.
The staff draft would have added several cybersecurity provisions, including an additional study by the National Institute of Standards and Technology that would recommend ways vehicles can be protected from cybersecurity incidents.
Privacy. Before selling autonomous vehicles, manufacturers would have been required by the House-passed bill to develop written privacy plans concerning the collection and storage of data generated by the vehicles, as well as a method of conveying that information to vehicle owners and occupants. However, a manufacturer would have been allowed to exclude processes from its privacy policy that encrypt or make anonymous the sources of data. The Federal Trade Commission would have been tasked with developing a report for Congress on a number of vehicle privacy issues.
Although S. 1885 would not have explicitly required privacy plans by developers and manufacturers, it would have required NHTSA to establish an online, searchable motor vehicle privacy database that would include a description of the types of information, including personally identifiable information (PII), that are collected about individuals during operation of a motor vehicle. This database would have covered all types of vehiclesânot just autonomous vehiclesâand would have included the privacy policies of manufacturers. The database would also have included an explanation about how PII would be collected, retained, and destroyed when no longer relevant.
The Senate staff draft would have added new passenger motor vehicle privacy protections.
Research and advisory panels. Both bills would have established several new advisory bodies to conduct further research on autonomous vehicles and advise DOT on possible new vehicle standards. H.R. 3388 would have established a NHTSA advisory group with a broad cross-section of members to advise on mobility access for senior citizens and the disabled; cybersecurity; labor, employment, environmental, and privacy issues; and testing and information sharing among manufacturers.
S. 1885 would have established other panels, including a Highly Automated Vehicles Technical Committee to advise DOT on rulemaking policy and vehicle safety; a working group comprising industry and consumer groups to identify marketing strategies and educational outreach to consumers; and a committee of transportation and environmental experts to evaluate the impact of autonomous vehicles on transportation infrastructure, mobility, the environment, and fuel consumption. Separately, DOT would have been required to study ways in which autonomous vehicles and parts could be produced domestically, with recommendations on how to incentivize U.S. manufacturing.
The Senate staff draft would have consolidated some of the advisory committees in S. 1885 into a Highly Automated Vehicle Advisory Council with diverse stakeholder representation, and mandated to report on mobility for the disabled, senior citizens and populations underserved by public transportation; cybersecurity; employment and environmental issues; and privacy and data sharing.
No similar comprehensive autonomous vehicle legislation has been introduced in the 116 th Congress, although discussions on a bicameral bill have been ongoing. In addition, the Senate Committee on Environment and Public Works has reported America's Transportation Infrastructure Act of 2019, S. 2302 , which includes several provisions in Subtitle D addressing the possible impact of autonomous vehicles on highway infrastructure. It would establish a grant program to modernize the U.S. charging and fueling infrastructure so that it would be responsive to technology advancements, including autonomous vehicles. The legislation would also require research on ways in which roadway infrastructure should be improved for autonomous vehicles.

	State Concerns

State and local rules and regulations may affect how autonomous vehicles are tested and deployed. The National Governors Association (NGA) has noted that state governments have a role with respect to vehicle and pedestrian safety, privacy, cybersecurity, and linkage with advanced communications networks. While supporting technology innovations in transportation, a recent NGA report notes that "the existing regulatory structure and related incentives have not kept pace with the new technology" and that "recent accidents have raised concerns about the safety of drivers, pedestrians and other road users in the period during which autonomous and non-autonomous vehicles share the road."
NGA has joined with other state and local government organizations to call for modifications in forthcoming autonomous vehicle legislation, including
clarity that states and local governments not only can enforce existing laws governing operation of motor vehicles on public roads, but also originate new statutes and regulations; requiring submission of more detailed automaker and developer reports to DOT on the safety of their technologies, so that states and cities can be assured that autonomous vehicle testing is being conducted in a safe manner; differentiation between limited vehicle testing and the commercial deployment of large numbers of autonomous vehicles through an expanded exemptions process; and expansion of plans for consumer education about "safe use and interaction" with respect to autonomous vehicles.
According to the National Conference of State Legislatures (NCSL), at least 41 states and the District of Columbia considered legislation related to autonomous vehicles between 2013 and October 2019; in that time, 29 states and the District of Columbia enacted legislation, governors in 11 states issued executive orders, and 5 states issued both an executive order and enacted legislation. ( Figure 4 ).
Of the states that have enacted laws in 2017, 2018, and 2019 pertaining to autonomous vehicles, NCSL reports that the largest number of states have passed laws that clarify certain types of commercial activity, such as how closely autonomous vehicles can follow each other when they are coordinated, as in truck platooning. According to NCSL, no recent state laws have been enacted dealing with cybersecurity or vehicle inspection reports. NCSL has organized and categorized the types of state legislation ( Table 4 ). For a more thorough description of the legislation passed in 2017, 2018, and 2019, the NCSL Table of Enacted State Legislation provides more detail.

	Implications for Highway Infrastructure

Deployment of fully autonomous vehicles will require not only a suite of new technologies, but also changes to the highway infrastructure on which those vehicles will operate. Autonomous vehicles being tested today rely on clear pavement markings and legible signage to stay in their lanes and navigate through traffic. Major highways as well as side roads in urban and rural settings will need to accommodate autonomous vehicles in addition to a large fleet of conventional vehicles with human drivers.
In this transition period to more autonomous vehiclesâwhich many anticipate will last several decades âthe Federal Highway Administration (FHWA) is expected to play a significant role through its administration of the Manual on Uniform Traffic Control Devices (MUTCD), which sets standards for all traffic control devices, including signs, intersection signals, and road markings. For example, overhead signage on Interstate Highways contains white lettering on a green background in all 50 statesâeasily recognizable to any U.S. driverâdue to MUTCD standards. FHWA is in the process of updating the 2009 MUTCD to address issues specific to autonomous vehicle technologies. However, state compliance with MUTCD is voluntary, and not all states uniformly apply all standards. Audi reportedly announced in 2018 that it would not make its new Level 3 autonomous vehicle technology, called Traffic Jam Pilot, available in the United States because of "laws that change from one state to the next, insurance requirements, and things like lane lines and road signs that look different in different regions." Other automakers have made similar complaints about U.S. roads.
In the near term, improvement and better maintenance of pavement markings, signage and intersection design may be the most helpful steps that federal and state transportation officials can take. Despite national standards based on MUTCD, not all states maintain their highway markings at a level that would be useful to guide autonomous vehicles. Inadequate road maintenance may affect the pace of autonomous vehicle deployment. Some 21% of major U.S. roads are in poor condition, and a road with many potholes or temporary pavement repairs may also lack continuous lane markings. Many minor roads, which are generally the responsibility of county or municipal governments, may lack road edge lines as well as center lines, potentially making it difficult for autonomous vehicles to position themselves correctly. Dirt and gravel roads may pose particular challenges for autonomous vehicles, as they generally have no pavement markings and cameras may be unable to detect potholes or edges in low-visibility conditions.
Closely tied to the need for clearer road markings and signage will be ways in which federal and state transportation agencies develop a standardized method to communicate information to vehicles and motorists about construction, road accidents, detours, and other changes to road environments. Many of the perceived benefits of autonomous vehiclesâreduced vehicle fatalities, congestion mitigation, and pollution reductionâmay depend on the ability of vehicles to exchange information with surrounding infrastructure. The Transportation Research Board (TRB) has been evaluating how states should begin now to plan and develop the types of connected vehicle infrastructure that will be necessary for full autonomous vehicle deployment. TRB's research is also focused on how cash-strapped transportation agencies can identify the large investments that will in turn be necessary to implement connectivity on top of regular maintenance of highways, bridges, and other traditional infrastructure.
Other options to facilitate autonomous vehicle travel may include designation of special highway corridors that would include all V2X systems necessary for safe autonomous vehicle operation; three European countries have agreed to build such a corridor.
Over a longer time line, the importance of highway markings may fade as automakers and developers find new ways for autonomous vehicles to navigate, including greater use of guardrails and roadside barriers, sensors, and three-dimensional maps. If highly detailed mapping is deemed to be one replacement for visual cues such as lane markings, then transportation agencies and automakers may need to develop an open standard so that all vehicles will understand the mapping technology. V2X communications through DSRC and cellular may evolve to provide a mechanism for new types of vehicle guidance.

		Appendix. Image of Nuro Robot, R2X