RECOMMENDATIONS
sane ee

The PHS Should Work With The States To Develop A Process For Identifying Emerging
Mobile Health Services And Their Providers.

The mobile health services industry is not well known or understood, even to State regulators
with some responsibility for oversight. Yet this study reveals that health services of all types
are increasingly being delivered in mobile settings, and that some of them may offer
advantages related to access and cost.

We believe that the first step in learning more about mobile health services is to be able to
identify services and their providers. As the Department’s lead agency in matters related to
health care services, we believe that PHS should assist the States in developing a process for
this purpose.

The PHS And HCFA Should Develop Priorities And Protocols For Regulating Various
Types Of Mobile Health Services.

Few of the services described in this Teport are regulated to any significant degree, whether by
Federal or State Government. Yet, State respondents in this study raise serious concerns about
the issue of quatity relative to mobile health services. Furthermore, there are indications that
some services are growing in prevalence, especially mobile testing of all kinds, which may
already be reaching millions of Americans.

Accordingly, we recommend that PHS and HCFA Prioritize specific types of mobile health
services and develop regulatory protocols for them. Factors which should be addressed in

- developing these protocols include: (1) whether Tegulation is best carried out by State or local
Government, or professional associations (for example, the Joint Commission for the
Accreditation of Healthcare Organizations); (2) what role is appropriate for the Federal
Government; (3) what special tegulatory requirements are necessary given the mobile nature
of these services; and, (4) what requirements are needed for the oversight of the equipment,
provider, and operator for any given service.

For services involving laboratory testing, the development of protocols should be undertaken
in conjunction with HCFA’s implementation of the Clinical Laboratory Improvement
Amendments of 1988.

Agency Comments:

Both PHS and HCFA concur with our recommendations and are willing to work-cooperatively
to achieve them. The complete texts of their comments are contained in Appendix B.

TA


FDA reviews documentation from the manufacturer and may also perform On-site inspections
of the manufacturer’s facility, test the Product, or inspect equipment at a purchaser’s place of
business.

from annual, to every five years, to Sporadic. One State Tespondent admitted that their On-site
inspections consisted of only “very cursory checks” and that they were only “looking for gross
problems.” Eight State Tespondents admitted that Some x-ray equipment in their States has
never been inspected.

State-mandated quality assurance Programs and operator qualifications for mobile x-ray
services are neither Prevalent nor universal. Staff Tange from certified radiological technicians
(those who have Passed the American Registry of Radiological Technicians exam or are
certified by the State’s to Office assistants with no Special training. One State respondent,
echoing the concerns of several others, called the lack of quality assurance “a sore spot”, and
the issue of staff ‘training “a thorn in my side... an MD gives a couple of lessons to someone
off the street and they’re qualified.”

Mobile nuclear medicine services, which involve the use of radioactive byproduct material,
are regulated by either the NRC Or one of the 29 so-called “Agreement States”, that is, States
that have agreed to enforce, at a minimum, NRC Tegulations Concerning such services, These
States have the authority to license Tadioactive materials used or Possessed within their

. Oversight consists of health and safety surveys concerning the transportation, use,
and disposal of radioactive by-product material,

Mobile Screening

Only some States have Mammography Screening guidelines for Providers. Few States actually
Prohibit self-referral. One State, which does prohibit self-referral, also has a State law
whereby “medical liability” is incurred by the Screening radiologist if the patient does not
have a primary care Physician. The State respondent credited this law with minimizing


Hearth Care

DEPARTMENT OF HEALTH & HUMAN SERVICES Financing Aaministration

MAY | 4 1990 Memorandu-

Gail R. Wilensky. Ph.D. a
Administrator ~

OIG Dratt Report: Mobile Health Services, OEI-05-89.01331

The Inspector General
Office of the Secretary

We have reviewed the subject draft report. This report Provides a national
Overview of the 'ypes and prevalence of mobile health Services, the quality of
these services, and the degree of regulation.

Protocols for regulating various 'ypes of mobile health Services. We believe that
PHS. with its technical expertise and resources, should have the lead in
developing such Priorities and Protocols. We would then evaluate PHS’
recommendations and apply them as appropriate. As an example of such a

B-2


governing legislative authorities to ensure protocols that contained defined measures of
quality of care.

We wish to thank those in PHS and HCFA who commented on the report. The complete texts
of their comments are contained in Appendix B. Several editorial changes were made based
on PHS’s comments.

iii


el

APPENDIX A

APN

Current Regulatory Oversight Mechanisms for Mobile Health Services
The Clinical Laboratory Improvement Amendments of 1988 (CLIA of 1988)

These amendments brought all clinical laboratories under Federal regulation. Under CLIA of
1988, all clinical laboratories, regardless of site or test volume, must meet several
requirements in order to obtain a certificate, or license to operate.

Prior to this, title 18 of the Social Security Act required that hospitals and independent
laboratories meet certain conditions of coverage in order to receive reimbursement under
Medicare and Medicaid. The CLIA regulated laboratories involved in interstate trade. With
the passage of OBRA 1990, laboratories, including mobile laboratories, must now be certified
under CLIA of 1988.

Each State has its own licensure requirements for clinical laboratories. Some are more
stringent than those required by the Federal Government.

The FDA Device Approval Process

The Medical Device Amendments of 1976 require that all models of medical devices not on
the market by the date of the amendments be reviewed by FDA prior to marketing in one of
two processes: premarket notification (known as 510(k)) or premarket approval. Under
510(k), any device which FDA deems “substantially equivalent” to a device already on the
market is not subject to any special testing by FDA. Only a few devices which are
-life-supporting or sustaining, or which represent a major change in technology, go through the
much longer and more extensive pre-market approval process, where they are tested by FDA
prior to approval.

The FDA Radiation Control Responsibility

The comprehensive Radiation Control for Health and Safety Act was enacted in 1968 to
protect the public from unnecessary exposure to radiation from electronic products.
‘Administration of the law is carried on through the setting and enforcement of performance
standards to limit radiation emissions. The standards apply to products offered for sale or use
in the United States, whether manufactured in this country or elsewhere.

Performance standards are prescribed for radiation-producing electronic products when FDA
determines that Federal regulations are necessary for the protection of the public health and
safety. The standards prescribe maximum allowable radiation levels and other approaches to
control of radiation emissions without specifying design features.


PHS Comment

We concur. PHS’ grant programs for community, migrant, and
rural health centers provide support for mobile health services
as a means of providing critical health care to medically
underserved populations.

QIG Recommendation

The PHS and HCFA should develop priorities and protocols for
regulating various types of mobile health services.

PHS Comment

We concur. However, before developing such protocols, PHS will
review, in concert with HCFA, the available empirical research
data as well as the governing legislative authorities. ~The
protocols will require objective measures for evaluating the
quality of the services provided in a way that is clinically
meaningful. Our experience in evaluating mammography image
quality has demonstrated to us that the development of such
measures is a complex task.

Technical Comments

1. Page 1, Background

We believe that OIG’s characterization that the mobile
health services industry is at an "embryonic stage" is
inaccurate. Mobile x-ray screening has been around for
decades, first with tuberculosis and now with mammography
screening. We suggest that the industry be characterized
as changing and expanding.

2. Page 2, Methodology

The OIG statement that no "... State database exists to
track ..." mobile health service providers is inaccurate.
The statement should be modified to reflect that some
areas of the mobile health service providers (for example,
x-ray facilities) are monitored by the States.

3. Page 4, Screening Section

A statement should be included that non-referred x-ray
examinations are forbidden in most States. The exception
to this rule is mammography screening. We have worked
with the State health departments to eliminate ncen-
referred, mass chest x-ray screening programs for
tuberculosis. We are concerned that it would be a step
backward if the OIG report could be interpreted in any way

B-5


_
——— re

Agency Comments


“health care professionals” who are trained to perform specific types of tests. Two
respondents expressed the opinion that being a nurse, in and of itself, should not authorize a
Person to administer tests, since even a nurse may lack test-specific taining.

. There is no consensus on whether mobile health services are cost-effective.

of people at risk.

Multiphasic providers Say that their services are Cost-effective for both themselves and their
clients because their operations are highly automated, efficient, and serve a high volume of
patients, thus Teducing the cost per patient. They say further that their services reduce the time
lost from work by employees due to testing and prevent the development of major health
problems by identifying them early on.

Hospitals may provide mobile health services at a Profit or not. However, even if a mobile
Service operates at a loss, a hospital may continue to offer it in the hopes that it will encourage
People to use their hospital.

Some respondents think that the sharing or Contracting of expensive mobile health services,
such as MRI or CAT scanners, is cost-effective for Providers. However, one medical
Consultant reported that an MRI delivered in a tractor-trailer Costs more than the $600 average
Price for a scan with a Stationary MRI unit. Thus, even if these types of services are
Cost-effective for the provider in allowing the cost of the equipment to be shared, they may not
necessarily be so for the patient.

In the case of cardiac Catheterization, a change in Medicare reimbursement Procedures may
lead to cost Savings. Freestanding laboratories, some of which may be mobile, can now bill


FINDINGS
lh

Providers Deliver All Kinds Of Health Services In Mobile Settings. The Prevalence Of
Mobile Health Services Is Difficult To Determine.

. Health services as diverse as cholesterol screenings in shopping malls (by far the
most prevalent type of mobile health service), cardiac catheterization and physician
housecalls are being delivered in mobile settings.

Public Screening

Public Screening is the most nationally visible and prevalent type of mobile health service.
By public screening we mean testing that is not requested by a doctor or is performed in a
public setting. It is occurring in all 50 States and the District of Columbia. However, due to
the “here today and gone tomorrow” nature of many public screenings, the number of
screening providers operating in the nation is unknown.

Many screening providers set up in highly trafficked areas such as shopping malls, grocery
stores, pharmacies, and even State Fairs. Such public screenings are often called “health” or
“wellness fairs.” In addition to actual screening tests, such fairs usually involve self-reporting
from participants on their life style in order to develop a health risk appraisal.

Other providers also offer screening tests, usually as part of an array of health services
targeted at a special population such as farm workers, Tunaways or employees. They set up at
locations such as migrant camps, city street comers or industrial sites.

The public screening tests offered in mobile settings are very diverse, ranging from (1) blood
tests to identify high blood cholesterol, diabetes, acquired immunodeficiency syndrome
(AIDS), sickle cell anemia, pregnancy, or liver or kidney dysfunction; (2) x-rays, such as
mammography to detect breast cancer; (3) pulmonary function tests to identify impaired lung
function; and, (4) foot or dental examinations.

The most prevalent type of mobile screening service at this time is public cholesterol
screening, which we describe in detail in another report entitled “Public Cholesterol
Screening.” Mobile mammography screening for breast cancer is also growing in prevalence.
Four respondents reported that their States are, in the words of one, “flooded with
mammography units.” Some respondents believe that mobile mammography screening will
continue to grow.

Diagnostic Services

We also learned of a few providers who conduct a broad array of screening and diagnostic
testing out of specially-equipped trucks or vans. These so-called multiphasic providers are


INTRODUCTION

PURPOSE

This inspection provides a national overview of the types and prevalence of mobile health
services, the quality of these services, and the degree of regulation.

BACKGROUND

This is one in a series of reports on mobile health services. Two other reports describe: (1)
the prevalence, conduct, and regulation of public cholesterol screening; and, (2) and mobile
health care providers that serve medically underserved and uninsured populations in public
settings, or make physician housecalls.

We conducted these studies in response to a request by the Chairman of the House
Subcommittee on Regulation and Business Opportunities. They provide information
concerning mobile health services: services offered outside the traditional settings of a
hospital, clinic, or physician’s office. This report provides a preliminary look at the mobile
health services industry. An in-depth study would require a great deal more research, given
the wide variety of services and providers.

While it is difficult to generalize about an industry that is so diverse, all of the activities
described in this study share one common characteristic: they bring healthcare services to the
people. Public screening, for example, reaches millions in community settings across the
country. Providers using specially equipped vehicles go to employees on the job, visit frail,
chronically ill elderly in their homes, and park at migrant camps, homeless shelters, and rural
crossroads. Large, high-tech equipment, like that used for magnetic resonance imaging
(MRD), is loaded on trailers and shared by hospitals.

Demand for mobile health services is driven by the interaction of public policies, social
trends, the entrepreneurial spirit and technological advances. Federal health promotion
policies have made the public aware of health issues and interested in taking an active role in
their own health care, leading to interest in public screening. Public demands for ease and
convenience at low cost have also fostered the growth of mobile services. Providers are
seeking new ways to provide services in order to recoup revenue lost in part due to Federal
cost containment efforts. Private entrepreneurs show increasing interest in providing health
services traditionally offered by hospitals or clinics. Finally, mobile health services would not
be possible without technological advances that have produced equipment adaptable to use in
mobile settings.

This study reveals that the mobile health services industry is changing and expanding. At
present, public cholesterol screening is the only mobile health service which is both prevalent
and nationally visible. While it is not clear whether or to what extent the industry is growing,


el

TABLE OF CONTENTS

ES

EXECUTIVE SUMMARY
INTRODUCTION ..

PUrpOS ......ss0000 eee

Background......

Methodology ........scsssessseseres scensacersnen sesneasaraes nesarseseesenen: seseeeenesenenees sscersssesesssaeeren 2

FINDINGS...

Providers deliver all kinds of health services in mobile settings. The
prevalence of mobile health services is difficult to determine......... ateteseaneneese 4

Regulation of mobile health services varies widely for some services
and is non-existent for OtNELrs.....sssessereeeeneee

Respondents agree that mobile health services can improve access
to care. However, they raise questions related to the quality and
costs of such services...

RECOMMENDATIONG......... suseseneenesseneen eeeneeneaneneen easenennennenes eacenennanensens sosessecenecsensneasense 14
APPENDIX A.

seeneacee svsssussessernsceueceuconsecuecsonssoessensnsesnessoeessessneetscesecssessnsensceosenes AT

APPENDIX B...



Medicare Part B directly rather than through a hospital outpatient department as in the past.
As reported in Part B News (vol. 3, No. 10, 9/1 1/89), HCFA requires that a lab first get a

said that HCFA had become convinced that freestanding facilities could perform the procedure
just as safely, and at less expense, than inpatient facilities. It noted further: “Rough estimates
put the inpatient cost at about $6,000 and outpatient at $1,700-$2,600 for a left heart
catheterization.”

. It is not clear whether mobile health services are any more prone to fraud and
abuse than traditional health services,

Respondents acknowledge that since mobile providers can set up for only a couple of hours or
days in any one place, they may be “wide open for it (fraud),” yer they question whether
mobile services are any more prone to fraud and abuse than other health services. Few
Tespondents, including those from State consumer fraud agencies, were aware of Specific
cases,

In our discussions with Federal investigators, we did learn of a few cases where fraudulent
Providers have visited sites such as retirement homes, mobile home parks, or health clubs to
conduct screening such as “ultrasound scan and body composition” tests, hearing or


numbers were given, they reflected only those mobile services of which respondents were
aware, not necessarily all those operating in the State in question.


Oate

From

Subject

To

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Heath Service

Memorand:.
MAY = 9 1650

Assistant Secretary for Health

Report, "Mobile Health Services," OE1-05-89-91331
Inspector General, OS

Attached are the comments of the PHS on the subject draft
teport. We are supportive of improved mobite health care
service delivery as part of a total system of health care. Our
gtant-supported State and community health center programs have
effectively used mobile health services, particularly helping
disenfranchised populations. However, we do have concern abou
the wide-range of medical practice situations covered in the
report which do not differentiate between physician-referred
and non-referred screenings.

We concur with the report’s recommendations. However, before
developing the full array of potential priorities and
protocols, we will review the available empirical research daca
as well as the governing legislative authorities since the
protocols will require well-researched and defined measures of
quality of care.

OO: Maton
es 0. Mason, M.D., Dr.P.H.

Attachment

B-3


MOBILE HEALTH SERVICES _

SERVICES.

Oy
* €
*heavesa

OFFICE OF INSPECTOR GENERAL

OFFICE OF EVALUATION AND INSPECTIONS

"4,

sp HEALTH g

JULY 1990



of these innovative types of mobile Services in a separate report entitled “Health Care on
Wheels,”

. Sponsors of mobile health services vary greatly, from hospitals and health
departments, to private entrepreneurs, to civic and professional groups.

Health departments at all levels of Government, from Federal to local, provide mobile health
services to their employees, the public at large, or targeted groups, as a public service,

Hospitals provide services in mobile settings, often as a public service or as a public relations
or marketing strategy, to enhance their public image and increase their visibility. Seven out of
10 respondents from State hospital associations Say that hospitals are offering public screening
also contract out their services on a mobile basis to other entities, such as a nursing home,
skilled nursing facility or even an employer or union.

Hospitals sometimes turn to mobile services as a cost Containment measure, sharing
equipment or Contracting for a service with another entity, often a physician or physician
group practice. They do this either because: (1) the hospital’s utilization needs do not justify
the expense of Purchasing a highly expensive piece of equipment, like a lithotripter; or, (2) the
State has certificate of need (CON) utilization Tequirements that one hospital is unable to

Some respondents believe that as rural hospitals continue to close or limit services, remaining
hospitals will increasingly turn to “Dutting their services in vans and sending them out to

Physicians and independent clinical laboratories are delivering mobile health services to make
a profit. So are private entrepreneurs, both with or without a health care background. One
Tespondent said that private entrepreneurs, showing an “amazing interest in health care,” are
increasingly providing health services traditionally offered by hospitals or physician clinics,
Such as screening, multiphasic testing or MRI. Another remarked, “If it’s profitable, people
will be out there doing it.”

Unions and employers, either independently or under Contract with other entities such as
hospitals or private entrepreneurs, provide mobile health services to their members or
employees. They do so asa company benefit or as a preventive health measure, to comply
with OSHA requirements for mandatory testing for Occupational exposure to environmental


for-profit entities, both private companies and hospital affiliates. The term “mobile” is
particularly appropriate to them, since many have regional or even national service areas.

Multiphasic providers contract with entities such as unions, public and private organizations,
or employers (such as heavy industry, State or Federal governments, professional sports
teams, and even hospitals). They set up anywhere the client needs the service, whether a coal
mine, industrial site or parking lot. Their clients often request such services in order to
comply with OSHA standards, and providers tailor their services accordingly. A typical
“menu” of services may include a patient history, height, weight, vision and hearing tests,
blood pressure, blood tests, urinalysis, electrocardiogram, tonometry (for glaucoma),
spirometry (for lung capacity), and a chest x-ray.

Mobile X-ray and Imaging

Mobile x-ray providers exist in almost all of the States. They most often screen the
homebound or those in nursing homes for tuberculosis. However, some travel to industrial
sites, such as a tire plant, or even gold or uranium mines, to screen employees for lung cancer
or other diseases resulting from exposure to hazardous materials, like asbestos.

Mobile imaging services, specifically mammography and computerized axial tomography
(CAT), which can detect tumors or bleeding in the brain or other body organs, exist in nearly
half of the States. Ultrasound and MRI are other examples of such services. Providers station
trucks, trailers or coaches housing this equipment outside the hospital or clinic requiring these
diagnostic services for their patients.

Other Services

In a few States, more obscure yet innovative diagnostic procedures are also being pertormed
in vehicles, although the potential risks associated with them limits the choice of setting to a
hospital or clinic, where surgical and acute care backup is available. Twenty percent of the
States report having a mobile lithotripter (which uses shock waves to shatter kidney stones)
either operating or based in the State. The equipment is housed in the trailer of an 18-wheel
truck and transported to hospitals or clinics. Cardiac catheterization, where a plastic tube is
inserted into a blood. vessel of the heart, is also being performed on a mobile basis. Only a
few States knew of this type of mobile service. An article in Part B News (vol. 3, No. 10,
9/11/89) estimated that there are less than 100 freestanding cardiac catheterization labs. Some
of these may be mobile. The article projects an expansion in freestanding labs because they
are now allowed to bill HCFA directly rather than through a hospital, as in the past.

Housecalls may be making a comeback in America. Though few in number at this time, some
providers have developed a “roadside manner” by using vans to bring not just the doctor, but
the doctor’s office, to a patient’s home. Also, a few providers are using vans to take an array
of health services to medically underserved and uninsured groups in public settings. Such
services reach people who, for various reasons, have problems accessing care. Respondents
see them as an alternative to no care at all, or to emergency room services. We describe both


some mobile health services appear promising in terms of providing health care in new and
possibly cost-effective ways.

METHODOLOGY

We gathered information for this inspection through an extensive literature review and
telephone discussions with 241 persons. By necessity, most of the information is qualitative
in nature and was gathered from a wide variety of sources. All had some knowledge of a
particular service, but none had a broad perspective on the industry as a whole. Few mobile
health service providers register or are licensed as such, and States monitored only a very few
providers such as x-ray facilities. Hence, locating, much less systematically assessing, these
services is difficult.

The literature reviewed consisted of Federal and State laws, regulations and guidelines,
research papers, studies, reports and newspaper articles. The people we talked with included:

: 119 regulators from all 50 States and the District of Columbia responsible for
oversight of health care services;

. 25 Department of Health and Human Services officials, especially in the Public
Health Service (PHS), including the Food and Drug Administration (FDA) and the
Health Care Financing Administration (HCFA);

° 5 officials from the Occupational Safety and Health Administration (OSHA),
Nuclear Regulatory Commission (NRC), Department of Transportation, and
Environmental Protection Agency;

. 2 persons from the Office of Technology Assessment and the General Accounting
Office;

° 37 persons from 17 professional associations, 10 State hospital associations and 5
State consumer fraud agencies;

. 14 experts with special perspectives on the issue;
° 5 equipment and vehicle manufacturers; and
. 34 providers of mobile health services.

We asked respondents to describe the mobile health services of which they were aware, and
their prevalence. Even State regulators often relied on everything from first hand knowledge,
advertisements and word of mouth, to State licensing or registration of providers or equipment
to answer our questions. Some responses were only guesses or gut reactions. Even when


State Certificate of Need (CON) Programs

The National Health Planning and Resources Development Act of 1974, Public Law 93-641,
and its accompanying regulations, required States to implement CON Program by July 1, 1978
or be subject to the loss of Federal funds for health planning as well as for other purposes.

‘The unnecessary construction or modification of health care facilities and duplication of
health services were found to be substantial factors in the cost of health care. States

facilities and services, and would assist in providing quality health care at the lowest possible
Price.

State CON requirements vary widely, although all programs require that health care facilities
justify to the State the need for purchasing major medical equipment or building new
additions to, or modifying their facilities. The National Health Planning and Resources
Development Act lapsed in 1987. Asa result, CON is slowly being phased out and now exists
in 38 States, which have continued to use it voluntarily, some of them for quality assurance

purposes.
State and Local Regulations

Most health services are regulated in some way by State and/or local governments. This
includes regulation of the certification and licensure of various medical professionals.


as encouraging resumption of general, indiscriminate, non-
referred mass x-ray screening programs.

Page 5, First Paragraph

We believe that the OIG should use "coal mines" instead of
“gold mines" in view of the pneumoconiosis screening, and
the much larger number of coal miners.

Page 6, Fifth Paragraph

We recommend that OIG insert the word “routine” before
“health care needs" in order to differentiate the needs
that are more serious from those that are less serious.

Page 7, Third Paragraph from the bottom

We recommend that OIG delete the phrase, "... often tend
to ..." in the fourth sentence because it does not add any
clarity to the sentence.

Page 7, Last Paragraph

We believe that OIG should change the phrase, *... FDA
oversees x-ray equipment ..." to "... FDA regulates the
manufacture and installation of x-ray equipment ..." to
reflect a more accurate characterization of the Agency's
role.

Page 8, Pirst Paragraph

It would be more accurate to replace "... may contract
-.-" in the next to the last line with °... usually
contracts ..."

Page 8, Third Paragraph

We believe that there are two problems with the words in
parenthesis in the second sentence. First, it implies
that you can be a qualified radiological technologist only
by meeting one of the two criteria in the parenthesis and
this is not true. The majority of the States do not have
regulations to be met by machine operators and there are
no doubt many well-qualified radiological technologists in
those States who have not spent the time and money to take
the voluntary American Registry of Radiological
Technicians’ examination. Second, the words, "State's
equivalent" should be replaced by “are certified (or
credentialed) by the State."

B-6


FINDINGS

Providers Deliver All Kinds Of Health Services In Mobile Settings. The Prevalence Of
Mobile Health Services Is Difficult To Determine.

° Mobile health services are as diverse as public cholesterol screening, cardiac
catheterization, and physician housecalls.

. Sponsors of mobile health services range from hospitals and health departments, to
private entrepreneurs, to civic and professional groups.

Regulation Of Mobile Health Services Varies Widely For Some Services And Is
Non-Existent F or Others.

. Only Kentucky specifically regulates “mobile health services,” as such.

. Most State and Federal regulation varies according to type of service, type of
provider, place of service and/or cost of equipment.

Respondents Agree That Mobile Health Services Can Improve Access To Care. However,
They Raise Questions Related To The Quality And Costs Of Such Services.

. There is concern that mobile testing may be compromised by inadequate quality
assurance programs and ill-trained staff.

. There is no consensus on whether mobile health services are cost-effective.

. It is not clear whether mobile health services are any more prone to fraud and
abuse than traditional health services.

RECOMMENDATIONS

The Public Health Service (PHS) Should Work With The States To Develop A Process For
Identifying Emerging Mobile Health Services And Their Providers.

The PHS And The Health Care Financing Administration (HCFA) Should Develop
Priorities And Protocols For Regulating Various Types Of Mobile Health Services.

AGENCY COMMENTS:
Both PHS and HCFA concur with our recommendations. The HCFA believes that PHS, with

its technical expertise and resources should take the lead. The PHS agrees, but before
developing priorities and protocols will review the available imperial research data and


indiscriminate mammography screening in his State, such as that going on in neighboring
States, saying that once a Provider finds out about thi law, “they don’t want to get involved.”

Major Medical Equipment

Major medical equipment used in mobile settings (i.e., lithotripters, MRI, CAT Scanners and
cardiac catheterization units) is most often regulated through States’ CON process. This
Process requires that facilities such as hospitals justify utilization needs to the State in order to
purchase major medical equipment whose acquisition costs exceed a State pre-determined
dollar amount. (See appendix A for a further description of CON.)

There are gaps in regulation under CON, however. For example, regulation is sporadic
because CON is slowly being phased out and exists in 38 States. Also, one major drawback of

cost of medical equipment often Correspondingly decreases,

Maryland has approached regulation of major medical equipment somewhat differently than
other States. For example, since CON exempts some entities, such as Physician’s offices,
from coverage, the State has attempted to make regulation universal, They have replaced
CON with a licensure Program applicable to all major medical equipment Costing more than
$600,000, whether owned by a hospital or another entity such as a Private physician group or
freestanding clinic. Maryland also attempts to regulate both the quality of use and the growth
of major medical equipment regardless of setting,

Mobile Laboratory Services

On the Federal level, mobile clinical laboratory services, Tegardless of site or volume of
testing, are regulated by the Clinical Laboratory Improvement Amendments of 1988 (CLIA of
1988). The HCFA will now review mobile clinical laboratories for Certification. Prior to
CLIA of 1988, these types of entities were not federally regulated. (Appendix A contains a
description of CLIA of 1988.)


The standards prescribe approaches to control radiation emissions. There are no standards
specific to the use of the equipment in mobile Settings.

Respondents Agree That Mobile Health Services Can Improve Access To Care. However,
They Raise Questions Related To The Quality And Costs Of Such Services.

. According to Tespondents, the greatest benefit of mobile health services is that they
Provide access to health care.

Public screenings provide a convenient way for large numbers of people to undergo
preliminary health risk assessments at a low cost. For many people, it can be a first Step in
seeking medical care.

Mobile health services can either serve to motivate People to see a doctor, or in some cases,
actually be the doctor. Providers who bring services to the homebound, or to the medically
underserved and uninsured in Public settings, target these Populations to bring them into the
health care system. These types of services are described more fully in a separate Teport
entitled “Health Care on Wheels.”

They may replace services lost by closures of small rural hospitals or expand a small
hospital’s diagnostic testing capabilities, since they permit joint ownership or contracted

Services where there is insufficient capital or patient population to justify a permanent

. Respondents are concerned that mobile testing may be compromised by inadequate
quality assurance programs and ill-trained staff.

The major concem of Tespondents in this study has to do with the quality of testing conducted
in mobile Settings. Many States do not monitor mobile operations, raising questions in the
minds of respondents about the safety and accuracy of mobile testing. Some State
Tespondents suspect that mobile Operations lack adequate supervision, that units do not have

affiliated services, they feel that staff of mobile Providers are often inadequately trained. They
Suspect that some for-profit Providers train lay people on-the-job to conduct screenings,
finding it too Costly to hire highly qualified staff and still make a profit.


7

EXECUTIVE SUMMARY

PURPOSE

This inspection provides a national overview of the types and prevalence of mobile health
services, the quality of these services, and the degree of regulation.

BACKGROUND

This is one in a series of reports on mobile health services. Two other reports describe: (1) the
prevalence, conduct, and regulation of public cholesterol screening; and, (2) mobile health
care providers that serve medically underserved and uninsured populations in public settings,
or make physician housecalls.

We conducted these studies in response to a request by the Chairman of the House
Subcommittee on Regulation and Business Opportunities. They provide information
concerning mobile health services: services offered outside the traditional settings of a
hospital, clinic, or physician’s office. This report provides a preliminary look at the mobile
health services industry. An in-depth study would require a great deal more research, given
the wide variety of services and providers.

The services described in this study share one common characteristic: they bring healthcare to
the people. Public screening reaches millions in community settings across the country.
Providers using specially equipped vehicles go to. employees on the job, visit the chronically
ill in their homes, and park at migrant camps, homeless shelters, and rural crossroads. Large,
high-tech equipment is loaded on trailers and shared by hospitals.

This study reveals that the mobile health services industry is changing and expanding. At
present, public cholesterol screening is the only mobile health service which is both prevalent
and nationally visible. While it is not clear whether or to what extent the industry is growing,
some mobile health services appear promising in terms of providing health care in new and
possibly cost-effective ways.

METHODOLOGY

We conducted an extensive literature review and held telephone discussions with 241 persons,
including Federal and State regulators; persons from professional associations, State hospital
associations and State consumer fraud agencies; experts; equipment and vehicle
manufacturers; and providers of mobile health services. Most of the information is qualitative
in nature and was gathered from a wide variety of sources. All had some knowledge of a
particular service but none had a broad perspective on the industry as a whole. Few mobile
health service providers register or are licensed as such, and no national or State database
exists to track them. Hence, locating, much less systematically assessing, these services is
difficult.


COMMENTS OF THE PUBLIC HEALTH SERVICE ON THE OFFICE OF THE
INSPECTOR GENERAL DRAFT REPORT “MOBILE HEALTH SERVICES”

QOEI-05-89-01331, MARCH 1990

General Comments

We are in agreement with the overall intent of this report for
improved health care services through mobile health care
delivery as part of a total system of health care. The State
and community programs we have supported through grants for
disenfranchised populations, such as the homeless, migrants,
and those in rural areas, have used mobile services to meet the
critical health care needs. However, it should be recognized
that mobile health care service, such as screening programs,
must be considered to be part of a total care system, that is,
provided in collaboration with primary and tertiary care
systems to ensure appropriate follow-up and referral for
ongoing specialty care.

We have some concern about the wide range of health care
services that are addressed in the report under the
definitional grouping of "mobile health care services." We
find that the report’s groupings may be potentially confusing
to the medical community, in particular, if the use of mobile
health services for physician-referred, prescription service is
construed to be the same as services for non-referred, mass-
screening purposes. Such distinctions are important to
Physicians because of the degree of validity they place on the
results. We suggest some refocusing of the findings and
recommendations’ section of the report to address the adequacy
of health care by medical practice situation rather than merely
grouping by means of delivery of the services.

We believe that benefits of mobile services should not be
overlooked while focusing on perceived problem areas suggested
by respondents to the study. For instance, the costs of mobile
services may be justified if needy populations are served that
would not be reached by fixed care providers on a regular
basis. However, considerable judgment has to be employed in
the use of mobile health services for screening programs for
diseases such as AIDS because of concerns of patient
confidentiality and adequacy of the testing procedures.

QIG Recommendation
The PHS should work with the States to develop a process for

identifying emerging mobile health services and their
providers.


MOBILE HEALTH SERVICES

Richard P, Kusserow
INSPECTOR GENERAL

OEI-05-89-01331 JULY 1990


10.

ll.

12.

13.

14.

15.

Page 10, Third Paragraph

The second sentence says, "there are no special provisions
for the review of either portable medical devices or
devices used in mobile settings." We believe this
sentence conveys the erroneous implication that there is
something wrong about not having special provisions. We
believe the issue should be the quality of the service
provided not whether the service is mobile. Applying the
same high standards to both situations does not seem to be
appropriate.

Page 10, Last Paragraph

We suggest deleting the words "... maximum allowable
radiation levels and other." This general statement is
inaccurate as written. The fluoroscopy standard does give
maximum levels in the useful radiation beam but the other
standards basically give only maximum allowable leakage
rates. This is too complex to explain simply and a
detailed explanation is not needed in this context.

Page 10, Last Paragraph

We believe the OIG should make it clear that the standards
only apply to the manufacture and installation of
equipment, not to its use.

Page 11, Second Bullet

We recommend that this bullet be changed to reflect that
this concern applies to all mobile services not just
mobile testing.

Page Al - Under the FDA Device Approval Process

We believe the phrase, "... medical devices ...° in the
first line should be replaced with "... models of medical
devices not on the market by the date of the

amendments ..." to improve the accuracy of the statement.

Page Al- Under the FDA Device Approval Process:

We believe that the Radiation Control for Health and
Safety Act should also be mentioned in the Appendix. It
has different and/or additional requirements for radiation
emitting devices.

B-7


Public and private agencies, community health centers and organizations such as the American
Red Cross, the American Hospital Association, and even the American Medical Association
may sponsor or deliver mobile health Services, primarily as a public service.

Civic and professional groups are also sponsoring mobile health services, often as fundraisers.
Insurance companies Provide mobile services to assess the health of people seeking coverage.

Regulation Of Mobile Health Services Varies Widely For Some Services And Is
Non-Existent For Others,

. Kentucky is the only State that Specifically regulates “mobile health services,” as
such.

examination services, mobile treatment services, and any other medical or dental services
Provided through the use of a mobile vehicle or performed at various locations.”

. Most State and Federal regulation varies according to type of service, type of
Provider, place of service and/or cost of equipment.

mandates; (2) protect public health and safety; and, (3) contain costs, The extent of a State’s
Tegulatory oversight is frequently dependent on the funds and staff it has available, or on the
level of legislative interest that can be generated in favor of regulation.

Mobile X-ray and Nuclear Medicine

Mobile x-ray is the most regulated type of mobile health Service, and is regulated by the
Federal Government and, in some form, by all but one State (Wyoming). On the Federal
level, both equipment and providers are subject to some degree of oversight. The type and
extent of State oversight vary widely.

On the Federal level, HCFA certifies portable x-ray providers seeking Medicare
imbursement, The FDA regulates the manufacture and installation of x-ray equipment,
although there are no Special provisions relative to mobile units per se. X-ray equipment


Physician or independent clinical laboratory and, therefore, have to meet the same
requirements as their Stationary counterparts.

Mobile Ultrasound

Mobile ultrasound equipment is Tegulated by only one State (Kentucky), even though other
States have the Statutory authority to Tegulate them. Some State respondents believe that
ultrasound is not regulated either because States lack the money, staff or time to Tegulate, or
because ultrasound has not been demonstrated to be potentially harmful to the patient.

Devices Used in Mobile Settings

° In the Federal arena, FDA approves medical devices for market, but there is no
Special review for devices used in mobile settings, States regulate the use of
medical devices once they are approved for market.

thanks to rapid technological advancement, many devices once used only in hospitals are
increasingly being used in either the home or other non-traditional Settings. (See appendix A
for a description of the device review Process.)

The use of medical devices, once they are approved for marketing, constitutes the practice of
medicine and is Tegulated by States, The FDA imposes no special requirements on the use of
equipment in mobile settings, although it has two special Problem-reporting systems which
are intended to target life-threatening Problems related to the labeling or misuse of a device,
nO matter where used.

The Office of Inspector General is currently Conducting internal Control reviews of FDA’s
device review Processes, as well as conducting an inspection on the subject of problem
medical devices,

. The FDA also is responsible for Protecting the public from unnecessary exposure
to radiation from electronic Products, some of which may be medical in nature.

The Radiation Control for Health and Safety Act of 1968 assigns Tesponsibility to FDA for
Setting and enforcing radiation safety performance standards for electronic Products, that is,
all products or equipment capable of emitting ionizing or non-ionizing radiation, or sonic,
infrasonic, or ultrasonic waves, Such products may be medical--such as diagnostic or cabinet
X-Tay systems, laser Products or ultrasonic therapy equipment--or non-medical, such as
microwave ovens,