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| 2001
Report to Congress on Telemedicine |
Tommy G. Thompson, Secretary
Claude Earl Fox, MD, MPH, Administrator
Department of Health and Human Services
Health Resources and Services Administration
February 2001
The Healthcare Research and Quality Act of
1999, Section 6, requires the Secretary of Health
and Human Services (DHHS) to submit a Report
to Congress on Telemedicine by 2001. Congress
requested that the Report describe barriers
to telemedicine, determine the extent of patient
and physician satisfaction with this mode of
health delivery and assess patient benefits
from telemedicine services.What exactly is meant
by telemedicine and telehealth? In the Department
of Commerce's1997 Report to Congress, "telemedicine"
referred to "the use of electronic communication
and information technologies to provide or support
clinical care at a distance."1
Telehealth is a broader concept. For the purposes
of this Report, telehealth is defined as the
use of electronic information and telecommunications
technologies to support long-distance clinical
health care, patient and professional health-related
education, public health and health administration.
Current Trends
One of the most important trends to emerge
over the past four years is the remarkable growth
and development of the Internet. While much
of this report focuses on telehealth providers
and the barriers they face in expanding the
delivery of telehealth, this is only one part
of the story. The Internet is dramatically changing
the way consumers access health information,
receive diagnostics and purchase pharmaceuticals.
According to the Federal Trade Commission (FTC),
consumer searching for online health information
is increasing dramatically; it is predicted
that 30 million Americans will seek health information
online by 2001.2The
Internet will most likely play a key role in
expanding the reach of telehealth and telemedicine
to the average consumer. However, this potential
also brings other concerns about state jurisdiction
and enforcement, physician and other health
provider cross state licensure, privacy and
safety issues, as discussed throughout the Report
to Congress.
Key Issues
Key issues affecting the telemedicine
and telehealth industry have remained the same
over the past five years but their relative
importance has changed with the advent of dramatic
technology changes such as the wide spread adoption
of the Internet. These issues are:
- Lack of Reimbursement;
- Legal Issues;
- Safety and Standards;
- Privacy, Security and Confidentiality;
- Telecommunications Infrastructure
Lack of Reimbursement remains
a critical barrier to the expansion of telemedicine.
Even though technology has made it easier to
deliver health care services using advanced
communications and computers, historically few
public or private payers have covered them..The
Balanced Budget Act of 1997 (BBA) expanded coverage
options for telemedicine but also included several
requirements that preclude telemedicine's use
under conditions where it is commonly being
used outside of Medicare. The BBA required the
Health Care Financing Administration (HCFA)
to pay for telemedicine consultation services
as of January 1, 1999. Some important reimbursement
eligibility requirements are outlined in Table
1.
TABLE 1: HCFA Telemedicine
Reimbursement Requirements Under the Medicare,
Medicaid and SCHIP Benefits and Improvement
Protection Act of 2000
| Scope |
Eligibility
Requirements |
| Only patients located
in Rural Health Professional Shortage Areas
(HPSAs), counties in Non-MSAs and in approved
Federal demonstration projects are eligible
for telemedicine reimbursement. A list of
shortage areas can be found at http://www.access.gpo.gov. |
| Eligible
CPT Codes |
Eligible Current Procedural
Terminology (CPT) codes include professional
consultations, office visits, and office
psychiatry services (codes 99241-99275;
99201-99215;90804-90809) and any other additional
services specified by the DHHS Secretary. |
| The new law eliminates
the requirement to have a telehealth presenter
present a patient at a consultation unless
it is medically necessary (as determined
by the physician or practitioner at the
distant site) |
| Fee-Sharing |
The new law eliminates
the fee sharing requirement between a consultant
and referring physician. |
| The new Act provides for
reimbursement for store and forward technology
in demonstration projects in Alaska and
Hawaii but no other setting. HCFA's payment
policy was developed to replicate a standard
consultation as closely as possible. Under
Medicare, a separate payment for a consultation
requires a face to face examination of the
patient. This requirement is consistent
with the American Medical Association's
description of a consultation. To that end,
Medicare's teleconsultation rule requires
a certain level of interaction between the
patient and consulting practitioner because
it offers the best substitute for a "face-to-face"
consultation. Regardless of the technology,
the patient must be present during the consultation.
Medicare does not currently make separate
payment for the review and interpretation
of a previous examination, photos or records. |
| Home
Health Care |
The new Act clarifies
that home health agencies "may adopt
telehealth technology that it believes promotes
efficiencies or improves quality of care,
however, these technologies will not be
specifically recognized or reimbursed under
the home health benefit. Telehealth encounters
do not meet the definition of a Medicare
covered home health visit. But this does
not preclude a home health agency from spending
prospective payment dollars to furnish services
outside of the Medicare home health benefit
(i.e. for telehealth services to home health
beneficiaries). If a physician intends that
telehealth serivces be furnished while a
patient is under a home ehalth program of
care, this should be recorded in addition
to the Medicare covered home health services
to be furnished." |
In the first two years, many
telemedicine practitioners have found the requirements
under the BBA mandate too narrow for most practical
purposes. Between January 1, 1999 and September
30, 2000, HCFA had reimbursed 301 claims for
a total of $20,000. Several factors may account
for this small number. In particular, four requirements
greatly limited the number of consultations
eligible for reimbursement:
- Health Professional
Shortage Area (HPSA) Requirement: Medicare
paid for telemedicine services only in areas
that lack adequate primary care services,
even though many rural communities have little
or no access to specialists, such as cardiologists
or psychiatrists. Often the need for specialty
services drives the demand for telemedicine
services.
- Fee sharing requirement:
HCFA mandated fee sharing, requiring specialists
to provide services at a 75% fee that HFCA
then reports as a 100% fee to the IRS. Other
problems included accounting and fee tracking.
Most rural practitioners are not equipped
to track split fees. Finally, the eligible
presenter must either be the referring physician
or an employee of the referring physician.
In many cases, the presenter is an employee
of the local hospital or clinic.
- Eligible Presenters:
Although registered nurses, licensed practical
nurses and other similar types of health care
professionals were the most common presenters
in a telemedicine setting, they are not eligible
for reimbursement.
- Eligible Current Procedural
Terminology Codes: The allowable codes
greatly restricted what services were reimbursable
under the BBA and did not include those commonly
used by telemedicine practitioners.
During its last two sessions,
Congress introduced over nine bills that addressed
some of these limitations. On December 20th,
2000, Congress passed the Medicare, Medicaid
and SCHIP Benefits Improvement and Protection
Act ("the Act"). Among other things,
this Act eliminates the fee-split and telepresenter
requirements and expands the types of presenters,
current procedural terminology codes and geographic
area limits that are eligible for reimbursement.
(
Table 1). Appendix
1 presents a comparison of bills and a summary
of the Act.
Box
1: Medicaid State Coverage
Arkansas, California,
Georgia, Iowa, Illinois, Indiana, Kansas,
Kentucky, Louisiana, Montana, Nebraska,
North Carolina, North Dakota, South Dakota,
Oklahoma, Texas, Utah, Virginia, and West
Virginia.
In addition, Connecticut,
Maine and Minnesota are piloting telemedicine
programs.
Sources:
CTL "Medicaid Telemedicine and Telehealth
Update", July 2000, Health Care Finance
Administration
http://www.hcfa.gov/medicaid/telemed.htm |
Historically, telemedicine
reimbursement expansion has been prevented by
a lack of data on which to judge changes in
government expenditure. The Office for the Advancement
of Telehealth (OAT) worked with the Center for
Telemedicine Law (CTL) and OAT's grantees to
develop a series of cost models that will show
the impact of expanding telemedicine coverage
on any third party payer's expenditures . These
"scoring" models have the advantage
of being based on actual telemedicine experience
in the field. Preliminary results suggest that
many of the modest telemedicine reimbursement
expansions introduced in the 106th Congress
would have a minimal impact on Medicare expenditures.
(For example, CTL/OAT estimates of the budgetary
impact of Senate Bill 2505 range from $50 to
$100 million over five years, as compared to
the estimate of over a billion dollars for legislation
in earlier years.)
Aside from Medicare reimbursement,
20 state Medicaid programs now reimburse for
telemedicine services and three other states
are conducting pilot programs to assess telemedicine
efficacy as shown in Box
1. Some private insurers also provide limited
telemedicine coverage in certain states. For
example, California Blue Cross is currently
funding the build-out of a statewide telemedicine
network. Blue Cross- Blue Shield in Montana
and North Dakota also provides some telemedicine
coverage. Legal Issues, particularly those relating
to cross-state licensure, were thought to be
among the most critical to the expansion of
telemedicine five years ago. Today, traditional
licensure issues remain important, but telemedicine
practitioners have found that they can provide
many in state services. Moreover, consumer use
of the Internet (which knows no borders) for
health related information, purchase of prescription
drugs and online consultations may create new
legal and licensure issues, overshadowing the
more traditional issues. For example, a consumer,
located in state A, sues a health practitioner
in state B, who has provided consultations to
the consumer via a Web site. Who has jurisdiction
in this case? How easily can state A enforce
its state health licensure laws if the health
practitioner is not licensed in state A?
Box 2:
States that Adopted the Compact
Arkansas, Delaware,
Iowa, Maine, Maryland, Mississippi, Nebraska,
North Carolina, South Dakota, Texas, Utah
and Wisconsin. |
Currently, about 26 states
have laws regulating out-of-state telemedicine
practitioners. Twenty-one require full licensure
for an out-of state physician, providing telemedicine
services to a patient located in that state.
The other five states approach licensure in
a variety of ways, such as California's registration
requirement or Hawaii's permit for out-of-state
physician to provide consultation to an in-state
licensed physician. A list of states' licensure
laws is shown in Appendix
2.
While many more states restrict
physician's interstate telemedicine practice,
12 states have adopted the Interstate Nurses
Licensure Compact as shown in Box
2. The compact is a licensure model based
on mutual recognition. Under it, the head of
the nursing licensing board will administer
the Compact for his/her state.
Safety and Standards have
taken on greater importance in the past few
years, not only in the world of telemedicine
but also in the world at large. Without widely
adopted standards and guidelines, interoperability
and interconnection are not possible and the
great potential of telemedicine will be difficult
to achieve. Older equipment often will not interconnect
with newer versions of the same machine. Different
brands of the same equipment will not operate
with one another, making networking across projects
and sometimes within a project expensive and
frustrating.
In addition to technical standards,
there is a need for clinical protocols and guidelines.
Examples of clinical protocols for telemedicine
practice include preliminary scheduling procedures,
actual consult procedures and telemedicine equipment
operation procedures (such as telecommunications
transmission specifications). The clinical technical
standard for image quality in a video transmission
would specify the technical standards needed
by a specialist, such as a dermatologist, to
achieve the high levels of image clarity and
color required to correctly diagnose a patient.
Only a few professional associations have adopted
either clinical practice protocols or technical
standards and guidelines, as shown in Table
2. Additionally, some government agencies
have worked to develop technical guidelines
for telemedicine interoperability.
TABLE 2: Telemedicine Standards
and Guidelines
| Organization |
Standards
and Guidelines |
| Telehomecare
Clinical Guidelines: http://www.atmeda.org/news/guidelines.html.
ATA has also posted a May 1999 working draft
nes, posted at of its Clinical Guidelines
for Telepathology. |
| American
Psychological Association (APA) |
Clinical
Telepsychology guidelines posted on its
Web site at http://www.apa.org/ethics/stmnt01.html
|
| The American
Dermatology Association has drafted proposals
for clinical protocols for teledermatology. |
| American
Nurses Association |
Clinical
Core Principles on Telehealth, March 1998;
Competencies in Telehealth Technologies
in Nursing, March 1999 |
| Digital Imaging
and Communication in Medicine (DICOM) Standards
a uniform set of communication standards. |
| Health
Level Seven |
HL7 Standard
for data exchange |
| Under the
Administrative Simplification provision
of HIPAA, the Act mandates the development
and adoption of national electronic health
transaction standards. |
| Office
for the Advancement of Telehealth |
Practical
technical guidelines based on OAT Grantee
experiences at http://telehealth.hrsa.gov.
These guidelines are a work in progress.
Currently include specifications for teledermatology,
teleopthamology, emergency medical, telecardiology,telerehab.
OAT has also funded a grant to develop a
technical assessment center. |
Just as the wide adoption of
telemedicine standards and protocols plays an
important role in protecting public safety,
the Food and Drug Administration (FDA) and the
Federal Trade Commission (FTC) play a critical
regulatory role. The FDA ensures the safety
and effectiveness of telemedicine medical devices
and software, with the Center for Devices and
Radiological Health (CDRH) as the lead agency.
In oversight of telemammography -- regulating
standards, personnel, practice and procedures
-- the FDA plays an even more critical role.
A number of federal and state
regulatory agencies are working together to
address health-related consumer problems on
the Internet. They include state health authorities,
FDA, the Justice Department and FTC. FTC plays
a key oversight and enforcement role in Internet
Commerce as illustrated in its December 1999
Report: Protecting Consumers Online: A Federal
Trade Commission Report on the First Five Years
of Its Internet Law Enforcement Program.
In this report, the Commission discusses its
activities to combat general consumer fraud
and deception on the Internet. Since 1994, it
has focused on the largest and "most egregious"
fraud and deception examples, taking action
against companies in more than 100 cases.
Privacy, Security and Confidentiality
concerns are not unique to telemedicine. The
U.S. Congress and individual state legislatures
are all but certain to consider a wide range
of privacy-related Internet legislation that
could affect many industries next year. However,
the unique privacy problems associated with
personal patient information, such as HIV status,
cancer or mental health, raise many important
questions about personally identifiable information
and its protection.
An important national privacy
measure that may affect the telemedicine industry
is the Health Insurance Portability and Accountability
Act of 1996 (HIPAA). Under the Administrative
Simplification provision of HIPAA, the Act mandates
the development and adoption of a number of
national electronic health transaction standards,
including standards for electronic data exchange
of health information; standards for the privacy
of individually identifiable health information;
a national provider identifier; an employer
identifier and secure electronic signatures,
among others.
According to the Act, the
Secretary of DHHS must develop final regulations
relating to privacy standards by February 2000,
if Congress has not acted by August 1999. In
1997, the Secretary together with the National
Committee on Vital and Health Statistics (NCVHS),
sent preliminary recommendations to Congress.
In the absence of Congressional action by the
mandated deadline, DHHS published a notice of
proposed rulemaking in November 1999. Final
HIPAA privacy rules were published December
28, 2000 and an DHHS Fact sheet on these rules
can be found in Appendix 7. The complete text
can be found at: http://aspe.hhs.gov/admnsimp.
The general principles, for
the use and disclosure of personally identifiable
health information, are applicable regardless
of the form the information is kept in, the
methods of transmission, the time sequence of
its creation and use, or the way it is communicated.
HIPAA rules cover health plans
(e.g., insurers, managed care organizations,
federal health programs), clearinghouses (which
unify data in standardized formats) and health
care providers ,who use who engage, directly
or through contractual arrangements, in HIPAA
standard electronic transactions.
Potentially the most challenging
issue for telemedicine practitioners will be
DHHS' proposal for federal privacy law to preempt
state law only when states are less stringent.
Thus, if state requirements are in conflict
with federal ones, the rules providing more
stringent privacy protections would prevail.
Telemedicine practitioners could be faced with
a patchwork of state privacy standards.
State laws governing health
information exhibit wide discrepancies in protection,
complexity and coverage as illustrated by a
50-state survey4
of health privacy statutes that can be found
at the Health Privacy Project Web site at: http://www.healthprivacy.org/resources/statereports/exsum.html.
OAT and the Assistant Secretary's
Office of Planning and Evaluation have recently
funded a study and a conference entitled Privacy,
HIPAA and Telemedicine that will be completed
in Spring 2001. The purpose of the study is
to identify privacy issues unique to telemedicine
and to determine how HIPAA privacy rules may
affect telemedicine practitioners and patients.
Although a detailed discussion
of consumer privacy and the Internet is beyond
the scope of this Report, it is of growing concern
to the public. To address this problem, industry
has promoted self-regulatory mechanisms such
as standards for Web sites. The
Health on the Net Foundation (HON) (http://www.hon.ch)
and TRUSTe
(http://www.TRUSTe.org) have developed some
of the most widely accepted standards and "privacy
seals." "Ethical principles"
or "Ecodes" are another alternative.
Two new industry coalitions called the Internet
Healthcare Coalition (http://www.ihealthcoalition.org/ethics/ecode.html)
and the Health Internet Ethics Coalition have
promoted this type of self-regulation.
Despite industry's efforts
to self regulate, agencies, such as the FTC,
have found that industry self-regulation is
not sufficient to protect consumer privacy on
the Internet. In its report entitled, Privacy
Online: Fair Information Practices in the Electronic
Marketplace, May 2000, (http://www.ftc.gov/os/2000/05/index.htm#22)
the FTC offers legislative recommendations to
Congress that would set a basic level of privacy
protection for all visitors to consumer-oriented
commercial Web sites. The legislation would
"require all consumer oriented commercial
Web sites to the extent already covered by the
Children's Online Privacy Protection Act of
1998 (COPPA), to implement the four widely-accepted
fair information practice principles."5
These principles are outlined below.
- Notice: Provide
consumers clear and conspicuous notice of
information practices;
- Choice: Offer consumers
choices as to how their personal identifying
information is used;
- Access: Offer consumers
reasonable access to the information the Web
site has collected about them;
- Security: Take reasonable
steps to protect the security of the information
collected from consumers.
Telecommunications Infrastructure
costs continue to represent a large percentage
of overall costs in a telemedicine project's
monthly budget. To alleviate some of this burden,
the Telecommunications Act of 1996 charged the
FCC to administer the Universal Service program,
which would provide rural health care providers
with a discount on their telecommunication transmission
charges equaling the difference between urban
and rural transmission rates.
In 1997, the FCC established
the Universal Service Administrative Company
(USAC), a separate, not for profit entity, to
oversee both the E-Rate discount for Schools
and Libraries and the Rural Health Care Program
(RHCD). USAC's Rural Health Care Program issued
its first funding commitments on June 25, 1999,
five days before the end of the first 18-month
program year. In total, 483 rural Health Care
Providers received $3.4 million out of a possible
$400 million, which equaled the total requested
support for completed applications received
by USAC that year (January 1, 1998 through June
30, 1999). In the first year, few providers
completed applications for the discount, because
most found they could not benefit from it under
the original program.
Since the first year, the
FCC has adopted a number of reforms to the program,
which streamlines the discount application process,
and addresses practical concerns voiced by practitioners
and others. ( Appendix
5 provides a detailed history of RHCD and OAT's
FCC filing on Universal Service or at http://telehealth.hrsa.gov/pubs.htm).
Funding in the second year of the program, after
reforms were implemented, increased to $6.1
million. Moreover the FCC and USAC expect that
third year funding will increase to nearly $10
million, once all reforms have been in place
for a full year.
Research and Evaluation
Few statistically significant studies of patient/
physician satisfaction or telemedicine cost
savings have been conducted. This dearth of
research may be due to the relatively small
number of telemedicine consultations in any
one specialty and/or to the lack of a standard
evaluation methodology to study either efficacy
or patient/physician satisfaction across small
groups of specialties and projects.
Despite the lack of statistical
significance in most of the studies, all showed
high patient satisfaction with telemedicine
as shown in Table
3. Provider satisfaction was more variable,
but generally moderate to high. Moreover, although
one cannot generalize to all telemedicine applications,
studies of specific services, such as tele-homecare
and tele-dermatology, suggest that at least
for these services, there may be real cost savings
to be realized.
TABLE 3: Patient/Provider
Satisfaction with Telemedicine
| Name
of Report |
No.
of Studies Reviewed by Report |
Patient
Satisfaction |
Physician
Satisfaction |
Strengths/
Weaknesses |
| 30 studies |
Highly satisfied |
Highly satisfied |
Large survey of studies/
small data samples in each study. Studies
only look at one application, such as teledermatology |
| East Carolina
University (2000) |
12 studies plus ECU study
of 492 teleconsults |
Highly satisfied
98.3% rating |
NA |
Large data sample in ECU
study with different applications and different
settings/ small survey of 12 other studies
with small data samples. |
| Study based on 132 network
responses |
Not applicable |
Moderate to Highly Satisfied |
Large survey of users/
only looks at technology and users. |
Emerging
Trends and Policy Issues
Two important trends that may greatly affect
the telehealth industry and raise key policy
issues are rapid technology changes and America's
aging population. Shown below are technology
trends that already exist and will most likely
be common in the near future.
TABLE 4: Overview of Technology Trends
| Tech Trends |
Telehealth
Applications |
Related Policy
Issues |
| Most telehealth transactions
may be done over the next generation Internet
in video, voice, text, still images etc.:
on-line consultations, prescription purchases
and administrative transactions. |
- Retrofitting HIPAA
and other privacy concerns
- Blurring of borders
and scope of practice.
- Security issues
|
| Digitization |
Smart cards, digital medical
libraries, compressed video and images,
imbedded chips. |
- Interoperability
- Information inter-exchange
- Technical standards
|
| Hand held computers,
mobile videophones, and satellite-based
mobile hand-held devices with global access.
Emergency medical applications
such as two-way video consultations.
Wireless monitoring
in the home. Other home wireless equipment
with two way video and peripherals for
blood pressure, heart rate, etc. Biosensors,
data feedback loop. |
- Electromagnetic Interference
- Future spectrum bandwidth
needs.
- Interoperability
across equipment
- Interconnection problems
- Security issues
|
In addition to technological trends, demographic
trends will have an important impact on the health
and telehealth industry. The aging of the Baby
Boomer generation combined with a longer life
expectancy, will most likely mean a large population
of "fragile" and chronically ill elderly
, many those requiring rehabilitation after hospitalization.
Given this demographic trend, according to recent
studies and workshops,6
home care medical devices were the fastest growing
segment of the medical device industry throughout
the 1990s. And with the strong movement toward
home health care, tele-homecare will be an important
associated trend. Providing tele-home care to
the elderly or disabled populations, using telemedicine,
raises important policy questions about health
care access and the reimbursement of telemedicine
services for both rural and urban patients. It
can be argued that urban patients who are very
elderly, chronically ill, poor or disabled may
be as isolated and have as much difficulty getting
access to needed health services as those living
in rural areas. Most of these urban patients cannot
drive to local clinics and many require assistance
getting from point A to point B. Traveling a mile
for such an urban patient may be as onerous as
a rural patient's two hundred-mile drive to see
a specialist. Reimbursement for both rural and
urban patients may be a cost effective policy
decision. Studies show tele-homecare can save
money by decreasing unnecessary hospital and emergency
room admissions. Around the clock monitoring and
nurse availability via videoconferencing has helped
patients better self-diagnose and maintain drug
therapies on schedule. This policy issue may be
resolved at the third party payer level, if cost
savings are sufficiently great enough to attract
the attention of this group.Next Steps
Outlined below are some proposed "next steps"
for the Office for the Advancement of Telehealth
(OAT) and the Joint Working Group on Telemedicine
(JWGT). Payment
- OAT will collaborate
with HCFA, state Medicaid programs, private
third party payers and other relevant organizations
to create a forum in which the telemedicine
experiences of third party payers can be shared.
- OAT will continue
to refine its telemedicine scoring models
for a broad range of telemedicine applications.
Legal Issues
The JWGT will work with various state governmental
and professional groups to assess the feasibility
of developing common licensure application forms,
similar to the common college application form
accepted at a number of universities. Common applications
will reduce time and costs associated with completing
numerous different applications that vary in state
requirements and paperwork. States, in turn, can
more easily develop a comprehensive database of
practitioners and track them across state borders.
Safety and Standards
- OAT will work with its grantees, the American
Telemedicine Association (ATA) and other groups
to expand its clinical and technical guidelines.
(See http://telehealth.hrsa.gov/pubs.htm
for currently completed telemedicine application
guidelines).
- OAT will continue to support the work of
the Advanced Technology Institute, which is
developing a Telehealth Deployment Research
Testbed. This work is being conducted in conjunction
with the Medical University of South Carolina,
West Virginia University Concurrent Engineering
Research Center, Arthur D. Little, Oak Ridge
National Laboratory, the Low country Healthcare
Network and the CPRI-HOST consortium. The
testbed will evaluate the effectiveness and
practical utility of telehealth technologies
by providing both laboratory and "real-world"
evaluations.
- Medical Error reduction: OAT will develop
a series of measures to be included in GPRA
data elements to be collected by all OAT grantees.
Privacy, Security
and Confidentiality
- OAT together with
the Office for the Assistant Secretary of
Policy and Evaluation have funded a research
paper on "Privacy, HIPAA and Telemedicine"
as well as a conference on the same subject.
OAT and OASPE anticipate that the final paper
and conference will be completed by summer
2001 and the results made available to the
public both in print and on OAT's Web site,
shortly thereafter.
Telecommunications
Infrastructure
- OAT recently
filed comments with the FCC on the question
of "possible impediments to deployment
and subscribership in unserved and underserved
areas of the nation." (OAT's
FCC filing on Pacific Basin at http://telehealth.hrsa.gov/pubs.htm.)
Follow-up with the FCC on this issue continues.
- OAT also
filed comments on the FCC's proposal to set
aside spectrum for the use of Wireless Medical
Telemetry (http://telehealth.hrsa.gov/pubs.htm).
OAT's comments also reflected concern about
adequate spectrum for future telemedicine
applications, which may require more bandwidth
than currently allocated for telemetry. This
issue will most likely remain an issue in
the near future.
Research and Evaluation
- OAT will
collaborate with other Agencies within DHHS
as well as work with JWGT members to develop
an evaluation strategy that uses cross-project
evaluation methodologies to obtain more generalizable
findings.
- Future
evaluations should examine provider satisfaction,
quality and cost implications of telemedicine
for specific applications such as tele-homecare,
teledermatology and mental health.
|
| Introduction
top |
Overview
The beginning of the new millennium is a time
to look back from where we have come and to dream
of where we wish to go. For those in health care,
the scientific triumphs of the past, such as the
eradication of polio and small pox or the development
of immunization, point to a future, when closing
the health gap between the "haves and have
nots" in this country and throughout the
world, is possible.
Imagine a world, where no matter who you are
or where you are you get the health care you
need, when you need it. Such a dream could already
be a reality. Technologies such as interactive
videoconferencing, the Internet, store-and-forward
imaging, streaming media, satellite and other
wireless communications networks already exist
and can deliver health services or education
over vast distances. However, these are not
yet part of the landscape for our nation's rural
and urban underserved peoples.
Although these technologies are available, several
barriers, such as the lack of significant reimbursement,
cross-state licensure problems, privacy issues,
lack of universal standards and high transmission
costs, have inhibited the telemedicine and telehealth
industry from reaching its full potential in
the United States.
In addition to these traditional barriers,
the dramatic growth and use of the Internet
by health consumers poses new challenges. Despite
its great benefits, such as a wealth of health
information or fingertip access to prescription
drugs, the Internet has created serious threats
to industry expansion. These include new legal,
safety, privacy and confidentiality concerns
for the telemedicine industry.
The Healthcare Research and Quality Act of
1999, Section 6, requires the Secretary of Health
and Human Services (DHHS) to submit this Report
to Congress on Telemedicine, no later than January
10, 2001. Congress requested the Report describe
barriers to telemedicine, determine the extent
of patient and physician satisfaction with this
mode of health delivery and evaluate the extent
to which patients have benefitted from telemedicine
services.
What exactly is meant by telemedicine and telehealth?
In the Department of Commerce's 1997 Report
to Congress, "telemedicine" referred
to "the use of electronic communication
and information technologies to provide or support
clinical care at a distance."1 Telehealth
is a broader concept than telemedicine. For
the purposes of this Report, it is defined as
the use of electronic information and telecommunications
technologies to support long-distance clinical
health care, patient and professional health-related
education, public health and health administration.
Current Trends
One of the most important trends to emerge over
the past five years is the remarkable growth
and development of the Internet. While much
of this report focuses on telehealth providers
and the barriers they face in expanding the
delivery of telehealth, that is only part of
the story. The Internet is dramatically changing
the way consumers access health information,
receive diagnostics and purchase pharmaceuticals.
It is also conceivable that soon health providers
will move much of their administrative transmissions
onto the Internet. Hence, the Internet may greatly
affect different aspects of telemedicine and
telehealth.
According to the Federal Trade Commission (FTC),
consumer online searches for health information
are increasing dramatically. Thirty million
Americans are expected to seek health information
online by 2001.2
To establish a viable presence on the Internet
the banking, credit card and retail industry,
among others, have found it critical to reassure
their consumers about the protection of personally
identifiable information. Although online shopping,
banking and auction bidding are ubiquitous,
what consumer does not worry about the random
stealing of information by computer hackers?
More insidious is the possibility that entire
identities can be stolen after a person's social
security and other personal information has
been made public on the Internet.
Just as other industries have found the Internet
to be both a market boon and privacy bane, so
the health industry may find that consumers
of health information, prescriptions or other
health services on the Internet, may be vulnerable.
As the Georgetown University Health Privacy
Project notes:
"Although health Web sites now provide
a wide range of clinical and diagnostic information;
opportunities to purchase products and services;
interactions among consumers, patients, and
health care professionals; and the capability
to build a personalized health record, they
have not matured enough to guarantee the quality
of the information, protect consumers from product
fraud or inappropriate prescribing, or guarantee
the privacy of individuals' information."
Structure of the Report
The structure of the Telemedicine Report to
Congress, 2001 is similar to that of the 1997
Report. Chapter III describes the current Medicare
reimbursement rules for telemedicine, as well
as the preliminary outcomes for the first year
of this program. Chapter IV discusses legal
issues affecting the proliferation of telemedicine
and telehealth, including state licensure and
electronic health information issues as well
as other related issues, such as credentials.
Chapter V outlines safety and standards issues,
limited to specific telehealth concerns. Chapter
VI highlights DHHS privacy rules for personally
identifiable health related information that
is electronically stored or transferred. This
chapter also discusses how these proposed rules
may affect telehealth practitioners. Chapter
VII examines the Federal Communications Commission's
(FCC) Universal Service Administrative Company's
(USAC) Rural Health Care Program. This Chapter
also highlights recent FCC reforms that address
some telehealth practitioner concerns that they
consider to be major barriers to applying to
the program. Chapter VIII draws upon previous
research to summarize the current status of
patient and physician satisfaction with telemedicine
and anecdotal examples of telemedicine efficacy.
The final Chapter IX looks at issues that may
emerge over the next few years. Specifically,
Congress requests that DHHS report the following:
The extent to which patients receiving telemedicine
services have benefitted from them and are satisfied
with the treatment received pursuant to the
services;
The extent to which medical outcomes for such
patients would have differed if telemedicine
services had not been available to them;
The extent to which physicians involved with
telemedicine services have been satisfied with
the medical aspects of the services; and
The extent to which primary care physicians
are enhancing their medical knowledge and experience
through the interaction with specialists provided
by telemedicine consultations. |
| Payment
Issues top |
Overview
One of the greatest stumbling blocks to the
expansion of the telehealth industry has been
lack of reimbursement for telemedicine and telehealth
services. Advances in telemedicine technology
have made it easy to deliver health care services
over a distance but few public or private payers
will pay telemedicine costs. Until recently,
Medicare has not had an explicit policy to pay
for telemedicine services. Historically, Medicare
reimbursed some services that did not traditionally
require face-to-face contact between a patient
and practitioner. For example, it covered EKG
or EEG interpretation, teleradiology and telepathology
in most of the nation, depending on individual
Medicare carrier policies. However, the Balanced
Budget Act of 1997 (BBA) brought about a significant
change in Medicare telemedicine reimbursement
policy. As of Jan. 1, 1999, Congress required
the Health Care Financing Administration (HCFA)
to pay for telemedicine consultation services
under the BBA. Some important reimbursement
eligibility requirements are outlined in Table
1 below.
TABLE 1: HCFA Telemedicine
Reimbursement Requirements Under the Medicare,
Medicaid and SCHIP Benefits and Improvement
Protection Act of 2000
| Scope |
Eligibility
Requirements |
| Only patients located
in Rural Health Professional Shortage Areas
(HPSAs), counties in Non-MSAs and in approved
Federal demonstration projects are eligible
for telemedicine reimbursement. A list of
shortage areas can be found at http://www.access.gpo.gov. |
| Eligible
CPT Codes |
Eligible Current Procedural
Terminology (CPT) codes include professional
consultations, office visits, and office
psychiatry services (codes 99241-99275;
99201-99215;90804-90809) and any other additional
services specified by the DHHS Secretary. |
| The new law eliminates
the requirement to have a telehealth presenter
present a patient at a consultation unless
it is medically necessary (as determined
by the physician or practitioner at the
distant site) |
| Fee-Sharing |
The new law eliminates
the fee sharing requirement between a consultant
and referring physician. |
| The new Act provides for
reimbursement for store and forward technology
in demonstration projects in Alaska and
Hawaii but no other setting. HCFA's payment
policy was developed to replicate a standard
consultation as closely as possible. Under
Medicare, a separate payment for a consultation
requires a face to face examination of the
patient. This requirement is consistent
with the American Medical Association's
description of a consultation. To that end,
Medicare's teleconsultation rule requires
a certain level of interaction between the
patient and consulting practitioner because
it offers the best substitute for a "face-to-face"
consultation. Regardless of the technology,
the patient must be present during the consultation.
Medicare does not currently make separate
payment for the review and interpretation
of a previous examination, photos or records. |
| Home
Health Care |
The new Act clarifies
that home health agencies "may adopt
telehealth technology that it believes promotes
efficiencies or improves quality of care,
however, these technologies will not be
specifically recognized or reimbursed under
the home health benefit. Telehealth encounters
do not meet the definition of a Medicare
covered home health visit. But this does
not preclude a home health agency from spending
prospective payment dollars to furnish services
outside of the Medicare home health benefit
(i.e., for telehealth services to home health
beneficiaries). If a physician intends that
telehealth serivces be furnished while a
patient is under a home ehalth program of
care, this should be recorded in addition
to the Medicare covered home health services
to be furnished." |
Medicare Reimbursement-The First Two YearsOver
the first two years of the Medicare telemedicine
reimbursement rule, many telehealth practitioners
have found both the BBA mandates and HCFA's interpretation
of the BBA too narrow for most practical purposes.
On September 30, 2000, after almost two years
of telemedicine reimbursement, Medicare has reimbursed
a total of $20,000 for 301 teleconsultation claims.
Four major issues may have greatly limited the
number of reimbursable telemedicine consultations:
- Health Professional Shortage Area Limitations.
Only patients in Health Professional Shortage
Areas (HPSAs) were eligible for reimbursement
under the BBA. This restriction greatly narrows
the number of people, who might benefit from
telemedicine, and disregards the needs of
many rural patients, who may have access to
a nurse or general practitioner, but not to
specialists such as cardiologists, psychologists,
dermatologists, etc.
- Fee-sharing requirement. Consulting
physicians found fee-sharing problematic because
they receive only 75 percent of normal pay
for their services. Moreover, HFCA reports
consultant payment to the IRS at 100 percent.
Other problems with fee-sharing included accounting
and fee tracking. Most rural practitioners
are not equipped to track split fees. Finally,
perhaps the most important ramification of
the fee-sharing requirement is that, to be
paid, the eligible presenter must either be
the referring physician or an employee of
the referring physician. In many cases, the
presenter is an employee of the local hospital
or clinic.
- Eligible presenters. In many (if
not most) places rural clinics are staffed
only by registered nurses (RNs), licensed
practical nurses (LPNs) or by health technicians,
who were all ineligible presenters under the
Act. In a survey of 20 telehealth networks
representing 4,761 telehealth encounters between
Jan. 1, 1999 and June 30, 1999, the University
of Missouri found that:
- LPNs and RNs make up the majority of
patient presenters in almost all telehealth
networks, but they are not eligible presenters.
- 171 or 3.6% of all encounters involved
a patient interaction with either an occupational,
physical, speech therapist or clinical
psychologist.
- Only 7% of referring practitioners or
employees of the referring practitioner
acted as patient presenters in consultations.
This suggests that if all of the reported
4,761 telehealth activities were Medicare,
less than 7 percent of all cases would
meet HCFA's eligible presenter criteria.
- Eligible Current Procedural Terminology
Codes. Only a handful of CPT codes were
eligible for HCFA telemedicine reimbursement
under BBA. This limitation greatly restricted
the types of services for which practitioners
could be reimbursed. Many services that telemedicine
providers already offer were not included
in these codes.
Legislation
The House and Senate introduced nine bills with
telehealth provisions in the 106th Session to
address the BBA's telemedicine reimbursement limitations
and to allow more Medicare coverage for telemedicine
services. At the end of December 2000, Congress
passed the Medicare, Medicaid and SCHIP Benefits
Improvement and Protection Act of 2000 ("the
Act"), which is effective October 1,2001.Among
other things, Section 223 of the Act, eliminates
the presenter and fee-sharing requirements, expands
eligible locations to include HPSAs and counties
not included in a Metropolitan Statistical Area,
expands the number of CPT codes that are eligible
for Medicare reimbursement and provides full reimbursement
to a specialist for services rendered in a teleconsultation.
Section 503 addresses the use of telehealth in
the delivery of home health services. (See Appendix
1 for language of the Act and a comparison of
the bills) Historically, one of the key challenges
to the passage of any expansion of telemedicine
reimbursement has been the lack of data upon which
to judge its impact on government expenditures.
The Office for the Advancement of Telehealth (OAT)
has worked with the Center for Telemedicine Law
(CTL) and OAT's grantees to develop a series of
cost models that would provide a more accurate
estimate of the impact of expanded coverage on
third party payers. These "scoring"
models have the advantage of being able to use
actual telemedicine experience from the field.
Preliminary results suggest that many of the modest
telemedicine reimbursement expansions introduced
in the 106th Congress would have minimal impact
on Medicare expenditures. (For example, CTL/OAT
estimates of Senate Bill 2505 budgetary impact
range from $50 to $100 million over five years
as compared to an estimate of over a billion dollars
scored for legislation in earlier years.) Other
Payment Coverage
Box 1
Medicaid State Coverage
Arkansas, California, Georgia, Iowa, Illinois,
Indiana, Kansas, Kentucky, Louisiana, Montana,
Nebraska, North Carolina, North Dakota,
South Dakota, Oklahoma, Texas, Utah, Virginia,
and West Virginia. In addition, Connecticut,
Maine and Minnesota are piloting telemedicine
programs.
Sources: CTL "Medicaid Telemedicine
and Telehealth Update", July 2000,
Health Care Finance Administration http://www.hcfa.gov/medicaid/telemed.htm |
In addition to Medicare payments for telemedicine,
20 state Medicaid programs as shown in Box 1 and
several state Blue Cross/Blue Shield plans, as
well as some other private insurers, pay for select
telemedicine services. Several states have recently
passed laws that prohibit insurers from discriminating
between regular medical and telemedicine services'
reimbursement. These states include California,
Texas and Louisiana. Some private insurers also
provide limited telemedicine coverage in certain
states. For example, Blue Cross-Blue Shield in
Montana and North Dakota provides some telemedicine
coverage and Blue Cross of California is going
a step further by developing a statewide telemedicine
network. In July 1999, the Managed Risk Medical
Insurance Board awarded $1.8 million to Blue Cross
California to expand telemedicine capabilities
throughout California. Blue Cross planned to use
the funds to expand services at 17 existing clinics
to serve medically underserved populations and
to provide equipment and support to 22 new telemedicine
sites in 18 counties. Next Steps
- OAT will collaborate with HCFA, state Medicaid
programs, private third party payers and other
relevant organizations to create a forum in
which the experiences of third party payers
with telemedicine can be shared.
- OAT will continue to refine its telemedicine
scoring models for a broad range of telemedicine
applications.
|
| Legal
Issues top |
| Overview
Five years ago, interstate licensure issues
were thought to be among the most critical barriers
to telemedicine. Today, the problem has been
compounded by the growth and consumer use of
the Internet. The Internet has also raised new
legal issues that may grow to overshadow interstate
licensure.
Since the Department of Commerce's 1997 Report
to Congress on Telemedicine was published, the
problem of multiple state licensure requirements
for telemedicine providers has not improved
and in some ways has worsened. Since then, more
states have adopted restrictive laws requiring
out-of-state telemedicine practitioners to obtain
local state medical licenses.
State Medical Licensure and Licensure
Models
Historically, states have had the authority
to regulate activities affecting the health,
safety and welfare of their citizens. Hence,
health professionals in the United States are
licensed at the state level. States define the
process and procedures for granting a health
professional license, renewing a license and
regulating medical practice within the state.
The Federal government does have the authority
to establish national regulations such as those
under Medicare that set specific eligibility
requirements for reimbursement. However, there
is a strong legal presumption against federal
preemption of state licensure laws. Therefore,
unless Congress acts to regulate telemedicine
licensure, the states themselves must decide
to harmonize their standards and laws. Tables
2 and 3 below illustrate generic and specific
licensure models that could be used for multiple
state health licenses.
TABLE
2: General Licensure Models
| Consulting
Exceptions |
With
a consulting exception, a physician who
| | |