Medicare Program; Expanded Coverage for Outpatient Diabetes Self- Management Training Services
Federal RegisterFeb 11, 1999
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
42 CFR Parts 410, 414, 424, 476, and 498
[HCFA-3002-P]
RIN 0938-AI96
Medicare Program; Expanded Coverage for Outpatient Diabetes Self-
Management Training Services
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would provide for uniform coverage of
outpatient diabetes self-management training services. These services
include educational and training services furnished to a beneficiary
with diabetes by an entity deemed to meet certain quality standards
proposed in this rule. The physician or qualified nonphysician
practitioner treating the beneficiary's diabetes would certify that
these services are needed as part of a comprehensive plan of care. It
sets forth proposed payment amounts that have been established in
consultation with appropriate diabetes organizations. It would
implement section 4105 of the Balanced Budget Act of 1997.
COMMENT DATE: Comments will be considered if we receive them at the
appropriate address, as provided below, no later than 5 p.m. on April
12, 1999.
ADDRESSES: Mail written comments (1 original and 3 copies) to the
following address: Health Care Financing Administration, Department of
Health and Human Services, Attention: HCFA-3002-P, PO Box 31850,
Baltimore, MD 21207-8850.
If you prefer, you may deliver your written comments (1 original
and 3 copies) to one of the following addresses:
Room 309-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW.,
Washington, DC 20201, or
Room C5-09-26, 7500 Security Boulevard, Baltimore, MD 21244-1850.
Because of staffing and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. In commenting, please refer
to file code HCFA-3002-P. Comments received timely will be available
for public inspection as they are received, generally beginning
approximately 3 weeks after publication of a document, in Room 309-G of
the Department's offices at 200 Independence Avenue,
[[Page 6828]]
SW., Washington, DC, on Monday through Friday of each week from 8:30
a.m. to 5 p.m. (phone: (202) 690-7890).
FOR FURTHER INFORMATION CONTACT: Claude Mone, (410) 786-5666,
(Conditions for Coverage and Quality Standards); Angela Mason, (410)
786-7452, (Physician Fee Schedule Payments); Joan Brooks, (410) 786-
5526 (Accreditation and Deeming).
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I. Background
A. Diabetes--Background
1. Prevalence and Costs of Diabetes
In 1997, as reported by the Department of Health and Human
Services' Centers for Disease Control and Prevention, (CDC), 15.7
million people in the United States had diabetes, nearly six percent of
the United States population (Morbidity and Mortality Weekly Report
4643, 1014-1018, 1997 Center for Disease Control and Prevention).
Diabetes is the seventh leading cause of death in the United States,
and more than 187,000 persons died from the disease and its related
complications in 1995. The American Diabetes Association estimates that
$98.2 billion was spent in 1997 on diabetes care ($44.1 billion in
costs directly attributable to diabetes and $54.1 billion for indirect
medical costs, such as work loss, disability, and premature death.)
Among Americans aged 65 and older, 4 million persons (9.3 percent
of this group) are estimated to have diabetes. According to the
National Health and Nutrition Examination Survey (NHANES), as many as
18.7 percent of Americans over age 65 are at risk for developing
diabetes. The goals in the management of diabetes are to achieve normal
metabolic control and reduce the risk of micro and macro-vascular
complications. Numerous epidemiologic and interventional studies point
to the necessity of maintaining good glycemic control to reduce the
risk of the complications of diabetes. Despite this knowledge, diabetes
remains the leading cause of blindness, lower extremity amputations,
and kidney disease requiring dialysis. Diabetes and its complications
are primary or secondary factors in an estimated 9 percent of
hospitalizations (Aubert, RE, et al., Diabetes-related hospitalizations
and hospital utilization. In: Diabetes in America. 2nd ed. National
Institutes of Health, National Institute of Diabetes and Digestive and
Kidney Disease, NIH, Pub. No. 95-1468-1995: 553-570). Overall,
beneficiaries with diabetes are hospitalized 1.5 times more often than
beneficiaries without diabetes. Ten percent of these hospitalizations
are a direct result of uncontrolled diabetes, and more than half of
these admissions occur in beneficiaries 65 and older (National Hospital
Discharge Survey, U.S. National Center for Health Statistics, U.S.
Department of Health and Human Services, 1990). In expanding the
Medicare program to include outpatient diabetes self-management
training services, the Congress intended to empower Medicare
beneficiaries with diabetes to better manage and control their
conditions. The Conference Report indicates that the conferees believed
that ``this provision will provide significant Medicare savings over
time due to reduced hospitalizations and complications arising from
diabetes.'' (H.R. Conf. Rep. No. 105-217, at 701 (1997)).
2. Classification of Diabetes
Diabetes mellitus is a disease of metabolism presenting as a
complex group of syndromes that have in common elevated blood glucose
levels. It occurs because the insulin produced by the beta cells of the
pancreas is either absent, insufficient, or not used properly by target
tissues. As a result, the body is unable to metabolize macronutrients
in food in the normal way. Since the body cannot convert glucose into
energy, high levels of glucose remain in the blood and spill into the
urine, eventually resulting in micro-vascular complications (for
example, kidney disease and eye disease) and macro-vascular
complications (for example, stroke and ischemic heart disease).
There are two major types of diabetes that affect the Medicare
population, Type 1 diabetes, previously called insulin dependent
diabetes mellitus, and Type 2 diabetes, previously called non-insulin
dependent diabetes mellitus.
B. Medicare Coverage and Payment Before July 1, 1998
1. Medicare Coverage
Before July 1, 1998, Medicare covered diabetes self-management
training furnished through outpatient hospital-based programs (Coverage
Issues Manual (CIM), HCFA Pub. 6, Section 80-2). Specifically, the CIM
provided coverage of diabetes education if the services were furnished
under a physician's order by the provider's personnel; and under
medical staff supervision to beneficiaries who are registered patients
of that provider. We required that the services be closely linked to
the care and treatment of the individual beneficiary and provided the
beneficiary with essential knowledge that aided in the beneficiary's
active participation in his or her own treatment and the skills that
enabled self-management.
Finally, all services covered by Medicare had to be reasonable and
necessary to treat the beneficiary's diabetes and the referring
physician was responsible for maintaining documentation of the
necessity of the training program. Section 1862(a)(1)(A) of the Act
provides, in pertinent part, that Medicare may pay only for services
that are reasonable and necessary for the diagnosis or treatment of
illness or injury. In developing the Medicare policy on diabetes self-
management, we determined that certain educational services are
consistent with the provisions of section 1862(a)(1)(A) of the Act.
2. Medicare Payment
Since 1994, Medicare payment for diabetes education as a separate
service has been limited to services furnished in
[[Page 6829]]
the hospital outpatient department to the hospital's registered
outpatients. These services have been paid under Medicare Part B on a
reasonable cost basis. In all other Medicare settings, beneficiary
education related to diabetes is treated as an integral part of a
direct service if furnished by a physician or nonphysician practitioner
or furnished as incident to their services and no separate charge was
allowed.
Payment has been made for hospital outpatient diabetes education
programs that, at a minimum, teach the beneficiary diet and exercise
and blood glucose self-monitoring; establish treatment plans for
insulin-dependent beneficiaries; and motivate the beneficiaries to use
skills learned to enable them to manage their diabetes. Payment has
been made for facility costs associated with the provision of both
individual and group education sessions.
C. Recent Legislation
Section 4105(a) of the Balanced Budget Act of 1997 (BBA '97) (Pub.
L. 105-33, enacted on August 5, 1997), provides coverage for outpatient
diabetes self-management training. Under this coverage, training would
include educational and training services furnished in an outpatient
setting (according to frequency standards established by the Secretary)
to a beneficiary with diabetes by a ``certified provider'' that meets
certain quality standards. These services would be covered only if the
physician managing the beneficiary's diabetic condition certifies that
the services are needed under a comprehensive plan of care in order to
provide the beneficiary with the skills and knowledge necessary to help
manage his or her diabetes (including skills related to the self-
administration of injectable drugs). Services would be paid under the
physician fee schedule in amounts established by the Secretary after
consultation with appropriate organizations.
The statute states that a ``certified provider'' is a physician, or
other individual or entity designated by the Secretary, that, in
addition to providing outpatient diabetes self-management training
services, provides other items or services for which payment may be
made under Medicare. Moreover, the statute requires that a physician or
other individual or entity, must meet the quality standards that are
established by the Secretary or meet alternative quality standards
under the statute. A physician or other individual or entity may be
deemed to have met those quality standards by meeting the applicable
standards originally established by the National Diabetes Advisory
Board and subsequently revised by organizations who participated in the
establishment of standards by the Board. Finally, the Secretary may
recognize as a certified provider a physician, individual, or entity
that is recognized by an organization that represents individuals with
diabetes (including Medicare beneficiaries) as meeting standards for
furnishing these services.
The legislation also requires that Medicare payment for outpatient
diabetes self-management training be made to a certified provider under
the physician fee schedule effective July 1, 1998. In addition, it
requires the Secretary to consult with appropriate organizations,
including organizations representing individuals or Medicare
beneficiaries with diabetes in determining a payment amount for
diabetes education and training services under the fee schedule.
Section 1848 of the Act requires that payments under the physician fee
schedule be based on national uniform relative value units (RVUs) based
on the resources used in furnishing a service. Section 1848(c) of the
Act requires that national RVUs be established for physician work,
practice expense, and malpractice expense.
In addition, the law provides expanded coverage for blood glucose
monitors and testing strips for all beneficiaries with diabetes.
(Medicare previously covered these devices and supplies for only
insulin-treated diabetics.) In June of 1998, we announced a national
coverage decision concerning blood glucose monitors and testing strips
in Program Memorandum B98-26-60. This proposed rule addresses only the
coverage of, and payment for, outpatient diabetes self-management
training services, and the quality standards that we would require an
entity approved to furnish training services to meet.
D. Program Instructions
In June of 1998, we issued a program instruction that partially
implemented the outpatient diabetes self-management training benefit
beginning July 1, 1998 (PM AB-98-36). In this program memorandum, we
indicated that outpatient diabetes self-management training services
may be covered under Medicare only if the physician who is managing the
beneficiary's diabetic condition certifies that the services are needed
under a comprehensive plan of care related to the beneficiary's
diabetic condition to ensure therapy compliance or to provide the
beneficiary with necessary skills and knowledge in the management of
his or her disease.
We stated that for initial implementation of this benefit that we
were designating physicians, individuals, or entities that are paid
under the physician fee schedule and meet the National Diabetes
Advisory Board Standards, now called the National Standards for
Diabetes Self-Management Education Programs, recognized by the American
Diabetes Association (ADA) as approved entities. In addition, under our
existing authority, we would continue to pay hospitals that were paid
for diabetes self-management training services before July 1, 1998
under CIM 80-2 until we publish a final rule. Once the final rule is
published, we will cover only outpatient diabetes self-management
training services to those entities that meet the requirements for
coverage as explained in the final rule.
In September of 1998, we issued a program memorandum (PM AB-98-51)
that clarified a number of issues that occurred as a result of our
June, 1998 memorandum. In this program memorandum, we provided
additional information for contractors to facilitate implementation of
this provision. We explained that the two new Physician's Current
Procedural Terminology codes that must be used for billing outpatient
diabetes self-management training.
We also amended the contractor instructions concerning the
Education Recognition Program Certificate necessary in order to pay
claims. This September 1998 memorandum also advised the contractors to
publish a notice to the provider community that these certificates must
be sent in before the approved entity submits the first claim rather
than with the first claim.
We advised that individual training sessions can be provided for a
beneficiary if the beneficiary's physician decides that it is medically
necessary (for example, as indicated by language or physical
challenges, such as severely impaired hearing or sight). Diabetes
training sessions should be billed in 1 hour increments only (that is,
1 hour, 2 hours etc.).
In addition, we restated that a hospital outpatient diabetes self-
management training program that does not have an Education Recognition
Program Certificate that had been paid by Medicare for these services
before July 1, 1998, may continue to be paid on a reasonable cost
basis, without obtaining recognition until the final rule is published.
An approved entity must forward information to its contractor that it
has been paid by the Medicare program for outpatient diabetes self-
management training before July 1, 1998. Upon receipt of this
information,
[[Page 6830]]
the contractor would continue to pay claims for these services. Any new
hospital outpatient diabetes self-management training program must have
an Education Recognition Certificate showing that it meets the required
educational standards.
II. Industry Consultations and Rationale for Policy Changes
As required by statute, we have met individually with
representatives of various groups or organizations active in the field
of diabetes education and training. These organizations or groups
include the ADA, the American Medical Association (AMA), the American
Academy of Family Physicians, the Endocrine Society, the American
Association of Clinical Endocrinologists, the American Association of
Diabetes Educators, the American Dietetic Association, the Health
Industry Manufacturers Association, Merck-Medco, the Diabetes Treatment
Centers of America, American Pharmaceutical Association, the National
Association of Chain Drug Stores, and the National Community Pharmacy
Associations. We have also worked extensively with diabetes experts
from the CDC and the Department of Veterans Affairs. In addition, we
visited a number of diverse hospital-based training programs to obtain
an understanding of the current training programs that are available to
Medicare beneficiaries. In some cases, multiple meetings were held.
Each group was asked to address specific questions that covered all
aspects of this regulation and to provide scientific evidence to
support each of their responses to these questions. These meetings and
the information obtained from them were extremely useful to us. There
was a general sense among the industry that there was not conclusive
evidence and data on several issues involved in this proposed rule. As
a result, the responses of these groups were very diverse and often
conflicting. Thus, writing this proposed rule required sifting through
available evidence and balancing diverse interests and opinions, with
the benefit to the beneficiary, on both an individual and population
level, being the major concern.
Despite the importance of the need for diabetes self-management
education and abundant scientific literature on how to provide diabetes
self-management training, there is no clear consensus on several
issues. These issues include critical questions concerning who should
provide the training (and the specific qualifications necessary, that
is, the proposed requirements for Certified Diabetic Educators), who
should receive this training, and how, when, and where this training
should be provided. We solicit comments on all these issues and
explicitly request any available empirical data describing the impacts
of these or alternative requirements on beneficiary health outcomes.
We believe that all of the consulted parties agree that diabetes
self-management training is an interactive, collaborative process
involving beneficiaries with diabetes, their physician, and their
educators. The educational process should provide the beneficiary with
the knowledge and skills needed to perform self-care, manage crisis,
and make lifestyle changes required to successfully manage the disease.
The goal is to enable the beneficiary to become an active participant
in his or her diabetes care. It involves a four-step process that
includes the following:
(1) Assessment of the beneficiary's educational needs;
(2) Development of an educational plan, based on the individual
goals and needs of the beneficiary;
(3) Educational interventions; and
(4) Evaluation of the beneficiary's success in achieving the
beneficiary's self-management goals.
Effective diabetes self-management training recognizes that the
person with diabetes must be responsible for self-management of his or
her disease, and is based on established principles of learning,
especially the need for interactive skill-based learning as opposed to
only didactic education.
A 1997 GAO report concluded that Medicare beneficiaries with
diabetes are not receiving the quality of care needed to manage their
diabetes (Most Beneficiaries with Diabetes Do Not Receive Recommended
Monitoring Services, GAO/HHS07-48). Following the issuance of the GAO
report, and receiving testimony from clinicians, diabetes experts, and
other studies, the Congress expanded Medicare coverage to include
coverage of monitors and blood glucose test strips, as well as
outpatient self-management education and training for beneficiaries
with diabetes.
While it is important to increase access to diabetes training for
Medicare beneficiaries with diabetes, it is equally important to
maintain a level of quality that is at least equal to the programs
currently reimbursed by Medicare and to be able to evaluate the effect
of these programs. It is through the establishment and maintenance of
quality standards for diabetes training that we would promote desired
outcomes that result in improved health status for beneficiaries with
diabetes.
III. Provisions of the Proposed Rule
A. Diabetes Self-Management Training Services
We are proposing to add a new statutory authority, section 1865(b)
of the Act, to paragraph (a) of Sec. 410.1, ``Basis and scope.''
Section 1865(b) permits us to approve and recognize a national
accreditation organization and its accreditation program for
accrediting an entity to furnish outpatient diabetes self-management
training services.
We are proposing a new subpart H in part 410, ``Outpatient Diabetes
Self-Management Training Services.'' In Sec. 410.140, we are proposing
the following definitions for purposes of this new subpart:
Approved entity means an individual physician or entity accredited
by an approved organization to furnish training services and approved
by HCFA to furnish and receive Medicare payment for the training
services.
Deemed entity means an individual, physician, or entity accredited
by an approved organization, but that has not yet been approved by HCFA
to furnish and receive Medicare payment for the training. Upon being
approved by HCFA to receive Medicare payment for training, HCFA refers
to this entity as an ``approved entity.''
Organization means a national accreditation organization.
Training means outpatient diabetes self-management training.
We are proposing in Sec. 410.141(a) that admission into an
outpatient diabetes self-management training program would be on the
order of the physician (or qualified nonphysician practitioner)
treating the beneficiary's diabetes. To ensure access to these services
in rural areas we would recognize training services ordered by certain
nonphysician practitioners who treat a beneficiary's diabetes and whose
services would be covered under Medicare as physician services if
furnished by a physician. We would require these nonphysician
practitioners to be operating within the scope of the statutory benefit
and their authority under State law, or regulations. Nonphysician
practitioners who generally meet this definition are physician
assistants (section 1861(s)(2)(K)(i) of the Act), nurse practitioners
(section 1861(s)(2)(K)(ii) of the Act), clinical nurse specialists
(section 1861(s)(2)(K)(iii) of the Act), nurse-midwives (section
1861(s)(2)(L) and 1861(gg) of the Act), qualified psychologists
(section 1861(s)(2)(M) of
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the Act), and clinical social workers (section 1861(s)(2)(N) of the
Act). Patient self-referral would not be covered.
B. Conditions for Coverage
We are proposing that outpatient diabetes self-management training
must meet the following conditions (Sec. 410.141(b)).
1. Physician's Order
Following an evaluation of the beneficiary's need for the training,
we would require the physician or qualified nonphysician practitioner
who is treating the beneficiary's diabetes to order the training.
2. Plan of Care
We would require the physician or qualified nonphysician
practitioner to prepare a comprehensive plan of care that describes the
content, number, frequency, and duration of the diabetes self-
management training services. The plan would contain a statement, as
specified by us, and signed by the physician or qualified nonphysician
practitioner who is managing the beneficiary's diabetic condition, that
the services described in the plan of care are needed to ensure therapy
compliance or to provide the beneficiary with the skills and knowledge
to help manage the beneficiary's diabetes. This statement would
identify the beneficiary's specific medical conditions (described in
Sec. 410.141(d)(1)) that the training program should address. We are
proposing that any changes to the plan of care be signed by the
physician or nonphysician practitioner treating the beneficiary. In
addition, the plan of care would be incorporated into the approved
entity's permanent medical record for the beneficiary and be available
to us upon request.
3. Reasonable and Necessary Services
We propose that the outpatient diabetes self-management training
services be reasonable and necessary for the treatment of the
beneficiary's diabetes. Section 1862(a)(1)(A) of the Social Security
Act (the Act) provides that Medicare cover only services that are
reasonable and necessary for the diagnosis or treatment of a
beneficiary's illness or injury. Based on consultation with the
industry, we believe that certain outpatient diabetes self-management
and training programs are consistent with the reasonable and necessary
provisions of section 1862(a)(1)(A) of the Act.
4. Group vs Individual Training Sessions
Except under certain circumstances, we are proposing group training
sessions for all beneficiaries consisting of 2 to 20 individuals (all
of whom need not be Medicare beneficiaries (Sec. 410.141(b)(4)). We
would cover individual training sessions if no group session is
available within 2 months of the physician's order, or if the
beneficiary's physician or qualified nonphysician practitioner
certifies that he or she has special needs resulting from conditions
that would hinder effective participation in a group training session
(for example, severe language or physical challenges, such as impaired
hearing or sight) (Sec. 410.70(c)(3)). Within 2 months of a physician's
order for outpatient diabetes self-management training services, we
would expect that most patients, including those in rural areas, would
be able to attend a group session. However, in situations, for example,
when there is a geographic barrier that hinders a patient from
attending a group session, the regulation would allow for an individual
to have an individual training session.
C. Types and Frequency of Training
1. Initial Training
In Sec. 410.141(c)(1), we propose that Medicare cover up to 10
hours of initial outpatient diabetes self-management training within a
continuous 12-month period for each beneficiary that meets the
conditions described below. In addition, we are proposing that payment
would be only for those sessions attended (not for packages of sessions
unless there is documentation that the beneficiary attended all
sessions (Sec. 414.62(c)).
2. Additional Training
We propose that a beneficiary who receives the initial training
program be eligible for a single follow-up training session of up to
one hour each year. (A group session, unless an individual session is
needed, is based on the same criteria listed above.) The need for the
annual session would be documented by the physician or qualified
nonphysician practitioner ordering the services and identify the
specific medical conditions (described in Sec. 410.141(d)(1)) that the
program must address. The services must be reasonable and necessary.
Documentation of any of the criteria that resulted in the initial
eligibility would make a beneficiary eligible for the follow-up
session. There may be other situations that would qualify a beneficiary
for an annual session, for example, a change in physical functional
status. We would require that these situations also be documented by
the physician or qualified nonphysician practitioner and identified as
the situations that make the session reasonable and necessary.
A physician or qualified nonphysician practitioner certifying and
monitoring the need for diabetes self-management training would bill
for a single evaluation and management code, such as CPT code 99201
(for a new beneficiary when that beneficiary requires a problem focused
history, focused examination, and medical decision making) or CPT code
99212 (for an established beneficiary, due to the complexity of
monitoring and oversight of care furnished by another provider/site in
an offsite setting).
D. Beneficiaries Who May be Covered
1. Medical Conditions
As previously mentioned, the Congress has specifically delegated
authority to the Secretary to determine the times and frequency when
outpatient diabetes self-management training is appropriate. Since many
beneficiaries have longstanding stable diabetes and some beneficiaries
have already attended hospital-based outpatient diabetes self-
management training, we do not believe that it would be medically
reasonable and necessary for all beneficiaries with diabetes to
automatically attend self-management training. Therefore, we are
proposing in Sec. 410.141(d)(1) that any beneficiary who has any one of
the following medical conditions occurring within the 12-month period
before the physician's order for the training would be eligible for
Medicare coverage for training services from an approved entity:
New onset diabetes.
Poor glycemic control as evidenced by a glycosylated
hemoglobin (HbA1C) of 9.5 or more in the 90 days before attending the
training.
A change in treatment regimen from no diabetes medications
to any diabetes medication, or from oral diabetes medication to
insulin.
High risk for complications based on poor glycemic
control; documented acute episodes of severe hypoglycemia or acute
severe hyperglycemia occurring in the past year during which the
beneficiary needed third party assistance for either emergency room
visits or hospitalization.
High risk based on at least one of the following
documented complications:
[[Page 6832]]
+ Lack of feeling in the foot or other foot complications such as
foot ulcer or amputation.
+ Pre-proliferative or proliferative retinopathy or prior laser
treatment of the eye.
+ Kidney complications related to diabetes, such as
macroalbuminuria or elevated creatinine.
We are concerned that all beneficiaries with diabetes have access
to outpatient diabetes self-management training services while
recognizing that certain beneficiaries because of their medical
conditions have caregivers. The Medicare statute, however, provides
benefits only for services related to the beneficiary. Therefore, we
would encourage caregivers to attend the training with the beneficiary
or attend separate training, but Medicare payment would be limited to
the diabetes self-management training for the beneficiary.
2. Other Conditions
Beneficiaries who are inpatients in a hospital, skilled nursing
facility, hospice, or nursing home would not simultaneously be eligible
for services under this benefit. It is the responsibility of the
facility staff at these facilities to provide effective disease
management instruction as part of the basic care and treatment
furnished to the beneficiary while the beneficiary is an inpatient of
that facility.
If outpatient diabetes self-management training services are
furnished in a Federally qualified health center (FQHC) or a rural
health center (RHC) setting by a nonphysician practitioner, the
services would be bundled into the facility rate. Separate payment for
the professional services of nurse practitioners, physician assistants,
and clinical nurse specialists furnished in an RHC or FQHC setting is
not permitted. The professional services of these nonphysician
practitioners are bundled with other facility services when furnished
to patients under the RHC and FQHC benefits. The payment made to the
RHC or the FQHC under the all-inclusive rate specifically accounts for
the services of these nonphysician practitioners furnished in the RHC
or FQHC setting because the facility payment rate reflects the costs of
these services.
E. Approved Entities
The statute requires that physicians, individuals, or entities who
meet certain quality standards may provide outpatient diabetes self-
management services and may be designated by the Secretary as
``certified providers.'' Section 400.202 defines a Medicare
``provider'' as including ``a hospital, a (critical access hospital)
CAH, a skilled nursing facility, a comprehensive outpatient
rehabilitation facility, a home health agency, or a hospice that has in
effect an agreement to participate in Medicare, or a clinic, a
rehabilitation agency or a public health agency * * * '' Medicare also
covers services by suppliers. Suppliers are defined in Sec. 400.202 and
include a physician, or other practitioner, or an entity other than a
provider, that furnishes health care services under Medicare. The new
outpatient diabetes self-management training benefit could be furnished
by a provider or supplier that meets certain quality standards. For
consistency throughout this proposed rule, we use the term ``approved
entity'' to mean those entities that we may approve to furnish
outpatient diabetes self-management training services.
In Sec. 410.141(e), we identify the conditions we would require an
approved entity to meet. In order to be an ``approved entity,'' we
would require the physician, individual, or entity to furnish other
services for which direct Medicare payment may be made. In addition,
the approved entity must comply with the Medicare regulations on the
prohibition on reassignment of Medicare benefits in Secs. 424.73 and
424.80. In summary, these regulations prohibit payment for services to
entities other than the physician, provider, or supplier who furnished
the services unless there is a specific exception that authorizes
reassignment. In some cases, in order for Medicare payment to be
appropriate, there must be specific contractual language. We propose
that in order to be an ``approved entity'' an individual, physician, or
entity must be able to be paid properly under these regulations so that
payment would be consistent with the statutory prohibitions on
reassignment of benefits.
Also, we would require an approved entity to provide us with any
documentation that we may request, including information that is
necessary to pay a claim or to perform a focused post-payment medical
review study. Finally, we would approve an entity to furnish outpatient
diabetes training services if it meets the quality standards prescribed
by us; the National Standards for Diabetes Self-Management Education
Program, previously the NDAB standard; or standards developed by a
national organization that we have approved. In order to show that
these quality standards are met, an approved entity must show proof
that it has been accredited by an approved accreditation organization.
Entities that may meet the quality standards for furnishing
outpatient diabetes training services are hospitals, critical access
hospitals, End Stage Renal Disease facilities, and clinics. Individuals
that may be properly paid for outpatient diabetes education training
services are physicians, clinical nurse specialists, nurse
practitioners, clinical social workers, psychologists, and nurse
midwives. Moreover, a licensed pharmacist that is a Medicare supplier
of durable medical equipment under Sec. 424.57 could qualify as an
``approved entity'' if the individual or entity meets the payment and
quality standards.
Currently, physician assistants (PAs) cannot bill Part B of the
Medicare program directly for their professional services. The PA's
physician supervisor (or a physician designated by the supervising
physician or employer as provided under State law or regulation) is
primarily responsible for the overall direction and management of the
PA's professional activities and for assuring that the services
furnished are medically appropriate for the beneficiary. Medicare
payment for PA services is made only to the PA's employer regardless of
whether the PA is employed as a W-2 employee or whether the PA is an
independent contractor (section 4512 of the BBA '97). We would apply
these same payment rules to outpatient diabetes training services
furnished by PAS.
Dietitians and certified diabetic educators who are in independent
practice would not qualify as an approved entity for the purpose of
receiving payment for outpatient diabetes training services. We
believe, however, that the law and the Conference Report are clear that
only those physicians, individuals, and entities that furnish other
services for which Medicare payment may be made can be an approved
entity. The Conference Agreement specifically states that the Secretary
may designate entities ``who currently are reimbursed by Medicare.''
(H.R. Conf. 105-217, at 701.)
F. HCFA's Process for Approving National Accreditation Organizations
In the past, under section 1865 of the Act, HCFA approved national
accreditation organizations if HCFA found, taken as a whole, the
accreditation of a provider or supplier entity by the national
accreditation organization provided reasonable assurance that the
Medicare health and safety conditions or requirements for that Medicare
provider or supplier type were met. Therefore, in reviewing a
[[Page 6833]]
national accreditation organization's request for approval and
recognition, HCFA looked at the accreditation organization's program as
a whole and determined whether to approve the organization and deem the
provider or supplier entities it accredited to meet the applicable HCFA
conditions or requirements. In 1996, section 1865 of the Act was
amended. HCFA must now determine whether the accreditation of a
provider or supplier entity by the national accreditation organization
provides assurances that the applicable Medicare health and safety
conditions or requirements are met or exceeded. In 1997, Congress
passed deeming requirements for Medicare + Choice organizations that
require the accreditation organization to apply and enforce standards
that are at least as stringent as the HCFA requirements. We believe
that the deeming requirements for Medicare + Choice are a reflection of
Congress' current thinking about the degree to which HCFA holds
accreditation organizations accountable. In reviewing a national
accreditation organization's request for approval and recognition, HCFA
now looks standard-by-standard at the crosswalk between the
accreditation organization's standards and the applicable HCFA
conditions or requirements. HCFA expects to see that each Medicare
condition or requirement, for the provider or supplier that the
accreditation organization accredits, is covered by the accreditation
organization's standards. The accreditation organization's standards do
not have to adopt the exact language of the HCFA requirements. In fact,
the accreditation organization may have requirements that are more
stringent than HCFA's conditions or requirements. After evaluating the
accreditation organization's standards, HCFA looks at the accreditation
organization's processes for assuring that entities meet the
accreditation standards.
The process that we would use to deem compliance for outpatient
diabetes self-management training programs accredited by national
accreditation organizations would be similar to the process used for
deeming compliance with individual provider or supplier requirements
under Part 488, as well as the process for deeming compliance with the
Medicare + Choice quality requirements in part 422, subpart D. The
accreditation organization would apply and enforce either HCFA's
standards, the standards of the NDAB, or a set of standards established
by an organization representing individuals with diabetes and approved
by HCFA as standards that are substantially equivalent to the HCFA
standards.
In determining whether to approve and recognize a national
accreditation organization, we would determine whether the
accreditation organization applies and enforces quality standards that
have been determined by HCFA to be substantially equivalent to the
quality standards in Sec. 410.144 based on a comparison of the
accreditation organization's standards and its crosswalk. We would also
consider whether the accreditation organization meets the requirements
for approved accreditation organizations in Sec. 410.143. We would make
these determinations on the basis of the materials submitted by an
accreditation organization seeking our approval in accordance with
Sec. 410.142. We would, through submittal of appropriate documentation
by the national organization requesting accreditation approval from us,
determine whether the accreditation organization's requirements
concerning the frequency of accreditation, accreditation forms,
guidelines and instructions to evaluators are as rigorous as our
requirements with a similar emphasis on outcomes.
In Sec. 410.142, we propose the conditions a national accreditation
organization would have to meet to be an approved accreditation
organization. We may approve an accreditation organization if the
organization applies and enforces quality standards that have been
determined by HCFA to be substantially equivalent to the quality
standards in Sec. 410.144; is either a nonprofit or not-for-profit
organization with demonstrated experience in representing the interest
of individuals with diabetes; and is neither owned or controlled by any
entity it accredits, nor owns or controls an entity that could be
accredited, as defined at 42 CFR 413.17. Control exists if the
accredited entities have power, directly or indirectly, to
significantly influence or direct the activities or policies of the
accreditation organization. We have included this requirement to
preclude any conflict of interest that could compromise the integrity
of the accreditation process. In addition, we would require the
organization to comply with the application and reapplication
procedures set forth in Sec. 410.142(h)(1), ``Procedures for approval
of accreditation as a basis for deeming compliance.''
1. Required Information and Materials
We are proposing that a national accreditation organization
requesting our approval and recognition of its accreditation program
must furnish to us the information and materials discussed below.
We are proposing the organization may not use more than one set of
quality standards for its outpatient diabetes self-management training
program. In addition, the accreditation organization must inform us of
the quality standards it would use. These standards must include a
detailed comparison (including a crosswalk if the accreditation
organization does not use standards described in Sec. 410.144(a) in
their entirety) between the organization's accreditation requirements
and quality standards and our quality standards.
We are proposing that the organization provide us with detailed
information about its accreditation process, including the frequency of
accreditation, and copies of its accreditation forms, guidelines, and
instructions to evaluators.
We are proposing that the organization also provide: descriptions
of the accreditation review process, the accreditation status decision
making process, procedures used to notify an entity of deficiencies in
its outpatient diabetes self-management training program, procedures to
monitor the correction of those deficiencies, and procedures used to
enforce compliance with accreditation requirements. We are also
proposing the organization provide us with detailed information about
the individuals who perform evaluations for the accreditation
organization, including:
The education and experience requirements for the
individuals who perform evaluations.
The content and frequency of the continuing education
furnished to the individuals who perform evaluations.
The process used to monitor the performance of individuals
who perform evaluations.
The organization's policies and practices with respect to
the participation, in the accreditation process, by an individual who
is professionally or financially affiliated with the entity being
evaluated.
We are proposing that the organization provide us with a
description of the organization's data management and analysis system
with respect to its accreditation activities and decisions, including
the kinds of reports, tables, and other displays generated by that
system. The organization must also provide a description of the
organization's procedures for responding to and investigating
complaints against a
[[Page 6834]]
deemed entity, including policies and procedures regarding coordination
of these activities with appropriate licensing bodies, ombudsmen
programs, and us.
We are proposing that the organization must provide us with a
description of its policies and procedures with respect to the
withholding or removal of accreditation for failure to meet the
accreditation organization's quality standards or requirements, and
other actions the organization takes in response to noncompliance with
its quality standards and requirements. This description must identify
all types (for example, full or partial) and categories (for example,
provisional, conditional, or temporary) of accreditation offered by the
organizations, the duration of each type and category of accreditation
and a statement identifying the types and categories that would serve
as a basis for accreditation if we approve the accreditation
organization. We are also proposing that the organization provide us
with a list of all entities that it has currently accredited to furnish
outpatient diabetes self-management training and the type, category,
and expiration date of the accreditation held by each of them. In
addition, we are proposing that the organization provide us with the
name and address of each person with an ownership or control interest
in the accreditation organization; documentation that demonstrates its
ability to furnish us with electronic data in a format compatible to
ours; and a resource analysis that demonstrates that its staffing,
funding, and other resources are adequate to perform the required
accreditation activities. The organization must acknowledge that, as a
condition for approval and recognition by HCFA, it agrees to comply
with the requirements set forth in Secs. 410.142 through 410.144.
Finally, we are proposing that the national accreditation
organization agrees to provide us with any additional information that
we may request in order to respond to its request for our approval and
recognition of its accreditation program to accredit entities to
furnish outpatient diabetes self-management training services.
2. Onsite Visits
We are proposing that we or our agent may visit the prospective
accreditation organization's offices to verify information in the
organization's application, including, but not limited to, review of
documents, and interviews with the organization's staff.
3. Notice and Comment
Because the approval of a national accreditation organization could
have broad impact upon large numbers of organizations, providers, and
beneficiaries, we are providing notice and comment opportunities. We
would publish a proposed notice in the Federal Register if we consider
approving a national accreditation organization's application for
approval. The proposed notice would specify the basis for granting
approval, a description of how the organization's accreditation program
applies and enforces standards that have been determined by HCFA to be
substantially equivalent to the quality standards for outpatient
diabetes self-management training services set forth at Sec. 410.144.
We would also allow an opportunity for public comment.
We would publish a final notice in the Federal Register if we
approve a national accreditation organization's request. Publication of
the final notice would occur after we have reviewed the public comments
received in response to the proposed notice. The final notice would
specify the effective date of the approval, and the term of approval,
which may not exceed 6 years.
4. Criteria We Would Use to Approve National Accreditation
Organizations
Section 410.142(e) proposes that in deciding to approve and
recognize an organization's accreditation program to accredit entities
to furnish outpatient diabetes self-management training services, we
would consider the following criteria: (1) The organization applies and
enforces quality standards that have been determined by HCFA to be
substantially equivalent to the quality standards set forth at
Sec. 410.144, (2) The organization meets the requirements for approved
organizations in Sec. 410.143, (3) The organization is not owned or
controlled by the entities it accredits, as defined in
Sec. 413.17(b)(2) or (b)(3), respectively, of this chapter and (4) The
accreditation organization does not accredit any entity it owns or
controls.
5. Notice of Our Decision
In Sec. 410.142(f), we propose that we would notify the prospective
accreditation organization in writing of our decision. We would include
the following information in our notice to the affected organization:
(1) We would state whether we have approved or denied the
organization's request, (2) If we deny the request we would provide our
rationale for denial, and (3) We would communicate the procedures the
organization must use for reconsideration and reapplication.
6. Reconsideration of Adverse Decisions
Section 410.142(g) proposes that an accreditation organization that
has received our notice of denial of its request for our approval and
recognition of its accreditation program to accredit entities to
furnish outpatient diabetes self-management training services may
request reconsideration of our decision in accordance with part 488
subpart D.
7. Request for Approval Following Denial
Section 410.142(h) proposes that an accreditation organization that
has received our notice of denial of its request for approval and
recognition of its accreditation program to accredit entities to
furnish outpatient diabetes self-management training services may
submit a new request to us under the following conditions: (1) The
organization has revised its accreditation program to correct the
deficiencies we noted in our denial notice; (2) The organization must
demonstrate through documentation that the quality standards used by
the deemed entities have been determined by HCFA to be substantially
equivalent to the quality standards for outpatient diabetes self-
management training services set forth at Sec. 410.144; and (3) After
compiling this information, the organization must resubmit the
application in its entirety. We are proposing that an accreditation
organization that has requested reconsideration of our denial of its
request for approval and recognition of its accreditation program to
accredit entities to furnish outpatient diabetes self-management
training services may not submit a new request until all administrative
proceedings have been completed.
8. Withdrawal
We are proposing that an organization requesting our approval and
recognition of its accreditation program to accredit entities may
withdraw its application at any time.
9. Reapplying for Accreditation
We are proposing that an accreditation organization must request
continued approval and recognition at least 6 months before the
expiration of our approval and recognition of the accreditation
organization's program.
[[Page 6835]]
G. Requirements for Approved Accreditation Organizations
1. Ongoing Responsibilities of an Approved Accreditation Organization
Section 410.143 proposes the ongoing accreditation organization
responsibilities. These responsibilities parallel those currently
imposed on accreditors by other accreditation and deeming processes
under Medicare. An accreditation organization approved and recognized
by us must undertake the following activities on an ongoing basis. They
must provide to us in writing and on a monthly basis all of the
following information: (1) Copies of all accreditation decisions and
any accreditation-related information that we may require (including
corrective action plans and summaries of our quality standards that are
unmet), (2) A notice of all complaints related to accredited entities,
(3) If the organization takes any remedial action or adverse actions,
within 30 days of taking those actions, (including revocation,
withdrawal, or revision of an entity's accreditation status) against a
deemed entity, information describing the remedial or adverse action
and the circumstances that led to taking the action, (4) A notice of
any proposed changes in its accreditation standards and requirements or
evaluation process. If an organization implements changes without our
approval, we may withdraw our approval and recognition of the
organization's accreditation program.
We are proposing that within 30 days of notification of a change in
our quality standards, the organization submit to us its organization's
plan to alter its quality standards to conform to our revised standards
(including a crosswalk between our revised standards and the
organization's revised standards) within or by the effective date
specified in HCFA's notification of a change in the quality standards.
2. Oversight of Approved National Accreditation Organizations
Section 410.143(b) proposes the specific criteria and procedures
for continuing oversight. We perform oversight activities to ensure
that an approved national accreditation organization and the entities
the national accreditation organization accredits continue to meet our
quality standards. We may contract with an entity to perform these
oversight activities. Oversight consists of equivalency review,
validation review, and onsite observation.
3. Equivalency Review
We compare the national accreditation organization's standards and
its application and enforcement of those standards to our comparable
standards and processes when we impose new requirements or change our
process for approving and recognizing accreditation organizations, an
accreditation organization proposes to adopt new standards or changes
in its accreditation process, or an accreditation organization
reapplies to us for continuation of its approval and recognition by us
of its program to accredit entities to furnish outpatient diabetes
self-management training services.
4. Validation Reviews
We or our agent may conduct an evaluation of an accreditation
organization's own evaluation process, by conducting evaluations of
deemed entities approved by the accreditation organization and
comparing its results to the results of the accreditation
organization's evaluation of the deemed entities. At the conclusion of
the review, we identify any accreditation programs for which validation
evaluation results indicate (1) a 20-percent rate of disparity between
the accreditation organization's evaluation of the deemed entities and
HCFA's (or its agent's) evaluation on standards that do not constitute
immediate jeopardy to patient health and safety if unmet; or (2) any
disparity at all on standards that constitutes immediate jeopardy to
patient health and safety if unmet. Our beneficiary-centered approach
to diabetes self-management training oversight dictates zero tolerance
of accreditation organization failures to identify noncompliance that
expose beneficiaries to such serious risk. At the conclusion of a
validation review, we also identify any accreditation programs for
which validation evaluation results indicate, irrespective of the rate
of disparity, that there are widespread or systematic problems in an
organization's accreditation process such that accreditation no longer
provides assurance that the quality standards described in Sec. 410.144
are met. Accreditation programs identified as noncompliant through
validation review may be subject to withdrawal of our approval.
5. Onsite Inspections
We may conduct an onsite inspection of the accreditation
organization's operations and offices to verify information and assess
the organization's compliance with its own policies and procedures. The
onsite inspection may include, but is not limited to, reviewing
documents, auditing meetings concerning the accreditation process,
evaluating accreditation results or the accreditation status decision
making process, and interviewing the organization's staff.
6. Withdrawal of Our Approval and Recognition
If an equivalency review, validation review, onsite observation, or
our daily experience with the accreditation organization suggest that
an accreditation organization is not meeting the requirements of this
subpart, we give the accreditation organization written notice of its
intent to withdraw approval and recognition of the organization's
accreditation program. We may withdraw our approval of an accreditation
organization at any time if we determine that accreditation by the
organization no longer guarantees that the approved entity meets the
quality standards described in Sec. 410.144, and failure to meet those
standards could jeopardize the health or safety of Medicare
beneficiaries or constitute a significant hazard to the public health;
or the accreditation organization has failed to meet its obligations
for accreditation in Secs. 410.142 through 410.144.
7. Request for Reconsideration
The final provision of this section proposes the process for
reconsideration. An accreditation organization may request a
reconsideration of our decision to withdraw our approval and
recognition of the organization in accordance with subpart D of part
488 of this chapter.
H. Quality Standards for an Approved Entity
A national accreditation organization approved and recognized by us
may accredit an entity to meet one of the following sets of standards:
The quality standards prescribed by us; the National Standards for
Diabetes Self-Management Education Programs, which were originally
established by the National Diabetes Advisory Board (NDAB) and
subsequently revised by organizations who participated in the
establishment of standards by the Board; or a national nonprofit or
not-for-profit organization that represents individuals (including
individuals under Medicare) with diabetes as meeting standards for
furnishing services.
1. Our Standards
The BBA '97 authorized the Secretary to develop her own quality
standards.
[[Page 6836]]
We believe that our proposed standards offer sufficient assurances that
the outpatient diabetes self-management training programs would provide
quality care and the standards are flexible enough to apply in any
health care setting.
In developing our standards, we have been heavily influenced by the
National Standards for Diabetes Self-Management Education Program
standards and agree that the structure necessary to provide quality
diabetes self-management education consists of the human and material
resources and the management systems needed to achieve program and
participant goals. This structure includes the support and commitment
of the organization sponsoring the program.
We are committed to working with affected parties to implement
these proposed standards and to impose a minimum burden to approved
entities. Thus, in developing these proposed standards we have
solicited suggestions from organizations representing ADA Education
recognition programs, other organizations and the States. Many states
have begun to write laws for the establishment of diabetes self-
management education programs. Conversely, there are States that have
not developed laws to incorporate a diabetes self-management program
within their current health systems. Based on the literature in the
area of Diabetes Self-Management Education (Diabetes Care, Volume 18,
Number 1, January 1995) and considering the recommendations of
organizations such as the ADA, the American Association of Clinical
Endocrinologist, the Diabetes Treatment Centers of American and the
American Medical Association, the following are our proposed standards.
Standard (1) Organizational structure: (i) Provides the educational
resources to support the programs offered and the beneficiaries served,
including adequate space, personnel, budget, instructional materials,
confidentiality, privacy, and operational support.
(ii) Defines clearly and documents the organizational
relationships, lines of authority, staffing, job descriptions, and
operational policies.
(iii) Maintains a written policy that affirms education as an
integral component of diabetes care.
(iv) Assesses the service area to define the target population in
order to appropriately allocate personnel and resources.
(2) Environment. Maintains a safe and sanitary environment,
properly constructed, equipped, and maintained to protect the health
and safety of all patients and that meets all applicable fire
protection and life safety codes.
(3) Program staff. (i) Requires a program coordinator who is
responsible for program planning, implementation, and evaluation.
(ii) Requires nonphysician professional staff to obtain 14 hours of
continuing education about diabetes, educational principles, and
behavior change strategies every 2 years.
(4) Team approach. (i) Except as permitted under paragraph
(a)(4)(ii) of this section, furnishes services using a
multidisciplinary instructional staff who are qualified to teach the
training content areas required in paragraph (a)(5) of this section.
The team must include at least a registered dietitian and a Certified
Diabetic Educator (CDE) who have recent didactic and experiential
preparation in diabetes clinical and educational issues.
(ii) If the team includes a registered nurse, an approved entity
may delay implementation of the requirements for a CDE until 3 years
after the effective date of the final rule.
We are proposing in Sec. 410.144(a)(4) that outpatient diabetes
self-management training services must be furnished by a
multidisciplinary team of at least two health care professionals who
have didactic training or experience in diabetes clinical and
educational issues. The team must include at least a registered
dietitian and a CDE. We believe that accessibility to a CDE is
important to persons with diabetes because they like to call their
health care providers with questions about diabetes and any other
health concerns they may have. It is during these kinds of encounters
that the most active level of education and support in the behavior
change process occurs, and where the CDE can be extremely valuable to
the physician in managing patients with diabetes. By addressing the
self-management educational needs of patients with diabetes, the CDE is
able to alleviate the demand for time and attention that such patients
place on their physicians. Recognizing that there may be a shortage of
CDEs, we would delay the implementation of the CDE requirement. We
believe that the general management of the vast majority of patients
with diabetes is being provided by primary care physicians who may not
have a CDE on staff but employ a registered nurse to provide the
training at this time. Thus, we are allowing 3 years for a registered
nurse to substitute for a CDE.
The team members would be employees of an approved entity defined
in Sec. 410.141(e) or capable of reassigning Medicare benefits to the
approved entity.
(5) Training content. Offers training and is capable of meeting the
needs of its patients on the following subjects:
(i) Diabetes overview/pathophysiology of diabetes.
(ii) Nutrition.
(iii) Exercise and activity.
(iv) Diabetes medications (including skills related to the self-
administration of injectable drugs).
(v) Self-monitoring and use of the results.
(vi) Prevention, detection, and treatment of acute complications.
(vii) Prevention, detection, and treatment of chronic
complications.
(viii) Foot, skin, and dental care.
(ix) Behavior change strategies, goal-setting, risk factor
reduction, and problem solving.
(x) Preconception care, pregnancy, and gestational diabetes.
(xi) Relationships among nutrition, exercise, medication, and blood
glucose levels.
(xii) Stress and psychosocial adjustment.
(xiii) Family involvement and social support.
(xiv) Benefits, risks, and management options for improving glucose
control.
(xv) Use of health care systems and community resources.
(6) Training methods. (i) Offers individual and group instruction
for effective diabetes self-management training services.
(ii) Uses instructional methods and materials that are appropriate
for the target population, and participants being served.
(7) Review and plan of care and goals. (i) Reviews each
beneficiary's plan of care.
(ii) Develops and updates an individual assessment, in
collaboration with each beneficiary, that includes relevant medical
history, present health status, health service or resource utilization,
risk factors, diabetes knowledge and skills, cultural influences,
health beliefs and attitudes, health behaviors and goals, support
systems, barriers to learning, and socioeconomic factors. Based on the
assessment, develops, in collaboration with each beneficiary, an
individual education plan. Documents the results, including assessment,
intervention, evaluation and follow-up in the beneficiary's permanent
medical record.
(8) Educational intervention. Offers appropriate and timely
educational intervention based on referral from the beneficiary's
physician or nonphysician practitioner and based on periodic
reassessments of health status,
[[Page 6837]]
knowledge, skills, attitudes, goals, and self-care behaviors.
(9) Performance measurement and quality improvement. Establishes
and maintains a performance measurement and quality improvement program
that meets the following requirements:
(i) Stresses health outcomes (for example, improved beneficiary
diabetic control, beneficiary understanding, or beneficiary compliance)
and provide for the collection, analysis, and reporting of data that
permits measurement of performance outcomes, or other quality
indicators, such as, monitoring for compliance, lost work or school
days, metabolic control, or others.
(ii) Requires an entity to take the following actions:
(A) Evaluate itself on an annual basis as to its effectiveness in
using these measures.
(B) Improve its performance on at least one outcome or quality
indicator each year.
(C) If requested, report to us nationally standardized performance
measures to the extent that they become available in the future and the
Secretary determines they are appropriate.
(D) Meet minimum performance levels on performance measures
described in this paragraph (a)(9) established by us, which are based
on national or local empirical experience and are prospectively
announced to allow sufficient time for compliance.
(10) Peer Review Organization review. Has an agreement with a PRO,
which has a contract with us to perform quality assurance reviews. At a
minimum, the agreement allows the PRO access to beneficiary or group
therapy records and binds an approved entity to comply with corrective
actions or to participate in quality improvement projects that the PRO
determines are necessary.
We understand that there may be certain disincentives to adopt our
standards as a result of these last requirements because the approved
entity may not have access to all of the quality data requested by us.
However, we believe that any responsible outpatient diabetes self-
management training program would want to know how effective their
program is therefore, we do not think that it is unreasonable to
require the approved entity to report certain quality indicators to the
PRO. We are soliciting comments on this approach and whether or not it
appears to be too burdensome for the approved entities.
2. The National Standards for Diabetes Self-Management Education
Programs
The NDAB, in collaboration with other diabetes-related groups,
developed standards in 1983 in response to concerns that the quantity
and quality of diabetes education varied considerably throughout the
United States. It was hoped that the application of uniform standards
would increase the quality, availability, and effectiveness of diabetes
education, as well as accessibility, through third-party payment. The
standards were deliberately designed to be general enough to be
implemented in a variety of settings and to deal largely with the
process of development and maintenance of quality diabetes education
programs. The original standards consisted of 10 components, with each
component divided into elements applicable to the sponsoring
institution or the educational program. Review criteria were developed
as a method to measure a program's achievement of the standards. The
review criteria were extensively pilot tested and found to be feasible,
practical, and appropriately stringent.
Using these criteria, the ADA implemented a process in 1986 to
officially recognize programs that meet the National Standards for
Diabetes Self-Management Education Programs (NSDSMEP). To achieve
recognition, a program must undertake a voluntary extensive self-
evaluation and documentation process for each element of the standards.
Programs that meet these standards are awarded a certificate.
In 1993, the NDAB charged a task force of representatives from the
ADA and other organizations to review the current standards and make
recommendations for retention or revision. The revised National
Standards for Diabetes Self-Management Education Programs define
quality programs in terms of structure, process, and outcomes. Each of
these three program components is subdivided into elements. There are
standards for each of these elements. As mentioned previously in this
preamble, the statute has deemed the National Standards for Diabetes
Self-Management Programs as they appear in Diabetes Care, Volume 21,
Supplement 1, January 1998. If the ADA and other organizations votes by
majority vote to amend or change one of standards in the future, we
reserve the right to approve or disapprove such change as described in
Sec. 410.143, ``Requirements on approved accreditation organization.''
We expect that the ADA would apply to HCFA as an accreditation
organization and would be quickly approved and recognized because the
ADA uses the NSDSMEP. We would require all approved entities that meet
these standards to provide us with a copy of their certification from
the ADA as proof of meeting these standards. This would include a copy
of their proof of renewal at the time they are required to renew their
educational programs with the ADA.
Applying for Education Recognition by the ADA requires the
submission of an application plus a processing fee. Each application
must include demographic data on the participants served, instructor
qualifications, annual program review, the program's curriculum and
educational materials, education records with follow-up evaluations,
and outcomes data. To apply, a program must obtain a copy of the
current ``Meeting the Standards'' manual to understand the review
criteria and must have furnished training since and collected 12 months
of data. At the end of the 12 month data collection period, three
separate copies of the completed application are submitted to the ADA
Education Recognition Program along with the current processing fee.
The completed application is reviewed by an expert panel of
diabetes educators. After official notification of Education
Recognition, the program is sent an Education Recognition Certificate
from the ADA.
We are proposing in Sec. 410.72 that the program may be one that,
at a minimum meets all of the National Standards for Diabetes Self-
Management Education Programs established by the NDAB and revised by a
task force of representatives of diabetes and other organizations and
has a certificate of education recognition awarded by the ADA. The
National Standards for Diabetes Self-Management Education Programs and
ADA review criteria follows:
Standard 1. The sponsoring organization shall have a written policy
that affirms education as an integral component of diabetes care.
Review criterion: 1-1. There is a written statement from the
sponsoring organization to reflect that self-management education is an
integral component of diabetes care.
Standard 2. The sponsoring organization shall identify and provide
the educational resources required to achieve its educational
objectives in terms of its target population. These resources include
adequate space, personnel, budget, and instructional materials.
Review criterion: 2-1. For both individual and group instruction,
resources (including space, staff, budget, and educational materials)
are adequate to support the programs offered and the participants
served.
[[Page 6838]]
Standard 3. The organizational relationships, lines of authority,
staffing, job descriptions, and operational policies shall be clearly
defined and documented.
Review criterion: 3-1. The relationships among the sponsoring
organization and the diabetes program coordinator, staff, and the
advisory committee are clearly defined.
3-2. There is a description of the following for the coordinator
and each instructional staff member:
Role in the program.
Teaching responsibilities.
Other program responsibilities.
Amount of time spent in the program.
3-3. There are written policies approved by the advisory committee
concerning the operation of the program.
Standard 4. The service area shall be assessed in order to define
the target population and determine appropriate allocation of personnel
and resources to serve the educational needs of the target population.
Review criterion. 4-1. The target population is defined
(specifically the potential number to be served, types of diabetes, age
range, language, ethnicity, unique characteristics, and special
educational needs).
Standard 5. A standing advisory committee consisting of a
physician, a nurse educator, a dietitian, an individual with behavioral
science expertise, a consumer, and a community representative, at a
minimum, shall be established to oversee the program.
Review Criteria. 5-1. The advisory committee members specified
above attend at least two meetings a year.
5-2. The health professional members include at least one
physician, one nurse educator, and one registered dietitian, each with
expertise in diabetes.
5-3. The individual with behavioral science expertise is any
professional with academic preparation in the behavioral sciences; for
example, counseling, health behavior, psychology, social work, and
sociology.
5-4. The consumer is any individual with diabetes or the caretaker
thereof.
5-5. The community representative is any individual not employed by
the institution.
5-6. There is a written policy concerning the membership and
responsibilities of the advisory committee.
5-7. There is documentation that the advisory committee is
fulfilling its responsibilities to approve the program plan, recommend
and approve policy, and review the program annually.
Standard 6. The advisory committee shall participate in the annual
planning process, including determination of target audience, program
objectives, participant access mechanisms, instructional methods,
resource requirements (including space, personnel, budget, and
materials), participant follow-up mechanisms, and program evaluation.
Review criterion. 6-1. There is documentation that the advisory
committee approves a written program plan each year that includes the
items specified above.
Standard 7. Professional program staff shall have sufficient time
and resources for lesson planning, instruction, documentation,
evaluation, and follow-up.
Review criterion. 7-1. The instructor's available hours and
resources are adequate to meet the needs of the program and the
participants.
Standard 8. Community resources shall be assessed periodically.
Review criterion. 8-1. There is a list (including name, address,
and telephone number) of community resources within the service area
that serve the target population and their families. This list is
reviewed and updated yearly by the advisory committee.
Standard 9. A coordinator shall be designated who is responsible
for program planning, implementation, and evaluation.
Review Criteria. 9-1. The job description for the program
coordinator includes his/her responsibilities for:
Acting as a liaison between the program staff, the
advisory committee, and the administration of the institution.
Providing and/or coordinating the orientation and
continuing education for the professional program staff.
Participating in the planning and review of the program
each year.
Participating in the preparation of the program budget.
Evaluating program effectiveness.
Serving as the chair or a member of the advisory
committee.
Overseeing the program with on-site supervision.
9-2. The program coordinator is a CDE or has completed at least 24
hours of approved continuing education that includes a combination of
diabetes, educational principles, and behavior strategies.
Standard 10. Health care professionals with recent didactic and
experiential preparation in diabetes clinical and educational issues
shall serve as the program instructors. Certification as a diabetes
educator by the National Certification Board for Diabetes Educators
(NCBDE) is recommended. Multidisciplinary instructional staff who are
collectively qualified to teach the required content areas shall
include at least (1) a registered dietitian and (2) either a registered
nurse or other health professional who is a CDE.
Review criteria. 10-1. Program instructors are professional staff
who routinely teach in the diabetes self-management education program
and include at least (1) a registered dietitian and (2) either a
registered nurse or other health professional who is a CDE.
10-2. Program instructors are health care professionals with a
valid license, registration, or certification and who are CDEs or have
completed at least 16 hours of approved continuing education that
includes a combination of diabetes, educational principles, and
behavioral strategies.
Standard 11. Professional program staff shall obtain education
about diabetes, educational principles, and behavioral change
strategies on a continuing basis.
Review criterion. 11-1. The program coordinator and all instructors
complete at least 6 hours per year of approved continuing education
that includes a combination of diabetes, educational principles, and
behavioral strategies.
Standard 12. Based on the needs of the target population, the
program shall be capable of offering instruction in the following
content areas:
a. Diabetes overview.
b. Stress and psychosocial adjustment.
c. Family involvement and social support.
d. Nutrition.
e. Exercise and activity.
f. Medications.
g. Monitoring and use of results.
h. Relationships among nutrition, exercise, medication, and blood
glucose levels.
i. Prevention, detection, and treatment of acute complications.
j. Prevention, detection, and treatment of chronic complications.
k. Foot, skin, and dental care.
l. Behavior change strategies, goal setting, risk factor reduction,
and problem solving.
m. Benefits, risks, and management options for improving glucose
control.
n. Preconception care, pregnancy, and gestational diabetes.
o. Use of health care systems and community resources.
Review criteria. 12-1. There is a written curriculum that includes
educational objectives, content outline, instructional methods and
materials,
[[Page 6839]]
and the means for evaluating achievement of the objectives for each
content area or session of the program.
12-2. The curriculum is current and includes all 15 content areas
as appropriate for the identified target population.
Standard 13. The program shall use instructional methods and
materials that are appropriate for the target population and the
participants being served.
Review criterion. 13-1. Instructional methods and materials are
appropriate for the target population and participants in terms of
cultural relevance, age, language, reading levels, and special
educational needs.
Standard 14. A system shall be in place to inform the target
population and potential referral sources of the availability and
benefits of the program.
Review criterion. 14-1. The program reviews marketing strategies
for the target population and potential referral sources annually.
Standard 15. The program shall be conveniently and regularly
available.
Review criterion. 15-1. Program utilization, program completion
rate, and waiting periods are assessed yearly.
Standard 16. The program shall be responsive to requests for
information and referrals from consumers, health care professionals,
and health care agencies.
Review criterion. 16-1. There is a procedure for responding to
requests for information and referrals.
Standard 17. An individualized assessment shall be developed and
updated in collaboration with each participant. The assessment shall
include relevant medical history, present health status, health service
or resource utilization, risk factors, diabetes knowledge and skills,
cultural influences, health beliefs and attitudes, health behaviors and
goals, support systems, barriers to learning, and socioeconomic
factors.
Review criterion. 17-1. An initial assessment of the items
specified above is documented in the education record and updated as
needed.
Standard 18. An individualized education plan, based on the
assessment, shall be developed in collaboration with each participant.
Review criterion. 18-1. The participant's pre-program knowledge and
skill level in relation to the fifteen content areas of the National
Standards is assessed. Educational needs are identified with the
participant and documented in the education record.
Standard 19. The participant's educational experience, including
assessment, intervention, evaluation, and follow-up shall be documented
in a permanent medical or education record. There shall be
documentation of collaboration and coordination among program staff and
other providers.
Review criteria. 19-1. The participant's progress through the
program is documented in the educational record and includes:
The initial assessment and education plan as specified
above.
An indication of the content taught, dates of instruction,
and the instructors.
Post-program assessment of the participant's knowledge and
skill level of each of the appropriate content areas of the National
Standards.
Behavioral goals.
A plan for follow-up.
Communication of participant's progress and any follow-up
recommendations to the primary care provider.
Follow-up assessment and any resulting interventions.
19-2. Each program instruction documents his/her own interventions
with the participants.
19-3. Communication and collaboration among program staff are
facilitated by and documented in the education record.
Standard 20. The program shall offer appropriate and timely
educational interventions based on periodic reassessments of health
status, knowledge, skills, attitudes, goals, and self-care behaviors.
Review criteria. 20-1. At least one follow-up assessment of the
items specified above and any interventions are documented in the
education record.
20-2. Participants achievement of behavioral goals is assessed and
documented 1-3 months after goal setting.
Standard 21. The advisory committee shall review program
performance annually, including all components of the annual program
plan and curriculum, and use the information in subsequent planning and
program modification.
Review criteria. 21-1. The advisory committee conducts and
documents the results of an annual review of the program including:
Program objectives.
The curriculum, instructional methods, educational
materials, and community resource list.
Actual audience compared to the target population.
Participant access and follow-up mechanisms.
Program resources (space, personnel, and budget).
Program effectiveness/participant outcomes.
Marketing strategies to the target population and any
potential referral sources.
21-2. The results of the annual review are reflected in the next
annual program plan.
Standard 22. The advisory committee shall annually review and
evaluate predetermined outcomes for program participants.
Review criteria. 22-1. Participants' outcomes are measured and
evaluated, specifically, the degree to which the participants achieve
their behavioral goals and one other outcome measure (for example,
monitoring for complications, lost work or school days, metabolic
control, or others).
22-2. The program's effectiveness at improving outcomes among
participants is evaluated by the advisory committee and the results of
this evaluation are reflected in the next annual program plan.
3. Standards of an Organization That Represents Individuals With
Diabetes.
We propose that an organization may apply to us for approval of its
standards so that we can recognize it as an ``organization that
represents individuals with diabetes.'' Upon our approval, and
recognition, the organization may deem that a physician, individual, or
entity has met the quality standards for a deemed entity. We would
review and consider applications for approval and recognition only from
organizations that represent individuals with diabetes including
Medicare beneficiaries. Given the Congress' interest in ensuring the
well-being of Medicare beneficiaries with diabetes, we do not believe
that Congress intended that anyone with frivolous criteria could apply
to us for recognition as an accrediting organization. In fact, we
believe that these other organizations would have comprehensive bona
fide quality standards and be organizations that are either non-profit
or not-for-profit with demonstrated experience in representing the
interest of individuals with diabetes. This could include, 501(c)(3)
organizations, existing accrediting organizations, or professional
organizations that do not have a proprietary or financial interest with
the entities they would be accrediting. It is our intention to be able
to approve organizations as ``organizations that represent individuals
with diabetes'' upon the effective date of the final rule. Therefore,
we would begin accepting applications from organizations. Applications
should be mailed to the following address: Office of Clinical Standards
and Quality, Room S3-02-01,
[[Page 6840]]
Health Care Financing Administration, 7500 Security Blvd., Baltimore,
MD 21244.
I. Requirements for Deemed Entities
Section 1865 gives us the authority to deem that any provider
entity meets certain requirements if the entity is accredited and
periodically reaccredited by a national organization. The process that
must ensure that the entity, as a condition of accreditation, meets
standards that are at least as stringent as our applicable standards.
Section 410.145(a) specifies the conditions under which an approved
entity may be deemed to meet the quality requirements. The first
requirement is that the approved entity have submitted necessary
documentation and be fully accredited (and periodically reaccredited)
by a national accreditation organization approved by us. Only full
accreditation offers us adequate assurance that the approved entity
meets the quality standards. Entities that are conditionally or
provisionally accredited (or the equivalent thereof) by their
accreditation organization do not meet all of their accreditation
organization's standards, and for this reason, would not be deemed to
meet quality standards in Sec. 410.144.
The second requirement is that the entity may not be accredited by
an organization that owns or controls the entity. We believe this
requirement is necessary to prevent a conflict of interest.
1. Effective Date for Deemed Entities
Section 410.145(b) establishes when deemed status is effective.
Deemed status is effective on the later of the following dates: the
date on which the accreditation organization is approved by us, or the
date that the accreditation organization deems the entity to meet the
HCFA quality standards described in Sec. 410.144. Medicare payment may
not be made to an entity before the entity meets all of the
requirements to be approved by us under Sec. 410.141(e). Medicare
payment would be made only for those services that are furnished after
the date we approve the entity to furnish services (Sec. 424.44(d)).
2. Requirements for Deemed Entities
Section 410.145(c) establishes the obligations of deemed entities.
We are proposing that as a requirement for deemed status, an entity
must, before submitting a claim for Medicare payment, forward a copy of
its certificate or proof of accreditation from its accreditation
organization indicating that the entity meets the quality standards
described in Sec. 410.144. In addition, an entity deemed to meet
Medicare standards must submit to evaluations to validate its
accreditation organization's accreditation process, and authorize its
accreditation organization to release to us a copy of its most current
accreditation evaluation, together with any information related to the
evaluation that we may require (including corrective action plans.)
These two activities are part of our ongoing oversight strategy for
ensuring that the accreditation organization applies and enforces its
accreditation standards in a manner comparable to ours.
3. Removal of deemed status.
Section 410.145(d) addresses removal of deemed status. We would
remove an entity's deemed status if: (1) We determine, on the basis of
our own evaluation or the results of the accreditation evaluation, that
the entity does not meet the quality standards for outpatient diabetes
self-management training; (2) we withdraw our approval of the
accreditation organization that deemed the entity to furnish outpatient
diabetes self-management training; however, the removal of the entity's
deemed status would not occur until 60 days after the accreditation
organization is no longer recognized or (3) the entity fails to meet
the requirements for deemed entities in Sec. 410.145(c).
If we remove recognition of an accreditation organization because
of its failure to meet our requirements, those entities who have deemed
status with that accreditation organization would have up to 60 days to
become accredited by another accreditation organization approved by us.
The final paragraph in Sec. 410.145(d)(3) states that we can remove
deemed status if the entity fails to meet the requirements in
Sec. 410.145(c). We retain the authority to initiate enforcement action
against any entity that it determines, on the basis of its own
evaluation or the results of the accreditation evaluation, no longer
meets the Medicare standards for which deemed status was granted. We
expect the accreditation organization to have a system in place for
enforcing compliance with its standards, perhaps sanctions for
motivating correction of deficiencies, but we cannot delegate to the
accreditation organization the authority to terminate the entity's
approval.
J. Outpatient Diabetes Self-Management Training Payment Methodology
1. Proposed Method of Payment
a. Consultation With Industry
In keeping with the requirements of the BBA '97, we have consulted
individually with the same groups and organizations mentioned
previously to establish payment amounts for outpatient diabetes self-
management training services that would be paid under the physician fee
schedule. The consensus among the industry is that cost data on
providing diabetes training is inadequate. We consulted with the ADA to
provide us with guidance in assessing the types of resource inputs that
a typical diabetes training program would use in order for us to price
diabetes services.
b. Calculation of proposed RVUs
We do not expect to establish physician work RVUs for diabetes
outpatient self-management training services, because we believe
diabetes training can appropriately be performed by individuals other
than a physician. We would establish, however, practice expense and
malpractice expense RVUs for these services. Our plans for the future
are to develop the practice expense RVUs for diabetes training in a
manner consistent with the resource-based practice expense methodology
used for all other services paid under the physician fee schedule. The
development of resource-based practice expense RVUs is the subject of a
separate proposed rule (HCFA-1006-P) published in the Federal Register
on June 5, 1998 (63 FR 30818). Malpractice RVUs for diabetes training
have been extrapolated based on analogous procedures.
2. Costs Included in Developing Payment
The direct costs attributed to the provision of this service are
the costs of an hourly professional salary (for example, registered
nurse, registered dietitian, or certified diabetes educator),
counseling materials, special equipment, administrative costs of
billing, record maintenance, and the scheduling of patients. Indirect
costs include the cost of office equipment and supplies, continuing
training, accounting, office rent, utilities, and similar costs.
3. Determining Resource Inputs
Section 1848 of the Act requires that payments under the physician
fee schedule be based on national uniform RVUs based on the resources
used in furnishing a service. The resource
[[Page 6841]]
inputs that we would use to determine the practice expense RVUs for
this service would be based on the estimated cost for furnishing an
hourly training session by the ADA. In order to be consistent with
national RVUs under the physician fee schedule, we would adjust the
hourly professional salary, change the physician component to a
professional salary rate, disallow for appointment cancellations,
increase the scheduling secretary's salary, and adjust the allowance
for billing costs and telephone calls. We would recognize the legal
fees for malpractice insurance as part of the separate malpractice RVU.
The following shows the estimated cost determination worksheet provided
to us by the ADA along with our adjustments to the cost estimates in
order to make the ADA's estimated costs consistent with the national
physician fee schedule.
Table 1.--Diabetes Self-Management Training Resource Costs Provided by the American Diabetes Association (ADA) and HCFA's Adjustments Used to Determine
Proposed Payment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Services (data provided by ADA estimated HCFA adjustments HCFA adjusted costs
ADA) costs individual/group HCFA RVUs individual/group individual/group AMA category
--------------------------------------------------------------------------------------------------------------------------------------------------------
DIRECT COSTS
Professional Salary/Hour (RN $24.00........ .......................... .......................... .................... ...........................
or RD).
Benefits/hour (28% salary)... 6.72.......... $25.32=National .......................... .................... ...........................
Professional Rate
----------------------------------------------------------------------------------------------
Total.................... 30.72......... 25.32/2.53*............... 0.69/0.07................. $25.32/2.53*........ Clinical.
Physician Component 3/min......... .......................... .......................... .................... ...........................
(Oversight).
----------------------------------------------------------------------------------------------
Total.................... 6.00.......... 0.84/0.84................. 0.02/0.02................. 0.84/0.84........... Clinical.
Counseling Materials:
Printed Videos, Strips, 5.00.......... .......................... .......................... 5.00/5.00........... Medical supplies.
Medical Supplies.
Special Equipment:
Computer Software ($6,000 0.96.......... .......................... .......................... 0.96/0.96........... Office supplies.
over 3 years).
Calculators, Scales, 0.25.......... .......................... .......................... 0.25/0.25........... Medical supplies.
Gloves.
Reference Materials 0.25.......... .......................... .......................... 0.25/0.25........... Other.
(Journals, Books, etc.)
($500/year).
Costs of Operation:
Billing Insurance Forms/ 6.40.......... .......................... .......................... 2.13/2.13**......... Clerical.
Follow-Up (8% of cost).
Record Maintenance 3.00.......... .......................... .......................... 3.00/3.00........... Clerical.
(charts, files).
Scheduling Patients (10 2.00.......... 2.15 is National 0.06/0.06................. 2.15/2.15........... Clerical.
min. x $12). scheduling secretary rate.
Reports to Referral 4.32.......... .......................... .......................... 4.32/4.32........... Clerical.
Source.
No shows................. 3.00.......... 0.00...................... Not allowed cost.......... 0.00/0.00........... ...........................
Phone Calls (one 15- 7.50.......... .......................... .......................... 3.75/3.75***........ Office.
minute call/visit 30/
hour.
---------------- --------------------------------------------------
Total................ 32.68......... .......................... 0.59/0.59................. 21.81/21.81......... ...........................
Total Direct Costs... 69.40......... .......................... .......................... 47.97/25.18......... ...........................
INDIRECT COSTS
Rent......................... 2.25.......... .......................... .......................... 2.25/2.25........... Office.
Utilities.................... 1.40.......... .......................... .......................... 1.40/1.40........... Office.
Office Supplies & Equipment.. 1.73.......... .......................... .......................... 1.73/1.73........... Office.
Telephone ($125/m/173.3 wk. 0.72.......... .......................... .......................... 0.72/0.72........... Office.
Hrs. Mo.).
Continuing Education......... 0.72.......... .......................... .......................... 0.72/0.72........... Other.
Accounting................... 0.25.......... .......................... .......................... 0.25/0.25........... Other.
Total Indirect Costs..... 7.07.......... .......................... 0.19/0.19................. 7.07/7.07........... ...........................
---------------- --------------------------------------------------
Legal Fees=Total 0.20.......... 0.37...................... 0.01/0.01................. 0.37/0.37........... Malpractice Expense.
Malpractice RVU.
---------------- --------------------------------------------------
Total Individual/Group 76.67......... .......................... 1.51/0.89................. 55.41/32.62*........ ...........................
Costs.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Based on an average of 10 members in a group, since a group is defined as 2 to 20 individuals.
** Based on the average of three billings during an individual and group session.
*** Based on a 50% telephone contact to beneficiaries during individual and group sessions.
4. Payment
We propose to pay this service under the physician fee schedule
(Sec. 414.62). The proposed RVUs are as follows:
------------------------------------------------------------------------
Group sessions per
Individual sessions individual
------------------------------------------------------------------------
Physician Work RVUs = 0................... Physician Work RVUs = 0.
Practice Expense RVUs = 1.51.............. Practice Expense RVUs = .89.
[[Page 6842]]
Malpractice Expense RVUs = .01............ Malpractice Expense RVUs =
.01.
------------------------------------------------------------------------
Table 1 explains how we derived the proposed payment rates for
providing diabetes training on an individual basis and in a group
setting, based on the estimated resource costs provided by the ADA.
Since the number of beneficiaries within a group would vary, we have
based our methodology on an assumption that there would typically be 10
beneficiaries attending a group session.
The Act requires that payments vary among fee schedule areas
according to the extent that resource costs vary as measured by the
geographic practice cost indices (GPCIs). Section 1848(e)(1)(C) of the
Act requires us to review and, if necessary, adjust the GPCIs at least
every 3 years. On October 31, 1997, we published a final rule,
Revisions to Payment Policies and Adjustments to the Relative Value
Units Under the Physician Fee Schedule, Other Part B Payment Policies,
and Establishment of the Clinical Psychologist Fee Schedule for
Calendar Year 1998 (62 FR 59256). Addendum E to that rule identifies
the 1999 GPCIs for practice expense RVUs and malpractice expense RVUs.
Using the proposed RVUs, we would pay $55.41 for individual
sessions and $32.62 per person within a group session. These same
payment rates would apply for the 1-hour annual refresher training.
Actual payments to an entity approved by us would be adjusted for
geographic variation and determined based on the physician fee schedule
methodology as described in a separate final rule published in the
Federal Register on October 31, 1997 (62 FR 59048).
Billing for payment would be submitted in 60-minute increments. The
following CPT codes would be used for billing:
G0108--Outpatient diabetes self-management training services,
individual session, per 60 minutes of training.
G0109--Outpatient diabetes self-management training services, group
session, per individual, per 60 minutes of training.
Based on information received from the diabetes industry, we
propose that beneficiaries receive up to 10 hours of diabetes training
within the same year, either as an individual or within a group
setting. As previously stated in this proposed regulation, we are
proposing that all beneficiaries who receive the initial training
program be eligible for an annual single training session of up to one
hour (a group session, unless an individual session is needed based on
the same criteria listed above).
We would refine the diabetes training payment amount in the future
by incorporating this service into the refinement process used for
other Medicare services payable under the physician fee schedule.
Medicare co-payments and deductibles would apply for diabetes
outpatient self-management training services.
K. Time Limits for Filing Claims
We are proposing to add a new paragraph (d), ``Outpatient diabetes
self-management training,'' to Sec. 424.44, ``Time limits for filing
claims.'' New paragraph (d) would state that we would make payment to
an entity for the furnishing of outpatient diabetes self-management
training after we approve the entity to furnish the services under part
410 subpart H.
L. Photocopying Reimbursement and Mailing Costs for Practitioners
Section 4105(c) of the BBA '97 requires the Secretary to establish
outcome measures, including glycosylated hemoglobin (past 90-day
average blood sugar levels), for purposes of evaluating the improvement
of the health status of Medicare beneficiaries with diabetes mellitus.
In order to obtain adequate clinical documentation used in developing
these outcome measures, we would direct Peer Review Organizations to
collect this information from a physician or qualified nonphysician
practitioner treating a beneficiary with diabetes as authorized by
Sec. 476.111(a).
We are proposing to pay physicians and nonphysician practitioners
for photocopying and mailing cost directly attributable to the
physician or nonphysician's responsibility to the PROs to provide
photocopies of requested beneficiary medical records (Sec. 476.111(d)).
The proposed payment is $.10 per page for photocopying plus first class
postage costs for mailing the records. The proposed photocopying amount
includes the cost of labor, supplies, equipment, and overhead. We are
proposing the above amount based on the final rule establishing
photocopying payment for hospitals published in the Federal Register
(See 57 FR 47779 through 47787, October 20, 1992).
M. Appeals
We propose that in order to become an approved entity, a physician,
individual, or entity must be approved by an accreditation organization
and approved by us. If an individual, physician, or entity is found not
to meet the conditions in either Sec. 410.141(e), we would disapprove
the application. We would provide administrative review of this
decision by using the procedures for suppliers in part 498. Similarly,
in the event we find an approved entity not to be in compliance with
the conditions set forth in Sec. 410.141(e), we may revoke the approved
entity's Medicare billing number. In that event, we would also provide
administrative appeal rights under the procedures in Part 498.
Therefore, we have revised the definition of ``supplier'' that appears
in Sec. 498.2 to include an ``approved entity'' for furnishing
outpatient diabetes self-management training.
N. Outcome Measures
We are requesting comments on the type of process and outcome
measures we should be collecting in the future in order to review the
progress of beneficiaries and the success of programs. We also solicit
comments on the desirability in the future of replacing these proposed
prescriptive training and personnel requirements with reliance on
outcome measures.
IV. Collection of Information Requirements
Under the Paperwork Reduction Act (PRA) of 1995, we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the PRA requires that we
solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are soliciting public comment on each of these issues for the
information collection requirements (ICRs) as summarized and discussed
below.
Section 410.141 Outpatient Diabetes Self-management and Training
Section 410.141(b) states that diabetes self-management training
must be included in a comprehensive plan of
[[Page 6843]]
care and documented in the patient's medical record by the physician or
qualified nonphysician practitioner treating the beneficiary for
training services that meet the requirements of this section. In
addition, this section requires that HCFA-approved entities submit
their plan of care to HCFA upon request. While the documentation and
recordkeeping requirement imposed by this section is subject to the
PRA, the requirements to disclose information to HCFA upon request are
not subject to the PRA in accordance with 5 CFR 1320.4(a)(2), since the
disclosure of information to or for a Federal agency during the conduct
of an administrative action or audit involving an agency against
specific individuals or entities is exempt from the PRA.
Therefore, the burden associated with this section that is subject
to the PRA is the time and effort for the physician or qualified
nonphysician practitioner to ensure that each patient's plan of care is
documented and maintained in his or her medical record. We estimate
that it will require 30 minutes to document each plan of care. And, on
an annual basis there will be 2,250,000 required plans of care
(2,000,000 aged beneficiaries + 250,000 disabled beneficiaries).
Therefore, the total annual burden of this requirement is 1,125,000
hours (2,250,000 plans of care * 30 minutes = 1,125,000 hours).
Section 410.141(c)(2) requires the physician or qualified
nonphysician practitioner treating the beneficiary document in the
beneficiary's medical record the specific medical condition that the
additional beneficiary training must address.
While this ICR is subject to the PRA, we believe the burden
associated with this ICR is exempt in accordance with 5 CFR
1320.3(b)(2) because the time, effort, and financial resources
necessary to comply with these requirements would be incurred by
persons in the normal course of their activities.
Section 410.141(c)(3)(ii) states that the beneficiary's physician
or qualified nonphysician practitioner must document in the
beneficiary's medical record that the beneficiary has special needs,
such as severe vision, hearing, or language limitations that would
hinder effective participation in a group training session.
While this ICR is subject to the PRA, we believe the burden
associated with this ICR is exempt in accordance with 5 CFR
1320.3(b)(2) because the time, effort, and financial resources
necessary to comply with these requirements would be incurred by
persons in the normal course of their activities.
Section 410.141(e)(3) requires that an entity submit the necessary
documentation to, and is accredited by, an accreditation organization
approved by HCFA under Sec. 410.142 to meet one of the sets of quality
standards described in Sec. 410.144. The burden associated with this
requirement is the time and effort necessary for an entity requesting
to be deemed to submit the necessary documentation to an accreditation
organization. It is estimated that it will take each of the estimated
750 entities 60 hours to complete these requirements every 3 years, for
an annual burden of 20 hours. Therefore, the total annual burden
imposed by these requirements is estimated to be 15,000 hours.
Section 410.141(e)(4) states that a physician, individual, or
entity must provide documentation to HCFA as requested.
Since this requirement will be collected as part of an
investigation or audit against specific individuals or entities, we
believe that this ICR is exempt in accordance with 5 CFR 1320.4(a)(2).
In addition, we believe that since the request for information is
addressed to a single person as defined in 5 CFR 1320.3(h)(6), the
collection does not meet the definition of an information collection as
defined in 5 CFR 1320.3(c).
Section 410.142 HCFA Process for Approving National Accreditation
Organizations
Section 410.142(b) states that a national organization requesting
accreditation approval by HCFA must furnish to HCFA the information and
materials described in this section.
The burden associated with these requirements is the time and
effort to furnish to HCFA the information and materials described in
this section. It is estimated that during the first year it will take 5
national organizations 96 hours to comply with these requirements.
Since organizations will generally be approved for at least 6 years, we
have annualized the total burden to be 96 * 5 = 480 hours/6 years = 80
annual hours.
Section 410.142(c) states that HCFA may visit the prospective
accreditation organization's offices to verify information in the
organization's application, including, but not limited to, review of
documents, and interviews with the organization's staff.
The burden imposed by this section is the time and effort necessary
to disclose documentation related to the onsite visit. However, we
believe that these requirements are exempt from the PRA since they will
be imposed under the conditions defined in 5 CFR 1320.4 and meet the
exception(s) to the definition of information as set forth in 5 CFR
1320.3(h)(3), (h)(6), and (h)(9) and as such does not meet the
definition of an information collection.
Section 410.142(g) states that an accreditation organization that
has received HCFA's notice of denial of its request for HCFA approval
and recognition of its accreditation program to accredit entities to
furnish outpatient diabetes self-management training services may
request reconsideration of HCFA's decision in accordance with part 488
subpart D of this chapter.
We believe that this ICR is exempt in accordance with 5 CFR
1320.4(a)(2) since this requirement is the result of an administrative
action, investigation, or audit against specific individuals or
entities.
Section 410.142(h) states that an organization that has received
HCFA's notice of denial of its request for accreditation may submit a
new request to HCFA if it meets the conditions in this section.
We anticipate that these requirements will be imposed on less then
10 persons on an annual basis, and, therefore, are not subject to the
PRA as defined in 5 CFR 1320.3(c).
Section 410.142(j) states that at least 6 months before the
expiration of HCFA's approval and recognition of the accreditation
organization's program, an accreditation organization must request from
HCFA continued approval and recognition.
The burden associated with this requirement is the time and effort
necessary for an organization to submit to HCFA a request for
reapproval. The burden associated with this requirement is captured in
Sec. 410.142(b).
Section 410.143 Requirements for Approved Accreditation Organizations
Section 410.143(a)(1) states that an accreditation organization
approved by HCFA must provide to HCFA in a written form and on a
monthly basis all of the ICRs set forth in Sec. 410.143(a)(1)(i)
through (a)(1)(iv).
The burden associated with these requirements is the time and
effort for an accreditation organization to comply with the
requirements of this section. It is estimated that it will take each
organization 4 hours to complete these requirements. There are
approximately 5 respondents for a total of 20 annual hours.
Section 410.143(a)(2) states that within 30 days of a change in the
HCFA standards, submit to HCFA its organization's plan to alter its
standards to conform to the revised HCFA
[[Page 6844]]
standards (including a crosswalk between the revised HCFA standards and
the organization's revised standards) within the timeframes for
adopting the revised HCFA standards specified in the notification of
change it receives from HCFA.
The burden associated with these requirements are the time and
effort for an organization to submit its organization's plan. It is
estimated that it will take each organization 10 hours to comply with
these requirements. There are approximately 5 respondents for a total
of 50 hours.
Section 410.143(b) states that HCFA (or its agent(s)) may perform
oversight activities such equivalency reviews, validation reviews, and
onsite inspections ensure that an approved accreditation organization
and the entities the accreditation organization accredits continue to
meet the quality standards described in Sec. 410.144. In addition, an
accreditation organization that is dissatisfied with a determination to
withdraw HCFA approval and recognition may request a reconsideration of
HCFA's decision in accordance with part 488 subpart D of this chapter.
The burden imposed by this section is the time and effort necessary
to disclose documentation under the reviews and inspections.
However, we believe that these requirements are exempt from the PRA
since they will be imposed under the conditions defined in 5 CFR 1320.4
and meet the exception(s) to the definition of information as set forth
in 5 CFR 1320.3(h)(3), (h)(6), and (h)(9) and as such does not meet the
definition of an information collection.
Section 410.144 Quality Standards for a Deemed Entity
Section 410.144(a)(1)(ii) and (iii) states that a deemed entity
document the organizational relationships, lines of authority,
staffing, job descriptions, and operational policies. In addition, it
must maintain a written policy that affirms education as an integral
component of diabetes care.
The burden associated with this requirement is the time and effort
for an entity to document and maintain the information described above.
It is estimated these requirements will take each entity 8 hours. There
are approximately 750 entities for a total annual burden of 6,000
hours.
Section 410.144(a)(7) states that an entity must review each
beneficiary's plan of care, develop, and update an individual
assessment in collaboration with each beneficiary, and document the
results, including assessment, intervention, evaluation, and follow-up
in the beneficiary's permanent medical record.
The burden associated with this requirement is captured in
Sec. 410.141(b) above.
Section 410.144(a)(9) states that an entity must establish and
maintain a performance measurement and quality improvement program that
meets the requirements of this section. In addition, if requested, an
entity must report to HCFA nationally standardized performance measures
to the extent that they become available in the future and the
Secretary determines they are appropriate.
While the requirements to maintain documentation and the reporting
of nationally standardized performance measures are subject to the PRA,
the requirements to disclose information to HCFA upon request are not
subject to the PRA in accordance with 5 CFR 1320.4(a)(2), since the
disclosure of information to or for a Federal agency during the conduct
of an administrative action, investigation, or audit involving an
agency against specific individuals or entities is exempt from the PRA.
Therefore, the burden associated with this section, that is subject
to the PRA, is the time and effort necessary for an entity to maintain
documentation related to the performance measurement and quality
improvement program and the reporting of nationally standardized
performance measures. It is estimated that the recordkeeping
requirements will take each entity 3 hours on an annual basis since
there are approximately 750 entities for a total annual burden of 2,250
hours. Since HCFA is not currently requiring entities to report
nationally standardized performance measures, we are not assigning any
burden to this requirement. When HCFA does mandate the requirement to
report these performance measures, the burden associated with this
requirement will be adjusted accordingly.
Section 410.144(a)(10) states that each deemed entity must have an
agreement with a PRO, which has a contract with HCFA to perform quality
assurance reviews. At a minimum, the agreement must allow the PRO
access to beneficiary or group therapy records, and binds an approved
entity to comply with corrective actions or to participate in quality
improvement projects that the PRO determines are necessary.
The burden associated with this requirement is the time and effort
necessary to maintain the necessary documentation to demonstrate that
the deemed entity has entered into a written agreement with a PRO that
meet the requirements of this section.
We estimate that it will take 750 entities 5 minutes on an annual
basis to maintain the necessary documentation for an overall annual
burden of 63 hours.
Section 410.145 Requirements for Deemed Entities
Section 410.145(a)(10) states that an entity may be deemed to meet
the HCFA quality standards described in Sec. 410.144 if the entity has
submitted necessary documentation and is fully accredited (and
periodically reaccredited) by a national accreditation organization
approved by HCFA. The burden associated with meeting these requirements
is captured in Sec. 410.141(e)(3).
Section 410.145(c) states that an entity may be deemed to meet the
HCFA quality standards described in Sec. 410.144(a) if the entity--(1)
forwards a copy of its certificate from its accreditation organization
indicating that the entity meets the HCFA quality standards described
in Sec. 410.144(a) before submitting a claim for Medicare payment; (2)
agrees in writing to submit to evaluation (including onsite
inspections) by HCFA (or its agent) to validate its accreditation
organization's accreditation process; and (3) authorizes in writing for
its accreditation organization to release to HCFA a copy of its most
recent accreditation evaluation, and any accreditation-related
information that HCFA may require.
The burden associated with these requirements is the time and
effort for an entity to submit a copy of its certificate, along with
its agreement, and authorization.
It is estimated that it will take each entity 5 minutes to comply
with these requirements. There are approximately 750 respondents for a
total of 63 hours.
Section 414.62 Payment for Outpatient Diabetes Self-Management
Training Services
Section 414.62(c) states that beneficiary participation in training
sessions must be documented on attendance sheets.
While this ICR is subject to the PRA, we have not accounted for the
burden of this ICR because we believe the burden associated with this
ICR is exempt in accordance with 5 CFR 1320.3(b)(2) because the time,
effort, and financial resources necessary to comply with these
requirements would be incurred by persons in the normal course of their
activities. We solicit comment on our preliminary conclusion
[[Page 6845]]
that this activity would be done in the normal course of business and,
thus, would have no burden for providers.
We have submitted a copy of this proposed rule to OMB for its
review of the information collection requirements described above.
These requirements are not effective until they have been approved by
OMB.
If you comment on any of these information collection and record
keeping requirements, please mail copies directly to the following:
Health Care Financing Administration, Office of Information Services,
Security and Standards Group, Division of HCFA Enterprise Standards,
Room N2-14-26, 7500 Security Boulevard, Baltimore, MD 21244-1850, Attn:
Louis Blank, HCFA-3002-P
and
Office of Information and Regulatory Affairs, Office of Management and
Budget, Room 10235, New Executive Office Building, Washington, DC
20503, Attn: Allison Eydt, HCFA Desk Officer.
V. Regulatory Impact Analysis
A. Background
We have examined the impacts of this proposed rule as required by
Executive Order 12866, the Unfunded Mandates Act of 1995, and the
Regulatory Flexibility Act (RFA) (Public Law 96-354). Executive Order
12866 directs agencies to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety effects, distributive
impacts, and equity). A regulatory impact analysis (RIA) must be
prepared for major rules with economically significant effects ($100
million or more annually). The statutory provision that this rule
further implements would cause this to be a major rule because we have
estimated that the annual costs associated with this rule would be
significantly higher than $100 million beginning in 1999.
Section 1102(b) of the Social Security Act (the Act) requires us to
prepare an RIA if a rule may have a significant impact on the
operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 603 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 50 beds.
The Unfunded Mandates Reform Act of 1995 also requires (in section
202) that agencies prepare an assessment of anticipated costs and
benefits before proposing any rule that may mandate an annual
expenditure by State, local, or tribal governments, in the aggregate,
or by the private sector, of $100 million or more. We believe that this
proposed rule would not mandate such expenditures.
The RFA requires agencies to analyze options for regulatory relief
of small entities. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and governmental agencies.
Most hospitals and most other providers and suppliers are small
entities, either by nonprofit status or by having revenues of $5
million or less annually. States and tribal governments are not
considered to be small entities. This rule provides additional benefit
payments to providers for offering classes on diabetes self-management.
Therefore, there are no regulatory burden issues affecting small
entities to be considered with respect to these benefit payments. In
section C. of the RIA that discusses the accreditation approval
process, we acknowledge that some small entities may face a regulatory
burden in obtaining accreditation. We discuss proposed measures that we
believe will lessen the regulatory burden on these entities.
This proposed rule sets forth an expanded benefit for Medicare
beneficiaries with diabetes who meet the criteria for self-management
training services. It also identifies who may be an approved entity
that may furnish these services, and lists the quality standards that
must be met by these approved entities. This regulation would primarily
affect beneficiaries with diabetes and certain health care
professionals, such as physicians, nurses, physician-directed clinics,
and hospital outpatient departments.
We estimate that there are 4.5 million Medicare beneficiaries with
diabetes (approximately 4 million aged beneficiaries and .5 million
disabled beneficiaries). Of this total, we estimate that about half, or
2.25 million beneficiaries, would receive diabetes self-management
training services. This estimate assumes that the remaining 2.25
million Medicare beneficiaries either have already received the
training or do not currently meet the conditions of coverage. These
beneficiaries may meet the conditions of coverage at a later date, if
their medical condition changes.
B. Diabetes Costs and Benefits
After consultation with the industry, we believe it is reasonable
to cover up to 10 hours of initial diabetes self-management training
within a continuous 12-month period and up to 1 hour of additional
training annually (after the initial training) for each beneficiary
that meets the conditions of coverage. We estimate that there would
actually be 10 1-hour sessions billed in the first year and possibly
one follow-up session (up to 1 hour) billed each year thereafter, if
the beneficiary qualifies for the follow-up session. We have assumed
that most beneficiaries with diabetes that currently qualify would have
the training in the first few years of coverage. This accounts for the
large influx of spending in the first few years. The outyear estimates
assume that a limited number of beneficiaries with new diabetes
diagnoses would receive the full training benefit, and that others
would receive refresher courses if ordered by their physician. In
addition, we have assumed that there would be newly diagnosed
beneficiaries with diabetes each year that would receive up to 10 hours
of initial diabetes self-management training, but they represent a
smaller number of diabetics.
The following table displays the budgetary cost of the outpatient
diabetes self-management training program to the Medicare program.
Projected Budget Impact of New Benefit
[$ in millions]
----------------------------------------------------------------------------------------------------------------
FY 1998 FY 1999 FY 2000 FY 2001 FY 2002
----------------------------------------------------------------------------------------------------------------
$40.................. $390 $320 $180 $80
----------------------------------------------------------------------------------------------------------------
These costs are considerable, especially in the first few years,
but we also expect substantial benefits. When someone has diabetes, his
or her body has trouble making or using insulin, a hormone produced by
the pancreas.
[[Page 6846]]
Insulin enables the body's tissues to use glucose, a sugar that
circulates in the bloodstream and that normally provides energy for the
body's cells. Because a diabetic beneficiary cannot properly use
glucose in the blood, blood sugar levels remain high, unless a person
takes appropriate medication (such as insulin) or is able to reduce
blood sugar levels through diet and exercise. The consequences of
diabetes can be severe. It is the fourth leading cause of death by
disease in the United States. Diabetes can also result in many other
medical problems, including heart disease, stroke, kidney disease, loss
of sensation and circulation in the legs, possibly leading to
amputations, and blindness. Proper health care and self-management can
help circumvent these problems or slow their onset. There are two
critical questions that go to the heart of diabetes self-management
training. First, when should the person receive the training? Second,
how much training should the person receive? Initial training may bring
about short term behavioral changes. Some experts, however, express
concern about the difficulty people with diabetes have in maintaining
behavior changes unless they get additional education and support as a
follow-up to the initial training. To assure that our beneficiaries
receive the amount of training and support we believe they need to
maintain good health or improve their existing health status, we would
provide, when medically necessary, refresher training in a subsequent
year following the initial training. We believe that these actions
would have a positive result on the Medicare program, and we plan to
monitor specific outcome measures to assure that only quality programs
are reimbursed by the Medicare program.
There is a possibility of delays in enrolling newly approved
entities because of the accreditation process. However, existing
outpatient diabetes self-management programs would continue to be paid
as they are now. The estimates assume that roughly 70 percent of
beneficiaries would be able to receive the self-management training
from currently approved entities. Also, the estimates do not reflect
payments for beneficiaries who are inpatients in facilities such as
hospitals or nursing homes. Finally, we assume that the number of
beneficiaries with diabetes grows in the same manner as total Part B
enrollment. This results in increasing the number of beneficiaries with
diabetes by about 40,000 per year.
C. Accreditation Process
Section 1865 of the Act requires us to determine whether the
accreditation of a provider or supplier entity by a national
accreditation organization provides assurances that the applicable
Medicare health and safety conditions or requirements are met.
The BBA '97 authorized the Secretary to develop her own quality
standards. We have condensed the standards originally established by
the NDAB and recognized by the ADA, and we believe that our proposed
standards offer sufficient assurances that the outpatient diabetes
self-management training programs would provide quality care and the
standards are flexible enough to apply in any health care setting.
The ADA Education Recognition Program is a national voluntary
process that identifies diabetes self-management training programs that
meet National Standards for Diabetes Self-Management Education
Programs. The ADA currently recognizes outpatient diabetes self-
management programs. To date, the ADA has given recognition to
approximately 575 education programs. Under the conditions in this
proposed rule, the ADA, along with any other national accreditation
organization that wishes to be approved and recognized by HCFA, would
be required to submit appropriate documentation requesting
accreditation approval from us. Once we have determined that the
organizations meet the HCFA requirements concerning frequency of
accreditation, accreditation forms, and that they use guidelines and
instructions to evaluators that are as rigorous as our requirements
with a similar emphasis on outcomes, they may then be approved and
recognized as national accreditation organizations.
We fully expect that the ADA will apply to HCFA as a national
accreditation organization and be quickly approved to accredit
entities. Our review of the ADA-recognized programs indicates that
there is a minimum of at least one program in each State and the
District of Columbia. These programs are located in both small rural
hospitals as well as large urban hospitals. While the majority of these
programs are hospital-based, there are some that are clinics and one in
Arizona that is an insurance plan. Thus, we believe that the geographic
distribution of recognized programs is such that Medicare beneficiaries
would be able to receive training without a delay of the benefit.
We recognize that some small entities such as rural physicians and
qualified nonphysician practitioners may find the 12-month collection
of data and the start-up fees required by the ADA to be a burden to
their practices. The approximate cost for an entity to get accredited,
based on current ADA figures, is $682.50, which includes an $82.50
application fee and a $600 initial accreditation fee. The subsequent
triennial fee is $500. Additional items, such as recordkeeping costs
and other overhead costs, have not been factored into the cost of
becoming an approved entity. We estimate that there will be a total of
750 accredited entities when this rule is implemented and we estimate
there are currently 575 entities that are ADA-certified and that
already pay accreditation costs. The additional 175 entities would pay
the $682.50, so the additional private sector cost would be
$119,437.50.
In addition, we acknowledge that some existing programs are
currently accredited by their State or local agency and may now find it
a burden to become accredited by a national organization. However, we
expect that at least four other national accreditation organizations
would apply to us for recognition and that these entities may find the
quality standards of these organizations to be substantially equivalent
to the existing State or local standards. The CDC has a cooperative
agreement with the 50 States, all U.S. territories, and the District of
Columbia. This agreement provides funding to these geographic entities,
which they currently use to perform a variety of diabetes-related
activities. Ten of the 50 States use a portion of their funds to
administer their State diabetes self-management training accreditation
programs. Under this proposed rule, there will be no loss of revenue
from this cooperative agreement for any of these geographic entities.
Those States that currently use their funds from the cooperative
agreement to administer their State diabetes self-management training
programs can either choose to become an organization or choose instead
to fund other diabetes-related activities, including the development of
educational programs for the use of approved entities that desire to
obtain national accreditation in order to qualify for Medicare payment
under this benefit.
One way we are trying to lessen the burden on rural and small
entities is by postponement of the requirement for the CDE to be part
of the diabetes self-management team. This proposed rule requires that
nonphysician diabetes educators complete 14 hours of approved diabetes-
related continuing education every two years. The approximate cost of
obtaining these
[[Page 6847]]
credits is $300. (This estimate is based on diabetes-related training
information that we received from the American Association of Diabetes
Educators.) We believe that existing programs would have approximately
3\1/2\ years from the publication of this proposed rule to provide
outpatient diabetes self-management training while preparing to meet
the HCFA standard concerning the CDE.
We estimate that there would be 750 approved entities when this
final rule is fully implemented. Each approved entity would need a CDE.
The initial certification of a CDE costs $250 and another $250 every 5
years to maintain certification. It would cost approximately $37,500
(750 x $250 5) per year for CDE certification at the rate of
one CDE per approved entity. The continuing education requirement for a
CDE associated with this proposed rule would cost approximately $300
every 2 years. The estimated total cost for continuing education for
all CDEs would be $112,500 (750 x $300 2) per year at the
rate of one CDE per approved entity. The estimated total cost for
combined certification and continuing education for all CDEs would be
approximately $150,000 per year.
D. Conclusions
We anticipate that this proposed rule would improve health of
Medicare beneficiaries with diabetes by providing them with the skills
and knowledge necessary to effectively manage their diabetic condition.
We recognize that there may be some burden on existing and new entities
because of the requirement that they must be accredited by a national
accreditation body. However, we must ensure that Medicare pays only for
those programs that are of the highest quality. We believe that the
overall burden to these entities is worth the benefit that will be
gained to both the Medicare beneficiary and the program.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
List of Subjects
42 CFR Part 410
Health facilities, Health professions, Kidney diseases,
Laboratories, Medicare, Rural areas, X-rays.
42 CFR Part 414
Administrative practice and procedure, Health facilities, Health
professions, Kidney diseases, Medicare, Reporting and recordkeeping
requirements, Rural areas, X-rays.
42 CFR Part 424
Emergency medical services, Health facilities, Health professions,
Medicare.
42 CFR Part 476
Health care, Health professional, Health record, Peer Review
Organizations (PRO), Penalties, Privacy, Reporting and recordkeeping
requirements.
42 CFR Part 498
Administrative practice and procedure, Health facilities, Health
professions, Medicare.
For the reasons set forth in the preamble, 42 CFR Chapter IV would
be amended as set forth below:
PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS
A. Part 410 would be amended as follows:
1. The authority citation for part 410 continues to read as
follows:
Authority: Sections 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh), unless otherwise indicated.
2. Section 410.1, paragraph (a) is revised to read as follows:
Sec. 410.1 Basis and scope.
(a) Statutory basis. This part is based on the indicated provisions
of the following sections of the Act:
1832--Scope of benefits furnished under the Medicare Part B
supplementary medical insurance (SMI) program.
1833 through 1835 and 1862--Amounts of payment for SMI services,
the conditions for payment, and the exclusions from coverage.
1861--Definition of the kinds of services that may be covered.
1865(b)--Permission for HCFA to approve and recognize a national
accreditation organization and its accreditation program for
accrediting an entity to furnish outpatient diabetes self-management
services.
1881--Medicare coverage for end-stage renal disease beneficiaries.
* * * * *
3. New subpart H, consisting of Secs. 410.140 through 410.145, is
added to read as follows:
Subpart H--Outpatient Diabetes Self-Management Training Services
Sec.
410.140 Definitions.
410.141 Outpatient diabetes self-management training.
410.142 HCFA process for approving national accreditation
organizations.
410.143 Requirements for approved accreditation organizations.
410.144 Quality standards for a deemed entity.
410.145 Requirements for deemed entities.
Subpart H--Outpatient Diabetes Self-Management Training Services
Sec. 410.140 Definitions.
For purposes of this subpart, the following definitions apply:
Approved entity means an individual, physician, or entity
accredited by an approved organization to furnish training and approved
by HCFA to furnish and receive Medicare payment for the training.
Deemed entity means an individual, physician, or entity accredited
by an approved organization, but that has not yet been approved by HCFA
to furnish and receive Medicare payment for the training. Upon being
approved by HCFA to receive Medicare payment for training, HCFA refers
to this entity as an ``approved entity.''
Organization means a national accreditation organization.
Training means outpatient diabetes self-management training.
Sec. 410.141 Outpatient diabetes self-management training.
(a) General rule. Medicare Part B covers training defined in
Sec. 410.140 ordered by a physician or qualified nonphysician
practitioner (as these terms are defined in Sec. 410.32) for a
beneficiary with a diabetic condition to ensure therapy compliance or
to provide the beneficiary with necessary skills and knowledge to
manage the beneficiary's condition.
(b) Conditions for coverage. The training must meet the following
conditions:
(1) Following an evaluation of the beneficiary's need for the
training, it is ordered by the physician or qualified nonphysician
practitioner treating the beneficiary's diabetes.
(2) It is included in a comprehensive plan of care (established by
the physician or qualified nonphysician practitioner treating the
beneficiary for diabetes) that meets the following requirements:
(i) Describes the content, number, frequency, and duration of the
training as written by the physician or qualified nonphysician
practitioner treating the beneficiary.
(ii) Contains a statement specified by HCFA and signed by the
physician or qualified nonphysician practitioner managing the
beneficiary's diabetic condition. By signing this statement, the
physician or qualified nonphysician practitioner certifies that he or
she is managing the beneficiary's diabetic condition and the training
described in
[[Page 6848]]
the plan of care are needed to ensure therapy compliance or to provide
the beneficiary with the skills and knowledge to help manage the
beneficiary's diabetes. The physician's or qualified nonphysician
practitioner's statement must identify the beneficiary's specific
medical conditions (described in paragraph (d)(1) of this section) that
the training would address.
(iii) Provides that any changes to the plan of care are signed by
the physician or qualified nonphysician practitioner treating the
beneficiary.
(iv) Is incorporated into the approved entity's permanent medical
record for the beneficiary and is made available, upon request, to
HCFA.
(3) It is reasonable and necessary for treating or monitoring the
condition of a beneficiary who meets the conditions described in
paragraph (d) of this section.
(4) Except as permitted in paragraph (c)(3) of this section, it is
furnished in a group setting consisting of 2 to 20 individuals who need
not all be Medicare beneficiaries.
(c) Types and frequency of training--(1) Initial training. Medicare
Part B covers up to 10 hours of initial training within a continuous
12-month period for each beneficiary that meets the conditions in
paragraph (d) of this section.
(2) Additional training. After receiving the initial training
described in paragraph (c)(1) of this section, Medicare covers a single
follow-up training session lasting no more than 1 hour for a
beneficiary each year. The physician or qualified nonphysician
practitioner treating the beneficiary must document in the
beneficiary's medical record the specific medical condition (described
in paragraph (d)(1) of this section) that the additional training must
address.
(3) Exception. Medicare covers up to 10 hours of training on an
individual basis for a Medicare beneficiary who meets any of the
following conditions:
(i) No group session is available within 2 months of the date the
training is ordered.
(ii) The beneficiary's physician or qualified nonphysician
practitioner documents in the beneficiary's medical record that the
beneficiary has special needs resulting from conditions, such as severe
vision, hearing, or language limitations that would hinder effective
participation in a group training session.
(d) Beneficiaries who may be covered. Medicare Part B covers
initial training services for a beneficiary who meets the following
conditions:
(1) Medical conditions. A beneficiary has one of the following
medical conditions occurring within the 12-month period before the
physician's order for the training:
(i) New onset diabetes.
(ii) Poor glycemic control as evidenced by a glycosylated
hemoglobin (HbA1C) level of 9.5 or more in the 90 days before attending
the training.
(iii) A change in treatment regimen from no diabetes medications to
any diabetes medication, or from oral diabetes medication to insulin.
(iv) High risk for complications based on poor glycemic control
(documented acute episodes of severe hypoglycemia or acute severe
hyperglycemia occurring in the past year during which the beneficiary
needed third party assistance for either emergency room visits or
hospitalization).
(v) High risk based on at least one of the following documented
complications:
(A) Lack of feeling in the foot or other foot complications such as
foot ulcer or amputation.
(B) Pre-proliferative or proliferative retinopathy or prior laser
treatment of the eye.
(C) Kidney complications related to diabetes, such as
macroalbuminuria or elevated creatinine.
(2) Other conditions. The beneficiary--
(i) Has not received initial training; or
(ii) Is not receiving services as an inpatient in a hospital, SNF,
hospice, or nursing home.
(iii) Is not receiving services as an outpatient in an RHC or FQHC.
(e) Who may furnish services. Services may be furnished by a
physician, individual, or entity that meets the following conditions:
(1) In addition to furnishing diabetes training services described
in Sec. 410.141, furnishes other services for which direct Medicare
payment may be made.
(2) May properly receive Medicare payment under Sec. 424.73 or
Sec. 424.80 of this chapter, which set forth prohibitions on assignment
and reassignment of benefits.
(3) Submits necessary documentation to, and is accredited by, an
accreditation organization approved by HCFA under Sec. 410.142 to meet
one of the sets of quality standards described in Sec. 410.144.
(4) Provides documentation to HCFA, as requested.
Sec. 410.142 HCFA process for approving national accreditation
organizations.
(a) General rule. HCFA may approve and recognize an organization
that is either a nonprofit or not-for-profit organization with
demonstrated experience in representing the interest of individuals
with diabetes to accredit entities to furnish training services.
(b) Required information and materials. An organization requesting
HCFA's approval and recognition of its accreditation program must
furnish to HCFA the following information and materials:
(1) The standards that the organization uses to accredit entities
to furnish training services.
(2) A detailed comparison (including a crosswalk if the
organization does not use standards described in Sec. 410.144 in their
entirety) between the organization's accreditation requirements and
standards and the HCFA standards described in Sec. 410.144(a).
(3) Detailed information about the organization's accreditation
process, including all of the following information:
(i) Frequency of accreditation.
(ii) Copies of accreditation forms, guidelines, and instructions to
evaluators.
(iii) Descriptions of the following:
(A) The accreditation review process and the accreditation status
decision making process.
(B) The procedures used to notify an entity of deficiencies in its
outpatient diabetes self-management training program and procedures to
monitor the correction of those deficiencies.
(C) The procedures used to enforce compliance with accreditation
requirements.
(4) Detailed information about the individuals who perform
evaluations for the organization, including all of the following
information:
(i) The education and experience requirements for the individuals
who perform evaluations.
(ii) The content and frequency of continuing education furnished to
the individuals who perform evaluations.
(iii) The process used to monitor the performance of individuals
who perform evaluations.
(iv) The organization's policies and practices with respect to the
participation, in the accreditation process, by an individual who is
professionally or financially affiliated with the entity being
evaluated.
(5) A description of the organization's data management and
analysis system with respect to its accreditation activities and
decisions, including the kinds of reports, tables, and other displays
generated by that system.
(6) A description of the organization's procedures for responding
to and investigating complaints against a
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deemed entity, including policies and procedures regarding coordination
of these activities with appropriate licensing bodies, ombudsmen
programs, and HCFA.
(7) A description of the organization's policies and procedures
with respect to the withholding or removal of accreditation for failure
to meet the organization's standards or requirements, and other actions
the organization takes in response to noncompliance with its standards
and requirements.
(8) A description of all types (for example, full or partial) and
categories (for example, provisional, conditional, or temporary) of
accreditation offered by the organization, the duration of each type
and category of accreditation and a statement identifying the types and
categories that would serve as a basis for accreditation if HCFA
approves the organization.
(9) A list of all entities currently accredited to furnish training
and the type, category, and expiration date of the accreditation held
by each of them.
(10) The name and address of each person with an ownership or
control interest in the organization.
(11) Documentation that demonstrates its ability to furnish HCFA
with electronic data in HCFA-compatible format.
(12) A resource analysis that demonstrates that its staffing,
funding, and other resources are adequate to perform the required
accreditation activities.
(13) A statement acknowledging that, as a condition for approval
and recognition by HCFA of its accreditation program, it agrees to
comply with the requirements set forth in Secs. 410.142 through
410.144.
(14) Additional information HCFA requests to enable it to respond
to the organization's request for HCFA approval and recognition of its
accreditation program to accredit entities to furnish training
services.
(c) Onsite visit. HCFA may visit the prospective organization's
offices to verify information in the organization's application,
including, but not limited to, review of documents, and interviews with
the organization's staff.
(d) Notice and comment--(1) Proposed notice. HCFA publishes a
proposed notice in the Federal Register announcing its intention to
approve an organization's request for HCFA approval and recognition of
its accreditation program and the standards it uses to accredit
entities to furnish training services. The notice includes the
following information:
(i) The basis for approving the organization.
(ii) A description of how the organization's accreditation program
applies and enforces quality standards that have been determined by
HCFA to be substantially equivalent to the quality standards for
training services described in Sec. 410.144.
(iii) An opportunity for public comment.
(2) Final notice. (i) After considering public comments, HCFA
publishes a final notice in the Federal Register indicating whether it
has approved an organization's request for HCFA approval and
recognition of its accreditation program and the standards it uses to
accredit entities to furnish training services.
(ii) If HCFA approves the request, the final notice specifies the
effective date and the term of the approval, which may not exceed 6
years.
(e) Criteria HCFA uses to approve national accreditation
organizations. In deciding to approve and recognize an organization's
accreditation program to accredit entities to furnish training
services, HCFA considers the following criteria:
(1) The organization applies and enforces quality standards that
have been determined by HCFA to be substantially equivalent to the
quality standards described in Sec. 410.144.
(2) The organization meets the requirements for approved
organizations in Sec. 410.143.
(3) The organization is not owned or controlled by the entities it
accredits, as defined in Sec. 413.17(b)(2) or (b)(3), respectively, of
this chapter.
(4) The organization does not accredit any entity it owns or
controls.
(f) Notice of HCFA's decision. HCFA notifies the prospective
organization in writing of its decision. The notice includes the
following information:
(1) Statement of approval or denial.
(2) Rationale for denial.
(3) Reconsideration and reapplication procedures.
(g) Reconsideration of adverse decision. An organization that has
received HCFA's notice of denial of its request for HCFA approval and
recognition of its accreditation program to accredit entities to
furnish training services may request reconsideration of HCFA's
decision in accordance with part 488 subpart D of this chapter.
(h) Request for approval following denial. (1) Except as provided
in paragraph (h)(2) of this section, an organization that has received
HCFA's notice of denial of its request for HCFA approval and
recognition of its accreditation program to accredit entities to
furnish training services may submit a new request to HCFA if it meets
the following conditions:
(i) Has revised its accreditation program to correct the
deficiencies HCFA noted in its denial notice.
(ii) Demonstrates, through documentation, that the quality
standards used by the deemed entities are substantially equivalent to
the HCFA quality standards for training services described in
Sec. 410.144(a).
(iii) Resubmits the application in its entirety.
(2) An organization that has requested reconsideration of HCFA's
denial of its request for HCFA approval and recognition of its
accreditation program to accredit entities to furnish training services
may not submit a new request until all administrative proceedings have
been completed.
(i) Withdrawal. An organization requesting HCFA approval and
recognition of its accreditation program to accredit entities may
withdraw its application at any time.
(j) Reapplying for accreditation. At least 6 months before the
expiration of HCFA's approval and recognition of the organization's
program, an organization must request from HCFA continued approval and
recognition.
Sec. 410.143 Requirements for approved accreditation organizations.
(a) Ongoing responsibilities of an approved accreditation
organization. An organization approved and recognized by HCFA must
undertake the following activities on an ongoing basis:
(1) Provide to HCFA in writing and on a monthly basis all of the
following:
(i) Copies of all accreditation decisions and any accreditation-
related information that HCFA may require (including corrective action
plans and summaries of unmet HCFA standards).
(ii) Notice of all complaints related to accredited entities.
(iii) Within 30 days of taking remedial or adverse action
(including revocation, withdrawal, or revision of an entity's deemed
status) against a deemed entity, information describing the remedial or
adverse action and the circumstances that led to taking the action.
(iv) Notice of any proposed changes in its accreditation standards
and requirements or evaluation process. If an organization implements
changes without HCFA approval, HCFA may withdraw its approval and
recognition of the organization's accreditation program.
(2) Within 30 days of notification of a change in the HCFA quality
standards, submit to HCFA its organization's plan to alter its quality
standards to conform
[[Page 6850]]
to the revised HCFA standards (including a crosswalk between the
revised HCFA standards and the organization's revised standards) by the
effective date specified in HCFA's notification of the change in HCFA's
quality standards.
(b) HCFA oversight of approv
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