[Federal Register Volume 59, Number 184 (Friday, September 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-23280]
[[Page Unknown]]
[Federal Register: September 23, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 456
[MB-050-F]
RIN 0938-AF67
Medicaid Program; Drug Use Review Program and Electronic Claims
Management System for Outpatient Drug Claims
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Final rule.
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SUMMARY: This final rule revises some of the regulatory requirements
for the drug use review (DUR) program for covered outpatient drugs
furnished to recipients under the Medicaid program. The regulatory
requirements became effective on January 2, 1993, as a result of an
interim final rule with comment period that we published on November 2,
1992. Specifically, these revisions--
Clarify the definitions of overutilization,
underutilization, consensus process, peer-reviewed literature, adverse
medical result, adverse drug-drug interaction, appropriate and
medically necessary, and individual medical history;
Change the requirements for licensure of DUR board
members, and telephone counseling arrangements for mail order
pharmacies;
Include non-prescription drugs in the consideration of
alteration of therapeutic effect;
Require hospitals to give assurances that they have met
the requirements of the statute before claiming the hospital exemption
from DUR;
Specify the issues that State agencies must address when
formulating counseling standards;
Clarify the bases for DUR board recommendations;
Clarify the distinction between DUR and surveillance and
utilization review (SUR); and
Make certain technical and editorial corrections.
The November 1992 interim final rule with comment period
incorporated and interpreted certain provisions of section 4401 of the
Omnibus Budget Reconciliation Act of 1990.
DATES: These regulations are effective on October 24, 1994.
FOR FURTHER INFORMATION CONTACT: Thomas Fulda, (410) 966-3343.
SUPPLEMENTARY INFORMATION:
I. Background
Section 1927(g) of the Social Security Act (the Act), as added by
section 4401 of the Omnibus Budget Reconciliation Act of 1990 (OBRA
'90), provides that, for Federal financial participation (FFP) payment
to be made for covered outpatient drugs under the Medicaid program, the
State must have in operation a drug use review (DUR) program. The DUR
program must consist of prospective drug review, retrospective drug use
review, the application of explicit predetermined standards, and an
educational program. The purpose of the DUR program is to improve the
quality of pharmaceutical care by ensuring that prescriptions are
appropriate and medically necessary, and that they are not likely to
result in adverse medical effects. Section 1927(g) of the Act specifies
detailed requirements for conducting drug use reviews under the DUR
program, and requirements for the establishment, composition, and
functions of State DUR boards.
Section 1927(h) of the Act (also added by OBRA '90) requires the
Secretary to encourage each State Medicaid agency to establish a point-
of-sale electronic claims management (ECM) system for processing claims
for covered outpatient drugs. The ECM system must be capable of
performing on-line, real-time eligibility verifications, claims data
capture, and adjudication of claims and assisting pharmacists and other
authorized persons in applying for and receiving payment. If the State
acquired, through the applicable competitive procurement process, the
most cost-effective telecommunications network and automatic data
processing services and equipment, FFP at a matching rate of 90 percent
was available for expenditures made in calendar quarters during fiscal
years 1991 and 1992 for the development of the ECM system.
Section 1927(j)(1) of the Act exempts covered outpatient drugs
dispensed by health maintenance organizations (HMOs) from the
requirements of section 1927 of the Act. Section 1927(j)(2) further
requires that the Medicaid State plan provide that covered outpatient
drugs dispensed by a hospital using drug formulary systems and billed
to the State plan at no more than the hospital's purchasing costs are
not subject to the requirements of section 1927 of the Act.
In an interim final rule with comment period, published in the
Federal Register on November 2, 1992 (57 FR 49397), we established
regulations to incorporate and interpret the provisions of sections
1927 (g), (h), and (j) of the Act under 42 CFR part 456, subpart K. In
the interim final rule, we prescribed requirements for--
An outpatient DUR program that includes prospective drug
review, retrospective drug use review, and an educational program;
The establishment, composition, and functions of a State
DUR Board; and
An optional point-of-sale ECM system for processing claims
for covered outpatient drugs.
In response to the November 2, 1992, interim final rule, we
received comments from 72 pharmacists and organizations on a timely
basis. We summarize these comments and present our responses to them
under section II of this preamble. Prior to discussion of the public
comments, we present a summary of the individual provisions of the
interim final regulations related to each grouping of comments.
Note: Sections 1927 (g) and (h) of the Act use the term ``drug
use review'' to describe the total program (prospective review,
retrospective review, and education) and in speaking of the
retrospective review activity. These same sections use the term
``drug review'' to mean the prospective review activity. We maintain
that distinction in terminology in the following discussion.
II. Public Comments and Departmental Responses
A. Definitions
In Sec. 456.702 of the interim final regulations we define several
terms that are used in the DUR program to assess drug use, including
``adverse medical result'', ``appropriate and medically necessary'',
``overutilization'', and ``underutilization''.
Comment: Five commenters suggested that the definition of
``appropriate and medically necessary'' be expanded to permit the use
of professional prerogatives to allow for individualized drug therapy.
(We defined the term to mean drug prescribing and dispensing that is in
conformity with predetermined standards established in accordance with
provisions in the regulations under Sec. 456.703.) The commenters had a
concern that a specific criterion might identify one approach as
appropriate and, by omission, indicate that an equally acceptable
approach is inappropriate.
Response: Section 456.703 states that the goal of the State's DUR
program must be to ensure appropriate drug therapy, while permitting
sufficient professional prerogatives to allow for individualized drug
therapy. We believe that predetermined standards are necessary to
identify provider outliers whose prescribing, dispensing, and drug use
practices may not conform to accepted medical practice. Without
predetermined standards, each provider may claim ``professional
prerogative'' for any action taken. Within this system for developing
criteria and standards, there is adequate room for the exercise of
professional prerogatives because States may adopt standards to modify
criteria. Also, during retrospective DUR, States may use peer review to
recognize professional prerogatives in the prescribing and dispensing
of drugs. We do not believe that it is necessary to change this
definition.
Comment: Four commenters suggested that the definition of
``overutilization'' should be changed to conform with the definition of
``underutilization''. ``Overutilization'' is defined as the use of a
drug in quantities or for durations that put the recipient at risk of
an adverse medical effect while ``underutilization'' is defined as the
use of a drug by a recipient in insufficient quantity to achieve a
desired therapeutic goal. The commenters suggested that the definitions
indicate the use of a drug in quantities or duration greater than
necessary to achieve a desired therapeutic goal, and only when the use
of the drug puts the recipient at risk of a clinically significant
undesirable effect.
Response: We concur with the commenters and have revised these
definitions to incorporate their suggested language.
Comment: Two commenters suggested that the definition of
``underutilization'' also include a statement regarding insufficient
duration for drug therapy.
Response: We concur and have revised the regulation accordingly.
B. Exception for Nursing Facilities and HMOs
Section 456.703(b) of the interim final regulations provides an
exception to the DUR requirements for drugs dispensed to residents of
nursing facilities that are in compliance with the drug regimen review
requirements specified in regulations at Sec. 483.60, and an exception
for drugs dispensed by HMOs.
Comment: One commenter suggested clarification of Sec. 456.703(b)
to state that pharmacies owned by nursing homes, where reimbursement of
drugs is not included in the per diem rate, are subject to the DUR
requirements.
Response: We do not believe that this section needs any further
clarification. The regulation already states that the nursing
facilities exception applies only to drugs given to patients in a
nursing facility that is in compliance with the drug regimen review
requirements in Sec. 483.60. Ownership of the pharmacy by the nursing
home is not a factor.
Comment: Two commenters asked for clarification of the
applicability of DUR requirements to various types of residential care
facilities.
Response: The term ``facility'', as it applies to the exception to
the DUR requirements, is described at Sec. 483.5 and means a nursing
facility (NF) as defined in section 1919(a) of the Act. Drugs dispensed
by any facilities not meeting this definition would not be exempt from
drug use review. Residential care facilities for the treatment of
mental diseases do not meet the definition of section 1919(a) of the
Act. These facilities are subject to the DUR requirements and do not
qualify for the nursing facility exception.
Comment: One commenter suggested clarification that the nursing
facility exception also applies to rural health clinics and Federally
qualified health centers.
Response: Rural health clinics and Federally qualified health
centers do not meet the requirements for nursing facilities as defined
in section 1919(a) of the Act. Therefore, the DUR requirements under
section 1927(g) apply to these facilities.
Comment: One commenter suggested that States should not be able to
apply additional nursing home requirements without appropriate Federal
guidelines.
Response: The statute precludes Federal action to require DUR for
drugs dispensed by nursing facilities meeting the section 1927(g)(1)(D)
guidelines but leaves the States free to issue additional requirements.
The interim regulations that we issued explain the DUR requirements and
include guidelines for the States to implement the DUR requirements.
Comment: Four commenters suggested that HMOs not be excluded from
the DUR requirements.
Response: The exemption of drugs dispensed by HMOs from the DUR
requirements is in the statute and can only be changed by the Congress.
We are removing the HMO exception provision under Sec. 456.703(b),
because this is a technically incorrect location, and adding a
paragraph (c)(2) under Sec. 456.703 which specifies the exemption for
HMOs.
Comment: One commenter suggested that the nursing facility
exception to the DUR requirement be mandatory, rather than making the
exception optional.
Response: The Act precludes the Federal Government from requiring
States to perform additional drug use reviews with respect to drugs
dispensed to residents of nursing facilities in compliance with the
drug regimen review requirements specified at section 1919 of the Act,
as set forth in Sec. 483.60. States may nonetheless impose DUR
requirements on nursing facilities (see Sec. 456.703(b)).
C. Exemptions for Certain Covered Outpatient Drugs Dispensed by
Hospitals
Section 456.703(c) of the interim final regulations specifies that
a State plan must provide that covered outpatient drugs dispensed by
hospitals using a formulary system and billing Medicaid no more than
the hospital's purchasing cost are not subject to the DUR requirements.
Comment: One commenter suggested that a hospital pharmacy that is
separate from the inpatient pharmacy should be subject to the DUR
requirements as are other retail pharmacies.
Response: Section 1927(j) of the Act applies the exemption to
outpatient covered drugs dispensed by hospitals under certain specified
conditions. Pharmacies located on the hospital premises that are
separate in terms of ownership and fill only outpatient prescriptions
are not entitled to the exemption.
Comment: Two commenters suggested that outpatient prescription
drugs dispensed by hospital pharmacies should not be exempt from the
DUR requirements.
Response: Pharmacies that operate as part of a hospital and also
fill outpatient prescriptions are, by statute, entitled to the
exemption. We have amended Sec. 456.703(c)(1) to indicate that
hospitals which apply for the exemption must provide the State agency
with an assurance that they qualify for the exemption by meeting the
requirements at section 1927(j)(2).
Comment: One commenter suggested the need for clarification of
Sec. 456.703(c) by defining ``hospital's purchasing cost'' and
``formulary system''.
Response: The statute permits States, if they wish, to define the
terms ``formulary system'' and ``hospital's purchasing cost''. We do
not believe that it is necessary to do so in the regulations.
D. Predetermined Standards
Section 456.703(d) of the interim final regulations specifies that
the DUR program must assess drug use information against predetermined
standards as provided for in section 1927(g)(1)(B) of the Act. Sections
456.703 (e)(1) through (e)(4) specify the sources of predetermined
standards. Section 456.703(f) lists eight specific requirements that
predetermined standards must meet, including the requirement that the
source material for development of the standards must be consistent
with peer-reviewed medical literature. Section 456.703(g) requires that
predetermined standards be available to the public, and that
pharmacists and physicians must be informed of their existence and how
they may obtain copies.
Comment: One commenter requested clarification of the distinction
between criteria and standards.
Response: Section 1927(g)(1)(B) indicates that the DUR program is
to assess drug use, based on predetermined standards that are
consistent with three compendia and the peer-reviewed medical
literature. The compendia and the peer-reviewed literature are source
materials for criteria, but additional work is necessary to resolve
differences of opinion in source material and to consider the input of
professional experts. ``Criteria'', as defined in Sec. 466.1 and cross-
referenced in Sec. 456.702, are the predetermined elements of health
care, developed by health professionals relying on professional
expertise, prior experience, and the professional literature, with
which aspects of the quality, medical necessity, and appropriateness of
a health care service may be compared. ``Standards'', as defined in
Sec. 466.1, are professionally developed expressions of the range of
acceptable variation from a norm or criterion, which may be developed
by the States. If, for example, a criterion for the use of H2 receptor
antagonists indicates that acute therapy should not exceed 62 days, a
standard might indicate that acute therapy of up to 67 days would not
warrant consideration of intervention. Although section 1927(g)(1)(B)
of the Act does not define predetermined standards, we believe that the
definitions of criteria and standards at Sec. 466.1 provide an adequate
base to interpret the meaning of predetermined standards.
Comment: One commenter suggested that Sec. 456.703(e)(3) should
delete specific examples of independent organizations from which
predetermined standards may be obtained to broaden the sources of
independent standards. This comment also indicated a typographical
error in paragraph references at Sec. 456.703(e)(4).
Response: We need to specify certain organizations in the
regulations to indicate that criteria should be developed by
organizations which have no vested interest in the sale of drugs
covered by the criteria. Organizations with a vested interest would
have an opportunity to provide input during the DUR board approval
process. Therefore, we have retained the specific organization names.
We have corrected Sec. 456.703(e)(4) to refer to paragraphs (e)(1)
through (e)(4) rather than (f)(1) through (f)(4).
Comment: One commenter suggested the inclusion of additional
sources of predetermined standards, including relevant guidelines from
professional groups, experience of practitioners with expertise in drug
therapy, information from pharmaceutical manufacturers, and data as
well as experience from the DUR program.
Response: The statute provides that criteria developers are to
place primary reliance on compendia and peer-reviewed literature. They
may rely on other source materials to supplement what is in the
compendia and the peer-reviewed literature. In the event of conflicts
between primary materials and supplementary information, such as
professional experience, if the professional consensus process (as
specified in Sec. 456.703(f)(2)) is unable to resolve the conflict, the
supplementary information must not be relied on by the criteria
developer.
Comment: One commenter suggested an amendment to require Food and
Drug Administration (FDA) labeling as the primary source of DUR
criteria.
Response: The statute is specific regarding the primary sources for
predetermined standards. FDA labeling is not included as a primary
source.
Comment: Five commenters requested clarification of
Sec. 456.703(f)(2) regarding the consensus process and what to do if
consensus cannot be reached. Several commenters suggested resolving
disagreements with additional input from professional or medical
organizations or other outside sources. Others indicated that if
consensus is not reachable because of insufficient data or lack of
sufficient knowledge of therapeutic outcomes, it would be satisfactory
to have no criteria or to have more than one standard. One of these
commenters recommended taking into account community practice standards
in seeking consensus. One commenter suggested that the DUR board have
final authority in the case of disagreements.
Response: We have amended Sec. 456.703(f)(2) to specify that
consensus process means that the criteria developers should rely on
professional experts in drug therapy to consider differences in
criteria source materials and come to agreement on how differences
should be resolved. It is expected that the differences would be
resolved before a criterion was submitted to the DUR board for
approval. The DUR board must know the sources, decision guidelines used
in developing criteria, and any other information necessary to evaluate
criteria.
Comment: One commenter suggested a revision of Sec. 456.703(f)(5)
to consider patient as well as provider outliers in identifying
problems and to consider both dispensing and consumption practices. In
addition, the commenter suggested that standards may be considered in
deciding if in-depth review is needed to determine whether to
intervene, once potential therapeutic problems have been identified
through the use of clinical criteria.
Response: We agree and have revised Sec. 456.703(f)(5) to consider
recipients' consumption practices.
Comment: One commenter suggested that Sec. 456.703(f)(6) should be
clarified to indicate that testing against claims data should be to
test the accuracy and ability of criteria to detect significant
problems without undue levels of false positives.
Response: We have amended Sec. 456.703(f)(6) to specify that
criteria be tested against claims data prior to adoption by the
developer in order to validate the level of possibly significant
therapeutic problems without undue levels of false positives.
Comment: Two commenters suggested that criteria for predetermined
standards should be modified to conform to State standards of practice.
Four commenters were concerned with the process used to modify
criteria. One commenter suggested that the State should be required to
establish a process for review and modification of criteria which
provides a mechanism to get input from providers. One commenter
suggested an annual period for receipt of petitions for modification of
criteria. Another commenter suggested that the DUR board issue public
notice when it considers changing criteria. Another commenter suggested
that there is a risk of bogging down the process by establishing
procedures.
Response: The State may require DUR Boards to specify the
procedures suggested by the commenters. The DUR board would then
establish the mechanisms to obtain input, where appropriate, from
providers, the public, and other interested parties concerning
modification of the criteria or the approval of the criteria. To avoid
the possibility that these procedures might impede the efficient
operation of the DUR program, the State may use informal mechanisms
that it deems appropriate. There is no Federal requirement for the use
of notice and comment procedures during the criteria development
process.
Comment: Two commenters suggested that standards be accessible
during development, and public comment should be obtained during
criteria development. Two commenters suggested that it is unnecessarily
burdensome to have to furnish providers with criteria. One of these
commenters suggested providing only a general description, not the
complete criteria. One commenter suggested giving criteria to providers
and allowing reasonable time for compliance.
Response: We believe that making criteria and standards accessible
for public comment during the development period would impede the
development process. Section 456.703(g) does not require distribution
of the criteria to the public or to providers; nor does it require that
the State distribute the predetermined standards to the public. The
regulations, however, do require that predetermined standards must be
made available to the public after they are adopted by the State. They
also require that physicians and pharmacists be informed of what
predetermined standards have been adopted and how they can obtain
copies.
Comment: One commenter suggested that criteria should consider the
needs of the geriatric population. Another commenter suggested that
peer reviewers, not criteria and standards, determine what is necessary
and appropriate. One commenter suggested that professional
prerogatives, to allow for individualized therapy, be linked to the use
of criteria and standards.
Response: To the extent that the peer-reviewed medical literature
and the three compendia specified in the statute reflect the results of
the testing of drugs on elderly subjects, the needs of the geriatric
population will be taken into consideration. Criteria and standards
involve peer reviewers in the development and approval process. Also,
standards provide a basis for State DUR boards to decide the degree of
variation from a criterion which is acceptable to allow for such things
as individualized therapy. In most instances where retrospective drug
use review is conducted, peer reviewers evaluate the results of the
screening process to decide which types of interventions should be
applied to particular situations.
Comment: One commenter suggested that the description of ``peer-
reviewed'' medical literature in Sec. 456.703(f)(1) be revised to
indicate that original manuscripts are ``accepted'' for publication
rather than ``rejected''.
Response: We agree that if a manuscript was rejected, it would mean
that the manuscript had not become peer-reviewed literature. We have
deleted the words ``rejected or'' from the description of peer-reviewed
medical literature.
Comment: One commenter suggested that the Sec. 456.703(f)(1)
provision on ``peer-reviewed'' medical literature should address
conflicts between such literature and compendia.
Response: We realize that there will be conflict between peer-
reviewed medical literature and compendia. However, the resolution of
any such conflict will occur in the consensus process described in
Sec. 456.703(f)(2).
E. Confidentiality
Section 456.703(h) of the interim final regulations requires States
to establish policies concerning the confidentiality of patient-related
data consistent with Federal confidentiality requirements at part 431,
subpart F of the Medicaid regulations, State Pharmacy Practice Acts,
and guidelines adopted by the State Board of Pharmacy or other relevant
licensing authority.
Comment: Six commenters suggested that Sec. 456.703(h) should be
more detailed and should require that States provide pharmacies with
detailed information on how to comply with confidentiality
requirements. The commenters suggested that the section include
guidelines on protection of patient confidentiality in the electronic
claims environment and physician-to-pharmacist confidentiality; and
specify that confidentiality requirements which apply to medical
records also apply to patient profiles maintained by pharmacists.
Response: We believe that the Federal confidentiality requirements
in the regulations at part 431, subpart F, the State requirements
contained in Pharmacy Practice Acts, and the policies developed by
State bodies which regulate the practices of medicine and pharmacy
should be sufficient to protect the confidentiality of patient-related
data and at the same time allow providers access to data to make
informed judgments necessary to effectively conduct DUR. With regard to
the problem of maintaining confidentiality in an electronic
environment, the Workshop on Electronic Data Interchange (WEDI) is
studying these issues but has not yet developed policy recommendations.
In the interim, since use of the electronic drug claims processing
systems may present unique confidentiality problems, particularly with
prospective DUR, States may wish to establish policies to address these
problems.
Comment: One commenter indicated that, as important as
confidentiality is, it should not be allowed to be used to restrict
pharmacist access to relevant data needed to permit accurate assessment
of patient needs so the pharmacist can make informed medication-related
judgments.
Response: Section 456.703(h) of the regulations requires States to
establish policies concerning the confidentially of patient-related
data which is consistent with Federal confidentiality requirements and
State Pharmacy Practice Acts and State Pharmacy Board guidelines. We
believe that this can be accomplished in a manner which both protects
patient confidentiality and allows for access to data needed to
efficiently administer the Medicaid DUR program.
Comment: One commenter asked how HCFA will ensure that patient
confidentiality rules are adequate and how HCFA will monitor compliance
with them.
Response: Since States are primarily responsible for regulating
pharmacy and medical practice, they must determine the adequacy of
confidentiality rules and ensure compliance with them. HCFA will
monitor compliance with the confidentiality requirements through its
review process conducted by regional offices and through review of the
DUR annual reports required by Sec. 456.712.
Comment: Two commenters requested an explanation of why Federal
confidentiality requirements do not apply to patient profile
requirements at Sec. 456.705(d).
Response: The Federal Privacy Act requirements do not apply where
the Federal Government does not control the records in question.
F. Prospective DUR
Section 456.705(a) of the interim final regulations requires review
of drug therapy before each prescription is filled or delivered to a
recipient. This review, as described in Sec. 456.705(b)(1) through (7),
is done at the point of sale, based on predetermined standards, before
a prescription is filled or delivered to the recipient or the
recipient's caregiver. Reviews are to detect drug-disease
contraindications, therapeutic duplication, adverse drug-drug
interaction, incorrect drug dosage or duration of therapy, drug-allergy
interactions, and clinical abuse and/or misuse. Counseling and
maintenance of patient profiles by the pharmacist are required by
Secs. 456.705(c) and (d).
Comment: One commenter suggested that the word ``prescription'' be
changed to ``drug'' in the description of drug-disease
contraindications because contraindications can also occur with over-
the-counter drugs. The commenter also suggested that the term
``clinically significant'' be used to describe adverse medical effect.
This latter terminology would ensure that only significant events would
be reviewed and these regulations would not identify all adverse
effects as contraindications.
Response: We have revised Sec. 456.705(b)(2)(i) to incorporate the
commenter's suggestions.
Comment: Two commenters suggested that the definition of ``adverse
drug-drug interaction'' include the phrase ``clinically significant''
to describe ``adverse medical effect''. Again, this would ensure that
only significant effects would meet this definition, since all adverse
effects need to be reviewed.
Response: We have revised Sec. 456.705(b)(3) to incorporate the
commenters' suggestion. We have made a conforming change to
Sec. 456.703(f)(5).
Comment: One commenter suggested that the definition of ``adverse
drug-drug interaction'' should prohibit substitution of the FDA orange
book ``B'' rated drugs.
Response: It is not HCFA's responsibility to require generic
substitution of the FDA orange book ``B'' rated drugs. State laws
regarding product selection will determine the requirements regarding
generic substitution.
Comment: One commenter suggested an error in the definition of
``incorrect drug dosage'' at Sec. 456.705(b)(4) as a potential drug
therapy problem type that must be included in the screening in point-
of-sale or point-of-distribution reviews. The commenter pointed out
that the reference to ``daily dosage range'' should be ``daily dosage''
as the term ``range'' applies to the standard and is not a part of the
definition. A second commenter suggested that the correct ``duration''
of drug treatment was hard to assess as a potential drug therapy
problem type under Sec. 456.705(b)(5).
Response: We have deleted the references to ``range'' in
Sec. 456.705(b)(4), since we believe that the term is redundant. We
agree with the commenter that duration, in some instances, may be
difficult to assess. However, ranges provided in the predetermined
standards would allow for some variance in individual cases.
Comment: One commenter suggested that the definition of ``drug-
allergy interactions'' include a statement that such problems can only
be identified based upon history obtained from the patient or the
physician.
Response: We agree that information regarding drug- allergy
problems may be only available through contact with the physician or
the patient. However, such a statement is not a proper part of the
definition.
Comment: One commenter suggested that the prospective DUR screening
elements definitions should be consistent with definitions developed by
the National Council for Prescription Drug Programs (NCPDP).
Response: We did review the definitions of prospective DUR,
retrospective DUR, and concurrent DUR developed and recommended by the
NCPDP in developing the interim final regulations. Section 456.705
describes prospective DUR in detail and Sec. 456.709 describes
retrospective DUR in detail. We see no reason to define these terms in
Sec. 456.703. Because the statute does not refer to concurrent DUR, we
have no reason to include this term in the regulation.
Comment: Four commenters were concerned about performing
prospective DUR in an on-line electronic drug claims management
environment. Two commenters suggested not implementing prospective DUR
in an on-line ECM environment until demonstration projects required by
the statute have been completed. Another commenter suggested a
comparison of ECM-based DUR and pharmacy on-site DUR and the
implementation of the most effective approach. One commenter warned
against making prospective DUR too automated because the pharmacist is
essential as a problem solver. One commenter suggested that detailed
prospective DUR rules are unnecessary because prospective DUR can be
performed based on the pharmacist's professional judgment manually, or
electronically, or a combination of the two.
Response: Establishing electronic drug claims management systems
and including prospective DUR as part of such systems are options
available to the States; they are not required. Therefore, prospective
DUR can be done electronically or on site by each pharmacy. The purpose
of the demonstration project required by Congress at section
4401(c)(1)(d) of OBRA '90 is to determine the relative effectiveness of
the ECM-based prospective DUR versus the on-site pharmacy prospective
DUR, and thus assure implementation of ECD-based DUR. We recognize
that, even with automation, prospective DUR cannot be done without the
pharmacist because his or her professional judgment determines whether
and how to respond to an automated alert of a potential problem.
Comment: One commenter suggested that if electronic prospective DUR
is implemented, a professional oversight committee should work to keep
focus on serious problems and to avoid false positives.
Response: We agree that if an electronic prospective DUR is
implemented, a professional oversight committee is needed to ensure
that prospective DUR is focused on serious problems and avoids false
positives. We believe that the State DUR board would be the appropriate
entity to provide such oversight.
Comment: One commenter suggested that in the course of the
prospective DUR, prescriptions should not be changed or denied without
the physician's knowledge.
Response: Except for the quantity dispensed, State law prohibits
changing a prescription. It would be appropriate for the pharmacist to
notify the physician if the prescription is not filled for therapeutic
reasons. Establishing rules requiring such notification is in the
province of State boards of pharmacy and could be included in the State
Pharmacy Practice Acts. In the absence of such rules, the State
Medicaid agency could, where appropriate, establish them.
Comment: One commenter suggested that we define a prescription.
Response: The definition of a prescription is included in the State
Pharmacy Practice Acts.
Comment: One commenter suggested that approval of State plans for
DUR should be contingent on the State providing adequate financial
incentives for pharmacist interventions.
Response: There is no prohibition in the statute or the regulations
against the State providing financial incentives for pharmacist
interventions. The State is free to include, in its reimbursement for
the cost of filling a prescription, consistent with the requirements of
section 1902(a)(30)(A) of the Act with regard to efficiency, economy
and quality of care, amounts to compensate for DUR services.
Comment: One commenter suggested that instructions for compliance
with prospective DUR should go to the pharmacist, not the pharmacy.
Response: We believe that the instructions for compliance with
prospective DUR should be directed to the pharmacies since they are the
Medicaid providers. It would be more burdensome to furnish this
information to pharmacists in part because changes in the pharmacy
staff occur more frequently than do changes in the status of
pharmacies. The owners or managers of pharmacies, as Medicaid
providers, are responsible for furnishing their staff with information
pertaining to DUR.
Comment: One commenter suggested that pharmacists should not be
required to take medical histories.
Response: Nothing in the statute or the regulations requires
pharmacists to take medical histories. Pharmacists must make a
reasonable effort to maintain patient profiles and may, based on their
professional judgment, seek patient specific information for those
profiles.
Comment: Seven commenters pointed out the importance of diagnosis
information and the difficulty of conducting prospective DUR screening
to identify drug-disease and drug- allergy screening without patient-
specific information. One commenter suggested that inaccurate diagnosis
information would generate needless communication between physicians
and pharmacists.
Response: We agree that it is difficult to screen for drug-disease
contraindications and drug-allergy interactions without access to
patient-specific information. Clearly, access to such information
improves the ability to conduct prospective DUR, and obtaining accurate
information is a difficult technical problem. There is also the
question of the relationship of the diagnosis to the use of the
prescription, for example, the diagnosis may be cancer and the
prescription may be for pain. Given these difficulties, problems
associated with access to patient-specific information can best be
resolved by pharmacists cultivating relationships with physicians so
that it becomes possible for the pharmacist to seek patient-specific
information about diagnosis, allergies, and other matters when, in his
professional judgment, it is appropriate for counseling.
Comment: One commenter suggested that HCFA require physicians to
submit diagnosis information, while another suggested that physicians
not be required to provide diagnosis information. Other commenters
pointed to the difficulty of getting diagnosis information from
providers.
Response: Since States regulate the practice of medicine, placing
diagnosis information on prescriptions is a matter for States to
decide.
G. Counseling
Section 456.705(c) of the interim final regulations provides that
applicable State law, or other method satisfactory to the State, must
establish standards for counseling of the recipient or the recipient's
caregiver. The State must provide pharmacies with detailed information
as to what they must do to comply with prospective DUR requirements,
including guidelines on counseling, profiling, and documentation of
prospective DUR activities by the pharmacists. The State law, or other
method satisfactory to the State, must specify how counseling
requirements apply to mail order pharmacies.
The standards must specify whether the pharmacist or an ancillary
person may make the offer to counsel; must specify what documentation
must be maintained on refusals of counsel; and must include in the
counseling those matters considered significant by the pharmacist. The
standards need not require a pharmacist to provide consultation when a
recipient or recipient's caregiver refuses such consultation.
Comment: Five commenters addressed the physician-pharmacist
relationship concerning the provision of counseling services. One
commenter stated that counseling that involves the pharmacist
contacting the physician would create a hassle factor for the
physician. Four commenters suggested the expansion of Sec. 456.705(c)
to include specific statements regarding the physician-pharmacist
relationship: the physician should be able to direct the pharmacist to
include or exclude specific topics for specific patients; the
pharmacist should notify the physician if the patient refuses the
prescription after counseling. In addition, if the pharmacist
identifies a significant risk of an adverse medical result, he or she
should consult the physician prior to counseling. The commenters
indicated concern that inappropriate counseling would result without
the addition of these requirements.
Response: The individual State has the responsibility of
establishing standards of counseling for the pharmacist. Some States
may want to incorporate requirements regarding physician-pharmacist
interaction in their standard; others may not. We believe these
interactions will occur in the normal day-to-day relationships between
physicians and pharmacists. In any event, States should be given the
flexibility of either including, or not including, the suggested
requirements.
Comment: Seven commenters suggested that mail order pharmacies
should be treated the same as all other pharmacies. Counseling
requirements should apply equally to all pharmacy providers of
outpatient drugs.
Response: We concur and have removed the statement concerning mail
order pharmacies from Sec. 456.705(c). Since delivery of a prescription
to a person at home by a pharmacy and mail order prescriptions raise
the same issues about how to offer and provide counseling, we have
amended Sec. 456.705(c) to require State counseling standards to
address this issue.
Comment: Three commenters suggested that the regulations specify
whether the offer to provide counseling is required for new
prescriptions only, both new and refill prescriptions, or whether the
decision to make the offer should be left to the professional judgment
of the pharmacist. One commenter suggested limiting the offer to new
prescriptions; one commenter suggested that it apply to both new and
refill prescriptions; and the third commenter suggested leaving the
decision to the professional judgment of the pharmacist. Six commenters
suggested that the regulations specify the role of ancillary personnel
in making the offer to counsel to the patient or the patient's
representative. The commenters indicated that pharmacists may have
ancillary personnel make the offer of counseling on their behalf, but
the pharmacists must personally conduct counseling if the offer is
accepted.
Response: Since the statute requires each State to establish
standards for counseling, these State standards rather than Federal
regulations must, at a minimum, address the following issues:
Whether the offer to counsel is required for new
prescriptions only, or both new and refill prescriptions;
Whether only pharmacists must make the offer to counsel or
whether auxiliary personnel are authorized to make the offer;
Whether only a patient's refusal of the offer to counsel
must be documented or whether documentation of all offers is required;
Whether documentation of counseling is required; and
How counseling is to be addressed in situations where the
patient's representative is not readily available to receive a
counseling offer or the counseling itself.
We have amended Sec. 456.705(c) to specify that State counseling
standards must address these issues.
Comment: Seven commenters discussed the method of documenting a
patient's refusal of the offer to provide counsel. Six commenters
suggested that pharmacists be given the maximum flexibility in the
method of documenting a patient's refusal of the offer to provide
counsel. One of the six commenters suggested that documentation should
not be mandatory. The seventh commenter suggested that a recipient
should be able to sign a blanket refusal for all prescriptions.
Response: Again, we leave to the States decisions regarding
documentation of offers to counsel.
Comment: Five commenters addressed documentation of counseling in
general, although such documentation was not discussed in the interim
final regulation. Two commenters suggested that guidelines on
documentation be included and three commenters suggested that
documentation standards should be general and not specific.
Response: The statute requires the States to establish standards
for counseling. We have amended Sec. 456.705(c)(1) (formerly the
undesignated introductory paragraph of Sec. 456.705(c)) to specify the
subject matter that must be addressed by these standards.
Comment: Five commenters suggested that Sec. 456.705(c)(1) specify
that the content of counseling should be left to the professional
prerogative of the pharmacist, who should be given proper flexibility
in selecting how patient counseling should be administered in each
circumstance. One commenter requested that the control of the content
not be given to the prescriber.
Response: Section 456.705(c)(3), formerly Sec. 456.705(c)(2),
clearly specifies that the content of counseling is subject to the
professional judgment of the pharmacist. Determining how counseling
should be administered, that is, whether counseling must be oral or to
what extent written communication may be used, depends on the State
standards for counseling.
Comment: Six commenters discussed making an oral offer to counsel.
Two of the six suggested that, in all instances, the offer must be
oral. Three suggested that a written offer should be used where an oral
offer was not possible. The sixth commenter advised that written
material alone should not be substituted for the oral offer.
Response: We believe that the issue of whether the offer to counsel
must be oral, and the extent to which written material may be
substituted for an oral offer of counseling, are matters to be
addressed by State standards for counseling.
Comment: Six commenters suggested additional requirements for
offers of counseling when the patient was not available, when
deliveries were made via mail service or offsite deliveries outside the
area covered by the local telephone exchange. They suggested use of
written instructions (offer to counsel) with the prescription plus a
toll-free telephone number for the patient to call if there were any
questions.
Response: We concur and have amended Sec. 456.705(c)(2) to require
mail order pharmacies to provide toll-free telephone service for all
long distance calls. As stated in the regulation, other pharmacies
whose primary patient population is accessible through a local measured
or toll-free exchange may not be required to offer toll-free service. A
State agency's counseling standards must address special situations
where the patient, or the patient's representative, is not readily
available to receive the offer to counsel or the actual counseling, for
example, prescriptions delivered off site or through the mail.
Comment: Five commenters addressed the provision of a toll-free
telephone number for the patient to use to ask questions or obtain
additional information concerning his or her prescription. One
commenter stated that requiring such a number was not practical. One
commenter requested more information regarding toll-free numbers. One
commenter stated ``access to'' should mean that every patient has the
opportunity to telephone the pharmacist without cost to the patient.
The fourth commenter stated that managed care pharmacies should provide
a toll-free telephone counseling service. A fifth commenter also stated
that pharmacies should provide a toll-free number on the prescription
label which would, in part, meet the ``offer to counsel'' standard.
Response: As stated in the regulation, pharmacists whose primary
patient population is accessible through a local measured or toll-free
exchange may not be required to offer toll-free service. States are
free to further define, under the counseling standards, the term
``primary patient population'', or otherwise specify under what
circumstances pharmacies would or would not be required to provide
toll- free telephone service. Otherwise, pharmacists whose primary
population is not accessible as indicated above, would be required to
provide toll-free telephone service.
Comment: Four commenters suggested that counseling requirements
will alarm, confuse, or raise fears among recipients. Two commenters
indicated that recipients would not understand that refusal to provide
medical history or to accept counseling would not affect their
eligibility for medical services under the Medicaid program.
Response: We do not agree that counseling would alarm, confuse, or
raise fears among recipients. Overall, the program will increase the
knowledge, and the understanding by patients, of the impact of drugs on
their lives. With such increased knowledge, patients can better
participate in the administration of the medical care that they are
receiving. Rather than alarm patients, the offer to counsel and the
actual counseling can be used to alleviate their fears by providing an
explanation which could cover not only the items suggested in the law
and regulations but also the impact of the counseling program on the
individual's eligibility for medical services under the Medicaid
program.
Comment: One commenter suggested that the regulations be amended to
acknowledge what many States had done to implement model patient
counseling legislation that established how the ``offer to counsel'' is
made to the patient.
Response: We do not believe that an acknowledgement of what States
have done thus far would serve any purpose. It would not be feasible to
include a current list of such States in the regulations since the list
would be growing constantly. If such recognition is provided for model
patient counseling legislation, then recognition should also be
provided to States that have model retrospective review programs,
prospective programs, and point-of-sale ECM systems. HCFA intends to
share with the States information and technology that various States
have found effective for administering DUR.
Comment: One commenter suggested that the regulation distinguish
between the ``offer to counsel'' and the act of counseling itself.
Response: We believe that Secs. 456.705 (c)(1) and (c)(3) already
distinguish between the offer and the content of counseling.
Comment: Two commenters suggested that the counseling requirements
are an unwarranted Federal intrusion and may have adverse consequences
for the mentally ill. They stated that absolute confidentiality must be
maintained and counseling must be done in a discreet, supportive,
informative, and non-threatening manner.
Response: We agree that the protection of confidentiality and the
sensitivity with which counseling is conducted are critically
important. Since the States and pharmacists, not the Federal
Government, are responsible for counseling, we do not believe that an
unwarranted Federal intrusion has occurred.
Comment: One commenter asked whether the $1 to $2 cost estimate per
prescription for counseling services was based upon the pharmacist or
the ancillary personnel making the offer to counsel.
Response: This estimate was based upon the pharmacist making the
offer of counseling.
Comment: One commenter noted that the timing of the issuance of the
rule placed States and pharmacies at a serious disadvantage as it
permitted only 60 days for the adoption of counseling standards through
legislation or regulation.
Response: We agree that the timeframe for issuing the regulations
was unusually short and placed a burden on the States. However, most
States have successfully established counseling standards to comply
with the regulations.
H. Profiling
Section 456.705(d) of the interim final regulations requires
States, in the case of Medicaid recipients, to require pharmacists to
make a reasonable effort to obtain, record, and maintain patient
profiles. The profiles, at a minimum, must contain the following
information: (1) name, address, telephone number, date of birth (or
age), and gender of the patient; (2) individual history, if
significant, including disease state or states, known drug reactions,
and a comprehensive list of medications and relevant devices; and (3)
the pharmacist's comments relevant to the individual's drug therapy.
Comment: Two commenters suggested that ``individual history''
rather than ``individual medical history'' should be one of the minimum
information items.
Response: We agree and we have changed Sec. 456.705(d)(2) to delete
the word ``medical''. The term ``medical history'' is not appropriate,
as ``medical history'' includes obtaining specific information
regarding laboratory results, diagnosis, and other medical findings.
Comment: Three commenters suggested that the regulations should
include a statement that profile information can be obtained by
ancillary personnel, but the pharmacist must review and interpret the
information obtained.
Response: We believe this is an individual State decision. A State
that decides to authorize auxiliary personnel to obtain profile
information may include such authorization and the appropriate
requirements for the use of auxiliary personnel in their standards for
counseling.
Comment: Three commenters addressed the use of the term
``reasonable effort'' for obtaining profile information in
Sec. 456.705(d). One commenter suggested the term should be further
defined or deleted. One commenter suggested expansion of the term to
state that ``the pharmacist is responsible for ensuring that a
reasonable effort is made to obtain profile information.'' The third
commenter suggested expanding the statement to indicate that
``reasonable effort'' should not include additional burden or cost to
the pharmacist.
Response: We have decided not to define reasonable effort in the
regulations to allow States flexibility in implementing the DUR
requirements. States and their pharmacy boards may, or may not, choose
to further define ``reasonable effort''.
Comment: One commenter stated that Sec. 456.705(d)(2) should be
amended to make it explicit that the profiling requirements are limited
to recording information concerning drugs and devices dispensed at the
pharmacy where the pharmacist is employed.
Response: We have retained the phrase ``a comprehensive list of
medications and relevant devices'' as the statute specifies in section
1927(g)(2)(A)(ii) of the Act. Neither the statute nor the regulation
defines a ``comprehensive list''; therefore the State, if it chooses,
may further define the term according to section 1927(g)(2)(A)(ii) of
the Act. Methods for securing this information could include checking
the pharmacy's own record, receiving an alert message from the
electronic claims management system, or asking the patient, physician,
or other pharmacies for additional information if, in the professional
judgment of the pharmacist, it was appropriate to do so.
Comment: One commenter suggested that HCFA study the advantages and
disadvantages of requiring the collection of information for profiles.
Response: We will consider these matters as a subject for HCFA
studies of the DUR program and its impact on the industry and the
public.
I. Retrospective DUR
Section 456.709 of the interim final regulations requires that the
State Medicaid plan provide for a retrospective DUR program for ongoing
periodic examination of claims data and other records in order to
identify patterns of fraud, abuse, gross overuse, or inappropriate or
medically unnecessary care among physicians, pharmacists, and Medicaid
recipients, or associated with specific drugs or groups of drugs. This
examination must involve pattern analysis, using predetermined
standards of physician prescribing practices, dispensing practices of
pharmacies, and drug use by individual patients. This program must be
provided through the State's mechanized drug claims processing and
information retrieval system or an electronic drug claims processing
system that is integrated with the Medicaid Management Information
System (MMIS).
Comment: Two commenters suggested peer review prior to any
intervention suggested by DUR reports or outliers identified by
computerized DUR programs. A third commenter suggested that the
regulations state that the system should not produce punitive decisions
against physicians.
Response: It is up to each State to determine whether, and under
what circumstances, peer reviews of therapeutic problems identified
through screening applications based upon predetermined standards, will
be required. States may require peer review prior to all interventions
or identify circumstances where peer reviews are, or are not, required.
We do not believe that it is appropriate to address the question of
punitive decisions against physicians. The objective of the DUR is to
improve pharmaceutical care through education.
J. Education Program
Section 456.711 of the interim final regulations requires that the
State plan must provide for ongoing outreach programs that educate
practitioners on common drug therapy problems with the aim of improving
prescribing and dispensing practices. Section 456.716(d)(5) requires
the DUR Board to: (1) identify and develop educational programs if
needed; (2) make recommendations regarding interventions; and (3)
periodically reevaluate and, if necessary, modify interventions.
Section 456.716(d)(6) specifies that the Medicaid agency, or its
contractor, should apply predetermined standards to drug claims data
and generate reports for use by the board and carry out educational
programs specified by the board.
Comment: Five commenters suggested expanding Sec. 456.716(d)(5) to
make it more specific. One commenter suggested the creation of a fifth
provision to require more in-depth review prior to intervention. Other
commenters stressed ``appropriate and balanced'' education programs
based upon program experience, matching the education program to the
drug therapy problem identified, and placing more emphasis on
preliminary education.
Response: We have expanded Sec. 456.716(d)(5)(ii) to address the
commenters' suggestions. The DUR Board recommendations for educational
interventions must be based on an in-depth review of claims data
reports. The board may decide which educational intervention approaches
are suitable for the drug therapy problems identified. We have changed
Sec. 456.703(f)(5) to specify that standards (that is, exceptions to
criteria) may be used in deciding whether or not to intervene after the
potential therapeutic problems have been identified.
K. Annual Report
Section 456.712 of the interim final regulations provides that a
State must require the DUR Board to prepare and submit annual DUR
reports to the Medicaid agency. The Medicaid agency is required to
prepare and submit an annual report to the Secretary of the Department
of Health and Human Services that incorporates the DUR board's report
and includes detailed information on the DUR program operations and an
estimate of the cost savings attributable to the DUR program.
Comment: Ten commenters addressed the DUR cost savings estimate
required in the annual report. Three commenters suggested that
Sec. 456.712 should specify that savings resulting from reduced
physician visits and hospitalizations should be taken into account. Two
commenters suggested that we require comprehensive evaluations,
including both clinical and economic evaluations that would estimate
total savings of DUR.
Response: The requirement that State Medicaid agencies submit a
cost savings estimate refers to those savings that can be attributed to
the operation of prospective and retrospective DUR. The report on cost
savings must identify what is spent annually to operate the DUR program
and also identify the savings to the Medicaid drug program as a result
of DUR. It may include savings that result from reduced physician
visits and reduced hospitalizations if the State can document such
savings. We agree that evaluating both the economic and clinical impact
of DUR is important and the States should, to the extent that they are
able, take both types of outcomes into account when evaluating their
DUR programs. Demonstration projects are also addressing outcomes,
including physician visits, emergency room visits, and
hospitalizations. The Agency for Health Care Policy and Research of the
Public Health Service is conducting an evaluation of pharmaceutical
outcomes, and may cover this topic in its study.
Comment: Three commenters stated that it would be difficult to
estimate cost savings as a result of the DUR program and asked for
suggestions as how to perform this task. One commenter recommended that
HCFA define the word ``costs'' in Sec. 456.712(b)(10) when referring to
the cost savings estimates to be included in the annual report. Another
commenter suggested that the cost of DUR be expressed in terms of cost
per recipient.
Response: Currently HCFA is developing a cost savings methodology
for use by State Medicaid agencies, at their option, when estimating
the cost savings that result from DUR. These guidelines will specify
data collection needs. They will also suggest what costs are to be
considered and whether or not to express costs in terms of cost per
recipient. The guidelines for reporting cost savings will be
distributed to the States on an advisory basis.
Comment: One commenter suggested that Sec. 456.712(b)(3) be revised
to require States to include information in the annual report that
describes the process and sources used for establishing and revising
criteria.
Response: HCFA will provide guidance to the States about the
contents of the annual reports which will include information relating
to sources for criteria. We do not believe it is necessary to include
this as a regulatory requirement. The State DUR Boards will have such
information available if there are any questions about the selection of
criteria and standards.
Comment: One commenter suggested that providing complete criteria
in annual reports would be cumbersome and costly. Another questioned
whether the provision of criteria in the annual report would eliminate
the need for the State's cost savings estimate.
Response: Section 1927(g)(3)(D) of the Act identifies specific
information that must be included in the annual report to allow us to
evaluate the effectiveness of each State's DUR program. HCFA's Medicaid
Bureau has provided additional informal guidance with regard to the
contents of the annual reports. This guidance indicates that detailed
information about DUR-approved criteria must be provided but not
necessarily the criteria themselves. This approach addresses concerns
about the burdensome nature of submitting complete criteria in the
annual reports. The statute requires inclusion of a cost savings
estimate in the annual report; therefore provision of detailed
information on the criteria does not eliminate the requirement that the
State must submit a cost savings estimate.
Comment: One commenter suggested that a requirement be established
for adequate data to be collected by State Medicaid agencies, to prove
that the DUR program is beneficial.
Response: State agencies are required to submit an annual DUR
report to HCFA. As previously indicated, HCFA will provide guidance as
to what data are needed to determine cost effectiveness.
L. Drug Use Review and Surveillance and Utilization Review (SUR)
Section 456.714 of the interim final regulations states that the
retrospective DUR requirements parallel some portion of the
Surveillance and Utilization Review (SUR) requirements in subpart A of
part 456 and in part 455 of the Medicaid regulations.
Comment: Two commenters suggested that SUR and DUR activities
should be completely separate and distinct.
Response: We agree with the commenters and we have revised
Sec. 456.714 to indicate that the SUR program and the DUR program have
overlapping responsibilities to identify and reduce the frequency of
patterns of fraud, abuse, and gross overuse of drugs. Given the
historical emphasis of SUR units in this area, we believe that the DUR
staffs should focus their limited resources on what constitutes
appropriate and medically necessary pharmaceutical care. It is the
State's option, however, to establish what it considers to be the
appropriate balance between fraud and abuse and medical appropriateness
concerns.
Comment: One commenter requested clarification of Sec. 456.714 and
an explanation of how cost savings from SUR are to be taken into
account in calculating DUR cost savings required by
Sec. 456.712(b)(10).
Response: HCFA is developing specific guidance to assist the States
in determining DUR costs savings as required by Sec. 456.712(b)(10).
This guidance will address the issue of whether or not to include SUR
cost savings.
M. DUR Board
Sections 456.716(a) and (b) of the interim final regulations
require that each State establish a DUR Board and establish
requirements for the composition of the DUR Board and expertise of its
members. Section 456.716(c) specifies the relationship between the DUR
Board and the State Medicaid agency; Sec. 456.716(d) discusses
activities of the DUR Board; and Sec. 456.716(e) specifies funding
available for DUR Boards.
Comment: Five commenters expressed concern about the relationship
between the DUR Board and the State Medicaid agency as provided for in
Sec. 456.716(c). Four commenters suggested that the DUR Board be
separate from the Medicaid agency or have final authority with regard
to clinical issues such as approval of criteria. One commenter
suggested the DUR Board should have rulemaking authority. One commenter
suggested that DUR Boards should not be independent.
Response: Section 1902(a)(5) of the Act, which specifies that a
single State agency must administer or supervise the administration of
the Medicaid program, precludes making DUR Boards independent of the
State agency. While it is expected that a State will rely heavily on
the clinical expertise of the DUR Board, this does not preclude the
State agency from independently assessing the DUR Board's
recommendations to assist it in reaching its decisions.
Comment: Four commenters addressed the issue of procedures for DUR
Board action if a State agency overrules the DUR Board. Two commenters
suggested that DUR Boards have procedures to make their activities
public, including possible public comment procedure for responses to
outside input. Two commenters indicated that when the State agency
overrules the DUR Board, it must make public the reasons for its
actions and consider public comment.
Response: States may require DUR Boards to establish informal
procedures through which outside parties may contribute input with
regard to the application of predetermined standards. Section
456.716(c) gives the State agency the authority to overrule the DUR
Board. The State agency may or may not make its reasons public,
depending on the rules which it establishes for the creation of the DUR
Board.
Comment: Five commenters addressed the composition of the DUR
Boards. Some commenters suggested the need for more specifics about
membership such as the possibility of having public members,
representatives of chain pharmacies, and psychiatrists. One commenter
suggested that pharmacist members have DUR experience.
Response: The State agency is free to determine the size of the DUR
board and may include any types of members that it considers
appropriate so long as it complies with Secs. 456.716 (a) and (b).
Comment: One commenter suggested that the issue of possible
conflict of interest of Board members be dealt with.
Response: Section 1927(g)(3)(b) of the Act and Sec. 456.716 of this
regulation specify that members of the DUR boards must be health
professionals who have recognized knowledge and expertise in one or
more of the following: the clinically appropriate prescribing of
covered outpatient drugs; the clinically appropriate dispensing and
monitoring of covered outpatient drugs; drug use review, evaluation,
and intervention; or medical quality assurance. We are monitoring
compliance with these requirements and expect that States will take
whatever actions they deem appropriate, consistent with their laws and
regulations concerning conflict of interest, to protect against
conflict of interest in the operation of the DUR boards.
Comment: One commenter suggested that DUR Boards have the
flexibility to determine appropriate interventions and when to use
them. The commenter also suggested that there is no need to have all
interventions reviewed by peers before they are carried out.
Response: DUR Boards do have the flexibility to determine
appropriate interventions and when to perform them. It is up to the DUR
Board to decide under what circumstances peer review must occur prior
to interventions and when interventions may occur without such review.
Comment: Eighteen commenters responded to the request for comment
on the interim final regulations about the appropriateness of having
DUR Boards certify prospective DUR software. Ten of these commenters
indicated that the DUR Board should not take on the task of certifying
individual pharmacy prospective DUR software because of the enormity of
the task, the DUR Board's lack of expertise in this area, and because
the Board should not be put in a position of providing something
equivalent to a seal of approval for software products. Five of the
commenters suggested that DUR Boards should approve prospective DUR
software. One commenter suggested that it would be more economical for
HCFA to undertake evaluation of software packages. Two commenters
suggested that DUR Boards should not deal with evaluation of individual
pharmacy prospective DUR software but should provide guidance as to
which products available to pharmacies would meet statutory
requirements.
Response: We agree with those commenters who indicated that the DUR
Boards should not take on the task of certifying individual pharmacy
prospective DUR software. DUR Boards should know and understand the
criteria upon which the software is based, but they often do not have
the expertise to evaluate the quality and efficiency of the software
itself. Undertaking such certification would be excessively burdensome
and create the impression that some packages have State government
approval while others do not.
Comment: One commenter suggested that the requirement in
Sec. 456.716(b) that pharmacists must be licensed and actively
practicing in the State on whose DUR Board they serve would be
burdensome to small States seeking to recruit experts from nearby
States.
Response: We concur and have revised Sec. 456.716(b) by eliminating
the requirement for licensure by the State on whose DUR Board the
pharmacist is serving.
N. Electronic Drug Claims Processing
Section 456.722 of the interim final regulations establishes
functional requirements for those State Medicaid agencies that choose
to develop an on-line, real-time point-of-sale electronic claims
management (ECM) system to perform eligibility verification, claims
data capture, claims adjudication, and to assist pharmacists in
applying for and receiving reimbursement for services.
Comment: Four commenters addressed the costs of in-store
telecommunications and the installation and use of on-line dedicated
telecommunications lines. They recommended that pharmacy providers
should be compensated for the additional costs incurred. One commenter
suggested that the States should pay costs, charges, and fees related
to on-line communication. Four commenters addressed the issue of costs
associated with establishing an on-line, real-time ECM system and asked
who would be responsible for the costs. They questioned whether access
to the system would be toll free. They suggested that providers be
compensated for costs associated with telecommunications, software
enhancements, etc., that HCFA or fiscal agents, rather than pharmacies,
take responsibility for telecommunication costs, and that HCFA require
States to pay associated costs.
Response: State Medicaid agencies, who may receive FFP for the ECM
systematic MMIS at enhanced rates if functional requirements are met,
may also decide the amount of funding they will offer providers for
hardware, software, and telecommunications charges, if any. A State may
base this decision on such variables as what the average cost will be
for pharmacies to participate, the amount of FFP received by the State
for the ECM subsystem, and whether the State's budgets will enable it
to compensate pharmacies who have incurred additional costs due to ECM.
The State agency is free to pay transmission charges and other costs
associated with participation in an ECM system or to require pharmacies
to cover these costs.
Comment: One commenter stated that ``ECMS'' should require only the
minimum data elements necessary for processing and paying claims. No
variable data elements should be permitted.
Response: HCFA requires at least the minimum data set for
processing and paying claims as defined in Part 2 of the State Medicaid
Manual. Given the wide variation in State programs, however, we believe
that it would be unwise at this time to restrict data that States may
need for proper program administration. Thus, States have the option to
add other data elements, as necessary.
Comment: Eight commenters suggested that HCFA require State
Medicaid agencies to comply with one industry telecommunications
standard. Six of the eight commenters recommend NCPDP's Version 3.2 to
be incorporated into Sec. 456.722. One commenter suggested that HCFA
require the use of RFDS 3C in all State POS/ECM systems.
Response: Currently, the State may decide the format for its ECM as
long as it meets the requirements of the minimum data set provided in
Part 2, section 11375 of the State Medicaid Manual. However, with the
growing use of the Electronic Data Interchange (EDI) and the
possibility of a Federal requirement that mandates its use by the
Medicaid program, a standard format requirement for ECM subsystems may
be forthcoming. Moreover, HCFA announced in an advance notice of
proposed rulemaking in the Federal Register on October 19, 1992 (57 FR
47587) that it endorses electronic standards established by the
American National Standards Institute (ANSI). We anticipate final
adoption of the ANSI electronic standards as the required
telecommunications standard.
Comment: One commenter recommended that the ECM system develop
electronic payment capabilities by incorporating the electronic funds
transfer (EFT) program, or it will be of little value.
Response: The States may decide whether their ECMs will have an EFT
capability. HCFA requires only that ECMs take steps toward the payment
of the claim, in order to receive FFP, but not that funds be sent
electronically.
Comment: Four commenters addressed the establishment of ECM
systems. Two commenters suggested that providers be required by HCFA to
use ECM systems. One commenter suggested that participation in an ECM
system be an option for the pharmacy. One commenter requested that
batch processing of claims for prescriptions be included in any ECM
program.
Response: State Medicaid agencies may determine whether providers
will be required to use ECM systems and whether providers using the ECM
system will be required to rely on the State's prospective DUR, if the
State has one. At this time, HCFA does not require State Medicaid
agencies to establish ECM systems or to use them to accomplish
prospective DUR.
Comment: Two commenters suggested that HCFA should require mail
order pharmacies' ECM systems to be on-line, real-time. One commenter
suggested that the exemption allowing batch claims submission mentioned
in Sec. 456.722(b) also be available to retail pharmacies.
Response: States are responsible for determining whether mail order
dispensers and other providers are required to operate a real-time ECM
system, or a batch processing system at the end of each day or at a
time specified by the State Medicaid agency.
Comment: One commenter recommended that HCFA not require States to
obtain cost/benefit analyses prior to procuring point-of-sale ECM.
Response: An analysis that shows the cost effectiveness of the ECM
is required in order for the States to receive enhanced FFP for the
system.
O. Dispensing Physicians
The interim final regulations are silent on the subject of
dispensing physicians.
Comment: One commenter pointed out that the regulations do not deal
with the situation of dispensing physicians.
Response: Section 1927(k)(3) of the Act states that the term
``covered outpatient drug'' does not apply to drugs provided as
physicians services unless there is a separate reimbursement for the
drug. If there is a separate reimbursement claim for a drug dispensed
by a physician, all the requirements of section 1927(g) apply to that
physician, except for the requirements to offer patient counseling and
to collect, record, and maintain patient profiles. This is because the
Act specifically speaks to a pharmacist's responsibilities in these two
areas. The State is free to develop State requirements with regard to
patient counseling and patient profiles for dispensing physicians.
Comment: One commenter suggested that dispensing physicians not be
allowed to submit claims through ECM systems.
Response: While the Secretary has been explicitly directed by the
statute to encourage the use of ECM systems, States are free to
establish policy with regard to the submission of claims through ECM
systems.
P. Renal Dialysis
Section 1927(k)(3) of the Act does not include as a ``covered
outpatient drug'' under Medicaid, drugs provided for renal dialysis
unless direct reimbursement for the drug is involved.
Comment: One commenter pointed out that drugs administered to
Medicaid recipients in renal dialysis centers are or are not subject to
DUR, depending on whether or not there is separate reimbursement for
the drug.
Response: We agree with the commenter. Section 1927 (k)(3) of the
Act provides that drugs provided to Medicaid recipients in renal
dialysis centers are not subject to DUR unless there is a separate
reimbursement for the drug product.
Q. Liability
The Act and the interim final regulations are silent with regard to
additional liability incurred by pharmacists as a result of DUR
requirements.
Comment: Three commenters suggested that the preamble language that
pharmacies would not incur additional liability is not correct and
pharmacists should expect to have additional liability problems.
Response: Suits may result from pharmacy practice of DUR, but we
have no evidence to support or refute the contention that the level of
liability suits will increase. Since the DUR requirements specified in
OBRA '90 constitute standards of pharmacy practice for Medicaid
recipients, compliance with these standards provides the best
protection against possible liability actions.
Comment: Five commenters suggested that pharmacists be held
harmless from liability associated with conducting DUR or that HCFA
assume such liability.
Response: We know of no statutory basis for holding pharmacists
harmless from such liability or for having HCFA assume such liability
that may result from compliance with the DUR requirements.
Comment: One commenter asked about product liability.
Response: We do not believe that product liability would be
impacted by the OBRA '90 DUR requirements.
R. Comments on the Regulatory Impact Analysis
Comment: Two commenters questioned the Congressional Budget Office
estimate of $10 million to $40 million savings annually. One commenter
suggested that the DUR provisions will cost more than they save. The
other commenter stated that significant hardware and software costs
will reduce cost savings.
Response: Since these commenters provided no specific data, we will
not make changes to the Congressional Budget Office estimates.
Comment: Ten commenters questioned the hardware-software costs
associated with the DUR program. They included estimates for software
costs of: $1,500, $1,900, $2,000 to $5,000, and $3,500. One commenter
suggested the cost of a new computer would be $3,600 to $6,000; a
second commenter indicated that 10 percent of their group would need
new computers. One commenter indicated annual upgrade and modification
costs would be $995 per pharmacy.
Response: We concur with the majority opinion that our original
estimates may be low and probably should reflect costs in the $1,500 to
$3,500 range. However, due to the lack of any empirical data, we are
unable at this time to make this determination with any degree of
certainty.
Comment: Four commenters questioned the cost of counseling, all
indicating cost estimates should be higher; however, only two provided
their own estimates. One commenter suggested that 5 minutes would be
necessary for counseling and profiling at a cost of $2.50 per
prescription. Another commenter indicated that the time and cost per
prescription for the DUR requirements would be 4 minutes and $2.98
($2.98 includes 50 cents for hardware- software costs). One commenter
suggested that the usual and customary charge should be reimbursed to
ensure adequate compensation for DUR services. Four commenters
suggested that the dispensing fee will need to be changed to reflect
the increased requirements for DUR. None of the commenters suggested
specific cost figures.
Response: We believe that 5 minutes at a cost of $2.50 per
prescription is a reasonable estimate that would raise our top estimate
from $140 million to $175 million. However, as we stated earlier, we
lack any empirical data to substantiate this claim.
Comment: Six commenters suggested that the estimates in the interim
final regulations did not include, or consider, the cost of
interventions or consultations with physicians. One commenter, using
data from a study that the commenter conducted, reported that 1.9
percent of all prescriptions require interventions. Where interventions
are made, 87 percent of these interventions involve contact with the
physician. This commenter estimated that with 2 to 4 minutes per
consultation, at a pharmacist hourly rate of $30, the total cost would
be $10 to $20 million for approximately 140 million new prescriptions
per year.
Response: We generally agree that some of our estimates may be low.
However, we do not believe, absent any additional definitive research
studies that we can make any provisional changes as a result of this
study at this time.
Comment: Three commenters suggested reimbursement for ``cognitive
services.'' One commenter suggested that the cognitive fee be separate
from the dispensing fee. The second commenter indicated that a
cognitive fee payment would ensure that pharmacists would maximize
program efficiencies. The third simply advocated payment for such
services.
Response: Currently, there is no authorization in Federal statute
or regulation for a separate payment for cognitive services. However,
section 4401(c)(2) of OBRA '90 authorizes a demonstration project on
the cost-effectiveness of reimbursement for pharmacists' cognitive
services. When this demonstration project is completed, consideration
may be given to the inclusion of reimbursement for cognitive services
in the payments made to pharmacists.
Comment: The commenters addressed various subjects, all indicating
their impact on increasing costs. One commenter suggested that
recordkeeping and liability costs will increase. Three commenters
indicated that costs associated with establishing and maintaining
profiles were not included in the estimates. Six commenters were
concerned about increased costs (one comment indicated DUR costs would
be shifted to other payers).
Response: Some of these costs will be considered by the State in
establishing the dispensing fee. As indicated in existing Secs. 447.331
and 447.332 of the Medicaid regulations, the State is authorized to
include a reasonable dispensing fee in its payments to pharmacies. This
area is discussed in response to the comment regarding liability costs
in section II. Q. of this preamble.
Comment: One commenter stated that the regulatory impact analysis
was not adequate and seriously underestimated the impact of the rule on
small pharmacies. The commenter suggested a more comprehensive
regulatory flexibility analysis and recommended a longer compliance
schedule for small businesses and looking at other alternatives to ease
the burden.
Response: We disagree with the commenter. The analysis in the
interim final rule did address the impact on pharmacies, States,
dispensing fees, cost of counseling, and the costs of educational
outreach. Since the commenter offered no data to support the comment
and did not suggest a methodology for conducting the analysis, we are
not making a change in the regulation at this time.
III. Changes to the Interim Final Rule
In developing the November 1992 interim final regulations, we
essentially relied on the language of sections 1927 (g) and (h) of the
Act. We also sought and received advice from various national provider
associations, pharmaceutical companies, States, drug utilization review
firms, and others. The interim final regulations became effective on
January 2, 1993.
We have reviewed all of the public comments received on the interim
final regulations and, in summary, have made the following changes.
We have amended Sec. 456.702 to clarify the definitions of
``overutilization'' and ``underutilization''.
We have removed the technically incorrect HMO exception
from Sec. 456.703(b) and added a new paragraph at Sec. 456.703(c)(2) to
indicate the HMO exemption from DUR.
We have included under Sec. 456.703(c)(1) a provision that
those hospitals that claim the exemption from DUR must give assurances
to the State that they meet the requirements of section 1927(j)(2) of
the Act.
We have removed the words ``rejected or'' from
Sec. 456.703(f)(1) to clarify that only published peer-reviewed
literature is an acceptable criterion.
We have added a definition of ``the consensus process'' to
Sec. 456.703(f)(2).
We have amended Secs. 456.703(f)(5) and 456.705(b)(3) to
clarify that only ``clinically significant'' adverse medical results
warrant consideration in the prospective drug review. We also added
wording under Sec. 456.703(f)(5) to include the consideration of
patient consumption practices and standards.
We have added wording to Sec. 456.703(f)(6) to clarify the
reason for testing criteria against claims data.
We have changed the word ``prescription'' to ``drug'' in
Sec. 456.705(b)(2)(i) in order to include consideration of non-
prescription drugs with regard to alteration of therapeutic effect.
In Sec. 456.705(b)(4), we have specified ``daily dosage''
rather than ``daily dosage range'' in the description of what
constitutes incorrect drug dosage.
We have removed the reference to how drug counseling
requirements apply specifically to mail order pharmacies from
Sec. 456.705(c) (now designated as Sec. 456.705(c)(1)) so that we do
not give the impression that they are treated differently than other
pharmacies. Also, we have added language in Sec. 456.705(c)(1) (i)
through (v) to specify the issues that State agencies must address when
formulating their counseling standards.
We have added wording to Sec. 456.705(c)(2)(i), previously
Sec. 456.705(c)(1), to require mail-order pharmacies to provide toll-
free telephone service for long distance calls for counseling.
In Sec. 456.705(d)(2), we have replaced the phrase
``individual medical history'' with ``individual history'' since
medical history would indicate the need for much more complete records,
including such items as laboratory reports, X-rays, consultation
reports, and unrelated surgeries and illnesses.
We have added a paragraph to Sec. 456.714 clarifying the
distinction between the responsibilities of DUR and SUR.
We have amended Sec. 456.716(b) to change the requirement
for licensure of a DUR board member in the State on whose board he or
she serves, to licensure in any State.
In Sec. 456.716(d)(5)(ii) we have added wording to clarify
the bases for DUR board recommendations, and we have added wording to
Sec. 456.703(f)(5) to allow the consideration of standards if an in-
depth review is needed to determine whether to intervene once the
potential therapeutic problems have been identified through the use of
clinical criteria.
Also, we have made certain technical corrections and
corrections of typographical errors that appeared in the interim final
rule.
VI. Regulatory Impact Statement
A. Regulatory Flexibility Act
We generally prepare a regulatory flexibility analysis that is
consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
through 612) unless the Secretary certifies that a rule will not have a
significant economic impact on a substantial number of small entities.
For purposes of the RFA, all pharmacies and prescribing physicians are
considered to be small entities.
B. Comments on Regulatory Impact Analysis and Regulatory Flexibility
Analysis
In the interim final rule with comment period, we included a
regulatory impact and regulatory flexibility analysis because of the
financial impact on the operation of pharmacies, the States, and on
recipients. The analysis described the effects that the interim final
rule with comment period would have on these individuals and entities.
We received 35 comments concerning the costs of the drug use review
program, the cost of the DUR requirements on pharmacies, and the cost
estimates included in the interim final rule. All commenters indicated
that the actual costs of implementing the provisions will be higher
than the amounts presented. Eight of the commenters furnished specific
cost figures either for their particular operation or they supplied
estimates of specific costs per prescription, type of service rendered,
equipment costs, or total program costs.
The comments covered the following specific areas:
Initial hardware and software computer costs
Upgrade costs for computer programs
Counseling
Cognitive services
Dispensing fees
Consultation with physicians
Interventions by pharmacies
Recordkeeping
Additional liability for the pharmacist
Profiles
The other commenters suggested the cost saving estimate was too
high, advocated increased Federal funds to offset DUR costs, urged
voluntary compliance of prospective DUR requirements for small fragile
pharmacies, warned that DUR cost estimates were too low, and requested
a comprehensive regulatory analysis for small businesses. For a
complete summarization of these comments and our responses, see section
II of this preamble.
We were unable to provide a more quantitative analysis due to the
lack of empirical data. However, we did receive several studies from
commenters. Although these data were somewhat limited, we agree that
some of our estimates were low. We believe, however, that additional
research in the future concerning these issues is needed to provide us
with more specific results.
This final rule revises the November 2, 1992, interim final rule
with comment period based on comments submitted by the public. Costs
associated with implementing these regulations are a consequence of
section 4401 of OBRA '90, not the regulations. We do not believe,
absent any additional definitive research studies, that the changes
incorporated into this final rule as a result of public comments will
have any significant effect on DUR costs.
C. Impact on Small Rural Hospitals
Section 1102(b) of the Act requires the Secretary to prepare a
regulatory impact analysis if a final 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 604
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.
We are not preparing a rural impact analysis since we have
determined, and the Secretary certifies, that this final rule will not
have a significant impact on the operations of a substantial number of
small rural hospitals. In accordance with the provisions of Executive
Order 12866, this regulation was reviewed by the Office of Management
and Budget.
V. Collection of Information Requirements
Sections 456.703, 456.705, 456.709, 456.711, 456.712, 456.716, and
456.722 contain information collection or recordkeeping requirements or
both that are subject to review by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et
seq.). The information collection requirements concern the collection
of information for patient profiles of Medicaid recipients, preparation
by the State DUR boards of annual reports to the State agency, and
preparation of annual reports by the State agency to the Secretary.
These are statutory requirements. The respondents who will provide the
information include Medicaid recipients who will provide information
for profiles to pharmacists, State DUR boards that will provide annual
report information to the State agencies and State agencies that will
provide annual report information to the Secretary. Public reporting
burden for the collection of profile information is estimated to be 5
minutes for each initial encounter and 2 minutes for each subsequent
encounter. Public reporting burden for the collection of the annual
report information, which includes activities by the DUR board and by
the State agency, is estimated to be up to 60 hours a year per State.
A notice will be published in the Federal Register after approval
is obtained.
List of Subjects in 42 CFR Part 456
Administrative practice and procedure, Grant programs--health,
Health facilities, Medicaid, Reporting and recordkeeping requirements.
42 CFR part 456 is amended as set forth below:
PART 456--UTILIZATION CONTROL
1. The authority citation continues to read as follows:
Authority: Sec. 1102 of the Social Security Act (42 U.S.C.
1302), unless otherwise noted.
2. In Sec. 456.702 the definitions of ``overutilization'' and
``underutilization'' are revised to read as follows:
Sec. 456.702 Definitions.
* * * * *
Overutilization means use of a drug in a quantity, strength, or
duration that is greater than necessary to achieve a desired
therapeutic goal or that puts the recipient at risk of a clinically
significant undesirable effect, or both.
* * * * *
Underutilization means use of a drug by a recipient in insufficient
quantity, strength, or duration to achieve a desired therapeutic goal
or that puts the recipient at risk of a clinically significant
undesired effect, or both.
3. In Sec. 456.703, paragraphs (b), (c), and (e)(4) are revised,
the introductory text of paragraphs (e) and (f) are republished and
paragraphs (f)(1), (f)(2), (f)(5), (f)(6) and (h) are revised to read
as follows:
Sec. 456.703 Drug use review program.
* * * * *
(b) Exception for drugs dispensed to certain nursing facility
residents. Prospective drug review and retrospective drug use review
(including interventions and education) under the DUR program are not
required for drugs dispensed to residents of nursing facilities that
are in compliance with the drug regimen review procedures set forth in
part 483 of this chapter. This does not preclude the State agency from
making such drugs subject to prospective DUR or retrospective DUR or
both, provided the State agency makes the drugs subject to all the
requirements of this subpart applicable to the respective review.
(c) Exemption for certain covered outpatient drugs dispensed by
hospitals and health maintenance organizations.
(1) The State plan must provide that covered outpatient drugs
dispensed by a hospital using drug formulary systems and billed to the
plan at no more than the hospital's purchasing costs are not subject to
the requirements of this subpart. Individual hospitals requesting this
exemption must provide assurances to the State agency that they meet
the requirements specified in section 1927(j)(2) of the Act.
(2) The State plan must provide that covered outpatient drugs
dispensed by health maintenance organizations are not subject to the
requirements of this subpart.
* * * * *
(e) Source of predetermined standards. The predetermined standards
must be--
* * * * *
(4) Any combination of paragraphs (e)(1) through (e)(3) of this
section.
(f) Requirements for predetermined standards. The predetermined
standards used in the DUR program must meet the following requirements:
(1) The source materials for their development are consistent with
peer-reviewed medical literature (that is, scientific, medical, and
pharmaceutical publications in which original manuscripts are published
only after having been critically reviewed by unbiased independent
experts) and the following compendia:
(i) American Hospital Formulary Service Drug Information;
(ii) United States Pharmacopeia-Drug Information;
(iii) American Medical Association Drug Evaluations.
(2) Differences between source materials were resolved by
physicians and pharmacists developing consensus solutions. The
consensus process means the reliance, by the criteria developers, on
the expertise of physicians and pharmacists to evaluate differences in
criteria source materials and to come to agreement on how differences
should be resolved.
* * * * *
(5) The review based on clinical criteria uses predetermined
standards to determine the population at risk of a clinically
significant adverse medical result and applies standards, appropriate
to this population, across providers and patients to determine the
provider outliers whose prescribing, dispensing, or consumption
practices may not conform to accepted standards of care. Various
statistical measures (including mean, range, or other measures at the
discretion of the State) may be applied to these data. Standards may be
considered in deciding if an in-depth review is needed to determine
whether to intervene once the potential therapeutic problems have been
identified through the use of clinical criteria.
(6) They have been tested against claims data prior to adoption in
order to validate the level of possibly significant therapeutic
problems without undue levels of false positives.
* * * * *
(h) Confidentiality of patient related data. In implementing the
DUR program, the agency must establish, in regulations or through other
means, policies concerning confidentiality of patient related data that
are consistent with applicable Federal confidentiality requirements at
part 431, subpart F of this chapter; the State Pharmacy Practice Act;
and the guidelines adopted by the State Board of Pharmacy or other
relevant licensing bodies.
4. In Sec. 456.705, paragraph (b) introductory text is republished
and paragraphs (b)(2)(i), (b)(3), (b)(4), (c), and (d) are revised to
read as follows:
Sec. 456.705 Prospective drug review.
* * * * *
(b) Point-of-sale or point-of-distribution review.
* * * * *
(2) Drug-disease contraindication, that is, the potential for, or
the occurrence of--
(i) An undesirable alteration of the therapeutic effect of a given
drug because of the presence, in the patient for whom it is prescribed,
of a disease condition; or
* * * * *
(3) Adverse drug-drug interaction, that is, the potential for, or
occurrence of, a clinically significant adverse medical effect as a
result of the recipient using two or more drugs together.
(4) Incorrect drug dosage, that is, the dosage lies outside the
daily dosage specified in predetermined standards as necessary to
achieve therapeutic benefit. Dosage is the strength multiplied by the
quantity dispensed divided by day's supply.
* * * * *
(c) Drug counseling. (1) As part of the prospective drug review
program, standards for counseling by pharmacists of recipients or the
recipients' caregivers must be established by State law or other method
that is satisfactory to the State agency. A State agency's counseling
standards must address special situations where the patient or the
patient's representative, is not readily available to receive the offer
to counsel or the actual counseling, for example, prescriptions
delivered offsite or through the mail. The State agency, at a minimum,
must also address the following issues in their counseling standards:
(i) Whether the offer to counsel is required for new prescriptions
only, or for both new and refill prescriptions;
(ii) Whether pharmacists must make the offer to counsel or
auxiliary personnel are authorized to make the offer;
(iii) Whether only a patient's refusal of the offer to counsel must
be documented, or whether documentation of all offers is required;
(iv) Whether documentation of counseling is required; and
(v) Whether counseling is required in situations where the
patient's representative is not readily available to receive a
counseling offer or the counseling itself.
(2) The standards must meet the following requirements:
(i) They must require pharmacists to offer to counsel (in person,
whenever practicable, or through access to a telephone service that is
toll-free for long-distance calls) each recipient or recipient's
caregiver who presents a prescription. A pharmacist whose primary
patient population is accessible through a local measured or toll-free
exchange need not be required to offer toll-free service. Mail order
pharmacies are required to provide toll-free telephone service for long
distance calls.
(ii) They need not require a pharmacist to provide consultation
when a Medicaid recipient or the recipient's caregiver refuses that
consultation.
(iii) They must specify what documentation by the pharmacy of
refusal of the offer of counseling is required.
(3) The standards must specify that the counseling include those
matters listed in paragraphs (c)(3)(i) through (c)(3)(viii) of this
section that, in the exercise of his or her professional judgement
(consistent with State law regarding the provision of such
information), the pharmacist considers significant as well as other
matters the pharmacist considers significant.
(i) The name and description of the medication;
(ii) The dosage form, dosage, route of administration, and duration
of drug therapy;
(iii) Special directions and precautions for preparation,
administration, and use by the patient;
(iv) Common severe side or adverse effects or interactions and
therapeutic contraindications that may be encountered, including their
avoidance, and the action required if they occur;
(v) Techniques for self-monitoring drug therapy;
(vi) Proper storage;
(vii) Prescription refill information; and
(viii) Action to be taken in the event of a missed dose.
(d) Profiling. The State agency must require that, in the case of
Medicaid recipients, the pharmacist make a reasonable effort to obtain,
record, and maintain patient profiles containing, at a minimum, the
information listed in paragraphs (d)(1) through (d)(3) of this section.
(1) Name, address, telephone number, date of birth (or age), and
gender of the patient;
(2) Individual history, if significant, including disease state or
states, known allergies and drug reactions, and a comprehensive list of
medications and relevant devices; and
(3) Pharmacist's comments relevant to the individual's drug
therapy.
5. Section 456.714 is revised to read as follows:
Sec. 456.714 DUR/Surveillance and utilization review relationship.
(a) The retrospective DUR requirements in this subpart parallel a
portion of the surveillance and utilization review (SUR) requirements
in subpart A of this part and in part 455 of this chapter.
(b) A State agency may direct DUR staffs to limit review activities
to those that focus on what constitutes appropriate and medically
necessary care to avoid duplication of activities relating to fraud and
abuse under the SUR program.
6. In Sec. 456.716, paragraph (d) introductory text is republished
and paragraphs (b), (d)(5) introductory text and (d)(5)(ii) are revised
to read as follows:
Sec. 456.716 DUR Board.
* * * * *
(b) Board composition. At least one-third but not more than 51
percent of the DUR Board members must be physicians, and at least one-
third of the Board members must be pharmacists. These physicians and
pharmacists must be actively practicing and licensed.
* * * * *
(d) DUR Board activities.
* * * * *
(5) Education program (including interventions): Board's
activities. The DUR Board must perform the following activities:
* * * * *
(ii) Make recommendations as to which mix of the interventions set
forth in Secs. 456.711 (a) through (d) would most effectively lead to
improvement in the quality of drug therapy. The DUR board
recommendations must be based upon an in-depth review of the results of
the application of predetermined standards against claims data reports,
must be appropriate based upon program experience, and must match the
educational program with the drug therapy problems identified.
* * * * *
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program)
Dated: April 1, 1994.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
Dated: June 28, 1994.
Donna E. Shalala,
Secretary.
[FR Doc. 94-23280 Filed 9-22-94; 8:45 am]
BILLING CODE 4120-01-P