PROPOSED RULES
(Medicaid Program)
Original Notice.
Preproposal statement of inquiry was filed as WSR 11-19-005.
Title of Rule and Other Identifying Information: Amending WAC 182-531-0050 Physician-related services definitions and 182-530-7000 Reimbursement; and new WAC 182-531-1625 Outpatient hemophilia treatment requirements -- Center of excellence.
Hearing Location(s): Health Care Authority (HCA), Cherry Street Plaza Building, Sue Crystal Conference Room (106A), 626 8th Avenue, Olympia, WA 98504 (metered public parking is available street side around building. A map is available at http://maa.dshs.wa.gov/pdf/CherryStreetDirectionsNMap.pdf or directions can be obtained by calling (360) 725-1000), on May 22, 2012, at 10:00 a.m.
Date of Intended Adoption: Not sooner than May 23, 2012.
Submit Written Comments to: HCA Rules Coordinator, P.O. Box 45504, Olympia, WA 98504-5504, delivery 626 8th Avenue, Olympia, WA 98504, e-mail arc@hca.wa.gov, fax (360) 586-9727, by 5:00 p.m. on May 22, 2012.
Assistance for Persons with Disabilities: Contact Kelly Richters by May 15, 2012, TTY/TDD (800) 848-5429 or (360) 725-1307 or e-mail kelly.richters@hca.wa.gov.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: These revisions establish rules for hemophilia centers of excellence (COE) including requirements for qualifying for and maintaining hemophilia COE status. The rules specify that for fee-for-service clients, the agency pays only qualified hemophilia treatment COE for providing outpatient hemophilia related products and supplies. The agency also made housekeeping fixes within the text by changing "department" to "agency" - to align with the recent departure of medicaid from the department of social and health services and merger with HCA.
Reasons Supporting Proposal: To improve care oversight and link hemophilia product management to the comprehensive hemophilia diagnostic and treatment centers operating under the national hemophilia program and providing services that meet or exceed standards recommended by the National Hemophilia Foundation's Medical and Scientific Advisory Committee.
Statutory Authority for Adoption: RCW 41.05.021.
Statute Being Implemented: RCW 41.05.021.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: HCA, governmental.
Name of Agency Personnel Responsible for Drafting: Wendy L. Boedigheimer, HCA, P.O. Box 45504, Olympia, WA, (360) 725-1306; Implementation and Enforcement: Myra Davis, HCA, P.O. Box 45510, Olympia, WA, (360) 725-1847.
No small business economic impact statement has been prepared under chapter 19.85 RCW. The agency has analyzed the proposed rules and concludes that they do not impose more than minor costs for affected small businesses.
A cost-benefit analysis is not required under RCW 34.05.328. RCW 34.05.328 does not apply to HCA rules unless requested by the joint administrative rules [review] committee or applied voluntarily.
April 18, 2012
Kevin M. Sullivan
Rules Coordinator
OTS-4706.1
AMENDATORY SECTION(Amending WSR 11-14-075, filed 6/30/11,
effective 7/1/11)
WAC 182-530-7000
Reimbursement.
(1) The
((department's)) agency's total reimbursement for a
prescription drug must not exceed the lowest of:
(a) Estimated acquisition cost (EAC) plus a dispensing fee;
(b) Maximum allowable cost (MAC) plus a dispensing fee;
(c) Federal upper limit (FUL) plus a dispensing fee;
(d) Actual acquisition cost (AAC) plus a dispensing fee for drugs purchased under section 340B of the Public Health Service (PHS) Act;
(e) Automated maximum allowable cost (AMAC) plus a dispensing fee; or
(f) The provider's usual and customary charge to the nonmedicaid population.
(2) The ((department)) agency selects the sources for
pricing information used to set EAC and MAC.
(3) The ((department)) agency may solicit assistance from
pharmacy providers, pharmacy benefit managers (PBM), other
government agencies, actuaries, and/or other consultants when
establishing EAC and/or MAC.
(4) The ((department)) agency reimburses a pharmacy for
the least costly dosage form of a drug within the same route
of administration, unless the prescriber has designated a
medically necessary specific dosage form or the ((department))
agency has selected the more expensive dosage form as a
preferred drug.
(5) If the pharmacy provider offers a discount, rebate,
promotion or other incentive which directly relates to the
reduction of the price of a prescription to the individual
nonmedicaid customer, the provider must similarly reduce its
charge to the ((department)) agency for the prescription.
(6) If the pharmacy provider gives an otherwise covered
product for free to the general public, the pharmacy must not
submit a claim to the ((department)) agency.
(7) The ((department)) agency does not reimburse for:
(a) Prescriptions written on presigned prescription blanks filled out by nursing facility operators or pharmacists;
(b) Prescriptions without the date of the original order;
(c) Drugs used to replace those taken from a nursing facility emergency kit;
(d) Drugs used to replace a physician's stock supply;
(e) Outpatient drugs, biological products, insulin, supplies, appliances, and equipment included in other reimbursement methods including, but not limited to:
(i) Diagnosis-related group (DRG);
(ii) Ratio of costs-to-charges (RCC);
(iii) Nursing facility daily rates;
(iv) Managed care capitation rates;
(v) Block grants; or
(vi) Drugs prescribed for clients who are on the
((department's)) agency's hospice program when the drugs are
related to the client's terminal illness and related
condition.
(f) Products for treatment of hemophilia and von Willebrand disorders unless provided by an outpatient hemophilia treatment center of excellence (COE) as defined in WAC 182-531-1625.
[11-14-075, recodified as § 182-530-7000, filed 6/30/11, effective 7/1/11. Statutory Authority: RCW 74.04.050, 74.08.090, 74.09.530, and 74.09.700. 07-20-049, § 388-530-7000, filed 9/26/07, effective 11/1/07.]
OTS-4707.2
AMENDATORY SECTION(Amending WSR 11-14-075, filed 6/30/11,
effective 7/1/11)
WAC 182-531-0050
Physician-related services definitions.
The following definitions and abbreviations and those found in
((WAC 388-500-0005)) chapter 182-500 WAC, apply to this
chapter. ((Defined words and phrases are bolded the first
time they are used in the text.))
"Acquisition cost" ((means)) - The cost of an item
excluding shipping, handling, and any applicable taxes.
"Acute care" ((means)) - Care provided for clients who
are not medically stable. These clients require frequent
monitoring by a health care professional in order to maintain
their health status. See also WAC 246-335-015.
"Acute physical medicine and rehabilitation (PM&R)"
((means)) - A comprehensive inpatient and rehabilitative
program coordinated by a multidisciplinary team at ((a
department-approved)) an agency-approved rehabilitation
facility. The program provides twenty-four hour specialized
nursing services and an intense level of specialized therapy
(speech, physical, and occupational) for a diagnostic category
for which the client shows significant potential for
functional improvement (see WAC ((388-550-2501))
182-550-2501).
"Add-on procedure(s)" ((means)) - Secondary procedure(s)
that are performed in addition to another procedure.
"Admitting diagnosis" ((means)) - The medical condition
responsible for a hospital admission, as defined by ICD-9-M
diagnostic code.
"Advanced registered nurse practitioner (ARNP)" ((means)) - A registered nurse prepared in a formal educational program
to assume an expanded health services provider role in
accordance with WAC 246-840-300 and 246-840-305.
"Aging and disability services administration (ADSA)"
((means)) - The administration that administers directly or
contracts for long-term care services, including but not
limited to nursing facility care and home and community
services. See WAC 388-71-0202.
"Allowed charges" ((means)) - The maximum amount
reimbursed for any procedure that is allowed by the
((department)) agency.
"Anesthesia technical advisory group (ATAG)" ((means)) - An advisory group representing anesthesiologists who are
affected by the implementation of the anesthesiology fee
schedule.
"Bariatric surgery" ((means)) - Any surgical procedure,
whether open or by laparoscope, which reduces the size of the
stomach with or without bypassing a portion of the small
intestine and whose primary purpose is the reduction of body
weight in an obese individual.
"Base anesthesia units (BAU)" ((means)) - A number of
anesthesia units assigned to a surgical procedure that
includes the usual pre-operative, intra-operative, and
post-operative visits. This includes the administration of
fluids and/or blood incident to the anesthesia care, and
interpretation of noninvasive monitoring by the
anesthesiologist.
"Bundled services" ((means)) - Services integral to the
major procedure that are included in the fee for the major
procedure. Bundled services are not reimbursed separately.
"Bundled supplies" ((means)) - Supplies which are
considered to be included in the practice expense RVU of the
medical or surgical service of which they are an integral
part.
"By report (BR)," ((means a method of reimbursement in
which the department determines the amount it will pay for a
service that is not included in the department's published fee
schedules. The department may request the provider to submit
a "report" describing the nature, extent, time, effort, and/or
equipment necessary to deliver the service)) see WAC 182-500-0015.
"Call" ((means)) - A face-to-face encounter between the
client and the provider resulting in the provision of services
to the client.
"Cast material maximum allowable fee" ((means)) - A
reimbursement amount based on the average cost among suppliers
for one roll of cast material.
"Center of excellence (COE)" - A hospital, medical center, or other health care provider that meets or exceeds standards set by the agency for specific treatments or specialty care.
"Centers for Medicare and Medicaid Services (CMS),"
((means the agency within the federal Department of Health and
Human Services (DHHS) with oversight responsibility for
medicare and medicaid programs)) see WAC 182-500-0020.
"Certified registered nurse anesthetist (CRNA)" ((means)) - An advanced registered nurse practitioner (ARNP) with formal
training in anesthesia who meets all state and national
criteria for certification. The American Association of Nurse
Anesthetists specifies the National Certification and scope of
practice.
"Children's health insurance plan (CHIP)," see chapter
((388-542)) 182-542 WAC.
"Clinical Laboratory Improvement Amendment (CLIA)"
((means)) - Regulations from the U.S. Department of Health and
Human Services that require all laboratory testing sites to
have either a CLIA registration or a CLIA certificate of
waiver in order to legally perform testing anywhere in the
U.S.
"Conversion factors" ((means)) - Dollar amounts the
((department)) agency uses to calculate the maximum allowable
fee for physician-related services.
"Covered service" ((means)) - A service that is within
the scope of the eligible client's medical care program,
subject to the limitations in this chapter and other published
WAC.
"CPT," see "current procedural terminology."
"Critical care services" ((means)) - Physician services
for the care of critically ill or injured clients. A critical
illness or injury acutely impairs one or more vital organ
systems such that the client's survival is jeopardized. Critical care is given in a critical care area, such as the
coronary care unit, intensive care unit, respiratory care
unit, or the emergency care facility.
"Current procedural terminology (CPT)" ((means)) - A
systematic listing of descriptive terms and identifying codes
for reporting medical services, procedures, and interventions
performed by physicians and other practitioners who provide
physician-related services. CPT is copyrighted and published
annually by the American Medical Association (AMA).
"Diagnosis code" ((means)) - A set of numeric or
alphanumeric characters assigned by the ICD-9-CM, or successor
document, as a shorthand symbol to represent the nature of a
disease.
"Emergency medical condition(s)," ((means a medical
condition(s) that manifests itself by acute symptoms of
sufficient severity so that the absence of immediate medical
attention could reasonably be expected to result in placing
the patient's health in serious jeopardy, serious impairment
to bodily functions, or serious dysfunction of any bodily
organ or part)) see WAC 182-500-0030.
"Emergency services" ((means)) - Medical services
required by and provided to a patient experiencing an
emergency medical condition.
"Estimated acquisition cost (EAC)" ((means)) - The
((department's)) agency's best estimate of the price providers
generally and currently pay for drugs and supplies.
"Evaluation and management (E&M) codes" ((means)) - Procedure codes which categorize physician services by type of
service, place of service, and patient status.
"Expedited prior authorization" ((means)) - The process
of obtaining authorization that must be used for selected
services, in which providers use a set of numeric codes to
indicate to the ((department)) agency which acceptable
indications, conditions, diagnoses, and/or criteria are
applicable to a particular request for services.
"Experimental" ((means)) - A term to describe a
procedure, or course of treatment, which lacks sufficient
scientific evidence of safety and effectiveness. See WAC
((388-531-0550)) 182-531-0550. A service is not
"experimental" if the service:
(1) Is generally accepted by the medical profession as effective and appropriate; and
(2) Has been approved by the FDA or other requisite government body, if such approval is required.
"Federally approved hemophilia treatment center" - A hemophilia treatment center (HTC) which:
(1) Receives funding from the U.S. Department of Health and Human Services, Maternal and Child Health Bureau National Hemophilia Program;
(2) Is qualified to participate in 340B discount purchasing as an HTC;
(3) Has a U.S. Center for Disease Control (CDC) and prevention surveillance site identification number and is listed in the HTC directory on the CDC web site;
(4) Is recognized by the Federal Regional Hemophilia Network that includes Washington state; and
(5) Is a direct care provider offering comprehensive hemophilia care consistent with treatment recommendations set by the Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation in their standards and criteria for the care of persons with congenital bleeding disorders.
"Fee-for-service," ((means the general payment method the
department uses to reimburse providers for covered medical
services provided to medical assistance clients when those
services are not covered under the department's healthy
options program or children's health insurance program (CHIP)
programs)) see WAC 182-500-0035.
"Flat fee" ((means)) - The maximum allowable fee
established by the ((department)) agency for a service or item
that does not have a relative value unit (RVU) or has an RVU
that is not appropriate.
"Geographic practice cost index (GPCI)" - As defined by medicare, means a medicare adjustment factor that includes local geographic area estimates of how hard the provider has to work (work effort), what the practice expenses are, and what malpractice costs are. The GPCI reflects one-fourth the difference between the area average and the national average.
"Global surgery reimbursement," see WAC ((388-531-1700))
182-531-1700.
"HCPCS Level II" ((means)) - Health care common procedure
coding system, a coding system established by Centers for
Medicare and Medicaid Services (CMS) (((formerly known as the
Health Care Financing Administration))) to define services and
procedures not included in CPT.
"Health care financing administration common procedure
coding system (HCPCS)" ((means)) - The name used for the
Centers for Medicare and Medicaid Services (formerly known as
the Health Care Financing Administration) codes made up of CPT
and HCPCS level II codes.
"Health care team" ((means)) - A group of health care
providers involved in the care of a client.
"Hospice" ((means)) - A medically directed,
interdisciplinary program of palliative services which is
provided under arrangement with a Title XVIII Washington
licensed and certified Washington state hospice for terminally
ill clients and the clients' families.
"ICD-9-CM," see "International Classification of Diseases, 9th Revision, Clinical Modification."
"Informed consent" ((means)) - That an individual
consents to a procedure after the provider who obtained a
properly completed consent form has done all of the following:
(1) Disclosed and discussed the client's diagnosis; and
(2) Offered the client an opportunity to ask questions about the procedure and to request information in writing; and
(3) Given the client a copy of the consent form; and
(4) Communicated effectively using any language interpretation or special communication device necessary per 42 C.F.R. Chapter IV 441.257; and
(5) Given the client oral information about all of the following:
(a) The client's right to not obtain the procedure, including potential risks, benefits, and the consequences of not obtaining the procedure; and
(b) Alternatives to the procedure including potential risks, benefits, and consequences; and
(c) The procedure itself, including potential risks, benefits, and consequences.
"Inpatient hospital admission" ((means)) - An admission
to a hospital that is limited to medically necessary care
based on an evaluation of the client using objective clinical
indicators, assessment, monitoring, and therapeutic service
required to best manage the client's illness or injury, and
that is documented in the client's medical record.
"International Classification of Diseases, 9th Revision,
Clinical Modification (ICD-9-CM)" ((means)) - The systematic
listing that transforms verbal descriptions of diseases,
injuries, conditions, and procedures into numerical or
alphanumerical designations (coding).
"Investigational" ((means)) - A term to describe a
procedure, or course of treatment, which lacks sufficient
scientific evidence of benefit for a particular condition. A
service is not "investigational" if the service:
(1) Is generally accepted by the medical professional as effective and appropriate for the condition in question; or
(2) Is supported by an overall balance of objective scientific evidence, in which the potential risks and potential benefits are examined, demonstrating the proposed service to be of greater overall benefit to the client in the particular circumstance than another, generally available service.
"Life support" ((means)) - Mechanical systems, such as
ventilators or heart-lung respirators, which are used to
supplement or take the place of the normal autonomic functions
of a living person.
"Limitation extension," ((means a process for requesting
and approving reimbursement for covered services whose
proposed quantity, frequency, or intensity exceeds that which
the department routinely reimburses. Limitation extensions
require prior authorization)) see WAC 182-501-0169.
"Maximum allowable fee" ((means)) - The maximum dollar
amount that the ((department)) agency will reimburse a
provider for specific services, supplies, and equipment.
"Medically necessary," see WAC ((388-500-0005))
182-500-0070.
"Medicare physician fee schedule data base (MPFSDB)"
((means)) - The official ((HCFA)) CMS publication of the
medicare policies and RVUs for the RBRVS reimbursement
program.
"Medicare program fee schedule for physician services
(MPFSPS)" ((means)) - The official ((HCFA)) CMS publication of
the medicare fees for physician services.
"Medicare clinical diagnostic laboratory fee schedule"
((means)) - The fee schedule used by medicare to reimburse for
clinical diagnostic laboratory procedures in the state of
Washington.
"Mentally incompetent" ((means)) - A client who has been
declared mentally incompetent by a federal, state, or local
court.
"Modifier" ((means)) - A two-digit alphabetic and/or
numeric identifier that is added to the procedure code to
indicate the type of service performed. The modifier provides
the means by which the reporting physician can describe or
indicate that a performed service or procedure has been
altered by some specific circumstance but not changed in its
definition or code. The modifier can affect payment or be
used for information only. Modifiers are listed in fee
schedules.
"Outpatient," ((means a client who is receiving medical
services in other than an inpatient hospital setting)) see WAC 182-500-0080.
"Peer-reviewed medical literature" ((means)) - Medical
literature published in professional journals that submit
articles for review by experts who are not part of the
editorial staff. It does not include publications or
supplements to publications primarily intended as marketing
material for pharmaceutical, medical supplies, medical
devices, health service providers, or insurance carriers.
"Physician care plan" ((means)) - A written plan of
medically necessary treatment that is established by and
periodically reviewed and signed by a physician. The plan
describes the medically necessary services to be provided by a
home health agency, a hospice agency, or a nursing facility.
"Physician standby" ((means)) - Physician attendance
without direct face-to-face client contact and which does not
involve provision of care or services.
"Physician's current procedural terminology," see
"((CPT,)) current procedural terminology (CPT)."
"PM&R," see acute physical medicine and rehabilitation.
"Podiatric service" ((means)) - The diagnosis and
medical, surgical, mechanical, manipulative, and electrical
treatments of ailments of the foot and ankle.
"Pound indicator (#)" ((means)) - A symbol (#) indicating
a CPT procedure code listed in the ((department's)) agency's
fee schedules that is not routinely covered.
"Preventive" ((means)) - Medical practices that include
counseling, anticipatory guidance, risk factor reduction
interventions, and the ordering of appropriate laboratory and
diagnostic procedures intended to help a client avoid or
reduce the risk or incidence of illness or injury.
"Prior authorization," ((means a process by which clients
or providers must request and receive the department approval
for certain medical services, equipment, or supplies, based on
medical necessity, before the services are provided to
clients, as a precondition for provider reimbursement. Expedited prior authorization and limitation extension are
forms of prior authorization)) see WAC 182-500-0085.
"Professional component" ((means)) - The part of a
procedure or service that relies on the provider's
professional skill or training, or the part of that
reimbursement that recognizes the provider's cognitive skill.
"Prognosis" ((means)) - The probable outcome of a
client's illness, including the likelihood of improvement or
deterioration in the severity of the illness, the likelihood
for recurrence, and the client's probable life span as a
result of the illness.
"Prolonged services" ((means)) - Face-to-face client
services furnished by a provider, either in the inpatient or
outpatient setting, which involve time beyond what is usual
for such services. The time counted toward payment for
prolonged E&M services includes only face-to-face contact
between the provider and the client, even if the service was
not continuous.
"Provider," see WAC ((388-500-0005)) 182-500-0085.
"Radioallergosorbent test" or "RAST" ((means)) - A blood
test for specific allergies.
"RBRVS," see resource based relative value scale.
(("RVU," see relative value unit.))
"RBRVS RVU" - A measure of the resources required to perform an individual service or intervention. It is set by medicare based on three components - Physician work, practice cost, and malpractice expense. Practice cost varies depending on the place of service.
"Reimbursement" ((means)) - Payment to a provider or
other ((department-approved)) agency-approved entity who bills
according to the provisions in WAC ((388-502-0100))
182-502-0100.
"Reimbursement steering committee (RSC)" ((means)) - An
interagency work group that establishes and maintains RBRVS
physician fee schedules and other payment and purchasing
systems utilized by the ((health care authority, the
department,)) agency and the department of labor and
industries.
"Relative value guide (RVG)" ((means)) - A system used by
the American Society of Anesthesiologists for determining base
anesthesia units (BAUs).
"Relative value unit (RVU)" ((means)) - A unit which is
based on the resources required to perform an individual
service or intervention.
"Resource based relative value scale (RBRVS)" ((means)) - A scale that measures the relative value of a medical service
or intervention, based on the amount of physician resources
involved.
(("RBRVS RVU" means a measure of the resources required
to perform an individual service or intervention. It is set
by medicare based on three components - physician work,
practice cost, and malpractice expense. Practice cost varies
depending on the place of service.))
"RSC RVU" ((means)) - A unit established by the RSC for a
procedure that does not have an established RBRVS RVU or has
an RBRVS RVU deemed by the RSC as not appropriate for the
service.
"RVU," see relative value unit.
"Stat laboratory charges" ((means)) - Charges by a
laboratory for performing tests immediately. "Stat" is an
abbreviation for the Latin word "statim," meaning immediately.
"Sterile tray" ((means)) - A tray containing instruments
and supplies needed for certain surgical procedures normally
done in an office setting. For reimbursement purposes, tray
components are considered by ((HCFA)) CMS to be nonroutine and
reimbursed separately.
"Technical advisory group (TAG)" ((means)) - An advisory
group with representatives from professional organizations
whose members are affected by implementation of RBRVS
physician fee schedules and other payment and purchasing
systems utilized by the ((health care authority, the
department,)) agency and the department of labor and
industries.
"Technical component" ((means)) - The part of a procedure
or service that relates to the equipment set-up and
technician's time, or the part of the procedure and service
reimbursement that recognizes the equipment cost and
technician time.
[11-14-075, recodified as § 182-531-0050, filed 6/30/11, effective 7/1/11. Statutory Authority: RCW 74.08.090. 10-19-057, § 388-531-0050, filed 9/14/10, effective 10/15/10. Statutory Authority: RCW 74.08.090 and 74.09.500. 04-20-059, § 388-531-0050, filed 10/1/04, effective 11/1/04. Statutory Authority: RCW 74.04.050, 74.04.057, 74.08.090, and Public Law 104-191. 03-19-081, § 388-531-0050, filed 9/12/03, effective 10/13/03. Statutory Authority: RCW 74.08.090. 03-06-049, § 388-531-0050, filed 2/28/03, effective 3/31/03. Statutory Authority: RCW 74.08.090, 74.09.520. 01-01-012, § 388-531-0050, filed 12/6/00, effective 1/6/01.]
(1) The agency pays only qualified hemophilia treatment COEs for providing outpatient hemophilia and von Willebrand related products and supplies to eligible agency clients.
(2) To become a qualified hemophilia treatment COE, a hemophilia center must meet all of the following:
(a) Have a current core provider agreement in accordance with WAC 182-502-0005;
(b) Be a federally approved hemophilia treatment center (HTC) as defined in WAC 182-531-0050 and meet or exceed all Medical and Scientific Advisory Council (MASAC) standards of care and delivery of services;
(c) Participate in the public health service 340B provider drug discount program and be listed in the medicaid exclusion files maintained by the federal Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA);
(d) Submit a written request to the agency to be a qualified hemophilia treatment center of excellence and include proof of the following:
(i) U.S. Center for Disease Control (CDC) and prevention surveillance site identification number; and
(ii) Listing in the hemophilia treatment center (HTC) directory.
(e) Receive written approval including conditions of payment and billing procedures from the agency.
(3) To continue as a qualified hemophilia treatment COE, the HTC must annually submit to the agency:
(a) Copies of grant documents and reports submitted to the maternal and child health bureau/human resources and services administration/department of health and human services or to their designated subcontractors; and
(b) Proof of continued federal funding by the National Hemophilia Program and listing with the regional hemophilia network and the CDC.
(4) Services rendered by a hemophilia treatment COE may be subject to the agency's limitations and authorization requirements.
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