See other bills
under the
same topic
HOUSE AMENDED
PRIOR PRINTER'S NOS. 453, 948, 1809,
1837
PRINTER'S NO. 1924
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No.
225
Session of
2021
INTRODUCED BY PHILLIPS-HILL, MARTIN, J. WARD, MENSCH, COLLETT,
MUTH, KANE, STEFANO, AUMENT, CAPPELLETTI, BAKER, BROOKS,
BOSCOLA, HUTCHINSON, SABATINA, TOMLINSON, LAUGHLIN,
MASTRIANO, SANTARSIERO, KEARNEY, SCHWANK, DUSH, COMITTA,
FLYNN, L. WILLIAMS AND DILLON, MARCH 18, 2021
AS REPORTED FROM COMMITTEE ON INSURANCE, HOUSE OF
REPRESENTATIVES, AS AMENDED, SEPTEMBER 20, 2022
AN ACT
Amending the act of May 17, 1921 (P.L.682, No.284), entitled "An
act relating to insurance; amending, revising, and
consolidating the law providing for the incorporation of
insurance companies, and the regulation, supervision, and
protection of home and foreign insurance companies, Lloyds
associations, reciprocal and inter-insurance exchanges, and
fire insurance rating bureaus, and the regulation and
supervision of insurance carried by such companies,
associations, and exchanges, including insurance carried by
the State Workmen's Insurance Fund; providing penalties; and
repealing existing laws," in quality health care
accountability and protection, further providing for
definitions, for responsibilities of managed care plans, for
financial incentives prohibition, for medical gag clause
prohibition, for emergency services, for continuity of care,
providing for medication assisted treatment, further
providing for procedures, for confidentiality, for required
disclosure, providing for medical policy and clinical review
criteria adopted by insurer, MCO or contractor, further
providing for internal complaint process, for appeal of
complaint, for complaint resolution, for certification, for
operational standards, providing for step therapy
considerations, for prior authorization review and for
provider portal, further providing for internal grievances
process, for records, for external grievance process, for
prompt payment of claims, for health care provider and
managed care plan, for departmental powers and duties, for
penalties and sanctions, for compliance with National
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Accrediting Standards; and making editorial changes. IN
QUALITY HEALTH CARE ACCOUNTABILITY AND PROTECTION, FURTHER
PROVIDING FOR DEFINITIONS, FOR RESPONSIBILITIES OF MANAGED
CARE PLANS, FOR FINANCIAL INCENTIVES PROHIBITION, FOR MEDICAL
GAG CLAUSE PROHIBITION, FOR EMERGENCY SERVICES, FOR
CONTINUITY OF CARE, FOR PROCEDURES, FOR CONFIDENTIALITY, FOR
REQUIRED DISCLOSURE AND FOR INTERNAL COMPLAINT PROCESS,
PROVIDING FOR INTERNAL COMPLAINT PROCESS FOR ENROLLEES,
FURTHER PROVIDING FOR APPEAL OF COMPLAINT, FOR COMPLAINT
RESOLUTION, FOR CERTIFICATION AND FOR OPERATIONAL STANDARDS,
PROVIDING FOR UTILIZATION REVIEW STANDARDS, FURTHER PROVIDING
FOR INTERNAL GRIEVANCE PROCESS, FOR EXTERNAL GRIEVANCE
PROCESS AND FOR RECORDS, PROVIDING FOR ADVERSE BENEFIT
DETERMINATIONS, FURTHER PROVIDING FOR PROMPT PAYMENT OF
CLAIMS, FOR HEALTH CARE PROVIDER AND MANAGED CARE PLAN
PROTECTION, FOR DEPARTMENTAL POWERS AND DUTIES AND FOR
PENALTIES AND SANCTIONS, PROVIDING FOR REGULATIONS AND
FURTHER PROVIDING FOR COMPLIANCE WITH NATIONAL ACCREDITING
STANDARDS AND FOR EXCEPTIONS; MAKING REPEALS; AND MAKING
EDITORIAL CHANGES.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. The definitions of "complaint," "drug formulary,"
"enrollee," "grievance," "health care service," "prospective
utilization review," "provider network," "retrospective
utilization review," "utilization review" and "utilization
review entity" in section 2102 of the act of May 17, 1921
(P.L.682, No.284), known as The Insurance Company Law of 1921,
are amended and the section is amended by adding definitions to
read:
Section 2102. Definitions.--As used in this article, the
following words and phrases shall have the meanings given to
them in this section:
* * *
"Administrative policy." A written document or collection of
documents reflecting the terms of the contractual or operating
relationship between an insurer, MCO, contractor and a health
care provider.
"Administrative denial." A denial of prior authorization,
coverage or payment based on a lack of eligibility, failure to
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submit complete information or other failure to comply with
written administrative standards for the administration of
benefits under a health insurance policy, MCO contract or CHIP
contract. The term does not include a denial based on medical
necessity.
"Adverse benefit determination." A determination by an
insurer, MCO, contractor or a utilization review entity
designated by the insurer, MCO or contractor that a health care
service has been reviewed and, based upon the information
provided, does not meet the insurer's, MCO's or contractor's
requirements for medical necessity, appropriateness, health care
setting, level of care or effectiveness and the requested
service or payment for the service is therefore denied, reduced
or terminated.
* * *
"Applicable governmental guidelines." Clinical practice and
associated guidelines issued under the authority of the United
States Department of Health and Human Services, United States
Food and Drug Administration, Centers for Disease Control and
Prevention, Department of Health or other similarly situated
Federal or State agency, department or subunit thereof focused
on the provision or regulation of medical care, prescription
drugs or public health within the United States.
"Children's Health Insurance Program" or "CHIP." The
children's health care program under Article XXIII-A.
"CHIP contract." The agreement between an insurer and the
Department of Human Services to provide for services to a CHIP
enrollee.
* * *
"Clinical review criteria." The set of written screening
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procedures, decision abstracts, clinical protocols and practice
guidelines used by an insurer, MCO or contractor to determine
the necessity and appropriateness of health care services.
"Closely related service." One or more health care services
subject to prior authorization that are closely related in
purpose, diagnostic utility or designated health care billing
code and provided on the same date of service such that a
prudent health care provider, acting within the scope of the
health care provider's license and expertise, might reasonably
be expected to perform such service in conjunction with or in
lieu of the originally authorized service in response to minor
differences in observed patient characteristics or needs for
diagnostic information that were not readily identifiable until
the health care provider was actually performing the originally
authorized service. The term does not include an order for or
administration of a prescription drug or any part of a series or
course of treatments.
"Complaint." A dispute or objection regarding a
participating health care provider or the coverage, operations
or management policies of [a managed care plan] an insurer, MCO
or contractor, which has not been resolved by the [managed care
plan] insurer, MCO or contractor and has been filed with the
[plan] insurer, MCO or contractor or with the Department of
Health or the Insurance Department of the Commonwealth. The term
does not include a grievance.
"Complete prior authorization request." A request for prior
authorization that meets an insurer's, MCO's or contractor's
administrative policy requirements for such a request and that
includes the specific clinical information necessary only to
evaluate the request under the terms of the applicable medical
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policy. To the extent a health care provider network agreement
requires medical records to be transmitted electronically, or a
health care provider is capable of transmitting medical records
electronically to support a complete prior authorization request
for a health care service, the health care provider shall ensure
the insurer , MCO or contractor has electronic access to,
including the ability to print, the medical records that have
been transmitted electronically, subject to any applicable law
and the health care provider's corporate policies. The inability
of a health care provider to provide such access shall not
constitute a reason to deny an authorization request.
* * *
"Contractor." An insurer awarded a contract under section
2304-A to provide health care services. The term includes an
entity and an entity's subsidiary which is established under
this act, the act of December 29, 1972 (P.L.1701, No.364), known
as the Health Maintenance Organization Act or 40 Pa.C.S. Ch. 61
(relating to hospital plan corporation) or 63 (relating to
professional health services plan corporations).
* * *
"Drug formulary." A listing of [managed care plan] insurer,
MCO or contractor preferred therapeutic drugs.
* * *
"Enrollee." Any policyholder, subscriber, covered person or
other individual who is entitled to receive health care services
under a [managed care plan] health insurance policy, MCO
contract or CHIP contract.
"Grievance." As provided in subdivision (i), a request by an
enrollee or a health care provider, with the written consent of
the enrollee, to have [a managed care plan] an insurer, MCO,
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contractor or utilization review entity reconsider a decision
solely concerning the medical necessity [and], appropriateness,
health care setting, level of care or effectiveness of a health
care service. If the [managed care plan] insurer, MCO or
contractor is unable to resolve the matter, a grievance may be
filed regarding the decision that:
(1) disapproves full or partial payment for a requested
health care service;
(2) approves the provision of a requested health care
service for a lesser scope or duration than requested; or
(3) disapproves payment for the provision of a requested
health care service but approves payment for the provision of an
alternative health care service.
The term does not include a complaint.
* * *
"Health care service." Any covered treatment, admission,
procedure, medical supplies and equipment or other services,
including behavioral health, prescribed or otherwise provided or
proposed to be provided by a health care provider to an enrollee
[under a managed care plan contract.]
"Health insurance policy." A policy, subscriber contract,
certificate or plan issued by an insurer that provides medical
or health care coverage. The term does not include any of the
following:
(1) An accident only policy.
(2) A credit only policy.
(3) A long-term care or disability income policy.
(4) A specified disease policy.
(5) A Medicare supplement policy.
(6) A TRICARE policy, including a Civilian Health and
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Medical Program of the Uniformed Services (CHAMPUS) supplement
policy.
(7) A fixed indemnity policy.
(8) A hospital indemnity policy.
(9) A dental only policy.
(10) A vision only policy.
(11) A workers' compensation policy.
(12) An automobile medical payment policy.
(13) A homeowners' insurance policy.
(14) A short-term limited duration policy.
(15) Any other similar policy providing for limited
benefits.
"Inpatient admission." Admission to a facility for purposes
of receiving a health care service at the inpatient level of
care.
"Insurer." An entity licensed by the department to issue a
health insurance policy, subscriber contract, certificate or
plan that provides medical or health care coverage that is
offered or governed under any of the following:
(1) Article XXIV, section 630 or any other provision of this
act.
(2) A provision of 40 Pa.C.S. Ch. 61 or 63.
* * *
"MCO contract." The agreement between a medical assistance
managed care organization or MCO and the Department of Human
Services to provide for services to a Medicaid enrollee.
"Medical assistance managed care organization" or "MCO." A
Medicaid managed care organization as defined in section 1903(m)
(1)(A) of the Social Security Act (49 Stat. 620, 42 U.S.C. ยง
1396b(m)(1)(A)) that is a party to a Medicaid managed care
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contract with the Department of Human Services. The term does
not include a behavioral health managed care organization that
is a party to a Medicaid managed care contract with the
Department of Human Services.
"Medical policy." A written document formally adopted,
maintained and applied by an insurer, MCO or contractor that
combines the clinical coverage criteria and any additional
administrative requirements, as applicable, necessary to
articulate the insurer's, MCO's or contractor's standards for
coverage of a given service or set of services under the terms
of a health insurance policy, MCO contract or CHIP contract.
"Medical or scientific evidence." Evidence found in any of
the following sources:
(1) A peer-reviewed scientific study published in or
accepted for publication by a medical journal that meets
nationally recognized requirements for scientific manuscripts
and which journal submits most of its published articles for
review by experts who are not part of the journal's editorial
staff.
(2) Peer-reviewed medical literature, including literature
relating to a therapy reviewed and approved by a qualified
institutional review board, biomedical compendia and other
medical literature that meet the criteria of the National
Institutes of Health's Library of Medicine for indexing in Index
Medicus (Medline) and Elsevier Science Limited for indexing in
Excerpta Medica (EMBASE).
(3) A medical journal recognized by the Secretary of Health
and Human Services under section 1861(t)(2) of the Social
Security Act (49 Stat. 620, 42 U.S.C. ยง 1395x(t)(2)).
(4) One of the following standard reference compendia:
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(i) The American Hospital Formulary Service-Drug
Information.
(ii) Drug Facts and Comparison.
(iii) The American Dental Association Accepted Dental
Therapeutics.
(iv) The United States Pharmacopoeia-Drug Information.
(5) Findings, studies or research conducted by or under the
auspices of a Federal Government agency or nationally recognized
Federal research institute, including:
(i) The Federal Agency for Healthcare Research and Quality.
(ii) The National Institute of Health.
(iii) The National Cancer Institute.
(iv) The National Academy of Sciences.
(v) The Centers for Medicare and Medicaid Services.
(vi) The Food and Drug Administration.
(vii) Any national board recognized by the National
Institutes of Health for the purpose of evaluating the medical
value of health care services.
(6) Other medical or scientific evidence that is comparable
to the sources specified in paragraphs (1), (2), (3), (4) and
(5).
"Medication assisted treatment." United States Food and Drug
Administration approved prescription drugs used in combination
with counseling and behavioral health therapies in the treatment
of opioid use disorders.
"Nationally recognized medical standards." Clinical
criteria, practice guidelines and related standards established
by national quality and accreditation entities generally
recognized in the United States health care industry.
"Participating provider." A health care provider that has
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entered into a contractual or operating relationship with an
insurer, MCO or contractor to participate in one or more
designated networks of the insurer, MCO or contractor and to
provide health care services to enrollees under the terms of the
insurer's, MCO's or contractor's administrative policy.
* * *
"Prior authorization." A review by an insurer, MCO,
contractor or by a utilization review entity acting on behalf of
an insurer, MCO or contractor of all reasonably necessary
supporting information that occurs prior to the delivery or
provision of a health care service and results in a decision to
approve or deny payment for the health care service. The term
includes step therapy and associated exceptions for prescription
drugs.
["Prospective utilization review." A review by a utilization
review entity of all reasonably necessary supporting information
that occurs prior to the delivery or provision of a health care
service and results in a decision to approve or deny payment for
the health care service.]
"Provider network." The health care providers designated by
[a managed care plan] an insurer, MCO or contractor to provide
health care services.
"Provider portal." A designated section or functional
software module accessible via an insurer's, MCO's or
contractor's publicly accessible Internet website that
facilitates health care provider submission of electronic prior
authorization requests.
* * *
"Retrospective utilization review." A review by [a] an
insurer, MCO, contractor or utilization review entity acting on
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behalf of an insurer, MCO or contractor of all reasonably
necessary supporting information which occurs following delivery
or provision of a health care service and results in a decision
to approve or deny payment for the health care service.
* * *
"Step therapy." A course of treatment where certain
designated drugs or treatment protocols must be either
contraindicated or used and found to be ineffective prior to
approval of coverage for other designated drugs. The term does
not include requests for coverage of nonformulary drugs.
"Urgent health care service." A covered health care service
subject to prior authorization that is delivered on an expedited
basis for the treatment of an acute condition with symptoms of
sufficient severity pursuant to a determination by a duly
licensed and board-certified treating physician, operating
within the individual's scope of practice and professional
expertise, that the absence of such significant medical
intervention is likely to result in serious, long-term health
complications or a material deterioration in the enrollee's
condition and prognosis.
"Utilization review." A system of [prospective, concurrent]
prior authorization, concurrent utilization review or
retrospective utilization review performed by [a] an insurer,
MCO, contractor or utilization review entity on behalf of an
insurer, MCO or contractor of the medical necessity [and],
appropriateness, health care setting and level of care or
effectiveness of health care services prescribed, provided or
proposed to be provided to an enrollee. The term does not
include any of the following:
(1) Requests for clarification of coverage, eligibility or
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health care service verification.
(2) A health care provider's internal quality assurance or
utilization review process unless the review results in denial
of payment for a health care service.
"Utilization review entity." Any entity certified pursuant
to subdivision (h) that performs utilization review on behalf of
[a managed care plan] an insurer, MCO or contractor.
Section 2. Subarticle (b) heading of Article XXI and
sections 2111, 2112 and 2113 of the act are amended to read:
(b) [Managed Care Plan] Insurer, MCO and Contractor
Requirements.
Section 2111. Responsibilities of [Managed Care Plans]
Insurer, MCOs and Contractors.--[A managed care plan] An
insurer, MCO or contractor shall do all of the following:
(1) Assure availability and accessibility of adequate health
care providers in a timely manner, which enables enrollees to
have access to quality care and continuity of health care
services.
(2) Consult with health care providers in active clinical
practice regarding professional qualifications and necessary
specialists to be included in the [plan] health insurance
policy, MCO contract or CHIP contract.
(3) Adopt and maintain a definition of medical necessity
used by the [plan] health insurance policy, MCO contract or CHIP
contract in determining health care services.
(4) Ensure that emergency services are provided twenty-four
(24) hours a day, seven (7) days a week and provide reasonable
payment or reimbursement for emergency services.
(5) Adopt and maintain procedures by which an enrollee can
obtain health care services outside the [plan's] health
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insurance policy's, MCO contract's or CHIP contract's service
area.
(6) Adopt and maintain procedures by which an enrollee with
a life-threatening, degenerative or disabling disease or
condition shall, upon request, receive an evaluation and, if the
[plan's] insurer's, MCO's or contractor's established standards
are met, be permitted to receive:
(i) a standing referral to a specialist with clinical
expertise in treating the disease or condition; or
(ii) the designation of a specialist to provide and
coordinate the enrollee's primary and specialty care.
The referral to or designation of a specialist shall be pursuant
to a treatment plan approved by the [managed care plan] insurer,
MCO or contractor in consultation with the primary care
provider, the enrollee and, as appropriate, the specialist. When
possible, the specialist must be a health care provider
participating in the [plan] health insurance policy, MCO
contract or CHIP contract.
(7) Provide direct access to obstetrical and gynecological
services by permitting an enrollee to select a health care
provider participating in the [plan] health insurance policy,
MCO contract or CHIP contract to obtain maternity and
gynecological care, including medically necessary and
appropriate follow-up care and referrals for diagnostic testing
related to maternity and gynecological care, without prior
approval from a primary care provider. The health care services
shall be within the scope of practice of the selected health
care provider. The selected health care provider shall inform
the enrollee's primary care provider of all health care services
provided.
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(8) Adopt and maintain a complaint process as set forth in
subdivision (g).
(9) Adopt and maintain a grievance process as set forth in
subdivision (i).
(10) Adopt and maintain credentialing standards for health
care providers as set forth in subdivision (d).
(11) Ensure that there are participating health care
providers that are physically accessible to people with
disabilities and can communicate with individuals with sensory
disabilities in accordance with Title III of the Americans with
Disabilities Act of 1990 (Public Law 101-336, 42 U.S.C. ยง 12181
et seq.).
(12) Provide a list of health care providers participating
in the [plan] health insurance policy, MCO contract or CHIP
contract to the department every two (2) years or as may
otherwise be required by the department. The list shall include
the extent to which [health care] participating providers [in
the plan] are accepting new enrollees.
(13) Report to the department and the Insurance Department
in accordance with the requirements of this article. Such
information shall include the number, type and disposition of
all complaints and grievances filed with the [plan] insurer, MCO
or contractor.
Section 2112. Financial Incentives Prohibition.--No [managed
care plan] insurer, MCO or contractor shall use any financial
incentive that compensates a health care provider for providing
less than medically necessary and appropriate care to an
enrollee. Nothing in this section shall be deemed to prohibit [a
managed care plan] an insurer, MCO or contractor from using a
capitated payment arrangement or other risk-sharing arrangement.
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Section 2113. Medical Gag Clause Prohibition.--(a) No
[managed care plan] insurer, MCO or contractor may penalize or
restrict a health care provider from discussing:
(1) the process that the [plan] insurer, MCO or contractor
or any entity contracting with the [plan] insurer, MCO or
contractor uses or proposes to use to deny payment for a health
care service;
(2) medically necessary and appropriate care with or on
behalf of an enrollee, including information regarding the
nature of treatment; risks of treatment; alternative treatments;
or the availability of alternate therapies, consultation or
tests; or
(3) the decision of any [managed care plan] insurer, MCO or
contractor to deny payment for a health care service.
(b) A provision to prohibit or restrict disclosure of
medically necessary and appropriate health care information
contained in a contract with a health care provider is contrary
to public policy and shall be void and unenforceable.
(c) No [managed care plan] insurer, MCO or contractor shall
terminate the employment of or a contract with a health care
provider for any of the following:
(1) Advocating for medically necessary and appropriate
health care consistent with the degree of learning and skill
ordinarily possessed by a reputable health care provider
practicing according to the applicable legal standard of care.
(2) Filing a grievance pursuant to the procedures set forth
in this article.
(3) Protesting a decision, policy or practice that the
health care provider, consistent with the degree of learning and
skill ordinarily possessed by a reputable health care provider
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practicing according to the applicable legal standard of care,
reasonably believes interferes with the health care provider's
ability to provide medically necessary and appropriate health
care.
(d) Nothing in this section shall:
(1) Prohibit [a managed care plan] an insurer, MCO or
contractor from making a determination not to pay for a
particular medical treatment, supply or service, enforcing
reasonable peer review or utilization review protocols or making
a determination that a health care provider has or has not
complied with appropriate protocols.
(2) Be construed as requiring [a managed care plan] an
insurer, MCO or contractor to provide, reimburse for or cover
counseling, referral or other health care services if the [plan]
insurer, MCO or contractor:
(i) objects to the provision of that service on moral or
religious grounds; and
(ii) makes available information on its policies regarding
such health care services to enrollees and prospective
enrollees.
Section 3. Section 2116(a) and (b) of the act are amended
and the section is amended by adding a subsection to read:
Section 2116. Emergency Services.--(a) If an enrollee seeks
emergency services and the emergency health care provider
determines that emergency services are necessary, the emergency
health care provider shall initiate necessary intervention to
evaluate and, if necessary, stabilize the condition of the
enrollee without seeking or receiving authorization from the
[managed care plan. The managed care plan] insurer, MCO or
contractor. No insurer, MCO or contractor shall require a health
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care provider to submit a request for prior authorization for an
emergency service. The insurer, MCO or contractor shall pay all
reasonably necessary costs associated with emergency services
provided during the period of emergency, subject to all
copayments, coinsurances or deductibles[.], including testing
and other diagnostic services that are medically necessary to
evaluate or treat an emergency medical condition prior to the
point at which the condition is stabilized. When processing a
reimbursement claim for emergency services, [a managed care
plan] an insurer, MCO or contractor shall consider both the
presenting symptoms and the services provided. The [emergency]
health care provider shall notify the enrollee's [managed care
plan] insurer, MCO or contractor of the provision of emergency
services and the condition of the enrollee. If an enrollee's
condition has stabilized and the enrollee can be transported
without suffering detrimental consequences or aggravating the
enrollee's condition, the enrollee may be relocated to another
facility to receive continued care and treatment as necessary.
If an enrollee is admitted to inpatient care or placed in
observation immediately following receipt of a covered emergency
service, the inpatient facility shall have a minimum of twenty-
four (24) hours to notify the enrollee's insurer, MCO or
contractor of the admission or placement with such timeframe to
start at the later of:
(1) the time of the inpatient admission or placement; or
(2) in the case of an enrollee that is unconscious, comatose
or otherwise unable to effectively communicate pertinent
information, the time at which the inpatient facility knew or
reasonably should have known, through diligent efforts, the
identity of the enrollee's insurer, MCO or contractor.
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(b) For emergency services rendered by a licensed emergency
medical services agency, as defined in 35 Pa.C.S. ยง 8103
(relating to definitions), that has the ability to transport
patients or is providing and billing for emergency services
under an agreement with an emergency medical services agency
that has that ability, the [managed care plan] insurer, MCO or
contractor may not deny a claim for payment solely because the
enrollee did not require transport or refused to be transported.
* * *
(e) Nothing in this section shall require an insurer, MCO or
contractor to waive application of otherwise applicable clinical
review criteria.
Section 4. Section 2117 of the act is amended to read:
Section 2117. Continuity of Care.--(a) Except as provided
under subsection (b), if [a managed care plan] an insurer, MCO
or contractor initiates termination of its contract with a
participating health care provider, an enrollee may continue an
ongoing course of treatment with that health care provider at
the enrollee's option for a transitional period of up to sixty
(60) days from the date the enrollee was notified by the [plan]
insurer, MCO or contractor of the termination or pending
termination. The [managed care plan] insurer, MCO or contractor,
in consultation with the enrollee and the health care provider,
may extend the transitional period if determined to be
clinically appropriate. In the case of an enrollee in the second
or third trimester of pregnancy at the time of notice of the
termination or pending termination, the transitional period
shall extend through postpartum care related to the delivery.
Any health care service provided under this section shall be
covered by the [managed care plan] insurer, MCO or contractor
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under the same terms and conditions as applicable for
participating health care providers.
(b) If the [plan] insurer, MCO or contractor terminates the
contract of a participating health care provider for cause,
including breach of contract, fraud, criminal activity or posing
a danger to an enrollee or the health, safety or welfare of the
public as determined by the [plan] insurer, MCO or contractor,
the [plan] insurer, MCO or contractor shall not be responsible
for health care services provided to the enrollee following the
date of termination.
(c) If the [plan] insurer, MCO or contractor terminates the
contract of a participating primary care provider, the [plan]
insurer, MCO or contractor shall notify every enrollee served by
that provider of the [plan's] insurer's, MCO's or contractor's
termination of its contract and shall request that the enrollee
select another primary care provider.
(d) A new enrollee may continue an ongoing course of
treatment with a nonparticipating health care provider for a
transitional period of up to sixty (60) days from the effective
date of enrollment in a [managed care plan] health insurance
policy, MCO contract or CHIP contract. The [managed care plan]
insurer, MCO or contractor, in consultation with the enrollee
and the health care provider, may extend this transitional
period if determined to be clinically appropriate. In the case
of a new enrollee in the second or third trimester of pregnancy
on the effective date of enrollment, the transitional period
shall extend through postpartum care related to the delivery.
Any health care service provided under this section shall be
covered by the [managed care plan] insurer, MCO or contractor
under the same terms and conditions as applicable for
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participating health care providers.
(e) [A plan] An insurer, MCO or contractor may require a
nonparticipating health care provider whose health care services
are covered under this section to meet the same terms and
conditions as a participating health care provider.
(f) Nothing in this section shall require [a managed care
plan] an insurer, MCO or contractor to provide health care
services that are not otherwise covered under the terms and
conditions of the [plan] health insurance policy, MCO contract
or CHIP contract.
Section 5. The act is amended by adding a section to read:
Section 2118. Medication assisted treatment.--(a) An
insurer, MCO or contractor shall make available without initial
prior authorization coverage of at least one United States Food
and Drug Administration approved prescription drug classified as
Medication Assisted Treatment.
(b) Nothing in this section shall prohibit an insurer, MCO
or contractor from designating preferred medications for the
relevant component of medication assisted treatment when
multiple medications are available, subject to applicable
requirements for documenting and posting any relevant medical
policy or prescription drug formulary information.
(c) With the exception of prior authorization for initial
coverage, nothing in this section shall prohibit an insurer, MCO
or contractor from requiring prior authorization on subsequent
requests for medication assisted treatment to ensure adherence
with clinical guidelines.
Section 6. Sections 2121, 2131 and 2136 of the act are
amended to read:
Section 2121. Procedures.--(a) [A managed care plan] An
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insurer, MCO or contractor shall establish a credentialing
process to enroll qualified health care providers and create an
adequate provider network. The process shall be approved by the
department and shall include written criteria and procedures for
initial enrollment, renewal, restrictions and termination of
credentials for health care providers.
(b) The department shall establish credentialing standards
for [managed care plans.] insurers, MCOs and contractors. The
department may adopt nationally recognized accrediting standards
to establish the credentialing standards for [managed care
plans] insurers, MCOs and contractors.
(c) [A managed care plan] An insurer, MCO or contractor
shall submit a report to the department regarding its
credentialing process at least every two (2) years or as may
otherwise be required by the department.
(d) [A managed care plan] An insurer, MCO or contractor
shall disclose relevant credentialing criteria and procedures to
health care providers that apply to participate or that are
participating in the [plan's] insurer's, MCO's or contractor's
provider network. [A managed care plan] An insurer, MCO or
contractor shall also disclose relevant credentialing criteria
and procedures pursuant to a court order or rule. Any individual
providing information during the credentialing process of [a
managed care plan] an insurer, MCO or contractor shall have the
protections set forth in the act of July 20, 1974 (P.L.564,
No.193), known as the "Peer Review Protection Act."
(e) No [managed care plan] insurer, MCO or contractor shall
exclude or terminate a health care provider from participation
in the [plan] health insurance policy, MCO contract or CHIP
contract due to any of the following:
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(1) The health care provider engaged in any of the
activities set forth in section 2113(c).
(2) The health care provider has a practice that includes a
substantial number of patients with expensive medical
conditions.
(3) The health care provider objects to the provision of or
refuses to provide a health care service on moral or religious
grounds.
(f) If [a managed care plan] an insurer, MCO or contractor
denies enrollment or renewal of credentials to a health care
provider, the [managed care plan] insurer, MCO or contractor
shall provide the health care provider with written notice of
the decision. The notice shall include a clear rationale for the
decision.
Section 2131. Confidentiality.--(a) [A managed care plan]
An insurer, MCO, contractor and a utilization review entity
shall adopt and maintain procedures to ensure that all
identifiable information regarding enrollee health, diagnosis
and treatment is adequately protected and remains confidential
in compliance with all applicable Federal and State laws and
regulations and professional ethical standards.
(b) To the extent [a managed care plan] an insurer, MCO or
contractor maintains medical records, the [plan] insurer, MCO or
contractor shall adopt and maintain procedures to ensure that
enrollees have timely access to their medical records unless
prohibited by Federal or State law or regulation.
(c) (1) Information regarding an enrollee's health or
treatment shall be available to the enrollee, the enrollee's
designee or as necessary to prevent death or serious injury.
(2) Nothing in this section shall:
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(i) Prevent disclosure necessary to determine coverage,
review complaints or grievances, conduct utilization review or
facilitate payment of a claim.
(ii) Deny the department, the Insurance Department or the
Department of [Public Welfare] Human Services access to records
for purposes of quality assurance, investigation of complaints
or grievances, enforcement or other activities related to
compliance with this article and other laws of this
Commonwealth. Records shall be accessible only to department
employes or agents with direct responsibilities under the
provisions of this subparagraph.
(iii) Deny access to information necessary for a utilization
review entity to conduct a review under this article.
(iv) Deny access to the [managed care plan] insurer, MCO or
contractor for internal quality review, including reviews
conducted as part of the [plan's] insurer's, MCO's and
contractor's quality oversight process. During such reviews,
enrollees shall remain anonymous to the greatest extent
possible.
(v) Deny access to [managed care plans] insurers, MCOs,
contractors, health care providers and their respective
designees for the purpose of providing patient care management,
outcomes improvement and research. For this purpose, enrollees
shall provide consent and shall remain anonymous to the greatest
extent possible.
Section 2136. Required Disclosure.--(a) [A managed care
plan] An insurer, MCO or contractor shall supply each enrollee
and, upon written request, each prospective enrollee or health
care provider with the following written information. Such
information shall be easily understandable by the layperson and
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shall include, but not be limited to:
(1) A description of coverage, benefits and benefit
maximums, including benefit limitations and exclusions of
coverage, health care services and the definition of medical
necessity used by the [plan] health insurance, MCO contract or
CHIP contract in determining whether these benefits will be
covered. The following statement shall be included in all
marketing materials in boldface type:
This [managed care plan] health insurance policy or contract
may not cover all your health care expenses. Read your
contract carefully to determine which health care services
are covered.
The notice shall be followed by a telephone number to contact
the [plan] insurer, MCO or contractor.
(2) A description of all necessary prior authorizations or
other requirements for nonemergency health care services as
required in section 2154(b).
(3) An explanation of an enrollee's financial responsibility
for payment of premiums, coinsurance, copayments, deductibles
and other charges, annual limits on an enrollee's financial
responsibility and caps on payments for health care services
provided under the [plan] health insurance policy, MCO contract
or CHIP contract.
(4) An explanation of an enrollee's financial responsibility
for payment when a health care service is provided by a
nonparticipating health care provider, when a health care
service is provided by any health care provider without required
authorization or when the care rendered is not covered by the
[plan] health insurance policy, MCO contract or CHIP contract.
(5) A description of how the [managed care plan] insurer,
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MCO or contractor addresses the needs of non-English-speaking
enrollees.
(6) A notice of mailing addresses and telephone numbers
necessary to enable an enrollee to obtain approval or
authorization of a health care service or other information
regarding the [plan] health insurance policy, MCO contract or
CHIP contract.
(7) A summary of the [plan's] health insurance policy's, MCO
contract's or CHIP contract's utilization review policies and
procedures.
(8) A summary of all complaint and grievance procedures used
to resolve disputes between the [managed care plan] insurer, MCO
contractor and an enrollee or a health care provider, including:
(i) The procedure to file a complaint or grievance as set
forth in this article, including a toll-free telephone number to
obtain information regarding the filing and status of a
complaint or grievance.
(ii) The right to appeal a decision relating to a complaint
or grievance.
(iii) The enrollee's right to designate a representative to
participate in the complaint or grievance process as set forth
in this article.
(iv) A notice that all disputes involving denial of payment
for a health care service will be made by qualified personnel
with experience in the same or similar scope of practice and
that all notices of decisions will include information regarding
the basis for the determination.
(9) A description of the procedure for providing emergency
services twenty-four (24) hours a day. The description shall
include:
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(i) A definition of emergency services as set forth in this
article.
(ii) Notice that emergency services are not subject to prior
approval.
(iii) The enrollee's financial and other responsibilities
regarding emergency services, including the receipt of these
services outside the [managed care plan's] insurer's, MCO's or
contractor's service area.
(10) A description of the procedures for enrollees to select
a participating health care provider, including how to determine
whether a participating health care provider is accepting new
enrollees.
(11) A description of the procedures for changing primary
care providers and specialists.
(12) A description of the procedures by which an enrollee
may obtain a referral to a health care provider outside the
provider network when that provider network does not include a
health care provider with appropriate training and experience to
meet the health care service needs of an enrollee.
(13) A description of the procedures that an enrollee with a
life-threatening, degenerative or disabling disease or condition
shall follow and satisfy to be eligible for:
(i) a standing referral to a specialist with clinical
expertise in treating the disease or condition; or
(ii) the designation of a specialist to provide and
coordinate the enrollee's primary and specialty care.
(14) A list by specialty of the name, address and telephone
number of all participating health care providers. The list may
be a separate document and shall be updated at least annually.
(15) A list of the information available to enrollees or
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prospective enrollees, upon written request, under subsection
(b).
(b) Each [managed care plan] insurer, MCO or contractor
shall, upon written request of an enrollee or prospective
enrollee, provide the following written information:
(1) A list of the names, business addresses and official
positions of the membership of the board of directors or
officers of the [managed care plan] insurer, MCO or contractor.
(2) The procedures adopted to protect the confidentiality of
medical records and other enrollee information.
(3) A description of the credentialing process for health
care providers.
(4) A list of the participating health care providers
affiliated with participating hospitals.
(5) Whether a specifically identified drug is included or
excluded from coverage.
(6) A description of the process by which a health care
provider can prescribe specific drugs, drugs used for an off-
label purpose, biologicals and medications not included in the
drug formulary for prescription drugs or biologicals when the
formulary's equivalent has been ineffective in the treatment of
the enrollee's disease or if the drug causes or is reasonably
expected to cause adverse or harmful reactions to the enrollee.
(7) A description of the procedures followed by the [managed
care plan] insurer, MCO or contractor to make decisions about
the experimental nature of individual drugs, medical devices or
treatments.
(8) A summary of the methodologies used by the [managed care
plan] insurer, MCO or contractor to reimburse for health care
services. Nothing in this paragraph shall be construed to
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require disclosure of individual contracts or the specific
details of any financial arrangement between [a managed care
plan] an insurer, MCO, contractor and a health care provider.
(9) A description of the procedures used in the [managed
care plan's] insurer's, MCO's or contractor's quality assurance
program.
(10) Other information as may be required by the department
or the Insurance Department.
Section 7. The act is amended by adding a section to read:
Section 2137. Medical policy and clinical review criteria
adopted by an insurer, MCO or contractor.--(a) An insurer, MCO
or contractor shall make available its current medical policies
on the insurer's, MCO's and contractor's publicly accessible
Internet website or provider portal. The insurer's, MCO's or
contractor's medical policies shall include reference to the
clinical review criteria used in developing the medical policy.
If an insurer's, MCO's or contractor's medical policy
incorporates licensed third-party standards that also limit the
insurer's, MCO's or contractor's ability to publish those
standards in full, the insurer's, MCO's or contractor's posted
policies shall clearly identify these sources.
(b) An insurer, MCO or contractor shall review each adopted
medical policy on at least an annual basis.
(c) An insurer, MCO or contractor shall notify health care
providers of discretionary changes to medical policies at least
thirty (30) days prior to application of the changes. The
following apply:
(1) In the case of policy changes due to changes in Federal
or State law, regulation or binding agency guidance, an insurer,
MCO or contractor shall notify health care providers at least
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thirty (30) days prior to the application of the changes, except
that in cases where the timing of changes in binding guidance
makes such advance notice impracticable, an insurer, MCO or
contractor shall make commercially reasonable efforts to notify
providers of such changes prior to their application.
(2) Notification of changes may be provided through the
posting of an updated and dated medical policy reflecting the
change or through other reasonable means.
(3) In the case of changes to medical policies that modify,
eliminate or suspend either clinical or administrative criteria
and that directly result in less restrictive coverage of a given
service, an insurer, MCO or contractor shall notify health care
providers within (30) days after application of such change.
(d) Clinical review criteria adopted by an insurer, MCO or
contractor at the time of medical policy development or review
shall:
(1) Be based on nationally recognized medical standards.
(2) Be consistent with applicable governmental guidelines.
(3) Provide for the delivery of a health care service in a
clinically appropriate type, frequency, setting and duration.
(4) Reflect the current quality of medical and scientific
evidence regarding emerging procedures, clinical guidelines and
best practices as articulated in independent, peer-reviewed
medical literature.
(e) Nothing in this section shall require an insurer, MCO or
contractor to provide coverage for a health care service that is
otherwise excluded from coverage under a health insurance
policy, MCO contract or CHIP contract.
Section 8. Sections 2141, 2142(a) and (b), 2143, 2151(e) and
2152(a)(3), (4)(i) and (7) and (c) of the act are amended to
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read:
Section 2141. Internal Complaint Process.--(a) [A managed
care plan] An insurer, MCO or contractor shall establish and
maintain an internal complaint process [with two levels of
review] by which an enrollee shall be able to file a complaint
[regarding a participating health care provider or the coverage,
operations or management policies of the managed care plan].
(b) The complaint process shall consist of [an initial] a
review [to] by a committee of three or more individuals, a third
of which shall not be employed by the insurer, MCO or contractor
and shall include all of the following:
[(1) A review by an initial review committee consisting of
one or more employes of the managed care plan.]
(2) The allowance of a written or oral complaint.
(3) The allowance of written data or other information.
(4) A review or investigation of the complaint which shall
be completed within thirty (30) days of receipt of the
complaint.
(5) A written notification to the enrollee regarding the
decision of the [initial] review committee within five (5)
business days of the decision. [Notice shall include the basis
for the decision and the procedure to file a request for a
second level review of the decision of the initial review
committee.
(c) The complaint process shall include a second level
review that includes all of the following:
(1) A review of the decision of the initial review committee
by a second level review committee consisting of three or more
individuals who did not participate in the initial review. At
least one third of the second level review committee shall not
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be employed by the managed care plan.
(2) A written notification to the enrollee of the right to
appear before the second level review committee.
(3) A requirement that the second level review be completed
within forty-five (45) days of receipt of a request for such
review.
(4) A written notification to the enrollee regarding the
decision of the second level review committee within five (5)
business days of the decision.] The notice shall include the
basis for the decision and the procedure for appealing the
decision to the department or the Insurance Department.
Section 2142. Appeal of Complaint.--(a) An enrollee shall
have [fifteen (15) days] four (4) months from receipt of the
notice of the decision from the [second level] review committee
to appeal the decision to the department or the Insurance
Department, as appropriate.
(b) All records from the [initial] review [and second level
review] shall be transmitted to the appropriate department in
the manner prescribed. The enrollee, the health care provider or
the [managed care plan] insurer, MCO or contractor may submit
additional materials related to the complaint.
* * *
Section 2143. Complaint Resolution.--Nothing in this
subdivision shall prevent the department or the Insurance
Department from communicating with the enrollee, the health care
provider or the [managed care plan] insurer, MCO or contractor
as appropriate to assist in the resolution of a complaint. Such
communication may occur at any time during the complaint
process.
Section 2151. Certification.--* * *
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(e) [A licensed] An insurer [or a managed care plan], MCO or
contractor with a certificate of authority shall comply with the
standards and procedures of this subdivision but shall not be
required to obtain separate certification as a utilization
review entity.
Section 2152. Operational Standards.--(a) A utilization
review entity shall do all of the following:
* * *
(3) Ensure that a health care provider is able to verify
that an individual requesting information on behalf of the
[managed care plan] insurer, MCO or contractor is a legitimate
representative of the [plan] insurer, MCO or contractor.
(4) Conduct utilization reviews based on the medical
necessity [and], appropriateness, health care setting, level of
care or effectiveness of the health care service being reviewed
and provide notification within the following time frames:
(i) A [prospective utilization review] prior authorization
decision shall be communicated [within two (2) business days of
the receipt of all supporting information reasonably necessary
to complete the review.] pursuant to the review timelines
contained in section 2154(g).
* * *
(7) Notify the health care provider of additional facts or
documents required to complete the utilization review within
forty-eight (48) hours of receipt of the request for review[.]
or pursuant to section 2154(h) for missing clinical information
for all requests for prior authorization.
* * *
(c) Utilization review that results in a denial of payment
for a health care service, not including an administrative
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denial, shall be made by a licensed physician, except as
provided in subsection (d) or section 2154(c) for all requests
for prior authorization.
* * *
Section 9. The act is amended by adding sections to read:
Section 2153. Step Therapy Considerations.--The following:
(1) If an insurer's, MCO's or contractor's medical policy
adopted under section 2137 incorporates step therapy criteria
for prescription drugs, an insurer, MCO or contractor shall
consider as part of the insurer's, MCO's or contractor's initial
prior authorization process or a request for an exception to the
insurer's, MCO's or contractors step therapy criteria, and based
on the enrollee's individualized clinical condition, the
following:
(i) Contraindications, including adverse reactions.
(ii) Clinical effectiveness or ineffectiveness of the
required prerequisite prescription drugs or therapies.
(iii) Past clinical outcome of the required prerequisite
prescription drug or therapy.
(iv) The expected clinical outcomes of the requested
prescription drug prescribed by the enrollee's health care
provider.
(v) For new enrollees, whether the enrollee has already
satisfied a step therapy protocol with their previous health
insurer that required trials of drugs from each of the classes
that are required by the current insurer's, MCO's or
contractor's step therapy protocol.
(2) The provisions of section 2154 shall apply to step
therapy reviews conducted under this section.
Section 2154. Prior Authorization Review.-- (a) (1)
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Insurer, MCO or contractor review of a request for prior
authorization shall be based upon the insurer's, MCO's or
contractor's medical policy, administrative policy and all
medical information and evidence submitted by the requesting
provider.
(2) At the time of review, an insurer, MCO or contractor
shall also verify the enrollee's eligibility for coverage under
the terms of the applicable health insurance policy, MCO
contract or CHIP contract.
(3) Appeals of administrative denials shall be subject to
the complaint process under subarticle (g).
(b) An insurer, MCO or contractor shall make available a
list, posted in a publicly accessible format and location on the
insurer's, MCO's or contractor's publicly accessible Internet
website, and provider portal, that indicates the health services
for which the insurer, MCO or contractor requires prior
authorization.
(c) Other than an administrative denial, a request for prior
authorization may only be denied upon review by a properly
licensed medical professional with appropriate training,
knowledge or experience in the same or similar specialty that
typically manages or consults on the health care service in
question. Alternatively, an insurer, MCO or contractor may
satisfy this requirement through the completion of the review by
a licensed medical professional in consultation with an
appropriately qualified third-party medical professional,
licensed in the same or similar medical specialty as the
requesting health care provider or type of health care provider
that typically manages the enrollee's associated condition,
provided that any compensation paid to the consulting
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professional may not be contingent upon the outcome of the
review. Nothing in this section shall compel an insurer, MCO or
contractor to obtain third-party medical professionals in the
same specialty or subspecialty.
(d) In the case of a denied prior authorization, the
insurer, MCO or contractor shall make available to the
requesting health care provider a licensed medical professional
for a peer-to-peer review discussion. The peer-to-peer reviewer
provided by the insurer, MCO or contractor shall meet the
standards under subsection (c) and have authority to modify or
overturn the prior authorization decision. The procedure for
requesting a peer-to-peer review shall be available on the
insurer's, MCO's or contractor's publicly accessible Internet
website and provider portal. An insurer's, MCO's or contractor's
peer-to-peer procedure shall include, but not be limited to,
ability to request a peer-to-peer discussion:
(1) during normal business hours; or
(2) outside normal business hours subject to reasonable
limitations on the availability of qualified insurer, MCO or
contractor staff. In the event an insurer, MCO or contractor
uses a third-party vendor or utilization review entity to
conduct peer-to-peer reviews for denials administered by the
vendor or entity, the procedure under subsection (i) shall
include contact information and information on the hours of
availability of the vendor or entity necessary for a requesting
health care provider to schedule a peer-to-peer discussion.
(e) A health care provider may designate, and an insurer,
MCO or contractor shall accept, another licensed member of the
health care provider's affiliated or employed clinical staff
with knowledge of the enrollee's condition and requested
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procedure as a qualified proxy for purposes of completing a
peer-to-peer discussion. Individuals eligible to receive a proxy
designation shall be limited to licensed health care providers
whose actual authority and scope of practice is inclusive of
performing or prescribing the requested health care service.
Such authority may be established through a supervising
physician consistent with applicable State law for non-physician
practitioners. The insurer, MCO or contractor must accept and
review the information submitted by other members of a health
care provider's affiliated or employed staff in support of a
prior authorization request. The insurer, MCO or contractor may
not limit interactions with an insurer's, MCO's or contractor's
clinical staff solely to the requesting health care provider.
(f) A peer-to-peer discussion shall be available to a
requesting health care provider from the time of a denial of
prior authorization until the internal grievance process
commences. If a peer-to-peer discussion is available prior to
adjudicating a prior authorization request, the peer-to-peer
shall be offered within the timeline in subsection (g).
(g) An insurer's, MCO's or contractor's decision to approve
or deny prior authorization shall be rendered within the
following timeframes and following the submission of a complete
prior authorization request:
(1) An insurer, MCO or contractor shall issue a prior
authorization determination for a medical health care service in
accordance with the following timeframes:
(i) Review of request for urgent health care services as
expeditiously as the enrollee's health condition requires but no
more than seventy-two (72) hours.
(ii) Review of request for non-urgent medical services not
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more than fifteen (15) calendar days.
(2) Insurers, MCOs and contractors shall issue a prior
authorization determination for a prescription drug medication
or render a decision on step therapy under section 2153 in
accordance with the following timeframes:
(i) Review or urgent request not more than twenty-four (24)
hours.
(ii) Review of standard request not more than two (2)
business days and not to exceed seventy-two (72) hours.
(3) If at any time after requesting prior authorization the
health care provider determines the enrollee's medical condition
requires emergency services, such services may be provided under
section 2116.
(4) Upon receipt of a submission of a prior authorization
request, an insurer, MCO or contractor shall notify the health
care provider of any missing or other supporting information
necessary to make it a complete prior authorization request in
accordance with subsection (h).
(h) In the event that a prior authorization request is
missing clinical information that is reasonably necessary to
complete a review, the insurer, MCO or contractor shall notify
the health care provider of any missing clinical information
necessary to complete the review within twenty-four (24) hours
of receipt of the prior authorization request for urgent health
care services or within two (2) business days of receipt of all
other types of prior authorization requests and allow the
requesting health care provider or any member of the requesting
health care provider's clinical or administrative staff to
submit such information within the established review time
lines. A request for information under this subsection shall be
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made with sufficient specificity to enable the health care
provider to identify the necessary clinical or other supporting
information necessary to complete review.
(i) An insurer, MCO or contractor may supplement submitted
information based on current clinical records or other current
medical information for an enrollee as available, provided that
the supplemental information is also made available to the
enrollee or health care provider as part of the enrollee's
authorization case file upon request. In response to any request
for missing information, an insurer, MCO or contractor shall
also accept supplemental information from any member of the
health care provider's clinical staff.
(j) If a health care provider performs a closely related
service, the insurer, MCO or contractor may not deny a claim for
the closely related service for failure of the health care
provider to seek or obtain prior authorization, provided that:
(1) The health care provider notifies the insurer, MCO or
contractor of the performance of the closely related service no
later than seventy two (72) hours following completion of the
service but prior to the submission of the claim for
payment. The submission of the notification shall include the
submission of all relevant clinical information necessary for
the insurer, MCO or contractor to evaluate the medical necessity
and appropriateness of the service.
(2) Nothing in this subsection shall be construed to limit
an insurer's, MCO's or contractor's consideration of medical
necessity and appropriateness of the closely service, nor limit
the need for verification of the enrollee's eligibility for
coverage.
Section 2155. Provider portal.--(a) Within eighteen (18)
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months following the effective date of this section, an insurer,
MCO or contractor shall establish a provider portal that
includes, at minimum, the following features:
(1) Electronic submission of prior authorization requests.
(2) Access to an insurer's, MCO's or contractor's applicable
medical policies.
(3) Information necessary to request a peer-to-peer review.
(4) Contact information for an insurer's, MCO's or
contractor's relevant clinical or administrative staff.
(5) For any prior authorization service not subject to
electronic submission via the provider portal, copies of any
applicable submission forms.
(6) Instructions for the submission of prior authorization
requests in the event that an insurer's, MCO's or contractor's
provider portal is unavailable for any reason.
(b) Within six (6) months following the establishment of
provider portals under subsection (a), an insurer, MCO or
contractor shall make available to health care providers and
their affiliated or employed staff access to training on the use
of the insurer's, MCO's or contractor's provider portal.
(c) Within eighteen (18) months following the establishment
of provider portals under subsection (a), a health care provider
seeking prior authorization shall submit such request via an
insurer's, MCO's or contractor's provider portal, provided that:
(1) Submission via provider portal shall only be required to
the extent an insurer's, MCO's or contractor's provider portal
is available and operational at the time of attempted
submission.
(2) Submission via an insurer's, MCO's or contractor's
provider portal shall only be required to the extent the health
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care provider has access to the insurer's, MCO's or contractor's
operational provider portal.
(3) Insurers, MCOs and contractors may elect to maintain
allowances for submission of prior authorization requests
outside of the provider portal.
Section 10. Sections 2161, 2162, 2163, 2166, subarticle (k)
heading of Article XXI and sections 2171, 2181, 2182 and 2191 of
the act are amended to read:
Section 2161. Internal Grievance Process.--(a) [A managed
care plan] An insurer, MCO or contractor shall establish and
maintain an internal grievance process [with two levels of
review] and an expedited internal grievance process by which an
enrollee or a health care provider, with the written consent of
the enrollee, shall be able to file a written grievance
regarding the denial of payment for a health care service within
four (4) months of receiving an adverse benefit determination.
An enrollee who consents to the filing of a grievance by a
health care provider under this section may not file a separate
grievance.
(b) The internal grievance process shall consist of [an
initial] a review that includes all of the following:
(1) A review by [one] three or more persons selected by the
[managed care plan] insurer, MCO or contractor who did not
previously participate in the decision to deny payment for the
health care service.
(2) The completion of the review within thirty (30) days of
receipt of the grievance.
(3) A written notification to the enrollee and health care
provider[.] of the right to appear before the review committee
within five (5) business days of receiving the internal
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grievance.
(4) A written notification to the enrollee and health care
provider regarding the decision within five (5) business days of
the decision. The notice shall include the basis and clinical
rationale for the decision and the procedure to file a request
[for a second level review of] appealing the decision as an
external grievance.
[(c) The grievance process shall include a second level
review that includes all of the following:
(1) A review of the decision issued pursuant to subsection
(b) by a second level review committee consisting of three or
more persons who did not previously participate in any decision
to deny payment for the health care service.
(2) A written notification to the enrollee or the health
care provider of the right to appear before the second level
review committee.
(3) The completion of the second level review within forty-
five (45) days of receipt of a request for such review.
(4) A written notification to the enrollee and health care
provider regarding the decision of the second level review
committee within five (5) business days of the decision. The
notice shall include the basis and clinical rationale for the
decision and the procedure for appealing the decision.]
(d) Any [initial review or second level] review conducted
under this section shall include a licensed physician, or, where
appropriate, an approved licensed psychologist, in the same or
similar specialty that typically manages or consults on the
health care service.
(e) Should the enrollee's life, health or ability to regain
maximum function be in jeopardy, an expedited internal grievance
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process shall be available which shall include a requirement
that a decision with appropriate notification to the enrollee
and health care provider be made within forty-eight (48) hours
of the filing of the expedited grievance.
Section 2162. External Grievance Process.--(a) [A managed
care plan] An insurer, MCO or contractor shall establish and
maintain an external grievance process by which an enrollee or a
health care provider with the written consent of the enrollee
may appeal the denial of a grievance following completion of the
internal grievance process. The external grievance process shall
be conducted by an independent utilization review entity not
directly affiliated with the [managed care plan] insurer, MCO or
contractor.
(b) To conduct external grievances filed under this section:
(1) The department shall randomly assign a utilization
review entity on a rotational basis from the list maintained
under subsection (d) and notify the assigned utilization review
entity and the [managed care plan] insurer, MCO or contractor
within two (2) business days of receiving the request. If the
department fails to select a utilization review entity under
this subsection, the [managed care plan] insurer, MCO or
contractor shall designate and notify a certified utilization
review entity to conduct the external grievance.
(2) The [managed care plan] insurer, MCO or contractor shall
notify the enrollee or health care provider of the name, address
and telephone number of the utilization review entity assigned
under this subsection within two (2) business days.
(c) The external grievance process shall meet all of the
following requirements:
(1) Any external grievance shall be filed with the [managed
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care plan] insurer, MCO or contractor within [fifteen (15) days]
four (4) months of receipt of a notice of denial resulting from
the internal grievance process. The filing of the external
grievance shall include any material justification and all
reasonably necessary supporting information. Within five (5)
business days of the filing of an external grievance, the
[managed care plan] insurer, MCO or contractor shall notify the
enrollee or the health care provider, the utilization review
entity that conducted the internal grievance and the department
that an external grievance has been filed.
(2) The utilization review entity that conducted the
internal grievance shall forward copies of all written
documentation regarding the denial, including the decision, all
reasonably necessary supporting information, a summary of
applicable issues and the basis and clinical rationale for the
decision, to the utilization review entity conducting the
external grievance within fifteen (15) days of receipt of notice
that the external grievance was filed. Any additional written
information may be submitted by the enrollee or the health care
provider within fifteen (15) days of receipt of notice that the
external grievance was filed.
(3) The utilization review entity conducting the external
grievance shall review all information considered in reaching
any prior decisions to deny payment for the health care service
and any other written submission by the enrollee or the health
care provider.
(4) An external grievance decision shall be made by:
(i) one or more licensed physicians or approved licensed
psychologists in active clinical practice or in the same or
similar specialty that typically manages or recommends treatment
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for the health care service being reviewed; or
(ii) one or more physicians currently certified by a board
approved by the American Board of Medical Specialists or the
American Board of Osteopathic Specialties in the same or similar
specialty that typically manages or recommends treatment for the
health care service being reviewed.
(5) Within sixty (60) days of the filing of the external
grievance, the utilization review entity conducting the external
grievance shall issue a written decision to the [managed care
plan] insurer, MCO or contractor, the enrollee and the health
care provider, including the basis and clinical rationale for
the decision. The standard of review shall be whether the health
care service denied by the internal grievance process was
medically necessary and appropriate under the terms of the
[plan] health insurance policy, MCO contract or CHIP contract.
The external grievance decision shall be subject to appeal to a
court of competent jurisdiction within sixty (60) days of
receipt of notice of the external grievance decision. There
shall be a rebuttable presumption in favor of the decision of
the utilization review entity conducting the external grievance.
(6) The [managed care plan] insurer, MCO or contractor shall
authorize any health care service or pay a claim determined to
be medically necessary and appropriate under paragraph (5)
pursuant to section 2166 whether or not an appeal to a court of
competent jurisdiction has been filed.
(7) All fees and costs related to an external grievance
shall be paid by the nonprevailing party if the external
grievance was filed by the health care provider. The health care
provider and the utilization review entity or [managed care
plan] insurer, MCO or contractor shall each place in escrow an
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amount equal to one-half of the estimated costs of the external
grievance process. If the external grievance was filed by the
enrollee, all fees and costs related thereto shall be paid by
the [managed care plan] insurer, MCO or contractor. For purposes
of this paragraph, fees and costs shall not include attorney
fees.
(d) The department shall compile and maintain a list of
certified utilization review entities that meet the requirements
of this article. The department may remove a utilization review
entity from the list if such an entity is incapable of
performing its responsibilities in a reasonable manner, charges
excessive fees or violates this article.
(e) A fee may be imposed by [a managed care plan] an
insurer, MCO or contractor for filing an external grievance
pursuant to this article which shall not exceed twenty-five
($25) dollars.
(f) Written contracts between [managed care plans] insurers,
MCO or contractor and health care providers may provide an
alternative dispute resolution system to the external grievance
process set forth in this article if the department approves the
contract. The alternative dispute resolution system shall be
impartial, include specific time limitations to initiate
appeals, receive written information, conduct hearings and
render decisions and otherwise satisfy the requirements of this
section. A written decision pursuant to an alternative dispute
resolution system shall be final and binding on all parties. An
alternative dispute resolution system shall not be utilized for
any external grievance filed by an enrollee.
Section 2163. Records.--Records regarding grievances filed
under this subdivision that result in decisions adverse to
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enrollees shall be maintained by the [plan] insurer, MCO or
contractor for not less than three (3) years. These records
shall be provided to the department, if requested, in accordance
with section 2131(c)(2)(ii).
Section 2166. Prompt Payment of Claims.--(a) [A licensed]
An insurer [or a managed care plan], MCO or contractor shall pay
a clean claim submitted by a health care provider within forty-
five (45) days of receipt of the clean claim.
(b) If [a licensed] an insurer [or a managed care plan], MCO
or contractor fails to remit the payment as provided under
subsection (a), interest at ten per centum (10%) per annum shall
be added to the amount owed on the clean claim. Interest shall
be calculated beginning the day after the required payment date
and ending on the date the claim is paid. The licensed insurer
or [managed care plan] insurer, MCO or contractor shall not be
required to pay any interest calculated to be less than two ($2)
dollars.
(k) Health Care Provider [and Managed Care Plan], Insurer, MCO
and Contractor Protection.
Section 2171. Health Care Provider [and Managed Care Plan],
Insurer, MCO and Contractor Protection.--(a) [A managed care
plan] An insurer, MCO or contractor shall not exclude,
discriminate against or penalize any health care provider for
its refusal to allow, perform, participate in or refer for
health care services when the refusal of the health care
provider is based on moral or religious grounds and that
provider makes adequate information available to enrollees or,
if applicable, prospective enrollees.
(b) No public institution, public official or public agency
may take disciplinary action against, deny licensure or
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certification or penalize any person, association or corporation
attempting to establish a [plan] health insurance policy, MCO
contract, CHIP contract or operating, expanding or improving an
existing [plan] health insurance policy, MCO contract or CHIP
contract because the person, association or corporation refuses
to provide any particular form of health care services or other
services or supplies covered by other [plans] health insurance
policies, MCO contracts or CHIP contracts when the refusal is
based on moral or religious grounds.
Section 2181. Departmental Powers and Duties.--(a) The
department shall require that records and documents submitted to
[a managed care plan] an insurer, MCO, contractor or utilization
review entity as part of any complaint or grievance be made
available to the department, upon request, for purposes of
enforcement or compliance with this article.
(b) The department shall compile data received from [a
managed care plan] an insurer, MCO or contractor on an annual
basis regarding the number, type and disposition of complaints
and grievances filed with [a managed care plan] an insurer, MCO
or contractor under this article.
(c) The department shall issue guidelines identifying those
provisions of this article that exceed or are not included in
the "Standards for the Accreditation of Managed Care
Organizations" published by the National Committee for Quality
Assurance. These guidelines shall be published in the
Pennsylvania Bulletin and updated as necessary. Copies of the
guidelines shall be made available to [managed care plans]
insurers, MCOs, contractors, health care providers and enrollees
upon request.
(d) The department and the Insurance Department shall ensure
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compliance with this article. The appropriate department shall
investigate potential violations of the article based upon
information received from enrollees, health care providers and
other sources in order to ensure compliance with this article.
(e) The department and the Insurance Department shall
promulgate such regulations as may be necessary to carry out the
provisions of this article.
(f) The department in cooperation with the Insurance
Department shall submit an annual report to the General Assembly
regarding the implementation, operation and enforcement of this
article.
Section 2182. Penalties and Sanctions.--(a) The department
or the Insurance Department, as appropriate, may impose a civil
penalty of up to five thousand ($5,000) dollars for a violation
of this article.
(b) [A managed care plan] An insurer, MCO or contractor
shall be subject to the act of July 22, 1974 (P.L.589, No.205),
known as the "Unfair Insurance Practices Act."
(c) The department or the Insurance Department may maintain
an action in the name of the Commonwealth for an injunction to
prohibit any activity which violates the provisions of this
article.
(d) The department may issue an order temporarily
prohibiting [a managed care plan] an insurer, MCO or contractor
which violates this article from enrolling new members.
(e) The department may require [a managed care plan] an
insurer, MCO or contractor to develop and adhere to a plan of
correction approved by the department. The department shall
monitor compliance with the plan of correction. The plan of
correction shall be available to enrollees of the [managed care
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plan] insurer, MCO or contractor upon request.
(f) In no event shall the department and the Insurance
Department impose a penalty for the same violation.
Section 2191. Compliance with National Accrediting
Standards.--Notwithstanding any other provision of this article
to the contrary, the department shall give consideration to [a
managed care plan's] an insurer's, MCO's or contractor's
demonstrated compliance with the standards and requirements set
forth in the "Standards for the Accreditation of Managed Care
Organizations" published by the National Committee for Quality
Assurance or other department-approved quality review
organizations in determining compliance with the same or similar
provisions of this article. The [managed care plan] insurer, MCO
or contractor, however, shall remain subject to and shall comply
with any other provisions of this article that exceed or are not
included in the standards of the National Committee for Quality
Assurance or other department-approved quality review
organizations.
Section 11. This act shall take effect as follows:
(1) This section shall take effect immediately.
(2) The addition of section 2155 of the act shall take
effect January 1, 2023.
(3) The remainder of this act shall take effect January
1, 2024.
SECTION 1. SECTION 2102, SUBDIVISION (B) HEADING OF ARTICLE
XXI, SECTIONS 2111, 2112, 2113, 2116, 2117, 2121 AND 2131,
SUBDIVISION (F) HEADING OF ARTICLE XXI AND SECTION 2136 OF THE
ACT OF MAY 17, 1921 (P.L.682, NO.284), KNOWN AS THE INSURANCE
COMPANY LAW OF 1921, ARE AMENDED TO READ:
SECTION 2102. DEFINITIONS.--AS USED IN THIS ARTICLE, THE
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FOLLOWING WORDS AND PHRASES SHALL HAVE THE MEANINGS GIVEN TO
THEM IN THIS SECTION:
"ACTIVE CLINICAL PRACTICE." THE PRACTICE OF CLINICAL
MEDICINE BY A HEALTH CARE PROVIDER FOR AN AVERAGE OF NOT LESS
THAN TWENTY (20) HOURS PER WEEK.
"ADMINISTRATIVE DENIAL." AN ADVERSE BENEFIT DETERMINATION OF
PRIOR AUTHORIZATION, COVERAGE OR PAYMENT BASED ON A LACK OF
ELIGIBILITY, FAILURE TO SUBMIT COMPLETE INFORMATION OR OTHER
FAILURE TO COMPLY WITH AN ADMINISTRATIVE POLICY. THE TERM DOES
NOT INCLUDE AN ADVERSE BENEFIT DETERMINATION BASED ON MEDICAL
NECESSITY.
"ADMINISTRATIVE POLICY." A WRITTEN DOCUMENT OR COLLECTION OF
DOCUMENTS REFLECTING THE TERMS OF THE CONTRACTUAL OR OPERATING
RELATIONSHIP BETWEEN AN INSURER OR MA OR CHIP MANAGED CARE PLAN
AND A HEALTH CARE PROVIDER.
"ADVERSE BENEFIT DETERMINATION." AN ADVERSE BENEFIT
DETERMINATION MAY BE ANY OF THE FOLLOWING:
(1) A DETERMINATION BY AN INSURER OR A UTILIZATION REVIEW
ENTITY ON BEHALF OF AN INSURER THAT, BASED UPON THE INFORMATION
PROVIDED AND UPON APPLICATION OF UTILIZATION REVIEW, A REQUEST
FOR A BENEFIT UNDER A HEALTH INSURANCE POLICY DOES NOT MEET THE
INSURER'S REQUIREMENTS FOR MEDICAL NECESSITY, APPROPRIATENESS,
HEALTH CARE SETTING, LEVEL OF CARE OR EFFECTIVENESS OR IS
DETERMINED TO BE EXPERIMENTAL OR INVESTIGATIONAL, SUCH THAT THE
REQUESTED BENEFIT IS THEREFORE DENIED, REDUCED OR TERMINATED OR
PAYMENT IS NOT PROVIDED OR MADE, IN WHOLE OR IN PART, FOR THE
BENEFIT.
(2) THE DENIAL, REDUCTION, TERMINATION OR FAILURE TO PROVIDE
OR MAKE PAYMENT, IN WHOLE OR IN PART, FOR A BENEFIT BASED ON A
DETERMINATION BY AN INSURER OF A PERSON'S ELIGIBILITY FOR
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COVERAGE UNDER A HEALTH INSURANCE POLICY OR NONCOMPLIANCE WITH
AN ADMINISTRATIVE POLICY.
(3) A RESCISSION OF COVERAGE DETERMINATION.
"AGREEMENT WITH THE DEPARTMENT OF HUMAN SERVICES." A
CONTRACT BETWEEN AN MA OR CHIP MANAGED CARE PLAN AND THE
DEPARTMENT OF HUMAN SERVICES OR PRIMARY CONTRACTOR OF THE
DEPARTMENT OF HUMAN SERVICES TO MANAGE THE PURCHASE AND
PROVISION OF MEDICAL, BEHAVIORAL HEALTH OR HOME AND COMMUNITY-
BASED SERVICES.
"ANCILLARY SERVICE PLANS." ANY INDIVIDUAL OR GROUP HEALTH
INSURANCE PLAN, SUBSCRIBER CONTRACT OR CERTIFICATE THAT PROVIDES
EXCLUSIVE COVERAGE FOR DENTAL SERVICES OR VISION SERVICES. THE
TERM ALSO INCLUDES MEDICARE SUPPLEMENT POLICIES SUBJECT TO
SECTION 1882 OF THE SOCIAL SECURITY ACT (49 STAT. 620, 42 U.S.C.
ยง 1395SS) AND THE CIVILIAN HEALTH AND MEDICAL PROGRAM OF THE
UNIFORMED SERVICES (CHAMPUS) SUPPLEMENT.
"APPLICABLE GOVERNMENTAL GUIDELINES." CLINICAL PRACTICE AND
ASSOCIATED GUIDELINES ISSUED UNDER THE AUTHORITY OF THE UNITED
STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES
FOOD AND DRUG ADMINISTRATION, CENTERS FOR DISEASE CONTROL AND
PREVENTION, PENNSYLVANIA DEPARTMENT OF HEALTH OR OTHER SIMILARLY
SITUATED FEDERAL OR STATE AGENCY, DEPARTMENT OR SUBUNIT THEREOF
FOCUSED ON THE PROVISION OR REGULATION OF MEDICAL CARE,
PRESCRIPTION DRUGS OR PUBLIC HEALTH WITHIN THE UNITED STATES.
"AUTHORIZED REPRESENTATIVE." ONE OF THE FOLLOWING:
(1) A PERSON, INCLUDING A HEALTH CARE PROVIDER, TO WHOM A
COVERED PERSON OR ENROLLEE HAS GIVEN EXPRESS WRITTEN CONSENT TO
REPRESENT THE COVERED PERSON OR ENROLLEE IN A COMPLAINT,
GRIEVANCE, ADVERSE BENEFIT DETERMINATION, INTERNAL APPEAL OR
EXTERNAL REVIEW PROCESS.
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(2) A PERSON AUTHORIZED BY LAW TO PROVIDE SUBSTITUTED
CONSENT FOR A COVERED PERSON OR ENROLLEE.
(3) A FAMILY MEMBER OR TREATING HEALTH CARE PROVIDER
INVOLVED IN PROVIDING HEALTH CARE TO A COVERED PERSON OR
ENROLLEE IF THE COVERED PERSON OR ENROLLEE IS INCAPACITATED OR
UNAVAILABLE TO PROVIDE CONSENT DUE TO A MEDICAL EMERGENCY OR
NECESSARY TO PREVENT A SERIOUS AND IMMINENT THREAT TO THE HEALTH
OR SAFETY OF THE COVERED PERSON OR ENROLLEE.
"CLEAN CLAIM." A CLAIM FOR PAYMENT FOR A HEALTH CARE SERVICE
WHICH HAS NO DEFECT OR IMPROPRIETY. A DEFECT OR IMPROPRIETY
SHALL INCLUDE LACK OF REQUIRED SUBSTANTIATING DOCUMENTATION OR A
PARTICULAR CIRCUMSTANCE REQUIRING SPECIAL TREATMENT WHICH
PREVENTS TIMELY PAYMENT FROM BEING MADE ON THE CLAIM. THE TERM
SHALL NOT INCLUDE A CLAIM FROM A HEALTH CARE PROVIDER WHO IS
UNDER INVESTIGATION FOR FRAUD OR ABUSE REGARDING THAT CLAIM.
"CLINICAL REVIEW CRITERIA." THE SET OF WRITTEN SCREENING
PROCEDURES, DECISION ABSTRACTS, CLINICAL PROTOCOLS AND PRACTICE
GUIDELINES USED BY AN INSURER OR MA OR CHIP MANAGED CARE PLAN TO
DETERMINE THE NECESSITY AND APPROPRIATENESS OF HEALTH CARE
SERVICES.
"CLOSELY-RELATED SERVICE." A HEALTH CARE SERVICE SUBJECT TO
PRIOR AUTHORIZATION THAT IS CLOSELY RELATED IN PURPOSE,
DIAGNOSTIC UTILITY OR DESIGNATED HEALTH CARE BILLING CODE, AND
PROVIDED ON THE SAME DATE OF SERVICE AS AN AUTHORIZED SERVICE,
SUCH THAT A PRUDENT HEALTH CARE PROVIDER, ACTING WITHIN THE
SCOPE OF THE PROVIDER'S LICENSE AND EXPERTISE, MAY REASONABLY BE
EXPECTED TO PERFORM THE SERVICE IN CONJUNCTION WITH OR IN LIEU
OF THE ORIGINALLY AUTHORIZED SERVICE IN RESPONSE TO MINOR
DIFFERENCES IN OBSERVED PATIENT CHARACTERISTICS OR NEEDS FOR
DIAGNOSTIC INFORMATION THAT WERE NOT READILY IDENTIFIABLE UNTIL
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THE PROVIDER WAS ACTUALLY PERFORMING THE ORIGINALLY AUTHORIZED
SERVICE. THE TERM DOES NOT INCLUDE AN ORDER FOR OR
ADMINISTRATION OF A PRESCRIPTION DRUG OR ANY PART OF A SERIES OR
COURSE OF TREATMENTS.
"COMMISSIONER." THE INSURANCE COMMISSIONER OF THE
COMMONWEALTH.
"COMPLAINT." A DISPUTE OR OBJECTION REGARDING A
PARTICIPATING HEALTH CARE PROVIDER OR THE COVERAGE, OPERATIONS
OR MANAGEMENT POLICIES OF [A] AN INSURER OR MA OR CHIP MANAGED
CARE PLAN WHICH HAS NOT BEEN RESOLVED BY THE INSURER OR MA OR
CHIP MANAGED CARE PLAN AND HAS BEEN FILED WITH THE INSURER, MA
OR CHIP MANAGED CARE PLAN OR [WITH THE DEPARTMENT OF HEALTH OR
THE INSURANCE DEPARTMENT OF THE COMMONWEALTH] DEPARTMENT. THE
TERM DOES NOT INCLUDE A GRIEVANCE OR AN ADVERSE BENEFIT
DETERMINATION ELIGIBLE FOR EXTERNAL REVIEW.
"CONCURRENT [UTILIZATION] REVIEW." A REVIEW [BY A
UTILIZATION REVIEW ENTITY] PERFORMED BY AN INSURER OR MA OR CHIP
MANAGED CARE PLAN, OR BY A UTILIZATION REVIEW ENTITY ACTING ON
BEHALF OF AN INSURER OR MA OR CHIP MANAGED CARE PLAN OF ALL
REASONABLY NECESSARY SUPPORTING INFORMATION WHICH OCCURS DURING
AN ENROLLEE'S HOSPITAL STAY OR COURSE OF TREATMENT AND RESULTS
IN A DECISION TO APPROVE OR DENY PAYMENT FOR THE HEALTH CARE
SERVICE.
"COVERED BENEFIT." A HEALTH CARE SERVICE AS SET FORTH IN THE
TERMS OF A HEALTH INSURANCE POLICY OR AN AGREEMENT WITH THE
DEPARTMENT OF HUMAN SERVICES. THE TERM INCLUDES A COVERED
SERVICE.
"COVERED PERSON." A POLICYHOLDER, SUBSCRIBER OR OTHER
INDIVIDUAL WHO IS ENTITLED TO RECEIVE HEALTH CARE SERVICES UNDER
A HEALTH INSURANCE POLICY.
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"COVERED SERVICE." A HEALTH CARE SERVICE ELIGIBLE FOR
PAYMENT UNDER THE TERMS OF A HEALTH INSURANCE POLICY OR AN
AGREEMENT WITH THE DEPARTMENT OF HUMAN SERVICES.
"DEPARTMENT." THE [DEPARTMENT OF HEALTH] INSURANCE
DEPARTMENT OF THE COMMONWEALTH.
"DISCHARGE PLANNING." THE FORMAL PROCESS FOR DETERMINING,
PRIOR TO DISCHARGE FROM A FACILITY, THE COORDINATION AND
MANAGEMENT OF CARE THAT A COVERED PERSON OR ENROLLEE WILL
RECEIVE FOLLOWING THE DISCHARGE.
"DRUG FORMULARY." A LISTING OF HEALTH INSURANCE POLICY OR MA
OR CHIP MANAGED CARE PLAN PREFERRED THERAPEUTIC DRUGS.
"EMERGENCY SERVICE." [ANY] A HEALTH CARE SERVICE PROVIDED TO
[AN] A COVERED PERSON OR ENROLLEE AFTER THE SUDDEN ONSET OF A
MEDICAL CONDITION THAT MANIFESTS ITSELF BY ACUTE SYMPTOMS OF
SUFFICIENT SEVERITY OR SEVERE PAIN SUCH THAT A PRUDENT LAYPERSON
WHO POSSESSES AN AVERAGE KNOWLEDGE OF HEALTH AND MEDICINE COULD
REASONABLY EXPECT THE ABSENCE OF IMMEDIATE MEDICAL ATTENTION TO
RESULT IN:
(1) PLACING THE HEALTH OF THE COVERED PERSON OR ENROLLEE IN
SERIOUS JEOPARDY OR, WITH RESPECT TO A PREGNANT WOMAN, THE
HEALTH OF THE WOMAN OR HER UNBORN CHILD IN SERIOUS JEOPARDY;
(2) SERIOUS IMPAIRMENT TO BODILY FUNCTIONS; OR
(3) SERIOUS DYSFUNCTION OF ANY BODILY ORGAN OR PART.
[EMERGENCY TRANSPORTATION AND RELATED EMERGENCY SERVICE PROVIDED
BY A LICENSED AMBULANCE SERVICE SHALL CONSTITUTE AN EMERGENCY
SERVICE.] THE TERM INCLUDES EMERGENCY TRANSPORTATION AND RELATED
EMERGENCY SERVICES PROVIDED BY A LICENSED AMBULANCE SERVICE.
"ENROLLEE." [ANY POLICYHOLDER, SUBSCRIBER, COVERED PERSON OR
OTHER INDIVIDUAL] AN INDIVIDUAL WHO IS ENTITLED TO RECEIVE
HEALTH CARE SERVICES UNDER [A MANAGED CARE PLAN] AN AGREEMENT
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WITH THE DEPARTMENT OF HUMAN SERVICES.
"EVIDENCE-BASED STANDARD." INTERVENTIONS AND TREATMENT
APPROACHES THAT HAVE BEEN PROVEN EFFECTIVE THROUGH APPROPRIATE
EMPIRICAL ANALYSIS.
"FACILITY." A HEALTH CARE SETTING OR INSTITUTION PROVIDING
HEALTH CARE SERVICES, INCLUDING:
(1) A GENERAL, SPECIAL, PSYCHIATRIC OR REHABILITATION
HOSPITAL.
(2) AN AMBULATORY SURGICAL FACILITY.
(3) A CANCER TREATMENT CENTER.
(4) A BIRTH CENTER.
(5) A SKILLED NURSING CENTER.
(6) AN INPATIENT, OUTPATIENT OR RESIDENTIAL DRUG AND ALCOHOL
TREATMENT FACILITY.
(7) A LABORATORY, IMAGING, DIAGNOSTIC OR OTHER OUTPATIENT
MEDICAL SERVICE OR TESTING FACILITY.
(8) A HEALTH CARE PROVIDER OFFICE OR CLINIC.
"FINAL ADVERSE BENEFIT DETERMINATION." AN ADVERSE BENEFIT
DETERMINATION THAT HAS BEEN UPHELD BY AN INSURER OR A
UTILIZATION REVIEW ENTITY DESIGNATED BY THE INSURER AT THE
COMPLETION OF THE INSURER'S INTERNAL CLAIM AND APPEAL PROCEDURES
AS SPECIFIED IN SECTION 2161.1.
"GRIEVANCE." [AS PROVIDED IN SUBDIVISION (I), A] A REQUEST
TO AN MA OR CHIP MANAGED CARE PLAN BY AN ENROLLEE OR [A HEALTH
CARE PROVIDER, WITH THE WRITTEN CONSENT OF THE ENROLLEE,] AN
ENROLLEE'S AUTHORIZED REPRESENTATIVE TO HAVE [A] AN MA OR CHIP
MANAGED CARE PLAN [OR UTILIZATION REVIEW ENTITY] RECONSIDER A
DECISION SOLELY CONCERNING THE MEDICAL NECESSITY [AND],
APPROPRIATENESS, HEALTH CARE SETTING, LEVEL OF CARE OR
EFFECTIVENESS OF A HEALTH CARE SERVICE. IF THE MA OR CHIP
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MANAGED CARE PLAN IS UNABLE TO RESOLVE THE MATTER, A GRIEVANCE
MAY BE FILED REGARDING THE DECISION THAT:
(1) DISAPPROVES FULL OR PARTIAL PAYMENT FOR A REQUESTED
HEALTH CARE SERVICE;
(2) APPROVES THE PROVISION OF A REQUESTED HEALTH CARE
SERVICE FOR A LESSER SCOPE OR DURATION THAN REQUESTED; OR
(3) DISAPPROVES PAYMENT FOR THE PROVISION OF A REQUESTED
HEALTH CARE SERVICE BUT APPROVES PAYMENT FOR THE PROVISION OF AN
ALTERNATIVE HEALTH CARE SERVICE.
THE TERM DOES NOT INCLUDE A COMPLAINT OR AN ADVERSE BENEFIT
DETERMINATION.
"HEALTH CARE PROVIDER." A LICENSED HOSPITAL OR HEALTH CARE
FACILITY, MEDICAL EQUIPMENT SUPPLIER OR PERSON WHO IS LICENSED,
CERTIFIED OR OTHERWISE REGULATED TO PROVIDE HEALTH CARE SERVICES
UNDER THE LAWS OF THIS COMMONWEALTH, INCLUDING A PHYSICIAN,
PODIATRIST, OPTOMETRIST, PSYCHOLOGIST, PHYSICAL THERAPIST,
CERTIFIED NURSE PRACTITIONER, REGISTERED NURSE, NURSE MIDWIFE,
PHYSICIAN'S ASSISTANT, CHIROPRACTOR, DENTIST, PHARMACIST OR AN
INDIVIDUAL ACCREDITED OR CERTIFIED TO PROVIDE BEHAVIORAL HEALTH
SERVICES. FOR MA OR CHIP MANAGED CARE PLANS, THE TERM SHALL ALSO
REFER TO AN INDIVIDUAL PROVIDING PERSONAL ASSISTANCE OR
REHABILITATIVE SERVICES.
"HEALTH CARE SERVICE." ANY COVERED TREATMENT, ADMISSION,
PROCEDURE, MEDICAL SUPPLIES AND EQUIPMENT OR OTHER SERVICES,
INCLUDING BEHAVIORAL HEALTH, PRESCRIBED OR OTHERWISE PROVIDED OR
PROPOSED TO BE PROVIDED BY A HEALTH CARE PROVIDER TO [AN] A
COVERED PERSON OR ENROLLEE [UNDER A MANAGED CARE PLAN CONTRACT.]
FOR THE DIAGNOSIS, PREVENTION, TREATMENT, CURE OR RELIEF OF A
HEALTH CONDITION, ILLNESS, INJURY, DISEASE OR FUNCTIONAL
LIMITATION UNDER THE TERMS OF EITHER A HEALTH INSURANCE POLICY
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OR AN AGREEMENT WITH THE DEPARTMENT OF HUMAN SERVICES. THE TERM
INCLUDES HOME-AND-COMMUNITY-BASED SERVICES PROVIDED TO AN
ENROLLEE UNDER THE TERMS OF AN AGREEMENT WITH THE DEPARTMENT OF
HUMAN SERVICES.
"HEALTH INSURANCE POLICY." A POLICY, SUBSCRIBER CONTRACT,
CERTIFICATE OR PLAN ISSUED BY AN INSURER THAT PROVIDES MEDICAL
OR HEALTH CARE COVERAGE. THE TERM DOES NOT INCLUDE ANY OF THE
FOLLOWING:
(1) AN ACCIDENT ONLY POLICY.
(2) A CREDIT ONLY POLICY.
(3) A LONG-TERM CARE OR DISABILITY INCOME POLICY.
(4) A SPECIFIED DISEASE POLICY.
(5) A MEDICARE SUPPLEMENT POLICY.
(6) A TRICARE POLICY, INCLUDING A CIVILIAN HEALTH AND
MEDICAL PROGRAM OF THE UNIFORMED SERVICES (CHAMPUS) SUPPLEMENT
POLICY.
(7) A FIXED INDEMNITY POLICY.
(8) A HOSPITAL INDEMNITY POLICY.
(9) A DENTAL ONLY POLICY.
(10) A VISION ONLY POLICY.
(11) A WORKERS' COMPENSATION POLICY.
(12) AN AUTOMOBILE MEDICAL PAYMENT POLICY UNDER 75 PA.C.S.
(RELATING TO VEHICLES).
(13) A HOMEOWNER'S INSURANCE POLICY.
(14) ANY OTHER SIMILAR POLICIES PROVIDING FOR LIMITED
BENEFITS.
"INDEPENDENT REVIEW ORGANIZATION" OR "IRO." AN ENTITY
APPROVED BY THE DEPARTMENT UNDER SECTION 2161.10 THAT CONDUCTS
INDEPENDENT REVIEWS OF ADVERSE BENEFIT DETERMINATIONS, FINAL
ADVERSE BENEFIT DETERMINATIONS AND GRIEVANCES.
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"INPATIENT ADMISSION." ADMISSION TO A FACILITY FOR PURPOSES
OF RECEIVING A HEALTH CARE SERVICE.
"INSURER." AN ENTITY LICENSED BY THE DEPARTMENT THAT OFFERS,
ISSUES OR RENEWS AN INDIVIDUAL OR GROUP HEALTH INSURANCE POLICY
THAT IS OFFERED OR GOVERNED UNDER ANY OF THE FOLLOWING:
(1) THIS ACT, INCLUDING SECTION 630 AND ARTICLE XXIV.
(2) THE ACT OF DECEMBER 29, 1972 (P.L.1701, NO.364), KNOWN
AS THE "HEALTH MAINTENANCE ORGANIZATION ACT."
(3) 40 PA.C.S. CH. 61 (RELATING TO HEALTH PLAN CORPORATIONS)
OR 63 (RELATING TO PROFESSIONAL HEALTH SERVICES PLAN
CORPORATIONS).
THE TERM DOES NOT INCLUDE AN ENTITY OPERATING AS AN MA OR
CHIP MANAGED CARE PLAN.
["MANAGED CARE PLAN." A HEALTH CARE PLAN THAT USES A
GATEKEEPER TO MANAGE THE UTILIZATION OF HEALTH CARE SERVICES,
INTEGRATES THE FINANCING AND DELIVERY OF HEALTH CARE SERVICES TO
ENROLLEES BY ARRANGEMENTS WITH HEALTH CARE PROVIDERS SELECTED TO
PARTICIPATE ON THE BASIS OF SPECIFIC STANDARDS AND PROVIDES
FINANCIAL INCENTIVES FOR ENROLLEES TO USE THE PARTICIPATING
HEALTH CARE PROVIDERS IN ACCORDANCE WITH PROCEDURES ESTABLISHED
BY THE PLAN. A MANAGED CARE PLAN INCLUDES HEALTH CARE ARRANGED
THROUGH AN ENTITY OPERATING UNDER ANY OF THE FOLLOWING:
(1) SECTION 630.
(2) THE ACT OF DECEMBER 29, 1972 (P.L.1701, NO.364), KNOWN
AS THE "HEALTH MAINTENANCE ORGANIZATION ACT."
(3) THE ACT OF DECEMBER 14, 1992 (P.L.835, NO.134), KNOWN AS
THE "FRATERNAL BENEFIT SOCIETIES CODE."
(4) 40 PA.C.S. CH. 61 (RELATING TO HOSPITAL PLAN
CORPORATIONS).
(5) 40 PA.C.S. CH. 63 (RELATING TO PROFESSIONAL HEALTH
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SERVICES PLAN CORPORATIONS).
THE TERM INCLUDES AN ENTITY, INCLUDING A MUNICIPALITY,
WHETHER LICENSED OR UNLICENSED, THAT CONTRACTS WITH OR FUNCTIONS
AS A MANAGED CARE PLAN TO PROVIDE HEALTH CARE SERVICES TO
ENROLLEES. THE TERM DOES NOT INCLUDE ANCILLARY SERVICE PLANS OR
AN INDEMNITY ARRANGEMENT WHICH IS PRIMARILY FEE FOR SERVICE.]
"MEDICAL ASSISTANCE OR CHILDREN'S HEALTH INSURANCE PROGRAM
MANAGED CARE PLAN" OR "MA OR CHIP MANAGED CARE PLAN." A HEALTH
CARE PLAN THAT USES A GATEKEEPER TO MANAGE THE UTILIZATION OF
HEALTH CARE SERVICES BY MEDICAL ASSISTANCE OR CHILDREN'S HEALTH
INSURANCE PROGRAM ENROLLEES AND INTEGRATES THE FINANCING AND
DELIVERY OF HEALTH CARE SERVICES TO ENROLLEES BY ARRANGEMENTS
WITH HEALTH CARE PROVIDERS SELECTED TO PARTICIPATE.
"MEDICAL OR SCIENTIFIC EVIDENCE." EVIDENCE FOUND IN ANY OF
THE FOLLOWING SOURCES:
(1) A PEER-REVIEWED SCIENTIFIC STUDY PUBLISHED IN OR
ACCEPTED FOR PUBLICATION BY A MEDICAL JOURNAL THAT MEETS
NATIONALLY RECOGNIZED REQUIREMENTS FOR SCIENTIFIC MANUSCRIPTS
AND WHICH JOURNAL SUBMITS MOST OF ITS PUBLISHED ARTICLES FOR
REVIEW BY EXPERTS WHO ARE NOT PART OF THE JOURNAL'S EDITORIAL
STAFF.
(2) PEER-REVIEWED MEDICAL LITERATURE, INCLUDING LITERATURE
RELATING TO A THERAPY REVIEWED AND APPROVED BY A QUALIFIED
INSTITUTIONAL REVIEW BOARD, BIOMEDICAL COMPENDIA AND OTHER
MEDICAL LITERATURE THAT MEET THE CRITERIA OF THE NATIONAL
INSTITUTES OF HEALTH'S LIBRARY OF MEDICINE FOR INDEXING IN INDEX
MEDICUS (MEDLINE) AND ELSEVIER SCIENCE LIMITED FOR INDEXING IN
EXCERPTA MEDICA (EMBASE).
(3) A MEDICAL JOURNAL RECOGNIZED BY THE SECRETARY OF HEALTH
AND HUMAN SERVICES UNDER SECTION 1861(T)(2) OF THE SOCIAL
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SECURITY ACT (49 STAT. 620, 42 U.S.C. ยง 1395X(T)(2)).
(4) ONE OF THE FOLLOWING STANDARD REFERENCE COMPENDIA:
(I) THE AMERICAN HOSPITAL FORMULARY SERVICE-DRUG
INFORMATION.
(II) DRUGDEX INFORMATION SYSTEM.
(III) THE AMERICAN DENTAL ASSOCIATION ACCEPTED DENTAL
THERAPEUTICS.
(IV) THE UNITED STATES PHARMACOPOEIA-DRUG INFORMATION.
(5) FINDINGS, STUDIES OR RESEARCH CONDUCTED BY OR UNDER THE
AUSPICES OF A UNITED STATES GOVERNMENT AGENCY OR NATIONALLY
RECOGNIZED FEDERAL RESEARCH INSTITUTE, INCLUDING:
(I) THE UNITED STATES AGENCY FOR HEALTHCARE RESEARCH AND
QUALITY.
(II) THE NATIONAL INSTITUTES OF HEALTH.
(III) THE NATIONAL CANCER INSTITUTE.
(IV) THE NATIONAL ACADEMY OF SCIENCES.
(V) THE UNITED STATES DEPARTMENT OF HEALTH AND HUMAN
SERVICES.
(VI) THE FOOD AND DRUG ADMINISTRATION.
(VII) ANY NATIONAL BOARD RECOGNIZED BY THE NATIONAL
INSTITUTES OF HEALTH FOR THE PURPOSE OF EVALUATING THE MEDICAL
VALUE OF HEALTH CARE SERVICES.
(6) OTHER MEDICAL OR SCIENTIFIC EVIDENCE THAT IS COMPARABLE
TO THE SOURCES SPECIFIED IN PARAGRAPHS (1), (2), (3), (4) AND
(5).
"MEDICAL POLICY." A WRITTEN DOCUMENT ADOPTED, MAINTAINED AND
APPLIED BY AN INSURER OR MA OR CHIP MANAGED CARE PLAN THAT
COMBINES THE CLINICAL REVIEW CRITERIA AND ANY ADDITIONAL
ADMINISTRATIVE REQUIREMENTS, AS APPLICABLE, NECESSARY TO
ARTICULATE THE INSURER'S OR MA OR CHIP MANAGED CARE PLAN'S
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STANDARDS FOR COVERAGE OF A GIVEN HEALTH CARE SERVICE OR SET OF
HEALTH CARE SERVICES UNDER THE TERMS OF A HEALTH INSURANCE
POLICY OR AN AGREEMENT WITH THE DEPARTMENT OF HUMAN SERVICES.
"MEDICATION-ASSISTED TREATMENT." UNITED STATES FOOD AND DRUG
ADMINISTRATION-APPROVED PRESCRIPTION DRUGS USED IN COMBINATION
WITH COUNSELING AND BEHAVIORAL HEALTH THERAPIES AND MANAGEMENT
IN THE TREATMENT OF OPIOID USE DISORDERS.
"NAIC." THE NATIONAL ASSOCIATION OF INSURANCE COMMISSIONERS.
"NATIONALLY RECOGNIZED MEDICAL STANDARDS." CLINICAL
CRITERIA, PRACTICE GUIDELINES AND RELATED STANDARDS ESTABLISHED
BY NATIONAL QUALITY AND ACCREDITATION ENTITIES GENERALLY
RECOGNIZED IN THE UNITED STATES HEALTH CARE INDUSTRY.
"PARTICIPATING HEALTH CARE PROVIDER." A HEALTH CARE PROVIDER
THAT HAS ENTERED INTO A CONTRACTUAL OR OPERATING RELATIONSHIP
WITH AN INSURER OR MA OR CHIP MANAGED CARE PLAN TO PARTICIPATE
IN ONE OR MORE DESIGNATED NETWORKS OF THE INSURER AND TO PROVIDE
HEALTH CARE SERVICES TO COVERED PERSONS OR ENROLLEES UNDER THE
TERMS OF THE INSURER'S ADMINISTRATIVE POLICY OR AN AGREEMENT
WITH THE DEPARTMENT OF HUMAN SERVICES.
["PLAN." A MANAGED CARE PLAN.]
"PRESCRIPTION DRUG." A DRUG OR BIOLOGICAL PRODUCT, AS BOTH
OF THOSE TERMS ARE DEFINED IN THE ACT OF NOVEMBER 24, 1976
(P.L.1163, NO.259), REFERRED TO AS THE GENERIC EQUIVALENT DRUG
LAW.
"PRIMARY CARE PROVIDER." A HEALTH CARE PROVIDER WHO, WITHIN
THE SCOPE OF THE PROVIDER'S PRACTICE, SUPERVISES, COORDINATES,
PRESCRIBES OR OTHERWISE PROVIDES OR PROPOSES TO PROVIDE HEALTH
CARE SERVICES TO [AN] A COVERED PERSON OR ENROLLEE, INITIATES
[ENROLLEE] A REFERRAL FOR SPECIALIST CARE AND MAINTAINS
CONTINUITY OF [ENROLLEE] CARE FOR THE COVERED PERSON OR
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ENROLLEE.
"PRIMARY CONTRACTOR." A COUNTY, CONSORTIUM OF COUNTIES, MA
OR CHIP MANAGED CARE PLAN OR OTHER ENTITY THAT HAS AN AGREEMENT
WITH THE DEPARTMENT OF HUMAN SERVICES TO MANAGE THE PURCHASE AND
PROVISION OF BEHAVIOR HEALTH SERVICES.
"PRIOR AUTHORIZATION." A PROSPECTIVE UTILIZATION REVIEW
PERFORMED BY AN INSURER OR MA OR CHIP MANAGED CARE PLAN, OR BY A
UTILIZATION REVIEW ENTITY ACTING ON BEHALF OF AN INSURER OR MA
OR CHIP MANAGED CARE PLAN, OF ALL REASONABLY NECESSARY
SUPPORTING INFORMATION THAT OCCURS PRIOR TO THE DELIVERY OR
PROVISION OF A HEALTH CARE SERVICE AND RESULTS IN A DECISION TO
APPROVE OR DENY PAYMENT FOR THE HEALTH CARE SERVICE. THE TERM
INCLUDES STEP THERAPY AND STEP THERAPY EXCEPTION REQUESTS.
"PRIOR AUTHORIZATION REQUEST." A REQUEST FOR PRIOR
AUTHORIZATION OF A HEALTH CARE SERVICE THAT MEETS AN INSURER'S
OR MA OR CHIP MANAGED CARE PLAN'S ADMINISTRATIVE POLICY
REQUIREMENTS FOR SUCH A REQUEST AND INCLUDES THE SPECIFIC
CLINICAL INFORMATION NECESSARY TO EVALUATE THE REQUEST UNDER THE
TERMS OF THE APPLICABLE MEDICAL POLICY.
["PROSPECTIVE UTILIZATION REVIEW." A REVIEW BY A UTILIZATION
REVIEW ENTITY OF ALL REASONABLY NECESSARY SUPPORTING INFORMATION
THAT OCCURS PRIOR TO THE DELIVERY OR PROVISION OF A HEALTH CARE
SERVICE AND RESULTS IN A DECISION TO APPROVE OR DENY PAYMENT FOR
THE HEALTH CARE SERVICE.]
"PROTECTED HEALTH INFORMATION." INFORMATION OR DATA, WHETHER
ORAL OR RECORDED IN ANY FORM OR MEDIUM, AND PERSONAL FACTS OR
INFORMATION ABOUT EVENTS OR RELATIONSHIPS THAT IDENTIFIES AN
INDIVIDUAL WHO IS THE SUBJECT OF THE INFORMATION OR FOR WHICH
THERE IS A REASONABLE BASIS TO BELIEVE THAT THE INFORMATION
COULD BE USED TO IDENTIFY AN INDIVIDUAL, THAT RELATES TO ANY OF
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THE FOLLOWING:
(1) THE PAST, PRESENT, OR FUTURE PHYSICAL, MENTAL OR
BEHAVIORAL HEALTH OR CONDITION OF AN INDIVIDUAL OR A MEMBER OF
THE INDIVIDUAL'S FAMILY.
(2) THE PROVISION OF HEALTH CARE SERVICES TO AN INDIVIDUAL.
(3) PAYMENT FOR THE PROVISION OF HEALTH CARE SERVICES TO AN
INDIVIDUAL.
"PROVIDER NETWORK." THE HEALTH CARE PROVIDERS DESIGNATED BY
[A] AN INSURER OR MA OR CHIP MANAGED CARE PLAN TO PROVIDE HEALTH
CARE SERVICES UNDER A HEALTH INSURANCE POLICY OR AN AGREEMENT
WITH THE DEPARTMENT OF HUMAN SERVICES.
"PROVIDER PORTAL." A DESIGNATED SECTION OR FUNCTIONAL
SOFTWARE MODULE ACCESSIBLE VIA AN INSURER'S OR MA OR CHIP
MANAGED CARE PLAN'S PUBLICLY ACCESSIBLE INTERNET WEBSITE THAT
FACILITATES HEALTH CARE PROVIDER SUBMISSION OF ELECTRONIC PRIOR
AUTHORIZATION REQUESTS.
"REFERRAL." A PRIOR AUTHORIZATION FROM [A] AN INSURER, MA OR
CHIP MANAGED CARE PLAN OR A PARTICIPATING HEALTH CARE PROVIDER
THAT ALLOWS [AN] A COVERED PERSON OR ENROLLEE TO HAVE ONE OR
MORE APPOINTMENTS WITH A HEALTH CARE PROVIDER FOR A HEALTH CARE
SERVICE.
"RETROSPECTIVE UTILIZATION REVIEW." [A REVIEW BY A
UTILIZATION REVIEW ENTITY OF ALL REASONABLY NECESSARY SUPPORTING
INFORMATION WHICH OCCURS FOLLOWING DELIVERY OR PROVISION OF A
HEALTH CARE SERVICE AND RESULTS IN A DECISION TO APPROVE OR DENY
PAYMENT FOR THE HEALTH CARE SERVICE.] REVIEW OF MEDICAL
NECESSITY PERFORMED BY AN INSURER OR MA OR CHIP MANAGED CARE
PLAN, OR BY A UTILIZATION REVIEW ENTITY ACTING ON BEHALF OF AN
INSURER OR MA OR CHIP MANAGED CARE PLAN AND CONDUCTED AFTER
HEALTH CARE SERVICES HAVE BEEN PROVIDED TO A COVERED PERSON OR
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ENROLLEE, NOT INCLUDING THE REVIEW OF A CLAIM THAT IS LIMITED TO
AN EVALUATION OF THE REIMBURSEMENT LEVELS, VERACITY OF
DOCUMENTATION, ACCURACY OF CODING OR ADJUSTMENT FOR PAYMENT.
"SERVICE AREA." THE GEOGRAPHIC AREA FOR WHICH [THE] AN
INSURER OR MA OR CHIP MANAGED CARE PLAN IS LICENSED OR HAS BEEN
ISSUED A CERTIFICATE OF AUTHORITY.
"SPECIALIST." A HEALTH CARE PROVIDER WHOSE PRACTICE IS NOT
LIMITED TO PRIMARY HEALTH CARE SERVICES AND WHO HAS ADDITIONAL
POSTGRADUATE OR SPECIALIZED TRAINING, HAS BOARD CERTIFICATION OR
PRACTICES IN A LICENSED SPECIALIZED AREA OF HEALTH CARE. THE
TERM INCLUDES A HEALTH CARE PROVIDER WHO IS NOT CLASSIFIED BY
[A] AN INSURER OR MA OR CHIP MANAGED CARE PLAN SOLELY AS A
PRIMARY CARE PROVIDER.
"STEP THERAPY." A COURSE OF TREATMENT IN WHICH CERTAIN
DESIGNATED DRUGS OR TREATMENT PROTOCOLS MUST BE EITHER
CONTRAINDICATED, OR USED AND FOUND TO BE INEFFECTIVE, PRIOR TO
APPROVAL OF COVERAGE OF OTHER DESIGNATED DRUGS OR TREATMENT
PROTOCOLS. THE TERM DOES NOT INCLUDE REQUESTS FOR COVERAGE OF
NONFORMULARY DRUGS.
"URGENT HEALTH CARE SERVICE." A COVERED HEALTH CARE SERVICE
SUBJECT TO PRIOR AUTHORIZATION THAT IS DELIVERED ON AN EXPEDITED
BASIS FOR THE TREATMENT OF AN ACUTE CONDITION WITH SYMPTOMS OF
SUFFICIENT SEVERITY PURSUANT TO A DETERMINATION BY A LICENSED
TREATING PHYSICIAN, OPERATING WITH THE INDIVIDUAL'S SCOPE OF
PRACTICE AND PROFESSIONAL EXPERTISE, THAT THE FAILURE TO PROVIDE
THE SERVICE IS LIKELY TO RESULT IN SERIOUS, LONG-TERM HEALTH
COMPLICATIONS OR A MATERIAL DETERIORATION IN THE COVERED
PERSON'S OR ENROLLEE'S CONDITION AND PROGNOSIS.
"URGENT REQUEST." A REQUEST FOR PRIOR AUTHORIZATION OF AN
URGENT HEALTHCARE SERVICE.
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"UTILIZATION REVIEW." [A SYSTEM OF PROSPECTIVE, CONCURRENT
OR RETROSPECTIVE UTILIZATION REVIEW PERFORMED BY A UTILIZATION
REVIEW ENTITY OF THE MEDICAL NECESSITY AND APPROPRIATENESS OF
HEALTH CARE SERVICES PRESCRIBED, PROVIDED OR PROPOSED TO BE
PROVIDED TO AN ENROLLEE. THE TERM DOES NOT INCLUDE ANY OF THE
FOLLOWING:
(1) REQUESTS FOR CLARIFICATION OF COVERAGE, ELIGIBILITY OR
HEALTH CARE SERVICE VERIFICATION.
(2) A HEALTH CARE PROVIDER'S INTERNAL QUALITY ASSURANCE OR
UTILIZATION REVIEW PROCESS UNLESS THE REVIEW RESULTS IN DENIAL
OF PAYMENT FOR A HEALTH CARE SERVICE.] A SET OF FORMAL
TECHNIQUES DESIGNED TO MONITOR THE USE OF OR EVALUATE THE
MEDICAL NECESSITY, APPROPRIATENESS, EFFICACY OR EFFICIENCY OF
HEALTH CARE SERVICES, PROCEDURES OR SETTINGS, INCLUDING PRIOR
AUTHORIZATION, SECOND OPINION, CERTIFICATION, CONCURRENT REVIEW,
CASE MANAGEMENT, DISCHARGE PLANNING OR RETROSPECTIVE REVIEW, IN
ORDER TO MAKE A DETERMINATION REGARDING COVERAGE OF THE SERVICE
UNDER THE TERMS OF A HEALTH INSURANCE POLICY OR AN AGREEMENT
WITH THE DEPARTMENT OF HUMAN SERVICES.
"UTILIZATION REVIEW ENTITY." ANY ENTITY CERTIFIED PURSUANT
TO SUBDIVISION (H) THAT PERFORMS UTILIZATION REVIEW ON BEHALF OF
[A] AN INSURER OR MA OR CHIP MANAGED CARE PLAN.
(B) INSURER AND MA AND CHIP MANAGED CARE
PLAN REQUIREMENTS.
SECTION 2111. RESPONSIBILITIES OF INSURERS AND MA AND CHIP
MANAGED CARE PLANS.--[A] AN INSURER OR MA OR CHIP MANAGED CARE
PLAN SHALL DO ALL OF THE FOLLOWING:
(1) ASSURE AVAILABILITY AND ACCESSIBILITY OF ADEQUATE HEALTH
CARE PROVIDERS IN A TIMELY MANNER, WHICH ENABLES COVERED PERSONS
OR ENROLLEES TO HAVE ACCESS TO QUALITY CARE AND CONTINUITY OF
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HEALTH CARE SERVICES.
(2) CONSULT WITH HEALTH CARE PROVIDERS IN ACTIVE CLINICAL
PRACTICE REGARDING PROFESSIONAL QUALIFICATIONS AND NECESSARY
SPECIALISTS TO BE INCLUDED IN [THE PLAN.] COVERAGE UNDER A
HEALTH INSURANCE POLICY OR AN AGREEMENT WITH THE DEPARTMENT OF
HUMAN SERVICES.
(3) ADOPT AND MAINTAIN A DEFINITION OF MEDICAL NECESSITY
USED BY [THE] AN INSURER OR MA OR CHIP MANAGED CARE PLAN IN
DETERMINING HEALTH CARE SERVICES.
(4) ENSURE THAT EMERGENCY SERVICES ARE PROVIDED TWENTY-FOUR
(24) HOURS A DAY, SEVEN (7) DAYS A WEEK AND PROVIDE REASONABLE
PAYMENT OR REIMBURSEMENT FOR EMERGENCY SERVICES.
(5) ADOPT AND MAINTAIN PROCEDURES BY WHICH [AN] A COVERED
PERSON OR ENROLLEE CAN OBTAIN HEALTH CARE SERVICES OUTSIDE THE
HEALTH INSURANCE POLICY'S OR MA OR CHIP MANAGED CARE PLAN'S
SERVICE AREA.
(6) ADOPT AND MAINTAIN PROCEDURES BY WHICH [AN] A COVERED
PERSON OR ENROLLEE WITH A LIFE-THREATENING, DEGENERATIVE OR
DISABLING DISEASE OR CONDITION SHALL, UPON REQUEST, RECEIVE AN
EVALUATION AND, IF THE HEALTH INSURANCE POLICY'S [PLAN'S]
ESTABLISHED STANDARDS ARE MET OR THE STANDARDS ESTABLISHED BY AN
AGREEMENT WITH THE DEPARTMENT OF HUMAN SERVICES, BE PERMITTED TO
RECEIVE:
(I) A STANDING REFERRAL TO A SPECIALIST WITH CLINICAL
EXPERTISE IN TREATING THE DISEASE OR CONDITION; OR
(II) THE DESIGNATION OF A SPECIALIST TO PROVIDE AND
COORDINATE THE COVERED PERSON'S OR ENROLLEE'S PRIMARY AND
SPECIALTY CARE.
THE REFERRAL TO OR DESIGNATION OF A SPECIALIST SHALL BE PURSUANT
TO A TREATMENT PLAN APPROVED BY THE INSURER OR MA OR CHIP
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MANAGED CARE PLAN IN CONSULTATION WITH THE PRIMARY CARE
PROVIDER, THE COVERED PERSON OR ENROLLEE AND, AS APPROPRIATE,
THE SPECIALIST. WHEN POSSIBLE, THE SPECIALIST MUST BE A HEALTH
CARE PROVIDER PARTICIPATING IN THE [PLAN.] HEALTH INSURANCE
POLICY OR MA OR CHIP MANAGED CARE PLAN'S PROVIDER NETWORK.
(7) PROVIDE DIRECT ACCESS TO OBSTETRICAL AND GYNECOLOGICAL
SERVICES BY PERMITTING [AN] A COVERED PERSON OR ENROLLEE TO
SELECT A HEALTH CARE PROVIDER PARTICIPATING IN THE [PLAN] HEALTH
INSURANCE POLICY OR MA OR CHIP MANAGED CARE PLAN'S PROVIDER
NETWORK TO OBTAIN MATERNITY AND GYNECOLOGICAL CARE, INCLUDING
MEDICALLY NECESSARY AND APPROPRIATE FOLLOW-UP CARE AND REFERRALS
FOR DIAGNOSTIC TESTING RELATED TO MATERNITY AND GYNECOLOGICAL
CARE, WITHOUT PRIOR APPROVAL FROM A PRIMARY CARE PROVIDER. THE
HEALTH CARE SERVICES SHALL BE WITHIN THE SCOPE OF PRACTICE OF
THE SELECTED HEALTH CARE PROVIDER. THE SELECTED HEALTH CARE
PROVIDER SHALL INFORM THE COVERED PERSON'S OR ENROLLEE'S PRIMARY
CARE PROVIDER OF ALL HEALTH CARE SERVICES PROVIDED.
(8) ADOPT AND MAINTAIN A COMPLAINT PROCESS AS SET FORTH IN
SUBDIVISION (G).
(9) ADOPT AND MAINTAIN A GRIEVANCE PROCESS AS SET FORTH IN
SUBDIVISION (I).
(10) ADOPT AND MAINTAIN CREDENTIALING STANDARDS FOR HEALTH
CARE PROVIDERS AS SET FORTH IN SUBDIVISION (D).
(11) ENSURE THAT THERE ARE PARTICIPATING HEALTH CARE
PROVIDERS THAT ARE PHYSICALLY ACCESSIBLE TO PEOPLE WITH
DISABILITIES AND CAN COMMUNICATE WITH INDIVIDUALS WITH SENSORY
DISABILITIES IN ACCORDANCE WITH TITLE III OF THE AMERICANS WITH
DISABILITIES ACT OF 1990 (PUBLIC LAW 101-336, 42 U.S.C. ยง 12181
ET SEQ.).
(12) PROVIDE A LIST OF HEALTH CARE PROVIDERS PARTICIPATING
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IN THE [PLAN] HEALTH INSURANCE POLICY OR MA OR CHIP MANAGED CARE
PLAN'S PROVIDER NETWORK TO THE DEPARTMENT EVERY TWO (2) YEARS OR
AS MAY OTHERWISE BE REQUIRED BY THE DEPARTMENT. THE LIST SHALL
INCLUDE THE EXTENT TO WHICH HEALTH CARE PROVIDERS IN THE [PLAN]
HEALTH INSURANCE POLICY OR MA OR CHIP MANAGED CARE PLAN'S
PROVIDER NETWORK ARE ACCEPTING NEW ENROLLEES.
(13) REPORT TO THE DEPARTMENT [AND THE INSURANCE DEPARTMENT]
IN ACCORDANCE WITH THE REQUIREMENTS OF THIS ARTICLE. SUCH
INFORMATION SHALL INCLUDE THE NUMBER, TYPE AND DISPOSITION OF
ALL COMPLAINTS [AND], GRIEVANCES [FILED WITH THE PLAN.] AND
ADVERSE BENEFIT DETERMINATIONS FILED WITH THE INSURER UNDER A
HEALTH INSURANCE POLICY OR WITH THE MA OR CHIP MANAGED CARE
PLAN, AS APPLICABLE.
SECTION 2112. FINANCIAL INCENTIVES PROHIBITION.--NO INSURER
OR MA OR CHIP MANAGED CARE PLAN [SHALL] MAY USE ANY FINANCIAL
INCENTIVE THAT COMPENSATES A HEALTH CARE PROVIDER FOR PROVIDING
LESS THAN MEDICALLY NECESSARY AND APPROPRIATE CARE TO [AN] A
COVERED PERSON OR ENROLLEE. NOTHING IN THIS SECTION SHALL BE
DEEMED TO PROHIBIT [A] AN INSURER OR MA OR CHIP MANAGED CARE
PLAN FROM USING A CAPITATED PAYMENT ARRANGEMENT OR OTHER RISK-
SHARING ARRANGEMENT.
SECTION 2113. MEDICAL GAG CLAUSE PROHIBITION.--(A) NO
INSURER OR MA OR CHIP MANAGED CARE PLAN MAY PENALIZE OR RESTRICT
A HEALTH CARE PROVIDER FROM DISCUSSING ANY OF THE FOLLOWING:
(1) [THE] THE PROCESS THAT THE INSURER OR MA OR CHIP MANAGED
CARE PLAN OR ANY ENTITY CONTRACTING WITH THE INSURER OR MA OR
CHIP MANAGED CARE PLAN USES OR PROPOSES TO USE TO DENY PAYMENT
FOR A HEALTH CARE SERVICE[;].
(2) [MEDICALLY] MEDICALLY NECESSARY AND APPROPRIATE CARE
WITH OR ON BEHALF OF [AN] A COVERED PERSON OR ENROLLEE,
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INCLUDING INFORMATION REGARDING THE NATURE OF TREATMENT; RISKS
OF TREATMENT; ALTERNATIVE TREATMENTS; OR THE AVAILABILITY OF
ALTERNATE THERAPIES, CONSULTATION OR TESTS[; OR].
(3) [THE] THE DECISION OF [ANY] AN INSURER OR MA OR CHIP
MANAGED CARE PLAN TO DENY PAYMENT FOR A HEALTH CARE SERVICE.
(B) A PROVISION TO PROHIBIT OR RESTRICT DISCLOSURE OF
MEDICALLY NECESSARY AND APPROPRIATE HEALTH CARE INFORMATION
CONTAINED IN A CONTRACT WITH A HEALTH CARE PROVIDER IS CONTRARY
TO PUBLIC POLICY AND SHALL BE VOID AND UNENFORCEABLE.
(C) NO INSURER OR MA OR CHIP MANAGED CARE PLAN [SHALL] MAY
TERMINATE THE EMPLOYMENT OF OR A CONTRACT WITH A HEALTH CARE
PROVIDER FOR ANY OF THE FOLLOWING:
(1) ADVOCATING FOR MEDICALLY NECESSARY AND APPROPRIATE
HEALTH CARE CONSISTENT WITH THE DEGREE OF LEARNING AND SKILL
ORDINARILY POSSESSED BY A REPUTABLE HEALTH CARE PROVIDER
PRACTICING ACCORDING TO THE APPLICABLE LEGAL STANDARD OF CARE.
(2) FILING A COMPLAINT, GRIEVANCE OR EXTERNAL REVIEW
PURSUANT TO THE PROCEDURES SET FORTH IN THIS ARTICLE.
(3) PROTESTING A DECISION, POLICY OR PRACTICE THAT THE
HEALTH CARE PROVIDER, CONSISTENT WITH THE DEGREE OF LEARNING AND
SKILL ORDINARILY POSSESSED BY A REPUTABLE HEALTH CARE PROVIDER
PRACTICING ACCORDING TO THE APPLICABLE LEGAL STANDARD OF CARE,
REASONABLY BELIEVES INTERFERES WITH THE HEALTH CARE PROVIDER'S
ABILITY TO PROVIDE MEDICALLY NECESSARY AND APPROPRIATE HEALTH
CARE.
(D) NOTHING IN THIS SECTION SHALL:
(1) PROHIBIT [A] AN INSURER OR MA OR CHIP MANAGED CARE PLAN
FROM MAKING A DETERMINATION NOT TO PAY FOR A PARTICULAR MEDICAL
TREATMENT, SUPPLY OR SERVICE, ENFORCING REASONABLE PEER REVIEW
OR UTILIZATION REVIEW PROTOCOLS OR MAKING A DETERMINATION THAT A
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HEALTH CARE PROVIDER HAS OR HAS NOT COMPLIED WITH APPROPRIATE
PROTOCOLS.
(2) BE CONSTRUED AS REQUIRING [A] AN INSURER OR MA OR CHIP
MANAGED CARE PLAN TO PROVIDE, REIMBURSE FOR OR COVER COUNSELING,
REFERRAL OR OTHER HEALTH CARE SERVICES IF THE INSURER OR MA OR
CHIP MANAGED CARE PLAN:
(I) OBJECTS TO THE PROVISION OF THAT SERVICE ON MORAL OR
RELIGIOUS GROUNDS; AND
(II) MAKES AVAILABLE INFORMATION ON ITS POLICIES REGARDING
SUCH HEALTH CARE SERVICES TO COVERED PERSON OR ENROLLEES AND
PROSPECTIVE COVERED PERSON OR ENROLLEES.
SECTION 2116. EMERGENCY SERVICES.--(A) IF [AN] A COVERED
PERSON OR ENROLLEE SEEKS EMERGENCY SERVICES AND THE EMERGENCY
HEALTH CARE PROVIDER DETERMINES THAT EMERGENCY SERVICES ARE
NECESSARY, THE EMERGENCY HEALTH CARE PROVIDER SHALL INITIATE
NECESSARY INTERVENTION TO EVALUATE AND, IF NECESSARY, STABILIZE
THE CONDITION OF THE COVERED PERSON OR ENROLLEE WITHOUT SEEKING
OR RECEIVING AUTHORIZATION FROM THE INSURER OR MA OR CHIP
MANAGED CARE PLAN. THE INSURER OR MA OR CHIP MANAGED CARE PLAN
MAY NOT REQUIRE A HEALTH CARE PROVIDER TO SUBMIT A REQUEST FOR
PRIOR AUTHORIZATION FOR AN EMERGENCY SERVICE. THE INSURER OR MA
OR CHIP MANAGED CARE PLAN SHALL PAY ALL REASONABLY NECESSARY
COSTS ASSOCIATED WITH EMERGENCY SERVICES PROVIDED DURING THE
PERIOD OF EMERGENCY, SUBJECT TO ALL COPAYMENTS, COINSURANCES OR
DEDUCTIBLES. WHEN PROCESSING A REIMBURSEMENT CLAIM FOR EMERGENCY
SERVICES, [A] AN INSURER OR MA OR CHIP MANAGED CARE PLAN SHALL
CONSIDER BOTH THE PRESENTING SYMPTOMS AND THE SERVICES PROVIDED.
(A.1) THE EMERGENCY HEALTH CARE PROVIDER SHALL NOTIFY THE
COVERED PERSON'S INSURER OR ENROLLEE'S MA OR CHIP MANAGED CARE
PLAN OF THE PROVISION OF EMERGENCY SERVICES AND THE CONDITION OF
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THE COVERED PERSON OR ENROLLEE.
(1) THE HEALTH CARE PROVIDER SHALL NOTIFY A COVERED PERSON'S
INSURER OF THE PROVISION OF EMERGENCY SERVICES AND THE CONDITION
OF THE COVERED PERSON WITHIN TWO BUSINESS DAYS FOLLOWING THE
PERIOD OF EMERGENCY.
(2) THE HEALTH CARE PROVIDER SHALL NOTIFY THE ENROLLEE'S MA
OR CHIP MANAGED CARE PLAN OF THE PROVISION OF EMERGENCY SERVICES
AND THE CONDITION OF THE ENROLLEE WITHIN TEN DAYS FOLLOWING THE
PERIOD OF EMERGENCY.
(A.2) IF [AN] A COVERED PERSON'S OR ENROLLEE'S CONDITION HAS
STABILIZED AND THE COVERED PERSON OR ENROLLEE CAN BE TRANSPORTED
WITHOUT SUFFERING DETRIMENTAL CONSEQUENCES OR AGGRAVATING THE
COVERED PERSON'S OR ENROLLEE'S CONDITION, THE COVERED PERSON OR
ENROLLEE MAY BE RELOCATED TO ANOTHER FACILITY TO RECEIVE
CONTINUED CARE AND TREATMENT AS NECESSARY.
(B) FOR EMERGENCY SERVICES RENDERED BY A LICENSED EMERGENCY
MEDICAL SERVICES AGENCY, AS DEFINED IN 35 PA.C.S. ยง 8103
(RELATING TO DEFINITIONS), THAT HAS THE ABILITY TO TRANSPORT
PATIENTS OR IS PROVIDING AND BILLING FOR EMERGENCY SERVICES
UNDER AN AGREEMENT WITH AN EMERGENCY MEDICAL SERVICES AGENCY
THAT HAS THAT ABILITY, THE INSURER OR MA OR CHIP MANAGED CARE
PLAN MAY NOT DENY A CLAIM FOR PAYMENT SOLELY BECAUSE THE
ENROLLEE DID NOT REQUIRE TRANSPORT OR REFUSED TO BE TRANSPORTED.
(C) FOR EMERGENCY SERVICES PROVIDED TO [MEDICAL ASSISTANCE
PARTICIPANTS] MA OR CHIP MANAGED CARE PLAN ENROLLEES, THE
FOLLOWING PROVISIONS SHALL APPLY:
(1) THE PROVISIONS OF SUBSECTION (B) SHALL APPLY TO THE SAME
SERVICES PROVIDED TO MEDICAL ASSISTANCE PARTICIPANTS UNDER
ARTICLE IV OF THE ACT OF JUNE 13, 1967 (P.L.31, NO.21), KNOWN AS
THE HUMAN SERVICES CODE.
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(2) PAYMENT FOR THE SERVICES SHALL BE IN ACCORDANCE WITH THE
CURRENT MA OR CHIP MANAGED CARE CONTRACTED RATES.
(3) SUFFICIENT FUNDS SHALL BE APPROPRIATED EACH FISCAL YEAR
FOR PAYMENT OF THE SERVICES.
[(D) THE PROVISIONS OF SUBSECTION (B) SHALL APPLY TO ALL
GROUP AND INDIVIDUAL MAJOR MEDICAL HEALTH INSURANCE POLICIES
ISSUED BY A LICENSED HEALTH INSURER.]
SECTION 2117. CONTINUITY OF CARE.--(A) EXCEPT AS PROVIDED
UNDER SUBSECTION (B), IF [A] AN INSURER OR MA OR CHIP MANAGED
CARE PLAN INITIATES TERMINATION OF ITS CONTRACT WITH A
PARTICIPATING HEALTH CARE PROVIDER, [AN] A COVERED PERSON OR
ENROLLEE MAY CONTINUE AN ONGOING COURSE OF TREATMENT WITH THAT
HEALTH CARE PROVIDER AT THE COVERED PERSON'S OR ENROLLEE'S
OPTION FOR A TRANSITIONAL PERIOD OF UP TO SIXTY (60) DAYS FROM
THE DATE THE COVERED PERSON OR ENROLLEE WAS NOTIFIED BY THE
INSURER OR MA OR CHIP MANAGED CARE PLAN OF THE TERMINATION OR
PENDING TERMINATION. THE INSURER OR MA OR CHIP MANAGED CARE
PLAN, IN CONSULTATION WITH THE COVERED PERSON OR ENROLLEE AND
THE HEALTH CARE PROVIDER, MAY EXTEND THE TRANSITIONAL PERIOD IF
DETERMINED TO BE CLINICALLY APPROPRIATE. IN THE CASE OF [AN] A
COVERED PERSON OR ENROLLEE IN THE SECOND OR THIRD TRIMESTER OF
PREGNANCY AT THE TIME OF NOTICE OF THE TERMINATION OR PENDING
TERMINATION, THE TRANSITIONAL PERIOD SHALL EXTEND THROUGH
POSTPARTUM CARE RELATED TO THE DELIVERY. ANY HEALTH CARE SERVICE
PROVIDED UNDER THIS SECTION SHALL BE COVERED BY THE INSURER OR
MA OR CHIP MANAGED CARE PLAN UNDER THE SAME TERMS AND CONDITIONS
AS APPLICABLE FOR PARTICIPATING HEALTH CARE PROVIDERS.
(B) IF [THE] AN INSURER OR MA OR CHIP MANAGED CARE PLAN
TERMINATES THE CONTRACT OF A PARTICIPATING HEALTH CARE PROVIDER
FOR CAUSE, INCLUDING BREACH OF CONTRACT, FRAUD, CRIMINAL
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ACTIVITY OR POSING A DANGER TO [AN] A COVERED PERSON OR ENROLLEE
OR THE HEALTH, SAFETY OR WELFARE OF THE PUBLIC AS DETERMINED BY
THE INSURER OR MA OR CHIP MANAGED CARE PLAN, THE INSURER OR MA
OR CHIP MANAGED CARE PLAN SHALL NOT BE RESPONSIBLE FOR HEALTH
CARE SERVICES PROVIDED TO THE COVERED PERSON OR ENROLLEE
FOLLOWING THE DATE OF TERMINATION.
(C) IF [THE] AN INSURER OR MA OR CHIP MANAGED CARE PLAN
TERMINATES THE CONTRACT OF A PARTICIPATING PRIMARY CARE
PROVIDER, THE INSURER OR MA OR CHIP MANAGED CARE PLAN SHALL
NOTIFY EVERY COVERED PERSON OR ENROLLEE SERVED BY THAT PROVIDER
OF THE INSURER'S OR MA OR CHIP MANAGED CARE PLAN'S TERMINATION
OF ITS CONTRACT AND SHALL REQUEST THAT THE COVERED PERSON OR
ENROLLEE SELECT ANOTHER PRIMARY CARE PROVIDER.
(D) A NEW COVERED PERSON OR ENROLLEE MAY CONTINUE AN ONGOING
COURSE OF TREATMENT WITH A NONPARTICIPATING HEALTH CARE PROVIDER
FOR A TRANSITIONAL PERIOD OF UP TO SIXTY (60) DAYS FROM THE
EFFECTIVE DATE OF ENROLLMENT IN A HEALTH INSURANCE POLICY OR MA
OR CHIP MANAGED CARE PLAN. THE INSURER OR MA OR CHIP MANAGED
CARE PLAN, IN CONSULTATION WITH THE COVERED PERSON OR ENROLLEE
AND THE HEALTH CARE PROVIDER, MAY EXTEND THIS TRANSITIONAL
PERIOD IF DETERMINED TO BE CLINICALLY APPROPRIATE. IN THE CASE
OF A NEW COVERED PERSON OR ENROLLEE IN THE SECOND OR THIRD
TRIMESTER OF PREGNANCY ON THE EFFECTIVE DATE OF ENROLLMENT, THE
TRANSITIONAL PERIOD SHALL EXTEND THROUGH POSTPARTUM CARE RELATED
TO THE DELIVERY. ANY HEALTH CARE SERVICE PROVIDED UNDER THIS
SECTION SHALL BE COVERED BY THE HEALTH INSURANCE POLICY OR MA OR
CHIP MANAGED CARE PLAN UNDER THE SAME TERMS AND CONDITIONS AS
APPLICABLE FOR PARTICIPATING HEALTH CARE PROVIDERS.
(E) [A] AN INSURER OR MA OR CHIP MANAGED CARE PLAN MAY
REQUIRE A NONPARTICIPATING HEALTH CARE PROVIDER WHOSE HEALTH
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CARE SERVICES ARE COVERED UNDER THIS SECTION TO MEET THE SAME
TERMS AND CONDITIONS AS A PARTICIPATING HEALTH CARE PROVIDER.
(F) NOTHING IN THIS SECTION SHALL REQUIRE [A] AN INSURER OR
MA OR CHIP MANAGED CARE PLAN TO PROVIDE HEALTH CARE SERVICES
THAT ARE NOT OTHERWISE COVERED UNDER THE TERMS AND CONDITIONS OF
THE [PLAN] COVERED PERSON'S HEALTH INSURANCE POLICY OR AN
AGREEMENT WITH THE DEPARTMENT OF HUMAN SERVICES.
SECTION 2121. CREDENTIALING PROCEDURES.--(A) [A] AN INSURER
OR MA OR CHIP MANAGED CARE PLAN SHALL ESTABLISH A CREDENTIALING
PROCESS TO ENROLL QUALIFIED HEALTH CARE PROVIDERS AND CREATE AN
ADEQUATE PROVIDER NETWORK. [THE PROCESS SHALL BE APPROVED BY THE
DEPARTMENT AND SHALL INCLUDE WRITTEN CRITERIA AND PROCEDURES FOR
INITIAL ENROLLMENT, RENEWAL, RESTRICTIONS AND TERMINATION OF
CREDENTIALS FOR HEALTH CARE PROVIDERS.]
(A.1) AN INSURER'S OR MA OR CHIP MANAGED CARE PLAN'S
CREDENTIALING PROCESS SHALL BE SUBJECT TO APPROVAL BY THE
DEPARTMENT AND SHALL INCLUDE WRITTEN CRITERIA AND PROCEDURES FOR
AT LEAST THE FOLLOWING:
(1) INITIAL CREDENTIALING.
(2) RENEWAL OF CREDENTIALING.
(3) RESTRICTING AND TERMINATING THE CREDENTIALS FOR HEALTH
CARE PROVIDERS.
(B) THE DEPARTMENT SHALL ESTABLISH CREDENTIALING STANDARDS
FOR INSURERS AND MA OR CHIP MANAGED CARE PLANS. THE DEPARTMENT
MAY ADOPT NATIONALLY RECOGNIZED ACCREDITING STANDARDS TO
ESTABLISH THE CREDENTIALING STANDARDS FOR INSURERS AND MA OR
CHIP MANAGED CARE PLANS.
(C) [A] AN INSURER OR MA OR CHIP MANAGED CARE PLAN SHALL
SUBMIT A REPORT TO THE DEPARTMENT REGARDING ITS CREDENTIALING
PROCESS AT LEAST EVERY TWO (2) YEARS OR AS MAY OTHERWISE BE
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REQUIRED BY THE DEPARTMENT.
(D) [A] AN INSURER OR MA OR CHIP MANAGED CARE PLAN SHALL
DISCLOSE RELEVANT CREDENTIALING CRITERIA AND PROCEDURES TO
HEALTH CARE PROVIDERS THAT APPLY TO PARTICIPATE OR THAT ARE
PARTICIPATING IN THE INSURER'S OR MANAGED CARE PLAN'S PROVIDER
NETWORK. [A] AN INSURER OR MA OR CHIP MANAGED CARE PLAN SHALL
ALSO DISCLOSE RELEVANT CREDENTIALING CRITERIA AND PROCEDURES
PURSUANT TO A COURT ORDER OR RULE. ANY INDIVIDUAL PROVIDING
INFORMATION DURING THE CREDENTIALING PROCESS OF [A] AN INSURER
OR MA OR CHIP MANAGED CARE PLAN SHALL HAVE THE PROTECTIONS SET
FORTH IN THE ACT OF JULY 20, 1974 (P.L.564, NO.193), KNOWN AS
THE "PEER REVIEW PROTECTION ACT."
(E) NO INSURER OR MA OR CHIP MANAGED CARE PLAN [SHALL] MAY
EXCLUDE OR TERMINATE A HEALTH CARE PROVIDER FROM PARTICIPATION
IN THE [PLAN] INSURER'S OR MA OR CHIP MANAGED CARE PLAN'S
PROVIDER NETWORK DUE TO ANY OF THE FOLLOWING:
(1) THE HEALTH CARE PROVIDER ENGAGED IN ANY OF THE
ACTIVITIES SET FORTH IN SECTION 2113(C).
(2) THE HEALTH CARE PROVIDER HAS A PRACTICE THAT INCLUDES A
SUBSTANTIAL NUMBER OF PATIENTS WITH EXPENSIVE MEDICAL
CONDITIONS.
(3) THE HEALTH CARE PROVIDER OBJECTS TO THE PROVISION OF OR
REFUSES TO PROVIDE A HEALTH CARE SERVICE ON MORAL OR RELIGIOUS
GROUNDS.
(F) IF [A] AN INSURER OR MA OR CHIP MANAGED CARE PLAN DENIES
ENROLLMENT OR RENEWAL OF CREDENTIALS TO A HEALTH CARE PROVIDER,
THE INSURER OR MA OR CHIP MANAGED CARE PLAN SHALL PROVIDE THE
HEALTH CARE PROVIDER WITH WRITTEN NOTICE OF THE DECISION. THE
NOTICE SHALL INCLUDE A CLEAR RATIONALE FOR THE DECISION.
SECTION 2131. CONFIDENTIALITY.--(A) [A] AN INSURER OR MA OR
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CHIP MANAGED CARE PLAN [AND A UTILIZATION REVIEW ENTITY] SHALL
ADOPT AND MAINTAIN PROCEDURES TO ENSURE THAT ALL [IDENTIFIABLE]
PROTECTED HEALTH INFORMATION REGARDING COVERED PERSON OR
ENROLLEE HEALTH, DIAGNOSIS AND TREATMENT IS ADEQUATELY PROTECTED
AND REMAINS CONFIDENTIAL IN COMPLIANCE WITH ALL APPLICABLE
FEDERAL AND STATE LAWS AND REGULATIONS AND PROFESSIONAL ETHICAL
STANDARDS.
(B) TO THE EXTENT [A] AN INSURER OR MA OR CHIP MANAGED CARE
PLAN MAINTAINS MEDICAL RECORDS, THE INSURER OR MA OR CHIP
MANAGED CARE PLAN SHALL ADOPT AND MAINTAIN PROCEDURES TO ENSURE
THAT COVERED PERSONS AND ENROLLEES HAVE TIMELY ACCESS TO THEIR
MEDICAL RECORDS, INCLUDING MEDICAL RECORDS PROVIDED BY A HEALTH
CARE PROVIDER IN THE CONTEXT OF UTILIZATION REVIEW OR A
COMPLAINT, GRIEVANCE OR ADVERSE BENEFIT DETERMINATION, UNLESS
PROHIBITED BY FEDERAL OR STATE LAW OR REGULATION.
(C) (1) INFORMATION REGARDING [AN] A COVERED PERSON'S OR
ENROLLEE'S HEALTH OR TREATMENT SHALL BE AVAILABLE TO THE COVERED
PERSON OR ENROLLEE, THE COVERED PERSON'S OR ENROLLEE'S
[DESIGNEE] AUTHORIZED REPRESENTATIVE OR AS NECESSARY TO PREVENT
DEATH OR SERIOUS INJURY.
(2) NOTHING IN THIS SECTION SHALL:
(I) PREVENT DISCLOSURE NECESSARY TO DETERMINE COVERAGE,
REVIEW COMPLAINTS [OR], GRIEVANCES OR ADVERSE BENEFIT
DETERMINATIONS, CONDUCT UTILIZATION REVIEW OR FACILITATE PAYMENT
OF A CLAIM.
(II) DENY THE DEPARTMENT[, THE INSURANCE DEPARTMENT] OR THE
DEPARTMENT OF [PUBLIC WELFARE] HUMAN SERVICES ACCESS TO RECORDS
FOR PURPOSES OF QUALITY ASSURANCE, INVESTIGATION OF COMPLAINTS
[OR], GRIEVANCES OR ADVERSE BENEFIT DETERMINATIONS, ENFORCEMENT
OR OTHER ACTIVITIES RELATED TO COMPLIANCE WITH THIS ARTICLE AND
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OTHER LAWS OF THIS COMMONWEALTH. RECORDS SHALL BE ACCESSIBLE
ONLY TO DEPARTMENT EMPLOYES OR AGENTS WITH DIRECT
RESPONSIBILITIES UNDER THE PROVISIONS OF THIS SUBPARAGRAPH.
(III) DENY ACCESS TO INFORMATION NECESSARY FOR A UTILIZATION
REVIEW ENTITY TO CONDUCT A REVIEW UNDER THIS ARTICLE.
(IV) DENY ACCESS TO THE INSURER OR MA OR CHIP MANAGED CARE
PLAN FOR INTERNAL QUALITY REVIEW, INCLUDING REVIEWS CONDUCTED AS
PART OF THE INSURER'S OR MA OR CHIP MANAGED CARE PLAN'S QUALITY
OVERSIGHT PROCESS. DURING SUCH REVIEWS, COVERED PERSONS AND
ENROLLEES SHALL REMAIN ANONYMOUS TO THE GREATEST EXTENT
POSSIBLE.
(V) DENY ACCESS TO INSURERS OR MA OR CHIP MANAGED CARE
PLANS, HEALTH CARE PROVIDERS AND THEIR RESPECTIVE DESIGNEES FOR
THE PURPOSE OF PROVIDING PATIENT CARE MANAGEMENT, OUTCOMES
IMPROVEMENT AND RESEARCH. FOR THIS PURPOSE, COVERED PERSONS AND
ENROLLEES SHALL PROVIDE CONSENT AND SHALL REMAIN ANONYMOUS TO
THE GREATEST EXTENT POSSIBLE.
(F) INFORMATION FOR COVERED
PERSONS AND ENROLLEES.
SECTION 2136. REQUIRED DISCLOSURE.--(A) [A] AN INSURER OR
MA OR CHIP MANAGED CARE PLAN SHALL SUPPLY EACH COVERED PERSON OR
ENROLLEE AND, UPON WRITTEN REQUEST, EACH PROSPECTIVE COVERED
PERSON OR ENROLLEE OR HEALTH CARE PROVIDER WITH THE FOLLOWING
WRITTEN INFORMATION. SUCH INFORMATION SHALL BE EASILY
UNDERSTANDABLE BY THE LAYPERSON AND SHALL INCLUDE, BUT NOT BE
LIMITED TO:
(1) A DESCRIPTION OF COVERAGE, BENEFITS AND BENEFIT
MAXIMUMS, INCLUDING BENEFIT LIMITATIONS AND EXCLUSIONS OF
COVERAGE, HEALTH CARE SERVICES AND THE DEFINITION OF MEDICAL
NECESSITY USED BY THE INSURER OR MA OR CHIP MANAGED CARE PLAN IN
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DETERMINING WHETHER THESE BENEFITS WILL BE COVERED. THE
FOLLOWING STATEMENT OR SUBSTANTIALLY SIMILAR STATEMENT SHALL BE
INCLUDED IN ALL MARKETING MATERIALS IN BOLDFACE TYPE:
FOR INSURERS: THIS [MANAGED CARE PLAN] HEALTH INSURANCE
POLICY MAY NOT COVER ALL YOUR HEALTH CARE EXPENSES. READ YOUR
CONTRACT OR MEMBER HANDBOOK CAREFULLY TO DETERMINE WHICH
HEALTH CARE SERVICES ARE COVERED.
FOR MA OR CHIP MANAGED CARE PLANS: YOUR MANAGED CARE PLAN MAY
NOT COVER ALL YOUR HEALTH CARE EXPENSES. READ YOUR MEMBER
HANDBOOK CAREFULLY TO DETERMINE WHICH HEALTH CARE SERVICES
ARE COVERED.
THE NOTICE SHALL BE FOLLOWED BY A TELEPHONE NUMBER TO CONTACT
THE INSURER OR MA OR CHIP MANAGED CARE PLAN.
(2) A DESCRIPTION OF ALL NECESSARY PRIOR AUTHORIZATIONS OR
OTHER REQUIREMENTS FOR NONEMERGENCY HEALTH CARE SERVICES AS
REQUIRED BY SECTION 2155.
(3) AN EXPLANATION OF [AN] A COVERED PERSON'S OR ENROLLEE'S
FINANCIAL RESPONSIBILITY FOR PAYMENT OF PREMIUMS, COINSURANCE,
COPAYMENTS, DEDUCTIBLES AND OTHER CHARGES, ANNUAL LIMITS ON [AN]
A COVERED PERSON'S OR ENROLLEE'S FINANCIAL RESPONSIBILITY AND
CAPS ON PAYMENTS FOR HEALTH CARE SERVICES PROVIDED UNDER THE
[PLAN] HEALTH INSURANCE POLICY OR AN AGREEMENT WITH THE
DEPARTMENT OF HUMAN SERVICES.
(4) AN EXPLANATION OF [AN] A COVERED PERSON'S OR ENROLLEE'S
FINANCIAL RESPONSIBILITY FOR PAYMENT WHEN A HEALTH CARE SERVICE
IS PROVIDED BY A NONPARTICIPATING HEALTH CARE PROVIDER, WHEN A
HEALTH CARE SERVICE IS PROVIDED BY ANY HEALTH CARE PROVIDER
WITHOUT REQUIRED AUTHORIZATION OR WHEN THE CARE RENDERED IS NOT
COVERED [BY THE PLAN] UNDER THE HEALTH INSURANCE POLICY OR BY AN
AGREEMENT WITH THE DEPARTMENT OF HUMAN SERVICES.
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(5) A DESCRIPTION OF HOW THE INSURER OR MA OR CHIP MANAGED
CARE PLAN ADDRESSES THE NEEDS OF NON-ENGLISH-SPEAKING COVERED
PERSONS OR ENROLLEES.
(6) A NOTICE OF MAILING ADDRESSES AND TELEPHONE NUMBERS
NECESSARY TO ENABLE [AN] A COVERED PERSON OR ENROLLEE TO OBTAIN
APPROVAL OR AUTHORIZATION OF A HEALTH CARE SERVICE OR OTHER
INFORMATION REGARDING THE HEALTH INSURANCE POLICY OR SERVICES
COVERED BY THE MA OR CHIP MANAGED CARE PLAN.
(7) A SUMMARY OF THE INSURER'S OR MA OR CHIP MANAGED CARE
PLAN'S UTILIZATION REVIEW POLICIES AND PROCEDURES.
(8) A SUMMARY OF ALL COMPLAINT [AND], GRIEVANCE OR ADVERSE
BENEFIT DETERMINATION PROCEDURES USED TO RESOLVE DISPUTES
BETWEEN THE INSURER OR MA OR CHIP MANAGED CARE PLAN AND [AN] A
COVERED PERSON OR ENROLLEE OR A HEALTH CARE PROVIDER, INCLUDING:
(I) THE PROCEDURE TO FILE A COMPLAINT [OR], GRIEVANCE OR
ADVERSE BENEFIT DETERMINATION APPEAL AS SET FORTH IN THIS
ARTICLE, INCLUDING A TOLL-FREE TELEPHONE NUMBER TO OBTAIN
INFORMATION REGARDING THE FILING AND STATUS OF A COMPLAINT [OR],
GRIEVANCE OR ADVERSE BENEFIT DETERMINATION.
(II) THE RIGHT TO APPEAL A DECISION RELATING TO A COMPLAINT
[OR], GRIEVANCE OR ADVERSE BENEFIT DETERMINATION.
(III) THE COVERED PERSON'S OR ENROLLEE'S RIGHT TO DESIGNATE
A REPRESENTATIVE TO PARTICIPATE IN THE COMPLAINT [OR], GRIEVANCE
OR ADVERSE BENEFIT DETERMINATION PROCESS AS SET FORTH IN THIS
ARTICLE.
(IV) A NOTICE THAT ALL [DISPUTES] DECISIONS INVOLVING DENIAL
OF PAYMENT FOR A HEALTH CARE SERVICE WILL BE MADE BY QUALIFIED
PERSONNEL WITH EXPERIENCE IN THE SAME OR SIMILAR SCOPE OF
PRACTICE AND THAT ALL NOTICES OF DECISIONS WILL INCLUDE
INFORMATION REGARDING THE BASIS FOR THE DETERMINATION.
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(9) A DESCRIPTION OF THE PROCEDURE FOR PROVIDING EMERGENCY
SERVICES TWENTY-FOUR (24) HOURS A DAY. THE DESCRIPTION SHALL
INCLUDE:
(I) A DEFINITION OF EMERGENCY SERVICES AS SET FORTH IN THIS
ARTICLE.
(II) NOTICE THAT EMERGENCY SERVICES ARE NOT SUBJECT TO PRIOR
APPROVAL.
(III) THE COVERED PERSON'S OR ENROLLEE'S FINANCIAL AND OTHER
RESPONSIBILITIES REGARDING EMERGENCY SERVICES, INCLUDING THE
RECEIPT OF THESE SERVICES OUTSIDE THE INSURER'S OR MA OR CHIP
MANAGED CARE PLAN'S SERVICE AREA.
(10) A DESCRIPTION OF THE PROCEDURES FOR COVERED PERSONS OR
ENROLLEES TO SELECT A PARTICIPATING HEALTH CARE PROVIDER,
INCLUDING HOW TO DETERMINE WHETHER A PARTICIPATING HEALTH CARE
PROVIDER IS ACCEPTING NEW [ENROLLEES] PATIENTS.
(11) A DESCRIPTION OF THE PROCEDURES FOR CHANGING PRIMARY
CARE PROVIDERS AND SPECIALISTS.
(12) A DESCRIPTION OF THE PROCEDURES BY WHICH [AN] A COVERED
PERSON OR ENROLLEE MAY OBTAIN A REFERRAL TO A HEALTH CARE
PROVIDER OUTSIDE THE HEALTH INSURANCE POLICY'S OR MA OR CHIP
MANAGED CARE PLAN'S PROVIDER NETWORK WHEN THAT PROVIDER NETWORK
DOES NOT INCLUDE A HEALTH CARE PROVIDER WITH APPROPRIATE
TRAINING AND EXPERIENCE TO MEET THE HEALTH CARE SERVICE NEEDS OF
[AN] A COVERED PERSON OR ENROLLEE.
(13) A DESCRIPTION OF THE PROCEDURES THAT [AN] A COVERED
PERSON OR ENROLLEE WITH A LIFE-THREATENING, DEGENERATIVE OR
DISABLING DISEASE OR CONDITION SHALL FOLLOW AND SATISFY TO BE
ELIGIBLE FOR EITHER OF THE FOLLOWING:
(I) [A] A STANDING REFERRAL TO A SPECIALIST WITH CLINICAL
EXPERTISE IN TREATING THE DISEASE OR CONDITION[; OR].
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(II) [THE] THE DESIGNATION OF A SPECIALIST TO PROVIDE AND
COORDINATE THE COVERED PERSON'S OR ENROLLEE'S PRIMARY AND
SPECIALTY CARE.
(14) A LIST BY SPECIALTY OF THE NAME, ADDRESS AND TELEPHONE
NUMBER OF ALL [PARTICIPATING] HEALTH CARE PROVIDERS
PARTICIPATING IN THE PROVIDER NETWORK FOR THE HEALTH INSURANCE
POLICY OR MA OR CHIP MANAGED CARE PLAN. THE LIST MAY BE A
SEPARATE DOCUMENT AND SHALL BE UPDATED AT LEAST [ANNUALLY.] ONCE
EVERY 90 DAYS OR MORE FREQUENTLY AS MAY BE REQUIRED BY FEDERAL
OR STATE LAW, INCLUDING SECTION 2799A-5 OF THE PUBLIC HEALTH
SERVICE ACT (58 STAT. 682, 42 U.S.C. ยง 201 ET SEQ.)
(15) A LIST OF THE INFORMATION AVAILABLE TO COVERED PERSONS
OR ENROLLEES OR PROSPECTIVE COVERED PERSONS OR ENROLLEES, UPON
WRITTEN REQUEST, UNDER SUBSECTION (B).
(B) EACH INSURER OR MA OR CHIP MANAGED CARE PLAN SHALL, UPON
WRITTEN REQUEST OF [AN] A COVERED PERSON OR ENROLLEE OR
PROSPECTIVE COVERED PERSON OR ENROLLEE, PROVIDE THE FOLLOWING
WRITTEN INFORMATION:
(1) A LIST OF THE NAMES, BUSINESS ADDRESSES AND OFFICIAL
POSITIONS OF THE MEMBERSHIP OF THE BOARD OF DIRECTORS OR
OFFICERS OF THE INSURER OR MA OR CHIP MANAGED CARE PLAN.
(2) THE PROCEDURES ADOPTED TO PROTECT THE CONFIDENTIALITY OF
MEDICAL RECORDS AND OTHER COVERED PERSON OR ENROLLEE
INFORMATION.
(3) A DESCRIPTION OF THE CREDENTIALING PROCESS FOR HEALTH
CARE PROVIDERS.
(4) A LIST OF THE PARTICIPATING HEALTH CARE PROVIDERS
AFFILIATED WITH PARTICIPATING HOSPITALS.
(5) WHETHER A SPECIFICALLY IDENTIFIED DRUG IS INCLUDED OR
EXCLUDED FROM COVERAGE.
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(6) A DESCRIPTION OF THE PROCESS BY WHICH A HEALTH CARE
PROVIDER CAN PRESCRIBE SPECIFIC DRUGS, DRUGS USED FOR AN OFF-
LABEL PURPOSE, BIOLOGICALS AND MEDICATIONS NOT INCLUDED IN THE
DRUG FORMULARY FOR PRESCRIPTION DRUGS [OR BIOLOGICALS] WHEN THE
FORMULARY'S EQUIVALENT HAS BEEN INEFFECTIVE IN THE TREATMENT OF
THE COVERED PERSON'S OR ENROLLEE'S DISEASE OR IF THE DRUG CAUSES
OR IS REASONABLY EXPECTED TO CAUSE ADVERSE OR HARMFUL REACTIONS
TO THE COVERED PERSON OR ENROLLEE.
(7) A DESCRIPTION OF THE PROCEDURES FOLLOWED BY THE INSURER
OR MA OR CHIP MANAGED CARE PLAN TO MAKE DECISIONS ABOUT THE
EXPERIMENTAL NATURE OF INDIVIDUAL DRUGS, MEDICAL DEVICES OR
TREATMENTS.
(8) A SUMMARY OF THE METHODOLOGIES USED BY THE INSURER OR MA
OR CHIP MANAGED CARE PLAN TO REIMBURSE FOR HEALTH CARE SERVICES.
NOTHING IN THIS PARAGRAPH SHALL BE CONSTRUED TO REQUIRE
DISCLOSURE OF INDIVIDUAL CONTRACTS OR THE SPECIFIC DETAILS OF
ANY FINANCIAL ARRANGEMENT BETWEEN [A] AN INSURER OR MA OR CHIP
MANAGED CARE PLAN AND A HEALTH CARE PROVIDER.
(9) A DESCRIPTION OF THE PROCEDURES USED IN THE INSURER'S OR
MA OR CHIP MANAGED CARE PLAN'S QUALITY ASSURANCE PROGRAM.
(10) OTHER INFORMATION AS MAY BE REQUIRED BY THE DEPARTMENT
OR THE INSURANCE DEPARTMENT.
(C) (1) AN INSURER SHALL INCLUDE A DESCRIPTION OF THE
INSURER'S EXTERNAL REVIEW PROCEDURES IN OR ATTACHED TO THE
POLICY, CERTIFICATE, MEMBERSHIP BOOKLET, OUTLINE OF COVERAGE OR
OTHER EVIDENCE OF COVERAGE THE INSURER PROVIDES TO COVERED
PERSONS, INCLUDING WHETHER THE INSURER HAS COMPLIED WITH THE
SURPRISE BILLING AND COST-SHARING PROTECTIONS UNDER THE NO
SURPRISES ACT (PUB. L. 116-260, DIV. BB, TITLE I, 134 STAT.
2758).
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(2) THE DISCLOSURE REQUIRED BY PARAGRAPH (1) SHALL BE IN A
FORMAT AS PRESCRIBED BY THE DEPARTMENT.
(3) THE DESCRIPTION OF PROCEDURES REQUIRED UNDER SUBSECTION
(A) SHALL INCLUDE:
(I) A STATEMENT THAT INFORMS THE COVERED PERSON OF THE RIGHT
TO FILE A REQUEST FOR EXTERNAL REVIEW OF AN ADVERSE BENEFIT
DETERMINATION OR FINAL ADVERSE BENEFIT DETERMINATION, INCLUDING
WHETHER THE INSURER HAS COMPLIED WITH THE SURPRISE BILLING AND
COST SHARING PROTECTIONS UNDER THE NO SURPRISE ACT.
(II) THE TELEPHONE NUMBER AND ADDRESS OF THE DEPARTMENT.
(III) A STATEMENT THAT, WHEN FILING A REQUEST FOR AN
EXTERNAL REVIEW, THE COVERED PERSON IS REQUIRED TO AUTHORIZE THE
RELEASE OF MEDICAL RECORDS OF THE COVERED PERSON THAT MAY BE
REQUIRED TO BE REVIEWED FOR THE PURPOSE OF REACHING A DECISION
ON THE EXTERNAL REVIEW.
(IV) AN EXPLANATION THAT EXTERNAL REVIEW IS AVAILABLE WHEN
THE ADVERSE BENEFIT DETERMINATION OR FINAL ADVERSE BENEFIT
DETERMINATION INVOLVES AN ISSUE OF MEDICAL NECESSITY,
APPROPRIATENESS, HEALTH CARE SETTING, LEVEL OF CARE OR
EFFECTIVENESS.
SECTION 2. SECTION 2141 OF THE ACT IS AMENDED TO READ:
SECTION 2141. INTERNAL COMPLAINT PROCESS FOR COVERED
PERSONS.--(A) [A MANAGED CARE PLAN] AN INSURER SHALL ESTABLISH
AND MAINTAIN AN INTERNAL COMPLAINT PROCESS WITH TWO LEVELS OF
REVIEW BY WHICH [AN ENROLLEE] A COVERED PERSON OR THE COVERED
PERSON'S AUTHORIZED REPRESENTATIVE SHALL BE ABLE TO FILE A
COMPLAINT [REGARDING A PARTICIPATING HEALTH CARE PROVIDER OR THE
COVERAGE, OPERATIONS OR MANAGEMENT POLICIES OF THE MANAGED CARE
PLAN].
(B) THE COMPLAINT PROCESS SHALL CONSIST OF AN INITIAL REVIEW
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TO INCLUDE ALL OF THE FOLLOWING:
(1) A REVIEW BY AN INITIAL REVIEW COMMITTEE CONSISTING OF
ONE OR MORE EMPLOYES OF THE [MANAGED CARE PLAN] INSURER.
(2) THE ALLOWANCE OF A WRITTEN OR ORAL COMPLAINT.
(3) THE ALLOWANCE OF WRITTEN DATA OR OTHER INFORMATION.
(4) A REVIEW OR INVESTIGATION OF THE COMPLAINT WHICH SHALL
BE COMPLETED WITHIN THIRTY (30) DAYS OF RECEIPT OF THE
COMPLAINT.
(5) A WRITTEN NOTIFICATION TO THE [ENROLLEE] COVERED PERSON
REGARDING THE DECISION OF THE INITIAL REVIEW COMMITTEE WITHIN
FIVE (5) BUSINESS DAYS OF THE DECISION. NOTICE SHALL INCLUDE THE
BASIS FOR THE DECISION AND THE PROCEDURE TO FILE A REQUEST FOR A
SECOND LEVEL REVIEW OF THE DECISION OF THE INITIAL REVIEW
COMMITTEE.
(C) THE COMPLAINT PROCESS SHALL INCLUDE A SECOND LEVEL
REVIEW THAT INCLUDES ALL OF THE FOLLOWING:
(1) A REVIEW OF THE DECISION OF THE INITIAL REVIEW COMMITTEE
BY A SECOND LEVEL REVIEW COMMITTEE CONSISTING OF THREE OR MORE
INDIVIDUALS WHO DID NOT PARTICIPATE IN THE INITIAL REVIEW. AT
LEAST ONE THIRD OF THE SECOND LEVEL REVIEW COMMITTEE SHALL NOT
BE EMPLOYED BY THE [MANAGED CARE PLAN] INSURER.
(2) A WRITTEN NOTIFICATION TO THE [ENROLLEE] COVERED PERSON
OF THE RIGHT TO APPEAR BEFORE THE SECOND LEVEL REVIEW COMMITTEE.
(3) A REQUIREMENT THAT THE SECOND LEVEL REVIEW BE COMPLETED
WITHIN FORTY-FIVE (45) DAYS OF RECEIPT OF A REQUEST FOR SUCH
REVIEW.
(4) A WRITTEN NOTIFICATION TO THE [ENROLLEE] COVERED PERSON
REGARDING THE DECISION OF THE SECOND LEVEL REVIEW COMMITTEE
WITHIN FIVE (5) BUSINESS DAYS OF THE DECISION. THE NOTICE SHALL
INCLUDE THE BASIS FOR THE DECISION AND THE PROCEDURE FOR
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APPEALING THE DECISION TO THE DEPARTMENT [OR THE INSURANCE
DEPARTMENT].
SECTION 3. THE ACT IS AMENDED BY ADDING A SECTION TO READ:
SECTION 2141.1. INTERNAL COMPLAINT PROCESS FOR ENROLLEES.--
(A) AN MA OR CHIP MANAGED CARE PLAN SHALL ESTABLISH AND
MAINTAIN AN INTERNAL COMPLAINT PROCESS BY WHICH AN ENROLLEE OR
THE ENROLLEE'S AUTHORIZED REPRESENTATIVE SHALL BE ABLE TO FILE A
COMPLAINT.
(B) THE COMPLAINT PROCESS SHALL CONSIST OF A REVIEW TO
INCLUDE ALL OF THE FOLLOWING:
(1) A REVIEW BY A REVIEW COMMITTEE CONSISTING OF ONE OR MORE
EMPLOYES OF THE MA OR CHIP MANAGED CARE PLAN.
(2) THE ALLOWANCE OF A WRITTEN OR ORAL COMPLAINT.
(3) THE ALLOWANCE OF WRITTEN DATA OR OTHER INFORMATION.
(4) WRITTEN NOTIFICATION TO THE ENROLLEE OF THE DECISION OF
THE REVIEW COMMITTEE WITHIN THIRTY (30) DAYS OF RECEIPT OF THE
COMPLAINT, UNLESS THE TIME FRAME FOR DECIDING THE COMPLAINT HAS
BEEN EXTENDED BY UP TO FOURTEEN (14) DAYS AT THE REQUEST OF THE
ENROLLEE.
(5) THE WRITTEN NOTIFICATION OF THE DECISION SHALL INCLUDE
THE BASIS FOR THE DECISION AND THE PROCEDURE TO FILE A REQUEST
FOR A SECOND LEVEL REVIEW OF THE DECISION OF THE REVIEW
COMMITTEE, EXCEPT AS PROVIDED IN PARAGRAPH (6).
(6) THE WRITTEN NOTIFICATION OF THE DECISION SHALL INCLUDE
THE BASIS FOR THE DECISION AND THE PROCEDURE TO FILE AN APPEAL
OF A COMPLAINT IF THE COMPLAINT IS ABOUT ONE OF THE FOLLOWING:
(I) A DENIAL BECAUSE THE SERVICE OR ITEM IS NOT A COVERED
SERVICE.
(II) THE FAILURE OF THE MA OR CHIP MANAGED CARE PLAN TO MEET
THE REQUIRED TIME FRAMES FOR PROVIDING A SERVICE OR ITEM IN A
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TIMELY MANNER.
(III) THE FAILURE OF THE MA OR CHIP MANAGED CARE PLAN TO
DECIDE A COMPLAINT OR GRIEVANCE WITHIN THE REQUIRED TIME FRAMES.
(IV) A DENIAL OF PAYMENT BY THE MA OR CHIP MANAGED CARE PLAN
AFTER THE SERVICE OR ITEM HAS BEEN DELIVERED BECAUSE THE SERVICE
OR ITEM WAS PROVIDED BY A HEALTH CARE PROVIDER NOT ENROLLED IN
THE MEDICAL ASSISTANCE PROGRAM.
(V) A DENIAL OF PAYMENT BY THE MA OR CHIP MANAGED CARE PLAN
AFTER THE SERVICE OR ITEM HAS BEEN DELIVERED BECAUSE THE SERVICE
OR ITEM PROVIDED IS NOT A COVERED SERVICE OR ITEM FOR THE
ENROLLEE.
(VI) A DENIAL OF AN ENROLLEE'S REQUEST TO DISPUTE A
FINANCIAL LIABILITY.
(C) FOR ALL COMPLAINTS EXCEPT COMPLAINTS LISTED IN
SUBSECTION (B)(6), THE COMPLAINT PROCESS SHALL INCLUDE A SECOND
LEVEL REVIEW THAT INCLUDES ALL OF THE FOLLOWING:
(1) A REVIEW OF THE DECISION OF THE REVIEW COMMITTEE BY A
SECOND LEVEL REVIEW COMMITTEE CONSISTING OF THREE OR MORE
INDIVIDUALS WHO DID NOT PARTICIPATE IN THE INITIAL REVIEW. AT
LEAST ONE-THIRD OF THE SECOND LEVEL REVIEW COMMITTEE SHALL NOT
BE EMPLOYED BY THE MA OR CHIP MANAGED CARE PLAN.
(2) A WRITTEN NOTIFICATION TO THE ENROLLEE OF THE RIGHT TO
APPEAR BEFORE THE SECOND LEVEL REVIEW COMMITTEE.
(3) A WRITTEN NOTIFICATION TO THE ENROLLEE OF THE DECISION
OF THE SECOND LEVEL REVIEW COMMITTEE WITHIN FORTY-FIVE (45) DAYS
OF RECEIPT OF THE SECOND LEVEL COMPLAINT, WHICH SHALL INCLUDE
THE BASIS FOR THE DECISION AND THE PROCEDURE FOR APPEALING THE
DECISION TO THE DEPARTMENT.
SECTION 4. SECTIONS 2142 AND 2143, SUBDIVISION (H) HEADING
OF ARTICLE XXI AND SECTIONS 2151 AND 2152 OF THE ACT ARE AMENDED
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TO READ:
SECTION 2142. APPEAL OF COMPLAINT OR ADMINISTRATIVE ADVERSE
BENEFIT DETERMINATION.--[(A) AN ENROLLEE SHALL HAVE FIFTEEN
(15) DAYS FROM RECEIPT OF THE NOTICE OF THE DECISION FROM THE
SECOND LEVEL REVIEW COMMITTEE TO APPEAL THE DECISION TO THE
DEPARTMENT OR THE INSURANCE DEPARTMENT, AS APPROPRIATE.
(B) ALL RECORDS FROM THE INITIAL REVIEW AND SECOND LEVEL
REVIEW SHALL BE TRANSMITTED TO THE APPROPRIATE DEPARTMENT IN THE
MANNER PRESCRIBED. THE ENROLLEE, THE HEALTH CARE PROVIDER OR THE
MANAGED CARE PLAN MAY SUBMIT ADDITIONAL MATERIALS RELATED TO THE
COMPLAINT.]
(A) THE FOLLOWING SHALL APPLY:
(1) A COVERED PERSON MAY APPEAL A DECISION ABOUT THE
COVERAGE, OPERATIONS OR MANAGEMENT POLICIES OF AN INSURER, OTHER
THAN DECISIONS THAT ARE ADVERSE BENEFIT DETERMINATIONS.
(2) AN ENROLLEE OR THE ENROLLEE'S AUTHORIZED REPRESENTATIVE
SHALL HAVE FIFTEEN (15) DAYS FROM RECEIPT OF THE NOTICE OF
DECISION TO APPEAL THE DECISION TO THE DEPARTMENT IF THE SUBJECT
OF THE COMPLAINT IS LISTED IN SECTION 2141.1(B)(6).
(3) A COVERED PERSON OR ENROLLEE, OR COVERED PERSON'S OR
ENROLLEE'S AUTHORIZED REPRESENTATIVE, SHALL HAVE FIFTEEN (15)
DAYS FROM RECEIPT OF THE NOTICE OF THE DECISION FROM THE SECOND
LEVEL REVIEW COMMITTEE TO APPEAL THE DECISION TO THE DEPARTMENT.
(4) ALL RECORDS FROM THE REVIEW SHALL BE TRANSMITTED TO THE
DEPARTMENT IN THE MANNER PRESCRIBED. THE COVERED PERSON,
ENROLLEE, HEALTH CARE PROVIDER OR INSURER OR MA OR CHIP MANAGED
CARE PLAN MAY SUBMIT ADDITIONAL MATERIALS RELATED TO THE
COMPLAINT.
(B) (1) A COVERED PERSON SHALL HAVE FIFTEEN (15) DAYS FROM
RECEIPT OF THE NOTICE OF A DECISION ON AN ADMINISTRATIVE ADVERSE
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BENEFIT DETERMINATION CONDUCTED UNDER SECTION 2161.1 TO APPEAL
THE DECISION TO THE DEPARTMENT.
(2) ALL RECORDS FROM THE INTERNAL CLAIM AND APPEAL PROCEDURE
SHALL BE TRANSMITTED TO THE DEPARTMENT IN THE MANNER PRESCRIBED.
THE COVERED PERSON, HEALTH CARE PROVIDER OR INSURER MAY SUBMIT
ADDITIONAL MATERIALS RELATED TO THE ADMINISTRATIVE ADVERSE
BENEFIT DETERMINATION.
(C) THE COVERED PERSON OR ENROLLEE MAY BE REPRESENTED BY AN
ATTORNEY OR OTHER INDIVIDUAL BEFORE THE APPROPRIATE DEPARTMENT.
(D) THE [APPROPRIATE] DEPARTMENT SHALL DETERMINE WHETHER A
VIOLATION OF THIS ARTICLE HAS OCCURRED AND MAY IMPOSE ANY
PENALTIES AUTHORIZED BY THIS ARTICLE.
SECTION 2143. COMPLAINT OR ADMINISTRATIVE ADVERSE BENEFIT
DETERMINATION RESOLUTION.--NOTHING IN THIS SUBDIVISION SHALL
PREVENT THE DEPARTMENT [OR THE INSURANCE DEPARTMENT] FROM
COMMUNICATING WITH THE COVERED PERSON OR ENROLLEE[,] OR THE
HEALTH CARE PROVIDER [OR THE], INSURER OR MA OR CHIP MANAGED
CARE PLAN AS APPROPRIATE TO ASSIST IN THE RESOLUTION OF A
COMPLAINT OR ADMINISTRATIVE ADVERSE BENEFIT DETERMINATION. SUCH
COMMUNICATION MAY OCCUR AT ANY TIME DURING THE [COMPLAINT]
PROCESS.
(H) UTILIZATION REVIEW ENTITY STANDARDS.
SECTION 2151. CERTIFICATION.--(A) A UTILIZATION REVIEW
ENTITY MAY NOT REVIEW HEALTH CARE SERVICES DELIVERED OR PROPOSED
TO BE DELIVERED IN THIS COMMONWEALTH UNLESS THE ENTITY IS
CERTIFIED BY THE DEPARTMENT TO PERFORM UTILIZATION REVIEW. [A
UTILIZATION REVIEW ENTITY OPERATING IN THIS COMMONWEALTH ON OR
BEFORE THE EFFECTIVE DATE OF THIS ARTICLE SHALL HAVE ONE YEAR
FROM THE EFFECTIVE DATE OF THIS ARTICLE TO APPLY FOR
CERTIFICATION.]
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(B) THE DEPARTMENT [SHALL] MAY GRANT CERTIFICATION TO A
UTILIZATION REVIEW ENTITY THAT MEETS THE REQUIREMENTS OF THIS
SECTION. CERTIFICATION SHALL BE RENEWED EVERY THREE YEARS UNLESS
OTHERWISE SUBJECT TO ADDITIONAL REVIEW, SUSPENSION OR REVOCATION
BY THE DEPARTMENT.
(C) THE DEPARTMENT MAY ADOPT A NATIONALLY RECOGNIZED
ACCREDITING BODY'S STANDARDS TO CERTIFY UTILIZATION REVIEW
ENTITIES TO THE EXTENT THE STANDARDS MEET OR EXCEED THE
STANDARDS SET FORTH IN THIS ARTICLE.
(D) THE DEPARTMENT MAY PRESCRIBE APPLICATION AND RENEWAL
FEES FOR CERTIFICATION. THE FEES SHALL REFLECT THE
ADMINISTRATIVE COSTS OF CERTIFICATION [AND SHALL BE DEPOSITED IN
THE GENERAL FUND].
(E) [A LICENSED INSURER OR A] AN INSURER OR MA OR CHIP
MANAGED CARE PLAN WITH A CERTIFICATE OF AUTHORITY SHALL COMPLY
WITH THE STANDARDS AND PROCEDURES OF THIS SUBDIVISION BUT SHALL
NOT BE REQUIRED TO OBTAIN SEPARATE CERTIFICATION AS A
UTILIZATION REVIEW ENTITY.
SECTION 2152. OPERATIONAL STANDARDS.--(A) A UTILIZATION
REVIEW ENTITY SHALL DO ALL OF THE FOLLOWING:
(1) RESPOND TO INQUIRIES RELATING TO UTILIZATION REVIEW
DETERMINATIONS BY:
(I) PROVIDING TOLL-FREE TELEPHONE ACCESS AT LEAST FORTY (40)
HOURS PER WEEK DURING NORMAL BUSINESS HOURS;
(II) MAINTAINING A TELEPHONE ANSWERING SERVICE OR RECORDING
SYSTEM DURING NONBUSINESS HOURS; AND
(III) RESPONDING TO EACH TELEPHONE CALL RECEIVED BY THE
ANSWERING SERVICE OR RECORDING SYSTEM REGARDING A UTILIZATION
REVIEW DETERMINATION WITHIN ONE (1) BUSINESS DAY OF THE RECEIPT
OF THE CALL.
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(2) PROTECT THE CONFIDENTIALITY OF COVERED PERSON OR
ENROLLEE MEDICAL RECORDS AS SET FORTH IN SECTION 2131.
(3) ENSURE THAT A HEALTH CARE PROVIDER IS ABLE TO VERIFY
THAT AN INDIVIDUAL REQUESTING INFORMATION ON BEHALF OF THE
INSURER OR MA OR CHIP MANAGED CARE PLAN IS [A LEGITIMATE] AN
AUTHORIZED REPRESENTATIVE OF THE INSURER OR MA OR CHIP MANAGED
CARE PLAN.
(4) CONDUCT UTILIZATION REVIEWS BASED ON THE MEDICAL
NECESSITY [AND], APPROPRIATENESS, HEALTH CARE SETTING, LEVEL OF
CARE OR EFFECTIVENESS OF THE HEALTH CARE SERVICE BEING REVIEWED
[AND PROVIDE NOTIFICATION WITHIN THE FOLLOWING TIME FRAMES:].
(4.1) IF PERFORMING A UTILIZATION REVIEW FOR A REQUEST FOR
HEALTH CARE SERVICES FOR AN COVERED PERSON OR ENROLLEE OF AN
INSURER OR MA OR CHIP MANAGED CARE PLAN, PROVIDE NOTIFICATION
WITHIN THE FOLLOWING TIME FRAMES:
(I) A PROSPECTIVE UTILIZATION REVIEW DECISION SHALL BE
COMMUNICATED WITHIN [TWO (2) BUSINESS DAYS OF THE RECEIPT OF ALL
SUPPORTING INFORMATION REASONABLY NECESSARY TO COMPLETE THE
REVIEW] THE TIME FRAME SPECIFIED IN SECTION 2155.
(II) A CONCURRENT UTILIZATION REVIEW DECISION SHALL BE
COMMUNICATED WITHIN ONE (1) BUSINESS DAY OF THE RECEIPT OF ALL
SUPPORTING INFORMATION REASONABLY NECESSARY TO COMPLETE THE
REVIEW.
(III) A RETROSPECTIVE UTILIZATION REVIEW DECISION SHALL BE
COMMUNICATED WITHIN THIRTY (30) DAYS OF THE RECEIPT OF ALL
SUPPORTING INFORMATION REASONABLY NECESSARY TO COMPLETE THE
REVIEW.
(5) ENSURE THAT PERSONNEL CONDUCTING A UTILIZATION REVIEW
HAVE CURRENT LICENSES IN GOOD STANDING OR OTHER REQUIRED
CREDENTIALS, WITHOUT RESTRICTIONS, FROM THE APPROPRIATE AGENCY.
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(6) PROVIDE ALL DECISIONS IN WRITING TO INCLUDE THE BASIS
AND CLINICAL RATIONALE FOR THE DECISION.
(7) NOTIFY THE HEALTH CARE PROVIDER OF ADDITIONAL FACTS OR
DOCUMENTS REQUIRED TO COMPLETE THE UTILIZATION REVIEW WITHIN
[FORTY-EIGHT (48) HOURS OF RECEIPT OF THE REQUEST FOR REVIEW]
THE TIME FRAMES SPECIFIED IN SECTION 2155.
(8) MAINTAIN A WRITTEN RECORD OF UTILIZATION REVIEW
DECISIONS ADVERSE TO COVERED PERSONS OR ENROLLEES FOR NOT LESS
THAN THREE (3) YEARS, INCLUDING A DETAILED JUSTIFICATION AND ALL
REQUIRED NOTIFICATIONS TO THE HEALTH CARE PROVIDER AND THE
COVERED PERSON OR ENROLLEE.
(B) COMPENSATION TO ANY PERSON OR ENTITY PERFORMING
UTILIZATION REVIEW MAY NOT CONTAIN INCENTIVES, DIRECT OR
INDIRECT, FOR THE PERSON OR ENTITY TO APPROVE OR DENY PAYMENT
FOR THE DELIVERY OF ANY HEALTH CARE SERVICE.
(C) UTILIZATION REVIEW THAT RESULTS IN A DENIAL OF PAYMENT
FOR A HEALTH CARE SERVICE SHALL BE MADE BY A LICENSED PHYSICIAN
THAT MEETS THE QUALIFICATIONS IN SECTION 2155(C), EXCEPT AS
PROVIDED IN [SUBSECTION (D)] SUBSECTIONS (D) AND (E).
(D) A LICENSED PSYCHOLOGIST MAY PERFORM A UTILIZATION REVIEW
FOR BEHAVIORAL HEALTH CARE SERVICES WITHIN THE PSYCHOLOGIST'S
SCOPE OF PRACTICE IF THE PSYCHOLOGIST'S CLINICAL EXPERIENCE
PROVIDES SUFFICIENT EXPERIENCE TO REVIEW THAT SPECIFIC
BEHAVIORAL HEALTH CARE SERVICE. THE USE OF A LICENSED
PSYCHOLOGIST TO PERFORM A UTILIZATION REVIEW OF A BEHAVIORAL
HEALTH CARE SERVICE SHALL BE APPROVED BY THE DEPARTMENT AS PART
OF THE CERTIFICATION PROCESS UNDER SECTION 2151. A LICENSED
PSYCHOLOGIST SHALL NOT REVIEW THE DENIAL OF PAYMENT FOR A HEALTH
CARE SERVICE INVOLVING INPATIENT CARE OR A PRESCRIPTION DRUG.
(E) A LICENSED DENTIST MAY PERFORM A UTILIZATION REVIEW FOR
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DENTAL SERVICES WITHIN THE DENTIST'S SCOPE OF PRACTICE IF THE
DENTIST'S CLINICAL EXPERIENCE PROVIDES SUFFICIENT EXPERIENCE TO
REVIEW THAT SPECIFIC DENTAL SERVICE. THE USE OF A LICENSED
DENTIST TO PERFORM A UTILIZATION REVIEW OF A DENTAL SERVICE
SHALL BE APPROVED BY THE DEPARTMENT AS PART OF THE CERTIFICATION
PROCESS UNDER SECTION 2151.
SECTION 5. ARTICLE XXI OF THE ACT IS AMENDED BY ADDING A
SUBDIVISION TO READ:
(H.1) UTILIZATION REVIEW STANDARDS.
SECTION 2153. PROVIDER PORTAL.
(A) ESTABLISHMENT OF PROVIDER PORTAL.--WITHIN 18 MONTHS
FOLLOWING THE EFFECTIVE DATE OF THIS SECTION, AN INSURER OR MA
OR CHIP MANAGED CARE PLAN SHALL ESTABLISH A PROVIDER PORTAL THAT
INCLUDES, AT MINIMUM, THE FOLLOWING FEATURES:
(1) ELECTRONIC SUBMISSION OF PRIOR AUTHORIZATION
REQUESTS.
(2) ACCESS TO THE INSURER'S OR MA OR CHIP MANAGED CARE
PLAN'S APPLICABLE MEDICAL POLICIES.
(3) INFORMATION NECESSARY TO REQUEST A PEER-TO-PEER
REVIEW.
(4) CONTACT INFORMATION FOR THE INSURER'S OR MA OR CHIP
MANAGED CARE PLAN'S RELEVANT CLINICAL OR ADMINISTRATIVE
STAFF.
(5) FOR PRIOR AUTHORIZATION SERVICE NOT SUBJECT TO
ELECTRONIC SUBMISSION VIA THE PROVIDER PORTAL, COPIES OF
APPLICABLE SUBMISSION FORMS.
(6) INSTRUCTIONS FOR THE SUBMISSION OF PRIOR
AUTHORIZATION REQUESTS IF THE INSURER'S OR MA OR CHIP MANAGED
CARE PLAN'S PROVIDER PORTAL IS UNAVAILABLE FOR ANY REASON.
(B) TRAINING AND SUPPORT FOR PORTAL USE.--WITHIN SIX MONTHS
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FOLLOWING THE ESTABLISHMENT OF A PROVIDER PORTAL UNDER
SUBSECTION (A), AN INSURER OR MA OR CHIP MANAGED CARE PLAN SHALL
MAKE AVAILABLE TO HEALTH CARE PROVIDERS AND THEIR AFFILIATED OR
EMPLOYED STAFF ACCESS TO TRAINING ON THE USE OF THE INSURER'S OR
MA OR CHIP MANAGED CARE PLAN'S PROVIDER PORTAL.
(C) REQUIRED USE OF PROVIDER PORTAL.--
(1) WITHIN 18 MONTHS FOLLOWING THE ESTABLISHMENT OF A
PROVIDER PORTAL UNDER SUBSECTION (A), A HEALTH CARE PROVIDER
SEEKING PRIOR AUTHORIZATION SHALL SUBMIT THE REQUEST VIA AN
INSURER'S OR MA OR CHIP MANAGED CARE PLAN'S PROVIDER PORTAL
UNLESS AN EXCEPTION APPLIES.
(2) AN INSURER OR MA OR CHIP MANAGED CARE PLAN MAY
REQUIRE A HEALTH CARE PROVIDER TO SUBMIT A PRIOR
AUTHORIZATION REQUEST THROUGH THE PROVIDER PORTAL UNLESS ANY
OF THE FOLLOWING EXCEPTIONS APPLIES:
(I) THE PORTAL IS NOT AVAILABLE AND OPERATIONAL AT
THE TIME OF ATTEMPTED SUBMISSION.
(II) THE HEALTH CARE PROVIDER DOES NOT HAVE ACCESS
TO THE INSURER'S OR MA OR CHIP MANAGED CARE PLAN'S
OPERATIONAL PROVIDER PORTAL.
(III) THE HEALTH CARE PROVIDER SATISFIES AN
ALLOWANCE BY THE INSURER OR MA OR CHIP MANAGED CARE PLAN
FOR SUBMISSION OTHER THAN THROUGH THE PROVIDER PORTAL.
SECTION 2154. MEDICAL POLICIES AND CLINICAL REVIEW CRITERIA.
(A) MEDICAL POLICIES.--
(1) AN INSURER OR MA OR CHIP MANAGED CARE PLAN SHALL
MAKE AVAILABLE ITS CURRENT MEDICAL POLICIES THROUGH THE
INSURER'S OR MA OR CHIP MANAGED CARE PLAN'S PUBLICLY
ACCESSIBLE INTERNET WEBSITE AND PROVIDER PORTAL.
(2) EACH MEDICAL POLICY DEVELOPED BY AN INSURER OR MA OR
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CHIP MANAGED CARE PLAN SHALL IDENTIFY THE CLINICAL REVIEW
CRITERIA USED IN THE POLICY'S DEVELOPMENT. THE INSURER OR MA
OR CHIP MANAGED CARE PLAN SHALL IDENTIFY ANY THIRD-PARTY
LICENSURE RESTRICTIONS PREVENTING DISCLOSURE OF ALL OR PART
OF CLINICAL REVIEW CRITERIA.
(3) AN INSURER OR MA OR CHIP MANAGED CARE PLAN SHALL
REVIEW EACH ADOPTED MEDICAL POLICY ON AT LEAST AN ANNUAL
BASIS.
(4) (I) AN INSURER OR MA OR CHIP MANAGED CARE PLAN
SHALL NOTIFY PROVIDERS OF A CHANGE TO A MEDICAL POLICY AS
FOLLOWS:
(A) IN THE CASE OF POLICY CHANGE DUE TO A CHANGE
IN FEDERAL OR STATE LAW OR BINDING AGENCY GUIDANCE,
WHEN THE REQUIRED IMPLEMENTATION DATE OF THAT POLICY
CHANGE IS SOONER THAN 30 DAYS, AS SOON AS
PRACTICABLE.
(B) IN THE CASE OF A CHANGE TO A MEDICAL POLICY
THAT MODIFIES, ELIMINATES OR SUSPENDS EITHER CLINICAL
OR ADMINISTRATIVE CRITERIA AND THAT DIRECTLY RESULTS
IN LESS RESTRICTIVE COVERAGE OF A GIVEN SERVICE,
WITHIN 30 DAYS AFTER APPLICATION OF THE CHANGE.
(C) IN CASES OTHER THAN IN CLAUSES (A) AND (B),
AT LEAST 30 DAYS PRIOR TO APPLICATION OF THE CHANGE.
(II) A CHANGE NOTIFICATION MAY BE PROVIDED THROUGH
REASONABLE MEANS, INCLUDING POSTING OF AN UPDATED AND
DATED MEDICAL POLICY REFLECTING THE CHANGE.
(B) CLINICAL REVIEW CRITERIA.--
(1) CLINICAL REVIEW CRITERIA ADOPTED BY AN INSURER OR MA
OR CHIP MANAGED CARE PLAN AT THE TIME OF MEDICAL POLICY
DEVELOPMENT OR REVIEW SHALL:
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(I) BE BASED ON APPLICABLE NATIONALLY RECOGNIZED
MEDICAL STANDARDS.
(II) BE CONSISTENT WITH APPLICABLE GOVERNMENTAL
GUIDELINES.
(III) PROVIDE FOR THE DELIVERY OF A HEALTH CARE
SERVICE IN A CLINICALLY APPROPRIATE TYPE, FREQUENCY AND
SETTING AND FOR A CLINICALLY APPROPRIATE DURATION.
(IV) REFLECT THE CURRENT MEDICAL AND SCIENTIFIC
EVIDENCE REGARDING EMERGING PROCEDURES, CLINICAL
GUIDELINES AND BEST PRACTICES AS ARTICULATED IN
INDEPENDENT, PEER-REVIEWED MEDICAL LITERATURE.
(2) NOTHING IN THIS SECTION SHALL REQUIRE AN INSURER OR
MA OR CHIP MANAGED CARE PLAN TO PROVIDE COVERAGE FOR A HEALTH
CARE SERVICE TO A COVERED PERSON OR ENROLLEE THAT IS
OTHERWISE EXCLUDED FROM COVERAGE UNDER A HEALTH INSURANCE
POLICY OR AN AGREEMENT WITH THE DEPARTMENT OF HUMAN SERVICES.
SECTION 2155. PRIOR AUTHORIZATION REVIEW.
(A) GENERAL RULE.--
(1) AN INSURER OR MA OR CHIP MANAGED CARE PLAN SHALL
MAKE A DETERMINATION RELATING TO PRIOR AUTHORIZATION BASED ON
THE INSURER'S OR MA OR CHIP MANAGED CARE PLAN'S REVIEW OF A
PRIOR AUTHORIZATION REQUEST AND THE FOLLOWING:
(I) THE INSURER'S OR MA OR CHIP MANAGED CARE PLAN'S
MEDICAL POLICY.
(II) THE INSURER'S OR MA OR CHIP MANAGED CARE PLAN'S
ADMINISTRATIVE POLICY.
(III) ALL MEDICAL INFORMATION RELATED TO THE
ENROLLEE OR COVERED PERSON.
(IV) ANY MEDICAL OR SCIENTIFIC EVIDENCE SUBMITTED BY
THE REQUESTING PROVIDER.
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(2) AT THE TIME OF REVIEW, AN INSURER OR MA OR CHIP
MANAGED CARE PLAN SHALL VERIFY THE COVERED PERSON'S OR
ENROLLEE'S ELIGIBILITY FOR COVERAGE UNDER THE TERMS OF THE
APPLICABLE HEALTH INSURANCE POLICY OR AN AGREEMENT WITH THE
DEPARTMENT OF HUMAN SERVICES.
(3) APPEALS OF ADMINISTRATIVE ADVERSE BENEFIT
DETERMINATIONS SHALL BE SUBJECT TO THE COMPLAINT PROCESS IN
SECTION 2142.
(B) LIST OF SERVICES SUBJECT TO REVIEW.--AN INSURER OR MA OR
CHIP MANAGED CARE PLAN SHALL MAKE AVAILABLE A LIST, POSTED IN A
PUBLICLY ACCESSIBLE FORMAT AND LOCATION ON THE INSURER'S OR MA
OR CHIP MANAGED CARE PLAN'S PUBLICLY ACCESSIBLE INTERNET
WEBSITE, THAT INDICATES THE HEALTH CARE SERVICES FOR WHICH THE
INSURER OR MA OR CHIP MANAGED CARE PLAN REQUIRES PRIOR
AUTHORIZATION.
(C) INFORMATION SUBMISSION.--
(1) UPON RECEIPT OF A SUBMISSION OF A PRIOR
AUTHORIZATION REQUEST, AN INSURER, MCO OR CHIP MANAGED CARE
PLAN SHALL NOTIFY THE HEALTH CARE PROVIDER SUBMITTING THE
PRIOR AUTHORIZATION REQUEST OF ANY MISSING INFORMATION NEEDED
BY THE INSURER, MCO OR CHIP MANAGED CARE PLAN TO MAKE A PRIOR
AUTHORIZATION DETERMINATION. AN INSURER, MCO OR CHIP MANAGED
CARE PLAN SHALL IDENTIFY THE MISSING INFORMATION NECESSARY TO
MAKE A PRIOR AUTHORIZATION DETERMINATION WITH SUFFICIENT
SPECIFICITY TO ENABLE THE HEALTH CARE PROVIDER TO SUBMIT THE
INFORMATION TO ALLOW THE INSURER TO MAKE A DETERMINATION IN
ACCORDANCE WITH THIS CHAPTER.
(2) IF AN INSURER OR MA OR CHIP MANAGED CARE PLAN
REQUIRES A PARTICIPATING HEALTH CARE PROVIDER TO TRANSMIT
MEDICAL RECORDS IN SUPPORT OF A PRIOR AUTHORIZATION REQUEST
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ELECTRONICALLY, AND A HEALTH CARE PROVIDER IS CAPABLE OF
TRANSMITTING MEDICAL RECORDS IN SUPPORT OF A PRIOR
AUTHORIZATION REQUEST ELECTRONICALLY, THE HEALTH CARE
PROVIDER SHALL ENSURE THAT THE INSURER OR MA OR CHIP MANAGED
CARE PLAN HAS ELECTRONIC ACCESS TO THE MEDICAL RECORDS,
INCLUDING ABILITY TO PRINT ANY MEDICAL RECORDS TRANSMITTED
ELECTRONICALLY, SUBJECT TO APPLICABLE LAW AND THE HEALTH CARE
PROVIDER'S CORPORATE POLICIES. THE INABILITY OF A HEALTH CARE
PROVIDER TO PROVIDE ELECTRONIC ACCESS SHALL NOT CONSTITUTE A
REASON TO DENY AN AUTHORIZATION REQUEST.
(D) CLINICAL KNOWLEDGE OF REVIEWER.--
(1) OTHER THAN AN ADMINISTRATIVE DENIAL OF A PRIOR
AUTHORIZATION REQUEST, A REQUEST FOR PRIOR AUTHORIZATION MAY
ONLY BE DENIED UPON REVIEW BY EITHER OF THE FOLLOWING:
(I) A LICENSED HEALTH CARE PROVIDER WITH APPROPRIATE
TRAINING, KNOWLEDGE OR EXPERIENCE IN THE SAME OR SIMILAR
SPECIALTY THAT TYPICALLY MANAGES OR CONSULTS ON THE
HEALTH CARE SERVICE IN QUESTION.
(II) A LICENSED HEALTH CARE PROVIDER, IN
CONSULTATION WITH AN APPROPRIATELY QUALIFIED THIRD-PARTY
HEALTH CARE PROVIDER, LICENSED IN THE SAME OR SIMILAR
MEDICAL SPECIALTY AS THE REQUESTING HEALTH CARE PROVIDER
OR TYPE OF HEALTH CARE PROVIDER THAT TYPICALLY MANAGES
THE COVERED PERSON'S OR ENROLLEE'S ASSOCIATED CONDITION,
EXCEPT THAT ANY COMPENSATION PAID TO THE CONSULTING
HEALTH CARE PROVIDER MAY NOT BE CONTINGENT UPON THE
OUTCOME OF THE REVIEW.
(2) (RESERVED).
(E) PEER-TO-PEER REVIEW AVAILABLE.--IN THE CASE OF A DENIED
PRIOR AUTHORIZATION OTHER THAN AN ADMINISTRATIVE ADVERSE BENEFIT
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DETERMINATION OF A CLAIM BY A COVERED PERSON OR AN MA OR CHIP
MANAGED CARE PLAN'S DENIAL OF A PRIOR AUTHORIZATION REQUEST THAT
DOES NOT INVOLVE MEDICAL JUDGMENT, AN INSURER OR MA OR CHIP
MANAGED CARE PLAN SHALL MAKE AVAILABLE TO THE REQUESTING
PROVIDER A LICENSED MEDICAL PROFESSIONAL FOR A PEER-TO-PEER
REVIEW DISCUSSION. THE PEER-TO-PEER REVIEWER PROVIDED BY THE
INSURER OR MA OR CHIP MANAGED CARE PLAN SHALL MEET THE STANDARDS
SPECIFIED IN SUBSECTION (C) AND HAVE AUTHORITY TO MODIFY OR
OVERTURN THE PRIOR AUTHORIZATION DECISION. THE FOLLOWING SHALL
APPLY:
(1) THE PROCEDURE FOR REQUESTING A PEER-TO-PEER REVIEW,
INCLUDING CONTACT INFORMATION FOR THE INSURER OR ITS
UTILIZATION REVIEW ENTITY, OR MA OR CHIP MANAGED CARE PLAN OR
ITS UTILIZATION REVIEW ENTITY, SHALL BE AVAILABLE ON THE
INSURER'S OR MA OR CHIP MANAGED CARE PLAN'S PUBLICLY
ACCESSIBLE INTERNET WEBSITE OR PROVIDER PORTAL.
(2) A PROVIDER MAY REQUEST A PEER-TO-PEER REVIEW
DISCUSSION:
(I) DURING NORMAL BUSINESS HOURS.
(II) OUTSIDE NORMAL BUSINESS HOURS, SUBJECT TO
REASONABLE LIMITATIONS ON THE AVAILABILITY OF QUALIFIED
INSURER OR MA OR CHIP MANAGED CARE PLAN OR UTILIZATION
REVIEW ENTITY STAFF.
(F) PEER-TO-PEER PROXY.--
(1) A HEALTH CARE PROVIDER MAY DESIGNATE, AND AN INSURER
OR MA OR CHIP MANAGED CARE PLAN SHALL ACCEPT, ANOTHER
LICENSED MEMBER OF THE PROVIDER'S AFFILIATED OR EMPLOYED
CLINICAL STAFF WITH KNOWLEDGE OF THE COVERED PERSON'S OR
ENROLLEE'S CONDITION AND REQUESTED PROCEDURE AS A QUALIFIED
PROXY FOR PURPOSES OF COMPLETING A PEER-TO-PEER DISCUSSION.
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(2) INDIVIDUALS ELIGIBLE TO RECEIVE A PROXY DESIGNATION
SHALL BE LIMITED TO LICENSED HEALTH CARE PROVIDERS WHOSE
ACTUAL AUTHORITY AND SCOPE OF PRACTICE IS INCLUSIVE OF
PERFORMING OR PRESCRIBING THE REQUESTED HEALTH CARE SERVICE.
(3) AUTHORITY MAY BE ESTABLISHED THROUGH A SUPERVISING
HEALTH CARE PROVIDER CONSISTENT WITH APPLICABLE STATE LAW FOR
NONPHYSICIAN PRACTITIONERS.
(4) THE INSURER OR MA OR CHIP MANAGED CARE PLAN MUST
ACCEPT AND REVIEW THE INFORMATION SUBMITTED BY OTHER MEMBERS
OF A HEALTH CARE PROVIDER'S AFFILIATED OR EMPLOYED STAFF IN
SUPPORT OF A PRIOR AUTHORIZATION REQUEST.
(5) THE INSURER OR MA OR CHIP MANAGED CARE PLAN MAY NOT
LIMIT INTERACTIONS WITH AN INSURER'S OR MA OR CHIP MANAGED
CARE PLAN'S CLINICAL STAFF SOLELY TO THE REQUESTING HEALTH
CARE PROVIDER.
(G) PEER-TO-PEER TIMELINE.--
(1) A PEER-TO-PEER DISCUSSION SHALL BE AVAILABLE TO A
REQUESTING HEALTH CARE PROVIDER FROM THE TIME OF A PRIOR
AUTHORIZATION DENIAL UNTIL THE INTERNAL GRIEVANCE PROCESS OR
INTERNAL ADVERSE BENEFIT DETERMINATION PROCESS COMMENCES.
(2) IF A PEER-TO-PEER DISCUSSION IS AVAILABLE PRIOR TO
ADJUDICATING A PRIOR AUTHORIZATION REQUEST, THE PEER-TO-PEER
DISCUSSION SHALL BE OFFERED WITHIN THE TIME LINES SPECIFIED
IN THIS SUBSECTION OR SUBSECTION (H).
(H) REVIEW TIME LINES FOR REQUESTS SUBMITTED TO AN MA OR
CHIP MANAGED CARE PLAN.--
(1) AN MA OR CHIP MANAGED CARE PLAN'S DECISION TO
APPROVE OR DENY PRIOR AUTHORIZATION SHALL BE COMMUNICATED
WITHIN TWO BUSINESS DAYS OF THE RECEIPT OF ALL SUPPORTING
INFORMATION REASONABLY NECESSARY TO COMPLETE THE REVIEW.
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(2) IF AT ANY TIME AFTER REQUESTING PRIOR AUTHORIZATION
THE PROVIDER DETERMINES THE ENROLLEE'S MEDICAL CONDITION
REQUIRES EMERGENCY SERVICES, THE EMERGENCY SERVICES MAY BE
PROVIDED UNDER SECTION 2116.
(3) THE FOLLOWING SHALL APPLY:
(I) IF A PRIOR AUTHORIZATION REQUEST IS MISSING
CLINICAL INFORMATION THAT IS REASONABLY NECESSARY TO
CONSTITUTE A PRIOR AUTHORIZATION REQUEST, THE MA OR CHIP
MANAGED CARE PLAN SHALL NOTIFY THE HEALTH CARE PROVIDER
OF THE SPECIFIC INFORMATION NECESSARY TO COMPLETE THE
REVIEW AS SOON AS POSSIBLE, BUT NOT LATER THAN 48 HOURS
AFTER RECEIPT OF THE PRIOR AUTHORIZATION REQUEST.
(II) THE REQUESTING HEALTH CARE PROVIDER OR A MEMBER
OF THE REQUESTING HEALTH CARE PROVIDER'S CLINICAL OR
ADMINISTRATIVE STAFF MAY SUBMIT THE SPECIFIED INFORMATION
WITHIN 14 DAYS OF THE NOTIFICATION THAT CLINICAL
INFORMATION IS MISSING.
(III) IF ADDITIONAL INFORMATION IS REQUESTED, THE MA
OR CHIP MANAGED CARE PLAN SHALL COMMUNICATE A DECISION ON
THE PRIOR AUTHORIZATION REQUEST WITHIN TWO BUSINESS DAYS
OF RECEIVING THE ADDITIONAL INFORMATION.
(4) AN MA OR CHIP MANAGED CARE PLAN MAY SUPPLEMENT
SUBMITTED INFORMATION BASED ON CURRENT CLINICAL RECORDS OR
OTHER CURRENT MEDICAL INFORMATION FOR AN ENROLLEE AS
AVAILABLE, IF THE SUPPLEMENTAL INFORMATION IS ALSO MADE
AVAILABLE TO THE ENROLLEE OR HEALTH CARE PROVIDER AS PART OF
THE ENROLLEE'S AUTHORIZATION CASE FILE UPON REQUEST. IN
RESPONSE TO A REQUEST FOR MISSING CLINICAL INFORMATION, AN MA
OR CHIP MANAGED CARE PLAN SHALL ACCEPT SUPPLEMENTAL
INFORMATION FROM A MEMBER OF THE HEALTH CARE PROVIDER'S
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CLINICAL STAFF.
(I) REVIEW TIME LINES.--DETERMINATIONS ON PRIOR
AUTHORIZATION REQUESTS THAT MAY BE SUBJECT TO THE ADVERSE
BENEFIT DETERMINATION PROCESSES SHALL BE IN ACCORDANCE WITH THE
FOLLOWING, UNLESS OTHERWISE REQUIRED BY FEDERAL LAW OR
REGULATION:
(1) FOR A REQUEST RELATED TO AN URGENT HEALTH CARE
SERVICE:
(I) IF THE URGENT HEALTH CARE SERVICE HAS NOT YET
BEEN INITIATED, AS SOON AS POSSIBLE, BUT NOT MORE THAN 72
HOURS.
(II) IF RELATED TO AN ONGOING URGENT HEALTH CARE
SERVICE AND THE REQUEST IS MADE AT LEAST 24 HOURS PRIOR
TO REDUCTION OR TERMINATION OF THE TREATMENT, WITHIN 24
HOURS.
(2) FOR A REQUEST INVOLVING CONCURRENT CARE OTHER THAN
AS SET FORTH IN PARAGRAPH (1)(II), SUFFICIENTLY IN ADVANCE TO
PERMIT AN APPEAL BEFORE REDUCTION OR TERMINATION OF THE
ONGOING TREATMENT.
(3) FOR PRIOR AUTHORIZATION REQUESTS OTHER THAN AS
SPECIFIED IN PARAGRAPHS (1) AND (2), WITHIN 15 DAYS. THE 15-
DAY DEADLINE MAY BE EXTENDED BY THE INSURER SUBJECT TO THE
FOLLOWING LIMITATIONS:
(I) UPON RECEIPT OF THE PRIOR AUTHORIZATION REQUEST,
THE INSURER PROVIDED NOTIFICATION OF MISSING INFORMATION
UNDER SECTION 2155(C)(1).
(II) THE NOTIFICATION OF MISSING INFORMATION WAS
COMMUNICATED AS SOON AS POSSIBLE FOLLOWING THE SUBMISSION
OF THE PRIOR AUTHORIZATION REQUEST TO ALLOW AN
OPPORTUNITY TO RESPOND PRIOR TO THE EXPIRATION OF THE 15-
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DAY DEADLINE WITH THE IDENTIFIED MISSING INFORMATION.
(III) IF THE HEALTH CARE PROVIDER SATISFIED THE
REQUIREMENTS FOR AN INSURER TO GRANT AN EXTENSION, THE
INSURER MAY EXTEND THE DEADLINE FOR AT LEAST 45 DAYS TO
ALLOW THE PROVIDER TO RESPOND. UPON RECEIPT OF THE
MISSING INFORMATION, THE INSURER SHALL RENDER A DECISION
WITHOUT DELAY.
(IV) NO INSURER SHALL UNREASONABLY DELAY OR WITHHOLD
THE SPECIFIC NOTICE OF ADDITIONAL INFORMATION NEEDED TO
COMPLETE A REVIEW OF A PRIOR AUTHORIZATION REQUEST.
(V) NOTHING IN THIS PARAGRAPH SHALL REQUIRE AN
INSURER TO EXTEND THE INITIAL 15-DAY DEADLINE.
(4) FOR A REQUEST RELATED TO A PRESCRIPTION DRUG
AUTHORIZATION REQUEST OR STEP THERAPY REQUEST:
(I) IF THE REQUEST IS URGENT, WITHIN 24 HOURS.
(II) IF THE REQUEST IS NOT URGENT, WITHIN TWO
BUSINESS DAYS, BUT NOT MORE THAN 72 HOURS.
(J) CLOSELY RELATED SERVICES.--IF A HEALTH CARE PROVIDER
PERFORMS A CLOSELY RELATED SERVICE, AN INSURER OR MA OR CHIP
MANAGED CARE PLAN MAY NOT DENY A CLAIM FOR THE CLOSELY RELATED
SERVICE FOR FAILURE OF THE HEALTH CARE PROVIDER TO SEEK OR
OBTAIN PRIOR AUTHORIZATION, IF:
(1) THE HEALTH CARE PROVIDER NOTIFIES THE INSURER OR MA
OR CHIP MANAGED CARE PLAN OF THE PERFORMANCE OF THE CLOSELY
RELATED SERVICE NO LATER THAN THREE BUSINESS DAYS FOLLOWING
COMPLETION OF THE SERVICE BUT PRIOR TO THE SUBMISSION OF THE
CLAIM FOR PAYMENT. THE SUBMISSION OF THE NOTIFICATION SHALL
INCLUDE THE SUBMISSION OF ALL RELEVANT CLINICAL INFORMATION
NECESSARY FOR THE INSURER OR MA OR CHIP MANAGED CARE PLAN TO
EVALUATE THE MEDICAL NECESSITY AND APPROPRIATENESS OF THE
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SERVICE.
(2) NOTHING IN THIS SUBSECTION SHALL BE CONSTRUED TO
LIMIT AN INSURER'S OR MA OR CHIP MANAGED CARE PLAN'S
RETROSPECTIVE UTILIZATION REVIEW OF MEDICAL NECESSITY AND
APPROPRIATENESS OF THE CLOSELY RELATED SERVICE, NOR LIMIT THE
NEED FOR VERIFICATION OF THE COVERED PERSON'S OR ENROLLEE'S
ELIGIBILITY FOR COVERAGE.
SECTION 2156. STEP THERAPY CONSIDERATIONS.
(A) STEP THERAPY CRITERIA.--IF AN INSURER OR MA OR CHIP
MANAGED CARE PLAN HAS A MEDICAL POLICY THAT INCLUDES STEP
THERAPY CRITERIA FOR A PRESCRIPTION DRUG, THE FOLLOWING APPLY:
(1) AN INSURER OR MA OR CHIP MANAGED CARE PLAN SHALL
CONSIDER AS PART OF THE INSURER'S OR MA OR CHIP MANAGED CARE
PLAN'S PRIOR AUTHORIZATION PROCESS A REQUEST FOR AN EXCEPTION
TO THE INSURER'S OR MA OR CHIP MANAGED CARE PLAN'S STEP
THERAPY CRITERIA.
(2) A REQUEST FOR AN EXCEPTION TO AN INSURER'S OR MA OR
CHIP MANAGED CARE PLAN'S STEP THERAPY CRITERIA SHALL BE BASED
ON THE COVERED PERSON'S OR ENROLLEE'S INDIVIDUALIZED CLINICAL
CONDITION, AND CONSIDER AT LEAST ALL OF THE FOLLOWING:
(I) CONTRAINDICATIONS, INCLUDING ADVERSE REACTIONS.
(II) CLINICAL EFFECTIVENESS OR INEFFECTIVENESS OF
EACH REQUIRED PREREQUISITE PRESCRIPTION DRUG OR THERAPY.
(III) PAST CLINICAL OUTCOME OF EACH REQUIRED
PREREQUISITE PRESCRIPTION DRUG OR THERAPY.
(IV) THE EXPECTED CLINICAL OUTCOMES OF THE REQUESTED
PRESCRIPTION DRUG PRESCRIBED BY THE COVERED PERSON'S OR
ENROLLEE'S PROVIDER.
(V) FOR COVERED PERSONS OR ENROLLEES WHO PREVIOUSLY
RECEIVED HEALTH CARE COVERAGE FROM ANOTHER ENTITY,
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WHETHER THE COVERED PERSON OR ENROLLEE HAS ALREADY
SATISFIED A STEP THERAPY PROTOCOL WITH THEIR PREVIOUS
INSURER OR MA OR CHIP MANAGED CARE PLAN THAT REQUIRED
TRIALS OF PRESCRIPTION DRUGS FROM EACH OF THE CLASSES
THAT ARE REQUIRED BY THE CURRENT INSURER'S OR MA OR CHIP
MANAGED CARE PLAN'S STEP THERAPY PROTOCOL.
(B) APPLICABILITY.--THE STANDARDS AND TIME LINES SPECIFIED
IN SECTION 2155 SHALL APPLY TO A REVIEW OF A REQUEST FOR A STEP
THERAPY EXCEPTION.
SECTION 2157. MEDICATION-ASSISTED TREATMENT.
(A) GENERAL RULE.--AN INSURER OR MA OR CHIP MANAGED CARE
PLAN SHALL MAKE AVAILABLE WITHOUT INITIAL PRIOR AUTHORIZATION
COVERAGE OF AT LEAST ONE PRESCRIPTION DRUG APPROVED BY THE
UNITED STATES FOOD AND DRUG ADMINISTRATION FOR USE IN EACH
COMPONENT OF A MEDICATION-ASSISTED TREATMENT PROTOCOL.
(B) PREFERRED DRUG DESIGNATION.--NOTHING IN THIS SECTION
SHALL PROHIBIT AN INSURER OR MA OR CHIP MANAGED CARE PLAN FROM
DESIGNATING PREFERRED DRUGS FOR THE RELEVANT COMPONENT OF A
MEDICATION-ASSISTED TREATMENT PROTOCOL WHEN MULTIPLE
PRESCRIPTION DRUGS ARE AVAILABLE, SUBJECT TO APPLICABLE MEDICAL
POLICY OR PRESCRIPTION DRUG FORMULARY INFORMATION AVAILABILITY
REQUIREMENTS.
(C) SUBSEQUENT REQUESTS.--WITH THE EXCEPTION OF PRIOR
AUTHORIZATION FOR INITIAL COVERAGE, NOTHING IN THIS SECTION
SHALL PROHIBIT AN INSURER OR MA OR CHIP MANAGED CARE PLAN FROM
REQUIRING PRIOR AUTHORIZATION ON SUBSEQUENT REQUESTS FOR
MEDICATION-ASSISTED TREATMENT TO ENSURE ADHERENCE WITH CLINICAL
GUIDELINES.
SECTION 6. SECTIONS 2161, 2162 AND 2163 OF THE ACT ARE
AMENDED TO READ:
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SECTION 2161. INTERNAL GRIEVANCE PROCESS.--(A) [A] AN MA OR
CHIP MANAGED CARE PLAN SHALL ESTABLISH AND MAINTAIN AN INTERNAL
GRIEVANCE PROCESS WITH TWO LEVELS OF REVIEW AND AN EXPEDITED
INTERNAL GRIEVANCE PROCESS BY WHICH AN ENROLLEE, AN ENROLLEE'S
AUTHORIZED REPRESENTATIVE OR A HEALTH CARE PROVIDER, WITH THE
WRITTEN CONSENT OF THE ENROLLEE, SHALL BE ABLE TO FILE A WRITTEN
GRIEVANCE REGARDING THE DENIAL OF PAYMENT FOR A HEALTH CARE
SERVICE. AN ENROLLEE OR AN ENROLLEE'S AUTHORIZED REPRESENTATIVE
WHO CONSENTS TO THE FILING OF A GRIEVANCE BY A HEALTH CARE
PROVIDER UNDER THIS SECTION MAY NOT FILE A SEPARATE GRIEVANCE.
(B) THE INTERNAL GRIEVANCE PROCESS SHALL CONSIST OF AN
INITIAL REVIEW THAT INCLUDES ALL OF THE FOLLOWING:
(1) A REVIEW BY [ONE] THREE OR MORE PERSONS SELECTED BY THE
MA OR CHIP MANAGED CARE PLAN WHO DID NOT PREVIOUSLY PARTICIPATE
IN THE DECISION TO DENY PAYMENT FOR THE HEALTH CARE SERVICE.
(2) [THE COMPLETION OF THE REVIEW WITHIN THIRTY (30) DAYS OF
RECEIPT OF THE GRIEVANCE.] A WRITTEN NOTIFICATION TO THE
ENROLLEE OR THE ENROLLEE'S AUTHORIZED REPRESENTATIVE OF THE
DECISION OF THE REVIEW COMMITTEE WITHIN THIRTY (30) DAYS OF
RECEIPT OF THE GRIEVANCE UNLESS THE TIME FRAME FOR DECIDING THE
GRIEVANCE HAS BEEN EXTENDED BY UP TO FOURTEEN (14) DAYS AT THE
REQUEST OF THE ENROLLEE OR THE ENROLLEE'S AUTHORIZED
REPRESENTATIVE.
(3) [A WRITTEN NOTIFICATION TO THE ENROLLEE AND HEALTH CARE
PROVIDER REGARDING THE DECISION WITHIN FIVE (5) BUSINESS DAYS OF
THE DECISION.] THE NOTICE SHALL INCLUDE THE BASIS AND CLINICAL
RATIONALE FOR THE DECISION AND THE PROCEDURE [TO FILE A REQUEST
FOR A SECOND LEVEL REVIEW OF THE DECISION] FOR APPEALING THE
DECISION.
(C) [THE GRIEVANCE PROCESS SHALL INCLUDE A SECOND LEVEL
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REVIEW THAT INCLUDES ALL OF THE FOLLOWING:
(1) A REVIEW OF THE DECISION ISSUED PURSUANT TO SUBSECTION
(B) BY A SECOND LEVEL REVIEW COMMITTEE CONSISTING OF THREE OR
MORE PERSONS WHO DID NOT PREVIOUSLY PARTICIPATE IN ANY DECISION
TO DENY PAYMENT FOR THE HEALTH CARE SERVICE.
(2) A WRITTEN NOTIFICATION TO THE ENROLLEE OR THE HEALTH
CARE PROVIDER OF THE RIGHT TO APPEAR BEFORE THE SECOND LEVEL
REVIEW COMMITTEE.
(3) THE COMPLETION OF THE SECOND LEVEL REVIEW WITHIN FORTY-
FIVE (45) DAYS OF RECEIPT OF A REQUEST FOR SUCH REVIEW.
(4) A WRITTEN NOTIFICATION TO THE ENROLLEE AND HEALTH CARE
PROVIDER REGARDING THE DECISION OF THE SECOND LEVEL REVIEW
COMMITTEE WITHIN FIVE (5) BUSINESS DAYS OF THE DECISION. THE
NOTICE SHALL INCLUDE THE BASIS AND CLINICAL RATIONALE FOR THE
DECISION AND THE PROCEDURE FOR APPEALING THE DECISION.
(D) ANY INITIAL REVIEW OR SECOND LEVEL REVIEW CONDUCTED
UNDER THIS SECTION SHALL INCLUDE A LICENSED PHYSICIAN, OR, WHERE
APPROPRIATE, AN APPROVED LICENSED PSYCHOLOGIST, IN THE SAME OR
SIMILAR SPECIALTY THAT TYPICALLY MANAGES OR CONSULTS ON THE
HEALTH CARE SERVICE.] A REVIEW CONDUCTED UNDER THIS SECTION
SHALL INCLUDE A LICENSED PHYSICIAN OR, WHERE APPROPRIATE, AN
APPROVED LICENSED PSYCHOLOGIST OR APPROVED LICENSED DENTIST, IN
THE SAME OR SIMILAR SPECIALTY THAT TYPICALLY MANAGES OR CONSULTS
ON THE HEALTH CARE SERVICE.
(E) SHOULD THE ENROLLEE'S LIFE, HEALTH OR ABILITY TO REGAIN
MAXIMUM FUNCTION BE IN JEOPARDY, AN EXPEDITED INTERNAL GRIEVANCE
PROCESS, INCLUDING AN EXPEDITED EXTERNAL GRIEVANCE PROCESS,
SHALL BE AVAILABLE WHICH SHALL INCLUDE A REQUIREMENT THAT A
DECISION WITH APPROPRIATE NOTIFICATION TO THE ENROLLEE AND
HEALTH CARE PROVIDER BE MADE WITHIN FORTY-EIGHT (48) HOURS OF
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THE FILING OF THE EXPEDITED GRIEVANCE.
SECTION 2162. EXTERNAL GRIEVANCE PROCESS.--(A) [A] AN MA OR
CHIP MANAGED CARE PLAN SHALL ESTABLISH AND MAINTAIN AN EXTERNAL
GRIEVANCE PROCESS, INCLUDING AN EXPEDITED GRIEVANCE PROCESS, BY
WHICH AN ENROLLEE, AN ENROLLEE'S AUTHORIZED REPRESENTATIVE OR A
HEALTH CARE PROVIDER WITH THE WRITTEN CONSENT OF THE ENROLLEE OR
THE ENROLLEE'S AUTHORIZED REPRESENTATIVE MAY APPEAL THE DENIAL
OF A GRIEVANCE FOLLOWING COMPLETION OF THE INTERNAL GRIEVANCE
PROCESS. THE EXTERNAL GRIEVANCE PROCESS SHALL BE CONDUCTED BY AN
INDEPENDENT UTILIZATION REVIEW ENTITY NOT DIRECTLY AFFILIATED
WITH THE MA OR CHIP MANAGED CARE PLAN.
(B) TO CONDUCT EXTERNAL GRIEVANCES FILED UNDER THIS SECTION:
(1) THE DEPARTMENT SHALL RANDOMLY ASSIGN [A UTILIZATION
REVIEW ENTITY] AN IRO ON A ROTATIONAL BASIS FROM THE LIST
MAINTAINED UNDER SUBSECTION (D) AND NOTIFY THE ASSIGNED
[UTILIZATION REVIEW ENTITY] IRO AND THE MA OR CHIP MANAGED CARE
PLAN WITHIN TWO (2) BUSINESS DAYS OF RECEIVING THE REQUEST. IF
THE DEPARTMENT FAILS TO SELECT [A UTILIZATION REVIEW ENTITY] AN
IRO UNDER THIS SUBSECTION, THE MA OR CHIP MANAGED CARE PLAN
SHALL DESIGNATE AND NOTIFY A CERTIFIED [UTILIZATION REVIEW
ENTITY] IRO TO CONDUCT THE EXTERNAL GRIEVANCE.
(2) THE MA OR CHIP MANAGED CARE PLAN SHALL NOTIFY THE
ENROLLEE, THE ENROLLEE'S AUTHORIZED REPRESENTATIVE OR HEALTH
CARE PROVIDER OF THE NAME, ADDRESS AND TELEPHONE NUMBER OF THE
[UTILIZATION REVIEW ENTITY] IRO ASSIGNED UNDER THIS SUBSECTION
WITHIN TWO (2) BUSINESS DAYS.
(C) THE EXTERNAL GRIEVANCE PROCESS SHALL MEET ALL OF THE
FOLLOWING REQUIREMENTS:
(1) ANY EXTERNAL GRIEVANCE SHALL BE FILED WITH THE MA OR
CHIP MANAGED CARE PLAN WITHIN FIFTEEN (15) DAYS OF RECEIPT OF A
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NOTICE OF DENIAL RESULTING FROM THE INTERNAL GRIEVANCE PROCESS.
THE FILING OF THE EXTERNAL GRIEVANCE SHALL INCLUDE ANY MATERIAL
JUSTIFICATION AND ALL REASONABLY NECESSARY SUPPORTING
INFORMATION. WITHIN FIVE (5) BUSINESS DAYS OF THE FILING OF AN
EXTERNAL GRIEVANCE, THE MA OR CHIP MANAGED CARE PLAN SHALL
NOTIFY THE ENROLLEE, THE ENROLLEE'S AUTHORIZED REPRESENTATIVE OR
THE HEALTH CARE PROVIDER, THE [UTILIZATION REVIEW ENTITY] IRO
THAT CONDUCTED THE INTERNAL GRIEVANCE AND THE DEPARTMENT THAT AN
EXTERNAL GRIEVANCE HAS BEEN FILED.
(2) THE [UTILIZATION REVIEW ENTITY] IRO THAT CONDUCTED THE
INTERNAL GRIEVANCE SHALL FORWARD COPIES OF ALL WRITTEN
DOCUMENTATION REGARDING THE DENIAL, INCLUDING THE DECISION, ALL
REASONABLY NECESSARY SUPPORTING INFORMATION, A SUMMARY OF
APPLICABLE ISSUES AND THE BASIS AND CLINICAL RATIONALE FOR THE
DECISION, TO THE UTILIZATION REVIEW ENTITY CONDUCTING THE
EXTERNAL GRIEVANCE WITHIN FIFTEEN (15) DAYS OF RECEIPT OF NOTICE
THAT THE EXTERNAL GRIEVANCE WAS FILED. ANY ADDITIONAL WRITTEN
INFORMATION MAY BE SUBMITTED BY THE ENROLLEE, THE ENROLLEE'S
AUTHORIZED REPRESENTATIVE OR THE HEALTH CARE PROVIDER WITHIN
[FIFTEEN (15) DAYS OF RECEIPT OF NOTICE THAT THE EXTERNAL
GRIEVANCE WAS FILED] TWENTY (20) DAYS OF THE DATE THE IRO
ASSIGNMENT WAS MAILED TO THE ENROLLEE OR ENROLLEE'S
REPRESENTATIVE.
(3) THE [UTILIZATION REVIEW ENTITY] IRO CONDUCTING THE
EXTERNAL GRIEVANCE SHALL REVIEW ALL INFORMATION CONSIDERED IN
REACHING ANY PRIOR DECISIONS TO DENY PAYMENT FOR THE HEALTH CARE
SERVICE AND ANY OTHER WRITTEN SUBMISSION BY THE ENROLLEE, THE
ENROLLEE'S AUTHORIZED REPRESENTATIVE OR THE HEALTH CARE
PROVIDER.
(4) AN EXTERNAL GRIEVANCE DECISION SHALL BE MADE BY:
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(I) ONE OR MORE LICENSED PHYSICIANS [OR], APPROVED LICENSED
PSYCHOLOGISTS OR APPROVED LICENSED DENTISTS IN ACTIVE CLINICAL
PRACTICE OR IN THE SAME OR SIMILAR SPECIALTY THAT TYPICALLY
MANAGES OR RECOMMENDS TREATMENT FOR THE HEALTH CARE SERVICE
BEING REVIEWED; OR
(II) ONE OR MORE PHYSICIANS CURRENTLY CERTIFIED BY A BOARD
APPROVED BY THE AMERICAN BOARD OF MEDICAL SPECIALISTS OR THE
AMERICAN BOARD OF OSTEOPATHIC SPECIALTIES IN THE SAME OR SIMILAR
SPECIALTY THAT TYPICALLY MANAGES OR RECOMMENDS TREATMENT FOR THE
HEALTH CARE SERVICE BEING REVIEWED.
(5) WITHIN SIXTY (60) DAYS OF THE FILING OF THE EXTERNAL
GRIEVANCE, THE [UTILIZATION REVIEW ENTITY] IRO CONDUCTING THE
EXTERNAL GRIEVANCE SHALL ISSUE A WRITTEN DECISION TO THE MA OR
CHIP MANAGED CARE PLAN, THE ENROLLEE, THE ENROLLEE'S AUTHORIZED
REPRESENTATIVE IF THE ENROLLEE'S AUTHORIZED REPRESENTATIVE
REQUESTED THE EXTERNAL REVIEW, AND THE HEALTH CARE PROVIDER,
INCLUDING THE BASIS AND CLINICAL RATIONALE FOR THE DECISION. THE
STANDARD OF REVIEW SHALL BE WHETHER THE HEALTH CARE SERVICE
DENIED BY THE INTERNAL GRIEVANCE PROCESS WAS MEDICALLY NECESSARY
AND APPROPRIATE UNDER THE TERMS OF THE MA OR CHIP MANAGED CARE
PLAN. THE EXTERNAL GRIEVANCE DECISION SHALL BE SUBJECT TO APPEAL
TO A COURT OF COMPETENT JURISDICTION WITHIN SIXTY (60) DAYS OF
RECEIPT OF NOTICE OF THE EXTERNAL GRIEVANCE DECISION. THERE
SHALL BE A REBUTTABLE PRESUMPTION IN FAVOR OF THE DECISION OF
THE [UTILIZATION REVIEW ENTITY] IRO CONDUCTING THE EXTERNAL
GRIEVANCE.
(6) THE MA OR CHIP MANAGED CARE PLAN SHALL AUTHORIZE ANY
HEALTH CARE SERVICE OR PAY A CLAIM DETERMINED TO BE MEDICALLY
NECESSARY AND APPROPRIATE UNDER PARAGRAPH (5) PURSUANT TO
SECTION 2166 WHETHER OR NOT AN APPEAL TO A COURT OF COMPETENT
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JURISDICTION HAS BEEN FILED.
(7) ALL FEES AND COSTS RELATED TO AN EXTERNAL GRIEVANCE
SHALL BE PAID BY THE NONPREVAILING PARTY IF THE EXTERNAL
GRIEVANCE WAS FILED BY THE HEALTH CARE PROVIDER. THE HEALTH CARE
PROVIDER AND THE [UTILIZATION REVIEW ENTITY] IRO OR MA OR CHIP
MANAGED CARE PLAN SHALL EACH PLACE IN ESCROW AN AMOUNT EQUAL TO
ONE-HALF OF THE ESTIMATED COSTS OF THE EXTERNAL GRIEVANCE
PROCESS. IF THE EXTERNAL GRIEVANCE WAS FILED BY THE ENROLLEE OR
THE ENROLLEE'S AUTHORIZED REPRESENTATIVE, ALL FEES AND COSTS
RELATED THERETO SHALL BE PAID BY THE MA OR CHIP MANAGED CARE
PLAN. FOR PURPOSES OF THIS PARAGRAPH, FEES AND COSTS SHALL NOT
INCLUDE ATTORNEY FEES.
(D) THE DEPARTMENT SHALL COMPILE AND MAINTAIN A LIST OF
[CERTIFIED UTILIZATION REVIEW ENTITIES] IROS THAT MEET THE
REQUIREMENTS OF THIS ARTICLE. THE DEPARTMENT MAY REMOVE [A
UTILIZATION REVIEW ENTITY] AN IRO FROM THE LIST IF SUCH AN
ENTITY IS INCAPABLE OF PERFORMING ITS RESPONSIBILITIES IN A
REASONABLE MANNER, CHARGES EXCESSIVE FEES OR VIOLATES THIS
ARTICLE.
(E) A FEE MAY BE IMPOSED BY [A] AN MA OR CHIP MANAGED CARE
PLAN FOR FILING AN EXTERNAL GRIEVANCE PURSUANT TO THIS ARTICLE
WHICH SHALL NOT EXCEED TWENTY-FIVE ($25) DOLLARS.
(F) WRITTEN CONTRACTS BETWEEN MA OR CHIP MANAGED CARE PLANS
AND HEALTH CARE PROVIDERS MAY PROVIDE AN ALTERNATIVE DISPUTE
RESOLUTION SYSTEM TO THE EXTERNAL GRIEVANCE PROCESS SET FORTH IN
THIS ARTICLE IF THE DEPARTMENT APPROVES THE CONTRACT. THE
ALTERNATIVE DISPUTE RESOLUTION SYSTEM SHALL BE IMPARTIAL,
INCLUDE SPECIFIC TIME LIMITATIONS TO INITIATE APPEALS, RECEIVE
WRITTEN INFORMATION, CONDUCT HEARINGS AND RENDER DECISIONS AND
OTHERWISE SATISFY THE REQUIREMENTS OF THIS SECTION. A WRITTEN
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DECISION PURSUANT TO AN ALTERNATIVE DISPUTE RESOLUTION SYSTEM
SHALL BE FINAL AND BINDING ON ALL PARTIES. AN ALTERNATIVE
DISPUTE RESOLUTION SYSTEM SHALL NOT BE UTILIZED FOR ANY EXTERNAL
GRIEVANCE FILED BY AN ENROLLEE OR ENROLLEE'S AUTHORIZED
REPRESENTATIVE.
SECTION 2163. RECORDS.--RECORDS REGARDING GRIEVANCES FILED
UNDER THIS SUBDIVISION THAT RESULT IN DECISIONS ADVERSE TO
ENROLLEES SHALL BE MAINTAINED BY THE MA OR CHIP MANAGED CARE
PLAN FOR NOT LESS THAN THREE (3) YEARS. THESE RECORDS SHALL BE
PROVIDED TO THE DEPARTMENT, IF REQUESTED, IN ACCORDANCE WITH
SECTION 2131(C)(2)(II).
SECTION 7. ARTICLE XXI OF THE ACT IS AMENDED BY ADDING A
SUBDIVISION TO READ:
(I.1) ADVERSE BENEFIT DETERMINATIONS.
SECTION 2164. INTERNAL ADVERSE BENEFIT DETERMINATION PROCESS
FOR INSURER.
(A) DETERMINATION PROCESS.--AN INSURER SHALL ESTABLISH AND
MAINTAIN AN INTERNAL ADVERSE BENEFIT DETERMINATION PROCESS THAT
COMPLIES WITH SECTION 2719 OF THE PUBLIC HEALTH SERVICE ACT (58
STAT. 682, 42 U.S.C. ยง 300GG-19) AND REGULATIONS PROMULGATED
UNDER THE PUBLIC HEALTH SERVICE ACT.
(B) NOTICE.--FOLLOWING AN ADVERSE BENEFIT DETERMINATION AND
PRIOR TO ANY APPEAL OF AN ADVERSE BENEFIT DETERMINATION UNDER
SUBSECTION (A), AN INSURER SHALL PROVIDE A COVERED PERSON OR
COVERED PERSON'S AUTHORIZED REPRESENTATIVE NOTICE OF THE COVERED
PERSON'S RIGHT TO APPEAL AN ADVERSE BENEFIT DETERMINATION WHICH
SHALL BE IN A FORM APPROVED BY THE DEPARTMENT.
SECTION 2164.1. EXTERNAL REVIEW APPLICABILITY AND SCOPE.
(A) APPLICABILITY.--THE EXTERNAL REVIEW PROVISIONS OF THIS
SUBDIVISION SHALL APPLY TO:
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(1) AN ADVERSE BENEFIT DETERMINATION RENDERED BY AN
INSURER THAT ARE BASED ON ANY OF THE FOLLOWING:
(I) MEDICAL NECESSITY.
(II) APPROPRIATENESS OF SERVICE.
(III) HEALTH CARE SETTING.
(IV) LEVEL OF CARE.
(V) EFFECTIVENESS OF A COVERED BENEFIT.
(2) (RESERVED).
(B) NONAPPLICABILITY.--THE EXTERNAL REVIEW PROVISIONS OF
THIS SUBDIVISION DO NOT APPLY TO:
(1) COMPLAINTS, WHICH MAY BE APPEALED UNDER SECTION
2142.
(2) GRIEVANCES, WHICH MAY BE REVIEWED UNDER SECTION
2162.
(3) ADMINISTRATIVE ADVERSE BENEFIT DETERMINATIONS, WHICH
MAY BE APPEALED UNDER SECTION 2142.
(C) NO MINIMUM THRESHOLD.--THE EXTERNAL REVIEW PROCESS IS
AVAILABLE TO A COVERED PERSON OR COVERED PERSON'S AUTHORIZED
REPRESENTATIVE WITH RESPECT TO HEALTH CARE SERVICES OF ANY
MONETARY VALUE. THERE IS NO MINIMUM FINANCIAL THRESHOLD FOR
FILING A REQUEST FOR EXTERNAL REVIEW.
SECTION 2164.2. NOTICE OF RIGHT TO EXTERNAL REVIEW.
(A) TIMING OF NOTICE.--AN INSURER SHALL NOTIFY A COVERED
PERSON IN WRITING OF THE COVERED PERSON'S RIGHT TO REQUEST AN
EXTERNAL REVIEW UNDER SECTION 2164.5, 2164.6 OR 2164.7 AT THE
SAME TIME THE INSURER SENDS WRITTEN NOTICE IN A FORM APPROVED BY
THE DEPARTMENT OF EITHER OF THE FOLLOWING:
(1) AN ADVERSE BENEFIT DETERMINATION UPON COMPLETION OF
THE INSURER'S UTILIZATION REVIEW PROCESS.
(2) A FINAL ADVERSE BENEFIT DETERMINATION.
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(B) CONTENT OF NOTICE.--THE NOTICE SHALL INCLUDE:
(1) THE FOLLOWING, OR SUBSTANTIALLY EQUIVALENT,
LANGUAGE:
WE HAVE DENIED YOUR REQUEST FOR THE PROVISION OF OR
PAYMENT FOR A HEALTH CARE SERVICE OR COURSE OF
TREATMENT. YOU MAY HAVE THE RIGHT TO HAVE OUR
DECISION REVIEWED BY HEALTH CARE PROVIDERS WHO HAVE
NO ASSOCIATION WITH US IF OUR DECISION INVOLVED
MAKING A JUDGMENT AS TO THE MEDICAL NECESSITY,
APPROPRIATENESS, HEALTH CARE SETTING, LEVEL OF CARE
OR EFFECTIVENESS OF THE HEALTH CARE SERVICE OR
TREATMENT YOU REQUESTED. YOU ALSO HAVE THE RIGHT TO A
REVIEW OF WHETHER WE HAVE COMPLIED WITH THE SURPRISE
BILLING AND COST-SHARING PROTECTIONS UNDER THE NO
SURPRISES ACT. YOU MAY SUBMIT A REQUEST FOR EXTERNAL
REVIEW TO THE PENNSYLVANIA INSURANCE DEPARTMENT.
(2) FOR A NOTICE RELATED TO AN ADVERSE BENEFIT
DETERMINATION, A STATEMENT INFORMING THE COVERED PERSON THAT:
(I) IF THE COVERED PERSON HAS A MEDICAL CONDITION
FOR WHICH THE TIME FRAME FOR COMPLETION OF AN EXPEDITED
REVIEW OF AN ADVERSE BENEFIT DETERMINATION UNDER SECTION
2164 WOULD SERIOUSLY JEOPARDIZE THE LIFE OR HEALTH OF THE
COVERED PERSON OR WOULD JEOPARDIZE THE COVERED PERSON'S
ABILITY TO REGAIN MAXIMUM FUNCTION, THE COVERED PERSON,
OR THE COVERED PERSON'S AUTHORIZED REPRESENTATIVE, MAY
FILE A REQUEST FOR AN EXPEDITED EXTERNAL REVIEW AT THE
SAME TIME AS A REQUEST FOR AN EXPEDITED REVIEW OF AN
ADVERSE BENEFIT DETERMINATION UNDER SECTION 2164. THE IRO
ASSIGNED TO CONDUCT THE EXPEDITED EXTERNAL REVIEW SHALL
DETERMINE WHETHER THE COVERED PERSON IS REQUIRED TO
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COMPLETE THE EXPEDITED REVIEW OF THE ADVERSE BENEFIT
DETERMINATION PRIOR TO CONDUCTING THE EXPEDITED EXTERNAL
REVIEW. THE REQUEST MAY BE FILED UNDER SECTION 2164.6 OR
2164.7 IF:
(A) THE ADVERSE BENEFIT DETERMINATION INVOLVES A
DENIAL OF COVERAGE BASED ON A DETERMINATION THAT THE
RECOMMENDED OR REQUESTED HEALTH CARE SERVICES ARE
EXPERIMENTAL OR INVESTIGATIONAL.
(B) THE COVERED PERSON'S TREATING HEALTH CARE
PROVIDER CERTIFIES IN WRITING THAT THE RECOMMENDED OR
REQUESTED HEALTH CARE SERVICES THAT ARE THE SUBJECT
OF THE ADVERSE BENEFIT DETERMINATION WOULD BE
SIGNIFICANTLY LESS EFFECTIVE IF NOT PROMPTLY
INITIATED.
(II) THE COVERED PERSON OR THE COVERED PERSON'S
AUTHORIZED REPRESENTATIVE MAY FILE AN APPEAL UNDER THE
INSURER'S INTERNAL APPEAL PROCESS UNDER SECTION 2164, BUT
SHALL BE CONSIDERED TO HAVE EXHAUSTED THE INSURER'S
INTERNAL APPEAL PROCESS FOR PURPOSES OF SECTION 2164.4
AND MAY IMMEDIATELY FILE A REQUEST FOR EXTERNAL REVIEW
UNDER SECTION 2164.3 IF:
(A) THE INSURER HAS NOT ISSUED A WRITTEN
DECISION TO THE COVERED PERSON OR THE COVERED
PERSON'S AUTHORIZED REPRESENTATIVE WITHIN 30 DAYS
FOLLOWING THE DATE THE COVERED PERSON OR THE COVERED
PERSON'S AUTHORIZED REPRESENTATIVE FILES THE APPEAL
WITH THE INSURER.
(B) THE COVERED PERSON OR THE COVERED PERSON'S
AUTHORIZED REPRESENTATIVE HAS NOT REQUESTED OR AGREED
TO A DELAY.
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(C) THE INSURER WAIVES ITS INTERNAL CLAIM AND
APPEAL PROCESS AND THE REQUIREMENT FOR A COVERED
PERSON OR COVERED PERSON'S AUTHORIZED REPRESENTATIVE
TO EXHAUST THE PROCESS BEFORE FILING A REQUEST FOR AN
EXTERNAL REVIEW OR AN EXPEDITED EXTERNAL REVIEW.
(D) THE INSURER HAS FAILED TO COMPLY WITH THE
REQUIREMENTS OF THE INTERNAL CLAIM AND APPEAL PROCESS
UNLESS THE FAILURE OR FAILURES ARE BASED ON DE
MINIMIS VIOLATIONS THAT DO NOT CAUSE, AND ARE NOT
LIKELY TO CAUSE, PREJUDICE OR HARM TO THE COVERED
PERSON OR COVERED PERSON'S AUTHORIZED REPRESENTATIVE.
(3) FOR A NOTICE RELATED TO A FINAL ADVERSE BENEFIT
DETERMINATION, A STATEMENT INFORMING THE COVERED PERSON THAT:
(I) IF THE COVERED PERSON HAS A MEDICAL CONDITION
FOR WHICH THE TIME FRAME FOR COMPLETION OF A STANDARD
EXTERNAL REVIEW UNDER SECTION 2164.5 WOULD SERIOUSLY
JEOPARDIZE THE LIFE OR HEALTH OF THE COVERED PERSON OR
WOULD JEOPARDIZE THE COVERED PERSON'S ABILITY TO REGAIN
MAXIMUM FUNCTION, THE COVERED PERSON OR COVERED PERSON'S
AUTHORIZED REPRESENTATIVE MAY FILE A REQUEST FOR AN
EXPEDITED EXTERNAL REVIEW UNDER SECTION 2164.6.
(II) IF THE FINAL ADVERSE BENEFIT DETERMINATION
CONCERNS:
(A) AN ADMISSION, AVAILABILITY OF CARE,
CONTINUED STAY OR HEALTH CARE SERVICE FOR WHICH THE
COVERED PERSON RECEIVED EMERGENCY SERVICES, BUT HAS
NOT BEEN DISCHARGED FROM A FACILITY, THE COVERED
PERSON OR THE COVERED PERSON'S AUTHORIZED
REPRESENTATIVE MAY REQUEST AN EXPEDITED EXTERNAL
REVIEW UNDER SECTION 2164.6.
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(B) A DENIAL OF COVERAGE BASED ON A
DETERMINATION THAT THE RECOMMENDED OR REQUESTED
HEALTH CARE SERVICE IS EXPERIMENTAL OR
INVESTIGATIONAL, THE COVERED PERSON OR COVERED
PERSON'S AUTHORIZED REPRESENTATIVE MAY FILE A REQUEST
FOR A STANDARD EXTERNAL REVIEW TO BE CONDUCTED UNDER
SECTION 2164.7.
(C) A WRITTEN CERTIFICATION BY THE TREATING
HEALTH CARE PROVIDER THAT THE RECOMMENDED OR
REQUESTED HEALTH CARE SERVICE THAT IS THE SUBJECT OF
THE REQUEST WOULD BE SIGNIFICANTLY LESS EFFECTIVE IF
NOT PROMPTLY INITIATED, THE COVERED PERSON OR THE
COVERED PERSON'S AUTHORIZED REPRESENTATIVE MAY
REQUEST AN EXPEDITED EXTERNAL REVIEW TO BE CONDUCTED
UNDER SECTION 2164.7.
(4) A COPY OF THE DESCRIPTION OF BOTH THE STANDARD AND
EXPEDITED EXTERNAL REVIEW PROCEDURES REQUIRED BY SECTION
2136.1 THAT HIGHLIGHTS THE PROVISIONS IN THE EXTERNAL REVIEW
PROCEDURES REGARDING THE OPPORTUNITY TO SUBMIT ADDITIONAL
INFORMATION AND ANY FORMS USED TO PROCESS AN EXTERNAL REVIEW.
(5) AN AUTHORIZATION FORM, OR OTHER DOCUMENT APPROVED BY
THE DEPARTMENT THAT COMPLIES WITH THE REQUIREMENTS OF 45 CFR
164.508 (RELATING TO USES AND DISCLOSURES FOR WHICH AN
AUTHORIZATION IS REQUIRED), BY WHICH THE COVERED PERSON, FOR
PURPOSES OF CONDUCTING AN EXTERNAL REVIEW UNDER THIS
SUBDIVISION, AUTHORIZES THE INSURER AND THE COVERED PERSON'S
TREATING HEALTH CARE PROVIDER TO DISCLOSE PROTECTED HEALTH
INFORMATION, INCLUDING MEDICAL RECORDS, CONCERNING THE
COVERED PERSON, THAT ARE PERTINENT TO THE EXTERNAL REVIEW.
SECTION 2164.3. REQUEST FOR EXTERNAL REVIEW.
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(A) FORM OF REQUEST.--
(1) EXCEPT FOR A REQUEST FOR AN EXPEDITED EXTERNAL
REVIEW UNDER SECTION 2164.6, A REQUEST FOR EXTERNAL REVIEW
SHALL BE MADE IN WRITING TO THE DEPARTMENT.
(2) THE DEPARTMENT MAY PRESCRIBE BY REGULATION THE FORM
AND CONTENT OF AN EXTERNAL REVIEW REQUEST REQUIRED TO BE
SUBMITTED UNDER THIS SECTION.
(B) PERMITTED REQUESTS.--A COVERED PERSON OR THE COVERED
PERSON'S AUTHORIZED REPRESENTATIVE MAY MAKE A REQUEST FOR AN
EXTERNAL REVIEW OF AN ADVERSE BENEFIT DETERMINATION OR FINAL
ADVERSE BENEFIT DETERMINATION.
SECTION 2164.4. EXHAUSTION OF INTERNAL APPEAL PROCESS.
(A) REQUIREMENT TO EXHAUST INTERNAL APPEAL PROCESS.--
(1) EXCEPT AS PROVIDED IN SUBSECTION (B), A REQUEST FOR
EXTERNAL REVIEW UNDER SECTION 2164.5, 2164.6 OR 2164.7 OR A
REQUEST FOR RETROSPECTIVE REVIEW UNDER SECTION 2164 MAY NOT
BE MADE UNTIL THE COVERED PERSON HAS EXHAUSTED THE INSURER'S
INTERNAL APPEAL PROCESS UNDER SECTION 2164.
(2) A COVERED PERSON IS CONSIDERED TO HAVE EXHAUSTED THE
INSURER'S INTERNAL APPEAL PROCESS FOR PURPOSES OF THIS
SECTION IF THE COVERED PERSON OR THE COVERED PERSON'S
AUTHORIZED REPRESENTATIVE:
(I) HAS FILED AN APPEAL INVOLVING AN ADVERSE BENEFIT
DETERMINATION UNDER SECTION 2164.
(II) EXCEPT TO THE EXTENT THE COVERED PERSON OR THE
COVERED PERSON'S AUTHORIZED REPRESENTATIVE REQUESTED OR
AGREED TO A DELAY, HAS NOT RECEIVED A WRITTEN DECISION ON
THE APPEAL FROM THE INSURER WITHIN 30 DAYS FOLLOWING THE
DATE THE COVERED PERSON OR THE COVERED PERSON'S
AUTHORIZED REPRESENTATIVE FILED THE APPEAL WITH THE
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INSURER.
(III) THE INSURER WAIVES ITS INTERNAL CLAIM AND
APPEAL PROCESS AND THE REQUIREMENT FOR A COVERED PERSON
OR COVERED PERSON'S AUTHORIZED REPRESENTATIVE TO EXHAUST
THE PROCESS BEFORE FILING A REQUEST FOR AN EXTERNAL
REVIEW OR AN EXPEDITED EXTERNAL REVIEW.
(IV) THE INSURER HAS FAILED TO COMPLY WITH THE
REQUIREMENTS OF THE INTERNAL CLAIM AND APPEAL PROCESS
UNLESS THE FAILURE OR FAILURES ARE BASED ON DE MINIMIS
VIOLATIONS THAT DO NOT CAUSE, AND ARE NOT LIKELY TO
CAUSE, PREJUDICE OR HARM TO THE COVERED PERSON OR COVERED
PERSON'S AUTHORIZED REPRESENTATIVE.
(B) PROCEDURE FOR REQUESTING EXPEDITED EXTERNAL REVIEW.--
(1) AT THE SAME TIME A COVERED PERSON OR THE COVERED
PERSON'S AUTHORIZED REPRESENTATIVE FILES A REQUEST FOR
EXPEDITED INTERNAL REVIEW OF AN ADVERSE BENEFIT DETERMINATION
UNDER SECTION 2164, THE COVERED PERSON OR THE COVERED
PERSON'S AUTHORIZED REPRESENTATIVE MAY FILE A REQUEST FOR AN
EXPEDITED EXTERNAL REVIEW OF THE ADVERSE BENEFIT
DETERMINATION:
(I) UNDER SECTION 2164.6, IF THE COVERED PERSON HAS
A MEDICAL CONDITION FOR WHICH THE TIME FRAME FOR
COMPLETION OF AN EXPEDITED INTERNAL REVIEW OF THE ADVERSE
BENEFIT DETERMINATION UNDER SECTION 2164 WOULD SERIOUSLY
JEOPARDIZE THE LIFE OR HEALTH OF THE COVERED PERSON OR
WOULD JEOPARDIZE THE COVERED PERSON'S ABILITY TO REGAIN
MAXIMUM FUNCTION.
(II) UNDER SECTION 2164.7, IF THE ADVERSE BENEFIT
DETERMINATION INVOLVES A DENIAL OF COVERAGE BASED ON A
DETERMINATION THAT THE RECOMMENDED OR REQUESTED HEALTH
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CARE SERVICE IS EXPERIMENTAL OR INVESTIGATIONAL, AND THE
COVERED PERSON'S TREATING HEALTH CARE PROVIDER CERTIFIES
IN WRITING THAT THE RECOMMENDED OR REQUESTED HEALTH CARE
SERVICE THAT IS THE SUBJECT OF THE ADVERSE BENEFIT
DETERMINATION WOULD BE SIGNIFICANTLY LESS EFFECTIVE IF
NOT PROMPTLY INITIATED.
(2) UPON RECEIPT OF A REQUEST FOR AN EXPEDITED EXTERNAL
REVIEW UNDER PARAGRAPH (1), THE IRO CONDUCTING THE EXTERNAL
REVIEW UNDER SECTION 2164.6 OR SECTION 2164.7 SHALL DETERMINE
WHETHER THE COVERED PERSON IS REQUIRED TO COMPLETE THE
EXPEDITED INTERNAL REVIEW PROCESS UNDER SECTION 2164 BEFORE
THE IRO CONDUCTS THE EXPEDITED EXTERNAL REVIEW.
(C) DENIAL OF REQUEST FOR EXPEDITED EXTERNAL REVIEW.--IF THE
IRO DETERMINES THAT THE COVERED PERSON IS REQUIRED TO FIRST
COMPLETE THE INTERNAL EXPEDITED APPEAL PROCESS UNDER SECTION
2164, THE IRO SHALL WITHIN 24 HOURS NOTIFY THE COVERED PERSON
AND, IF APPLICABLE, THE COVERED PERSON'S AUTHORIZED
REPRESENTATIVE, THAT THE IRO MAY NOT PROCEED WITH THE EXPEDITED
EXTERNAL REVIEW UNDER SECTION 2164.6 UNTIL THE INSURER HAS
COMPLETED THE EXPEDITED REVIEW PROCESS AND THE COVERED PERSON'S
ADVERSE BENEFIT DETERMINATION APPEAL REMAINS UNRESOLVED.
(D) WAIVER OF EXHAUSTION REQUIREMENT.--A REQUEST FOR
EXTERNAL REVIEW OF AN ADVERSE BENEFIT DETERMINATION MAY BE MADE
BEFORE THE COVERED PERSON HAS EXHAUSTED THE INSURER'S INTERNAL
APPEAL PROCEDURES UNDER SECTION 2164, IF THE INSURER AGREES TO
WAIVE THE EXHAUSTION REQUIREMENT. AT THAT TIME, THE COVERED
PERSON OR THE COVERED PERSON'S AUTHORIZED REPRESENTATIVE MAY
FILE A REQUEST IN WRITING FOR STANDARD EXTERNAL REVIEW AS
PROVIDED IN SECTION 2164.5 OR SECTION 2164.7.
SECTION 2164.5. STANDARD EXTERNAL REVIEW.
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(A) REQUEST FOR REVIEW.--
(1) A COVERED PERSON, OR THE COVERED PERSON'S AUTHORIZED
REPRESENTATIVE, MAY FILE A REQUEST FOR EXTERNAL REVIEW WITH
THE DEPARTMENT WITHIN FOUR MONTHS AFTER THE DATE OF RECEIPT
OF A NOTICE OF AN ADVERSE BENEFIT DETERMINATION OR FINAL
ADVERSE BENEFIT DETERMINATION UNDER SECTION 2164.2.
(2) THE DEPARTMENT SHALL SEND A COPY OF THE REQUEST TO
THE INSURER WITHIN ONE BUSINESS DAY OF THE DATE OF RECEIPT OF
A REQUEST FOR EXTERNAL REVIEW UNDER PARAGRAPH (1).
(B) PRELIMINARY REVIEW OF REQUEST.--WITHIN FIVE BUSINESS
DAYS OF THE DATE OF RECEIPT OF THE COPY OF THE EXTERNAL REVIEW
REQUEST RECEIVED UNDER SUBSECTION (A)(2), THE INSURER SHALL
COMPLETE A PRELIMINARY REVIEW OF THE REQUEST TO DETERMINE
WHETHER:
(1) THE INDIVIDUAL IS OR WAS A COVERED PERSON UNDER THE
HEALTH INSURANCE POLICY AT THE TIME THE HEALTH CARE SERVICE
WAS REQUESTED OR, IN THE CASE OF A RETROSPECTIVE REVIEW, WAS
A COVERED PERSON UNDER THE HEALTH INSURANCE POLICY AT THE
TIME THE HEALTH CARE SERVICE WAS PROVIDED.
(2) THE HEALTH CARE SERVICE THAT IS THE SUBJECT OF THE
ADVERSE BENEFIT DETERMINATION OR THE FINAL ADVERSE BENEFIT
DETERMINATION IS A COVERED SERVICE UNDER THE COVERED PERSON'S
HEALTH INSURANCE POLICY, EXCEPT FOR A DETERMINATION BY THE
INSURER THAT THE HEALTH CARE SERVICE IS NOT COVERED BECAUSE
IT DOES NOT MEET THE INSURER'S REQUIREMENTS FOR MEDICAL
NECESSITY, APPROPRIATENESS, HEALTH CARE SETTING, LEVEL OF
CARE OR EFFECTIVENESS.
(3) THE COVERED PERSON HAS EXHAUSTED THE INSURER'S
INTERNAL APPEAL PROCESS UNDER SECTION 2164, UNLESS THE
COVERED PERSON IS NOT REQUIRED TO EXHAUST THE INSURER'S
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INTERNAL APPEAL PROCESS UNDER SECTION 2164.4.
(4) THE COVERED PERSON HAS NOT PROVIDED ALL THE
INFORMATION AND FORMS REQUIRED TO PROCESS AN EXTERNAL REVIEW,
INCLUDING THE RELEASE FORM PROVIDED UNDER SECTION 2164.2(B).
(C) NOTICE OF INITIAL DETERMINATION.--
(1) WITHIN ONE BUSINESS DAY OF COMPLETION OF THE
PRELIMINARY REVIEW, THE INSURER SHALL NOTIFY THE DEPARTMENT
AND THE COVERED PERSON AND, IF APPLICABLE, THE COVERED
PERSON'S AUTHORIZED REPRESENTATIVE, IN WRITING WHETHER THE
REQUEST IS COMPLETE AND ELIGIBLE FOR EXTERNAL REVIEW. THE
FOLLOWING APPLY:
(I) IF THE REQUEST IS NOT COMPLETE, THE INSURER
SHALL INFORM THE COVERED PERSON AND, IF APPLICABLE, THE
COVERED PERSON'S AUTHORIZED REPRESENTATIVE, AND THE
DEPARTMENT IN WRITING AND INCLUDE IN THE NOTICE WHAT
INFORMATION OR MATERIALS ARE NEEDED TO MAKE THE REQUEST
COMPLETE.
(II) IF THE REQUEST IS NOT ELIGIBLE FOR EXTERNAL
REVIEW, THE INSURER SHALL INFORM THE COVERED PERSON AND,
IF APPLICABLE, THE COVERED PERSON'S AUTHORIZED
REPRESENTATIVE, AND THE DEPARTMENT IN WRITING AND INCLUDE
IN THE NOTICE THE REASONS FOR THE REQUEST'S
INELIGIBILITY.
(2) NOTIFICATION UNDER PARAGRAPH (1)(II) SHALL BE
PROVIDED IN A FORM AS SPECIFIED BY THE DEPARTMENT AND INCLUDE
A STATEMENT INFORMING THE COVERED PERSON AND, IF APPLICABLE,
THE COVERED PERSON'S AUTHORIZED REPRESENTATIVE THAT AN
INSURER'S INITIAL DETERMINATION THAT THE EXTERNAL REVIEW
REQUEST IS INELIGIBLE FOR REVIEW MAY BE APPEALED TO THE
DEPARTMENT.
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(3) NOTWITHSTANDING AN INSURER'S INITIAL DETERMINATION
THAT THE REQUEST IS INELIGIBLE FOR REVIEW, THE DEPARTMENT MAY
DETERMINE, BASED UPON THE TERMS OF THE COVERED PERSON'S
HEALTH INSURANCE POLICY, THAT A REQUEST IS ELIGIBLE FOR
EXTERNAL REVIEW UNDER SUBSECTION (B). THE DETERMINATION SHALL
BE BINDING ON THE INSURER AND THE COVERED PERSON AND MAY BE
APPEALED TO THE COMMISSIONER. CONSIDERATION OF THE APPEAL MAY
NOT DELAY OR TERMINATE THE EXTERNAL REVIEW.
(D) PROCEDURE FOR REVIEW OF ELIGIBLE REQUESTS.--
(1) WITHIN ONE BUSINESS DAY OF THE DATE OF RECEIPT OF
NOTICE THAT A REQUEST IS ELIGIBLE FOR EXTERNAL REVIEW
FOLLOWING THE PRELIMINARY REVIEW CONDUCTED UNDER SUBSECTION
(C), THE DEPARTMENT SHALL:
(I) ASSIGN AN IRO TO CONDUCT THE EXTERNAL REVIEW
FROM THE LIST OF APPROVED IROS COMPILED AND MAINTAINED BY
THE DEPARTMENT UNDER SECTION 2164.9 AND NOTIFY THE
INSURER OF THE NAME OF THE ASSIGNED IRO.
(II) NOTIFY IN WRITING THE COVERED PERSON AND, IF
APPLICABLE, THE COVERED PERSON'S AUTHORIZED
REPRESENTATIVE, OF THE REQUEST'S ELIGIBILITY AND
ACCEPTANCE FOR EXTERNAL REVIEW. THE NOTIFICATION SHALL
INCLUDE A STATEMENT THAT THE COVERED PERSON, OR THE
COVERED PERSON'S AUTHORIZED REPRESENTATIVE, MAY SUBMIT IN
WRITING TO THE ASSIGNED IRO, WITHIN 15 BUSINESS DAYS OF
THE DATE OF RECEIPT OF THE NOTICE PROVIDED UNDER
SUBPARAGRAPH (I), ADDITIONAL INFORMATION THAT THE IRO
SHALL CONSIDER WHEN CONDUCTING THE EXTERNAL REVIEW. THE
IRO MAY ACCEPT AND CONSIDER ADDITIONAL INFORMATION
SUBMITTED AFTER FIVE BUSINESS DAYS.
(2) THE ASSIGNED IRO SHALL NOT BE BOUND BY A DECISION OR
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CONCLUSION REACHED DURING THE INSURER'S INTERNAL CLAIMS AND
APPEAL PROCESS UNDER SECTION 2164.
(E) FORWARDING OF REQUIRED DOCUMENTS.--
(1) WITHIN FIVE BUSINESS DAYS OF THE DATE OF RECEIPT OF
THE NOTICE PROVIDED UNDER SUBSECTION (D)(1), THE INSURER, OR
A UTILIZATION REVIEW ORGANIZATION DESIGNATED BY THE INSURER,
SHALL PROVIDE TO THE ASSIGNED IRO THE DOCUMENTS AND
INFORMATION CONSIDERED IN MAKING THE ADVERSE BENEFIT
DETERMINATION OR FINAL ADVERSE BENEFIT DETERMINATION.
(2) IF THE INSURER, OR A UTILIZATION REVIEW ORGANIZATION
DESIGNATED BY THE INSURER, FAILS TO PROVIDE DOCUMENTS AND
INFORMATION WITHIN THE TIME PERIOD SPECIFIED IN PARAGRAPH
(1), THE IRO MAY PROCEED WITH THE REVIEW, TERMINATE THE
EXTERNAL REVIEW AND MAKE A DECISION TO REVERSE THE ADVERSE
BENEFIT DETERMINATION OR FINAL ADVERSE BENEFIT DETERMINATION.
WITHIN ONE BUSINESS DAY OF MAKING THE DECISION UNDER
PARAGRAPH (1), THE IRO SHALL NOTIFY THE DEPARTMENT, THE
INSURER, THE COVERED PERSON AND, IF APPLICABLE, THE COVERED
PERSON'S AUTHORIZED REPRESENTATIVE.
(F) REVIEW OF INFORMATION.--
(1) THE ASSIGNED IRO SHALL REVIEW ALL OF THE INFORMATION
AND DOCUMENTS RECEIVED UNDER SUBSECTION (E) AND OTHER
INFORMATION SUBMITTED IN WRITING TO THE IRO BY THE COVERED
PERSON OR THE COVERED PERSON'S AUTHORIZED REPRESENTATIVE
UNDER SUBSECTION (D)(1)(II).
(2) WITHIN ONE BUSINESS DAY OF RECEIPT OF INFORMATION
SUBMITTED BY THE COVERED PERSON OR THE COVERED PERSON'S
AUTHORIZED REPRESENTATIVE, THE ASSIGNED IRO SHALL FORWARD THE
INFORMATION TO THE INSURER.
(G) RECONSIDERATION BY INSURER.--
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(1) UPON RECEIPT OF THE INFORMATION, IF ANY, REQUIRED TO
BE FORWARDED UNDER SUBSECTION (F)(2), THE INSURER MAY
RECONSIDER AN ADVERSE BENEFIT DETERMINATION OR FINAL ADVERSE
BENEFIT DETERMINATION THAT IS THE SUBJECT OF THE EXTERNAL
REVIEW.
(2) RECONSIDERATION BY THE INSURER OF AN ADVERSE BENEFIT
DETERMINATION OR FINAL ADVERSE BENEFIT DETERMINATION UNDER
PARAGRAPH (1) MAY NOT DELAY OR TERMINATE THE EXTERNAL REVIEW.
(3) THE EXTERNAL REVIEW MAY BE TERMINATED WITHOUT AN IRO
DETERMINATION ONLY IF THE INSURER DECIDES, UPON COMPLETION OF
THE INSURER'S RECONSIDERATION, TO REVERSE THE INSURER'S
ADVERSE BENEFIT DETERMINATION OR FINAL ADVERSE BENEFIT
DETERMINATION AND PROVIDE COVERAGE OR PAYMENT FOR THE
RECOMMENDED HEALTH CARE SERVICE THAT IS THE SUBJECT OF THE
EXTERNAL REVIEW.
(4) WITHIN ONE BUSINESS DAY OF MAKING THE DECISION TO
REVERSE ITS ADVERSE BENEFIT DETERMINATION OR FINAL ADVERSE
BENEFIT DETERMINATION, AS PROVIDED IN PARAGRAPH (3), THE
INSURER SHALL NOTIFY THE DEPARTMENT, THE ASSIGNED IRO, THE
COVERED PERSON AND, IF APPLICABLE, THE COVERED PERSON'S
AUTHORIZED REPRESENTATIVE, IN WRITING OF ITS DECISION.
(5) THE ASSIGNED IRO SHALL TERMINATE THE EXTERNAL REVIEW
UPON RECEIPT OF THE NOTICE FROM THE INSURER SENT UNDER
PARAGRAPH (4).
(H) FACTORS TO BE CONSIDERED.--IN ADDITION TO THE DOCUMENTS
AND INFORMATION PROVIDED UNDER SUBSECTION (E), THE ASSIGNED IRO,
TO THE EXTENT THE INFORMATION OR DOCUMENTS ARE AVAILABLE AND THE
IRO CONSIDERS THEM APPROPRIATE, SHALL CONSIDER THE FOLLOWING
INFORMATION IN REACHING A DECISION:
(1) THE COVERED PERSON'S MEDICAL RECORDS.
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(2) THE ATTENDING HEALTH CARE PROVIDER'S RECOMMENDATION.
(3) CONSULTING REPORTS FROM APPROPRIATE HEALTH CARE
PROVIDERS AND OTHER DOCUMENTS SUBMITTED BY THE INSURER, THE
COVERED PERSON, THE COVERED PERSON'S AUTHORIZED
REPRESENTATIVE OR THE COVERED PERSON'S TREATING PROVIDER.
(4) THE TERMS OF COVERAGE UNDER THE COVERED PERSON'S
HEALTH INSURANCE POLICY TO ENSURE THAT THE IRO'S DECISION IS
NOT CONTRARY TO THE TERMS OF COVERAGE.
(5) THE MOST APPROPRIATE PRACTICE GUIDELINES, WHICH
SHALL INCLUDE APPLICABLE EVIDENCE-BASED STANDARDS AND MAY
INCLUDE OTHER PRACTICE GUIDELINES DEVELOPED BY THE FEDERAL
GOVERNMENT OR NATIONAL OR PROFESSIONAL MEDICAL SOCIETIES,
BOARDS AND ASSOCIATIONS.
(6) APPLICABLE CLINICAL REVIEW CRITERIA DEVELOPED AND
USED BY THE INSURER OR A UTILIZATION REVIEW ORGANIZATION
DESIGNATED BY THE INSURER.
(7) THE OPTION OPINION OF THE IRO'S CLINICAL REVIEWER OR
REVIEWERS AFTER CONSIDERING THE INFORMATION UNDER PARAGRAPHS
(1), (2), (3), (4), (5) AND (6).
(I) NOTICE OF DECISION.--
(1) WITHIN 45 DAYS OF THE DATE OF RECEIPT OF THE REQUEST
FOR AN EXTERNAL REVIEW, THE ASSIGNED IRO SHALL PROVIDE
WRITTEN NOTICE OF THE IRO'S DECISION TO UPHOLD OR REVERSE THE
ADVERSE BENEFIT DETERMINATION OR THE FINAL ADVERSE BENEFIT
DETERMINATION TO:
(I) THE COVERED PERSON.
(II) IF APPLICABLE, THE COVERED PERSON'S AUTHORIZED
REPRESENTATIVE.
(III) THE INSURER.
(IV) THE DEPARTMENT.
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(2) THE IRO SHALL INCLUDE IN THE NOTICE UNDER PARAGRAPH
(1):
(I) A GENERAL DESCRIPTION OF THE REASON FOR THE
REQUEST FOR EXTERNAL REVIEW.
(II) THE DATE THE IRO RECEIVED THE ASSIGNMENT FROM
THE DEPARTMENT TO CONDUCT THE EXTERNAL REVIEW.
(III) THE DATE THE EXTERNAL REVIEW WAS CONDUCTED.
(IV) THE DATE OF THE IRO'S DECISION.
(V) THE PRINCIPAL REASON OR REASONS FOR THE IRO'S
DECISION, INCLUDING WHAT APPLICABLE EVIDENCE-BASED
STANDARDS WERE CONSIDERED IN REACHING THE IRO'S DECISION.
(VI) THE RATIONALE FOR THE IRO'S DECISION.
(VII) REFERENCES TO THE EVIDENCE OR DOCUMENTATION,
INCLUDING EVIDENCE-BASED STANDARDS, CONSIDERED IN
REACHING THE IRO'S DECISION.
(3) UPON RECEIPT OF A NOTICE OF A DECISION UNDER
PARAGRAPH (1) REVERSING THE ADVERSE BENEFIT DETERMINATION OR
FINAL ADVERSE BENEFIT DETERMINATION, THE INSURER SHALL WITHIN
24 HOURS APPROVE THE COVERAGE THAT WAS THE SUBJECT OF THE
ADVERSE BENEFIT DETERMINATION OR FINAL ADVERSE BENEFIT
DETERMINATION.
(J) ASSIGNMENT OF IRO.--THE DEPARTMENT SHALL ASSIGN ON A
RANDOM BASIS AN APPROVED IRO FROM THOSE QUALIFIED TO CONDUCT THE
PARTICULAR EXTERNAL REVIEW BASED ON THE NATURE OF THE HEALTH
CARE SERVICE THAT IS THE SUBJECT OF THE ADVERSE BENEFIT
DETERMINATION OR FINAL ADVERSE BENEFIT DETERMINATION, AND SHALL
CONSIDER THE CONFLICT-OF-INTEREST CONCERNS UNDER SECTION
2164.10(D).
SECTION 2164.6. EXPEDITED EXTERNAL REVIEW.
(A) REQUEST FOR REVIEW.--EXCEPT AS PROVIDED IN SUBSECTION
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(F), A COVERED PERSON OR THE COVERED PERSON'S AUTHORIZED
REPRESENTATIVE MAY MAKE A REQUEST FOR EXPEDITED EXTERNAL REVIEW
WITH THE DEPARTMENT AT THE TIME THE COVERED PERSON RECEIVES:
(1) AN ADVERSE BENEFIT DETERMINATION, IF EITHER OF THE
FOLLOWING APPLIES:
(I) THE ADVERSE BENEFIT DETERMINATION INVOLVES A
MEDICAL CONDITION OF THE COVERED PERSON FOR WHICH THE
TIME FRAME FOR COMPLETION OF AN EXPEDITED INTERNAL REVIEW
UNDER SECTION 2164 WOULD SERIOUSLY JEOPARDIZE THE LIFE OR
HEALTH OF THE COVERED PERSON OR WOULD JEOPARDIZE THE
COVERED PERSON'S ABILITY TO REGAIN MAXIMUM FUNCTION.
(II) THE COVERED PERSON OR THE COVERED PERSON'S
AUTHORIZED REPRESENTATIVE HAS FILED A REQUEST FOR AN
EXPEDITED INTERNAL REVIEW OF AN ADVERSE BENEFIT
DETERMINATION UNDER SECTION 2164.
(2) A FINAL ADVERSE BENEFIT DETERMINATION IF EITHER OF
THE FOLLOWING APPLY:
(I) THE COVERED PERSON HAS A MEDICAL CONDITION FOR
WHICH THE TIME FRAME FOR COMPLETION OF A STANDARD
EXTERNAL REVIEW UNDER SECTION 2164.5 WOULD SERIOUSLY
JEOPARDIZE THE LIFE OR HEALTH OF THE COVERED PERSON OR
WOULD JEOPARDIZE THE COVERED PERSON'S ABILITY TO REGAIN
MAXIMUM FUNCTION.
(II) THE FINAL ADVERSE BENEFIT DETERMINATION
CONCERNS AN ADMISSION, AVAILABILITY OF CARE, CONTINUED
STAY OR HEALTH CARE SERVICE FOR WHICH THE COVERED PERSON
RECEIVED EMERGENCY SERVICES BUT HAS NOT BEEN DISCHARGED
FROM A FACILITY.
(B) PRELIMINARY REVIEW OF REQUEST.--
(1) UPON RECEIPT OF A REQUEST FOR AN EXPEDITED EXTERNAL
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REVIEW, THE DEPARTMENT SHALL, WITHIN 24 HOURS, SEND A COPY OF
THE REQUEST TO THE INSURER.
(2) WITHIN 24 HOURS UPON RECEIPT OF A REQUEST UNDER
PARAGRAPH (1), THE INSURER SHALL DETERMINE WHETHER THE
REQUEST MEETS THE REQUIREMENTS FOR REVIEW UNDER SECTION
2164.5(B). THE INSURER SHALL, WITHIN 24 HOURS, NOTIFY THE
DEPARTMENT, THE COVERED PERSON AND, IF APPLICABLE, THE
COVERED PERSON'S AUTHORIZED REPRESENTATIVE OF THE INSURER'S
ELIGIBILITY DETERMINATION.
(3) NOTIFICATION PROVIDED UNDER PARAGRAPH (2) SHALL BE
PROVIDED IN A FORM AS SPECIFIED BY THE DEPARTMENT AND INCLUDE
A STATEMENT INFORMING THE COVERED PERSON AND, IF APPLICABLE,
THE COVERED PERSON'S AUTHORIZED REPRESENTATIVE THAT AN
INSURER'S INITIAL DETERMINATION THAT THE EXTERNAL REVIEW
REQUEST IS INELIGIBLE FOR REVIEW MAY BE APPEALED TO THE
DEPARTMENT.
(4) NOTWITHSTANDING AN INSURER'S INITIAL DETERMINATION
THAT THE REQUEST IS INELIGIBLE FOR REVIEW, THE DEPARTMENT MAY
DECIDE, BASED UPON THE TERMS OF THE COVERED PERSON'S HEALTH
INSURANCE POLICY, THAT A REQUEST IS ELIGIBLE FOR EXTERNAL
REVIEW UNDER SECTION 2164.5(B). THE DEPARTMENT'S DECISION
SHALL BE BINDING ON THE INSURER AND THE COVERED PERSON AND
MAY BE APPEALED TO THE COMMISSIONER. CONSIDERATION OF AN
APPEAL MAY NOT DELAY OR TERMINATE THE EXTERNAL REVIEW.
(5) UPON RECEIPT OF THE NOTICE THAT THE REQUEST MEETS
THE REQUIREMENTS FOR REVIEW, THE DEPARTMENT SHALL, WITHIN 24
HOURS, ASSIGN AN IRO TO CONDUCT THE EXPEDITED EXTERNAL REVIEW
FROM THE LIST OF APPROVED IROS COMPILED AND MAINTAINED BY THE
DEPARTMENT UNDER SECTION 2164.9. THE DEPARTMENT SHALL, WITHIN
24 HOURS, NOTIFY THE INSURER OF THE NAME OF THE ASSIGNED IRO.
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(6) IN REACHING A DECISION IN ACCORDANCE WITH SUBSECTION
(E), THE ASSIGNED IRO SHALL NOT BE BOUND BY A DECISION OR
CONCLUSION REACHED DURING THE INTERNAL ADVERSE BENEFIT
DETERMINATION PROCESS FOR AN INSURER UNDER SECTION 2164.
(C) FORWARDING OF REQUIRED DOCUMENTS.--UPON RECEIPT OF
DEPARTMENTAL NOTICE OF THE NAME OF THE IRO ASSIGNED TO CONDUCT
THE EXPEDITED EXTERNAL REVIEW UNDER SUBSECTION (B)(5), THE
INSURER OR AN IRO DESIGNATED BY THE INSURER SHALL PROVIDE TO THE
ASSIGNED IRO THE DOCUMENTS AND INFORMATION CONSIDERED IN MAKING
THE ADVERSE BENEFIT DETERMINATION OR FINAL ADVERSE BENEFIT
DETERMINATION BY ONE OF THE FOLLOWING METHODS:
(1) ELECTRONICALLY.
(2) BY TELEPHONE.
(3) BY FACSIMILE.
(4) BY ANY OTHER AVAILABLE EXPEDITIOUS METHOD.
(D) FACTORS TO BE CONSIDERED.--IN ADDITION TO THE DOCUMENTS
AND INFORMATION PROVIDED UNDER SUBSECTION (C), THE ASSIGNED IRO,
TO THE EXTENT THE INFORMATION OR DOCUMENTS ARE AVAILABLE AND THE
IRO CONSIDERS THEM APPROPRIATE, SHALL CONSIDER THE FOLLOWING
INFORMATION IN REACHING A DECISION:
(1) THE COVERED PERSON'S MEDICAL RECORDS.
(2) THE ATTENDING HEALTH CARE PROVIDER'S RECOMMENDATION.
(3) CONSULTING REPORTS FROM APPROPRIATE HEALTH CARE
PROVIDERS AND OTHER DOCUMENTS SUBMITTED BY THE INSURER, THE
COVERED PERSON, THE COVERED PERSON'S AUTHORIZED
REPRESENTATIVE OR THE COVERED PERSON'S TREATING PROVIDER.
(4) THE TERMS OF COVERAGE UNDER THE COVERED PERSON'S
HEALTH INSURANCE POLICY TO ENSURE THAT THE IRO'S DECISION IS
NOT CONTRARY TO THE TERMS OF COVERAGE.
(5) THE MOST APPROPRIATE PRACTICE GUIDELINES, WHICH
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SHALL INCLUDE APPLICABLE EVIDENCE-BASED STANDARDS AND MAY
INCLUDE ANY OTHER PRACTICE GUIDELINES DEVELOPED BY THE
FEDERAL GOVERNMENT OR NATIONAL OR PROFESSIONAL MEDICAL
SOCIETIES, BOARDS AND ASSOCIATIONS.
(6) APPLICABLE CLINICAL REVIEW CRITERIA DEVELOPED AND
USED BY THE INSURER OR A UTILIZATION REVIEW ORGANIZATION
DESIGNATED BY THE INSURER.
(7) THE OPINION OF THE IRO'S CLINICAL REVIEWER OR
REVIEWERS AFTER CONSIDERING THE INFORMATION UNDER PARAGRAPHS
(1), (2), (3), (4), (5) AND (6).
(E) NOTICE OF DECISION.--
(1) AS EXPEDITIOUSLY AS THE COVERED PERSON'S MEDICAL
CONDITION OR CIRCUMSTANCES REQUIRE, BUT IN NO EVENT MORE THAN
72 HOURS AFTER THE DATE OF RECEIPT OF THE REQUEST FOR AN
EXPEDITED EXTERNAL REVIEW THAT MEETS THE REVIEWABILITY
REQUIREMENTS UNDER SECTION 2164.5(B), THE ASSIGNED IRO SHALL
PROVIDE NOTICE OF THE IRO'S DECISION TO UPHOLD OR REVERSE THE
ADVERSE BENEFIT DETERMINATION OR THE FINAL ADVERSE BENEFIT
DETERMINATION TO:
(I) THE COVERED PERSON.
(II) IF APPLICABLE, THE COVERED PERSON'S AUTHORIZED
REPRESENTATIVE.
(III) THE INSURER.
(IV) THE DEPARTMENT.
(2) IF THE NOTICE PROVIDED UNDER PARAGRAPH (1) IS NOT IN
WRITING, WITHIN 48 HOURS OF THE DATE OF PROVIDING THAT
NOTICE, THE ASSIGNED IRO SHALL PROVIDE WRITTEN NOTICE OF THE
IRO'S DECISION TO UPHOLD OR REVERSE THE ADVERSE BENEFIT
DETERMINATION OR THE FINAL ADVERSE BENEFIT DETERMINATION TO:
(I) THE COVERED PERSON.
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(II) IF APPLICABLE, THE COVERED PERSON'S AUTHORIZED
REPRESENTATIVE.
(III) THE INSURER.
(IV) THE DEPARTMENT.
(3) THE IRO SHALL INCLUDE IN THE NOTICE UNDER PARAGRAPH
(2):
(I) A GENERAL DESCRIPTION OF THE REASON FOR THE
REQUEST FOR EXTERNAL REVIEW.
(II) THE DATE THE IRO RECEIVED THE ASSIGNMENT FROM
THE DEPARTMENT TO CONDUCT THE EXTERNAL REVIEW.
(III) THE DATE THE EXTERNAL REVIEW WAS CONDUCTED.
(IV) THE DATE OF THE IRO'S DECISION.
(V) THE PRINCIPAL REASON OR REASON FOR THE IRO'S
DECISION, INCLUDING APPLICABLE EVIDENCE-BASED STANDARDS
CONSIDERED IN REACHING THE IRO'S DECISION.
(VI) THE RATIONALE FOR THE IRO'S DECISION.
(VII) REFERENCES TO THE EVIDENCE OR DOCUMENTATION,
INCLUDING EVIDENCE-BASED STANDARDS, CONSIDERED IN
REACHING THE IRO'S DECISION.
(4) UPON RECEIPT OF A NOTICE OF A DECISION UNDER
PARAGRAPH (1) REVERSING THE ADVERSE BENEFIT DETERMINATION OR
FINAL ADVERSE BENEFIT DETERMINATION, THE INSURER SHALL,
WITHIN 24 HOURS, APPROVE THE COVERAGE THAT WAS THE SUBJECT OF
THE ADVERSE BENEFIT DETERMINATION OR FINAL ADVERSE BENEFIT
DETERMINATION.
(F) PROHIBITION OF RETROSPECTIVE EXPEDITED EXTERNAL
REVIEW.--AN EXPEDITED EXTERNAL REVIEW MAY NOT BE PROVIDED FOR
RETROSPECTIVE ADVERSE OR FINAL ADVERSE BENEFIT DETERMINATIONS.
(G) ASSIGNMENT OF IRO.--THE DEPARTMENT SHALL ASSIGN ON A
RANDOM BASIS AN APPROVED IRO AMONG THOSE QUALIFIED TO CONDUCT
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THE PARTICULAR EXTERNAL REVIEW BASED ON THE NATURE OF THE HEALTH
CARE SERVICE THAT IS SUBJECT OF THE ADVERSE BENEFIT
DETERMINATION OR FINAL ADVERSE BENEFIT DETERMINATION, AND SHALL
CONSIDER THE CONFLICT-OF-INTEREST CONCERNS UNDER SECTION
2164.10(D).
SECTION 2164.7. EXTERNAL REVIEW OF EXPERIMENTAL OR
INVESTIGATIONAL TREATMENT ADVERSE BENEFIT
DETERMINATIONS.
(A) REQUEST FOR REVIEW.--
(1) WITHIN FOUR MONTHS OF THE DATE OF RECEIPT OF A
NOTICE OF AN ADVERSE BENEFIT DETERMINATION OR FINAL ADVERSE
BENEFIT DETERMINATION UNDER SECTION 2164.2 THAT INVOLVES A
DENIAL OF COVERAGE BASED ON A DETERMINATION THAT THE HEALTH
CARE SERVICES RECOMMENDED OR REQUESTED ARE EXPERIMENTAL OR
INVESTIGATIONAL, A COVERED PERSON, OR THE COVERED PERSON'S
AUTHORIZED REPRESENTATIVE, MAY FILE A REQUEST FOR EXTERNAL
REVIEW WITH THE DEPARTMENT.
(2) A COVERED PERSON, OR THE COVERED PERSON'S AUTHORIZED
REPRESENTATIVE, MAY MAKE AN ORAL REQUEST FOR EXPEDITED
EXTERNAL REVIEW OF THE ADVERSE BENEFIT DETERMINATION OR FINAL
ADVERSE BENEFIT DETERMINATION UNDER PARAGRAPH (1) IF THE
COVERED PERSON'S TREATING HEALTH CARE PROVIDER CERTIFICATES
IN WRITING THAT THE RECOMMENDED OR REQUESTED HEALTH CARE
SERVICES THAT ARE THE SUBJECT OF THE REQUEST WOULD BE
SIGNIFICANTLY LESS EFFECTIVE IF NOT PROMPTLY INITIATED. UPON
RECEIPT OF A REQUEST FOR AN EXPEDITED EXTERNAL REVIEW, THE
DEPARTMENT SHALL NOTIFY THE INSURER WITHIN 24 HOURS.
(3) WITH RESPECT TO NOTICE OF AN INSURER'S ELIGIBILITY
DETERMINATION:
(I) UPON NOTICE OF THE REQUEST FOR EXPEDITED
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EXTERNAL REVIEW, THE INSURER SHALL IMMEDIATELY DETERMINE
WHETHER THE REQUEST MEETS THE REQUIREMENTS FOR REVIEW
UNDER SUBSECTION (B). THE INSURER SHALL, WITHIN 24 HOURS,
NOTIFY THE DEPARTMENT, THE COVERED PERSON AND, IF
APPLICABLE, THE COVERED PERSON'S AUTHORIZED
REPRESENTATIVE, OF THE INSURER'S ELIGIBILITY
DETERMINATION.
(II) THE DEPARTMENT MAY SPECIFY THE FORM FOR THE
INSURER'S NOTICE OF INITIAL DETERMINATION UNDER
SUBPARAGRAPH (I) AND ANY SUPPORTING INFORMATION TO BE
INCLUDED IN THE NOTICE.
(III) THE NOTICE OF INITIAL DETERMINATION UNDER
SUBPARAGRAPH (I) SHALL INCLUDE A STATEMENT INFORMING THE
COVERED PERSON AND, IF APPLICABLE, THE COVERED PERSON'S
AUTHORIZED REPRESENTATIVE, OF AN INSURER'S INITIAL
DETERMINATION THAT THE EXTERNAL REVIEW REQUEST IS
INELIGIBLE FOR REVIEW AND THAT THE EXTERNAL REVIEW
REQUEST MAY BE APPEALED TO THE DEPARTMENT.
(3) NOTWITHSTANDING AN INSURER'S INITIAL DETERMINATION,
THE DEPARTMENT MAY DECIDE THAT A REQUEST IS ELIGIBLE FOR
EXTERNAL REVIEW UNDER PARAGRAPH (2) AND REQUIRE THAT THE
REQUEST BE REFERRED FOR EXTERNAL REVIEW. THE DEPARTMENT'S
DECISION SHALL BE MADE IN ACCORDANCE WITH THE TERMS OF THE
COVERED PERSON'S HEALTH INSURANCE POLICY AND SHALL BE SUBJECT
TO ALL APPLICABLE PROVISIONS OF THIS SUBDIVISION. THE
DEPARTMENT'S DECISION SHALL BE BINDING ON THE INSURER AND THE
COVERED PERSON AND MAY BE APPEALED TO THE COMMISSIONER.
CONSIDERATION OF AN APPEAL MAY NOT DELAY OR TERMINATE THE
EXTERNAL REVIEW.
(4) UPON RECEIPT OF A NOTICE UNDER PARAGRAPH (2), THE
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DEPARTMENT SHALL, WITHIN 24 HOURS, ASSIGN AN IRO TO REVIEW
THE EXPEDITED REQUEST FROM THE LIST OF APPROVED IROS COMPILED
AND MAINTAINED BY THE DEPARTMENT UNDER SECTION 2164.9 AND
NOTIFY THE INSURER OF THE NAME OF THE ASSIGNED IRO. THE
INSURER, OR A UTILIZATION REVIEW ORGANIZATION DESIGNATED BY
THE INSURER, SHALL THEN PROVIDE OR TRANSMIT ALL NECESSARY
DOCUMENTS AND INFORMATION CONSIDERED IN MAKING THE ADVERSE
BENEFIT DETERMINATION OR FINAL ADVERSE BENEFIT DETERMINATION
TO THE ASSIGNED IRO:
(I) ELECTRONICALLY.
(II) BY TELEPHONE.
(III) BY FACSIMILE.
(IV) BY ANY OTHER AVAILABLE EXPEDITIOUS METHOD.
(B) PRELIMINARY REVIEW REQUEST.--
(1) EXCEPT FOR A REQUEST FOR AN EXPEDITED EXTERNAL
REVIEW MADE UNDER SUBSECTION (A)(2), WITHIN ONE BUSINESS DAY
OF THE DATE OF RECEIPT OF THE REQUEST FOR EXTERNAL REVIEW,
THE DEPARTMENT SHALL NOTIFY THE INSURER OF THE DEPARTMENT'S
RECEIPT OF THE REQUEST.
(2) WITHIN FIVE BUSINESS DAYS OF THE DATE OF RECEIPT OF
THE NOTICE SENT UNDER PARAGRAPH (1), THE INSURER SHALL
CONDUCT AND COMPLETE A PRELIMINARY REVIEW OF THE REQUEST TO
DETERMINE WHETHER:
(I) THE INDIVIDUAL IS OR WAS A COVERED PERSON UNDER
THE HEALTH INSURANCE POLICY AT THE TIME THE HEALTH CARE
SERVICES WERE RECOMMENDED OR REQUESTED OR, IN THE CASE OF
A RETROSPECTIVE REVIEW, WAS A COVERED PERSON UNDER THE
HEALTH INSURANCE POLICY AT THE TIME THE HEALTH CARE
SERVICES WERE PROVIDED.
(II) THE RECOMMENDED OR REQUESTED HEALTH CARE
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SERVICE THAT IS THE SUBJECT OF THE ADVERSE BENEFIT
DETERMINATION OR FINAL ADVERSE BENEFIT DETERMINATION:
(A) IS A COVERED BENEFIT UNDER THE COVERED
PERSON'S HEALTH INSURANCE POLICY, EXCEPT FOR THE
INSURER'S DETERMINATION THAT THE HEALTH CARE SERVICE
IS EXPERIMENTAL OR INVESTIGATIONAL FOR A PARTICULAR
MEDICAL CONDITION.
(B) IS NOT EXPLICITLY LISTED AS AN EXCLUDED
BENEFIT UNDER THE COVERED PERSON'S HEALTH INSURANCE
POLICY.
(III) THE COVERED PERSON'S TREATING HEALTH CARE
PROVIDER HAS CERTIFIED THAT ONE OF THE FOLLOWING
SITUATIONS IS APPLICABLE:
(A) STANDARD HEALTH CARE SERVICES HAVE NOT BEEN
EFFECTIVE IN IMPROVING THE CONDITION OF THE COVERED
PERSON.
(B) STANDARD HEALTH CARE SERVICES ARE NOT
MEDICALLY APPROPRIATE FOR THE COVERED PERSON.
(C) THERE ARE NO AVAILABLE STANDARD HEALTH CARE
SERVICES COVERED UNDER THE HEALTH INSURANCE POLICY
THAT ARE MORE BENEFICIAL THAN THE RECOMMENDED OR
REQUESTED HEALTH CARE SERVICES DESCRIBED IN
SUBPARAGRAPH (IV).
(IV) THE COVERED PERSON'S TREATING HEALTH CARE
PROVIDER EITHER:
(A) HAS RECOMMENDED HEALTH CARE SERVICES THAT
THE HEALTH CARE PROVIDER CERTIFIES, IN WRITING, ARE
LIKELY TO BE MORE BENEFICIAL TO THE COVERED PERSON,
IN THE HEALTH CARE PROVIDER'S OPINION, THAN AVAILABLE
STANDARD HEALTH CARE SERVICES.
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(B) HAS CERTIFIED IN WRITING THAT SCIENTIFICALLY
VALID STUDIES USING ACCEPTED PROTOCOLS DEMONSTRATE
THAT THE HEALTH CARE SERVICES REQUESTED BY THE
COVERED PERSON WHO IS THE SUBJECT OF THE ADVERSE
BENEFIT DETERMINATION OR FINAL ADVERSE BENEFIT
DETERMINATION, ARE LIKELY TO BE MORE BENEFICIAL TO
THE COVERED PERSON THAN ANY AVAILABLE STANDARD HEALTH
CARE SERVICES, WHEN THE TREATING HEALTH CARE PROVIDER
IS A LICENSED, BOARD-CERTIFIED OR BOARD-ELIGIBLE
PHYSICIAN QUALIFIED TO PRACTICE IN THE AREA OF
MEDICINE APPROPRIATE TO TREAT THE COVERED PERSON'S
CONDITION.
(V) THE COVERED PERSON HAS EXHAUSTED THE INSURER'S
INTERNAL CLAIMS AND APPEAL PROCESS UNDER SECTION 2164,
UNLESS THE COVERED PERSON IS NOT REQUIRED TO EXHAUST THE
INSURER'S INTERNAL APPEAL PROCESS UNDER SECTION 2164.4.
(VI) THE COVERED PERSON HAS PROVIDED ALL THE
INFORMATION AND FORMS REQUIRED BY THE DEPARTMENT THAT ARE
NECESSARY TO PROCESS AN EXTERNAL REVIEW, INCLUDING THE
RELEASE FORM PROVIDED UNDER SECTION 2164.2(B).
(C) NOTICE OF INITIAL DETERMINATION.--
(1) WITHIN ONE BUSINESS DAY OF COMPLETION OF THE
PRELIMINARY REVIEW, THE INSURER SHALL NOTIFY THE DEPARTMENT
AND COVERED PERSON AND, IF APPLICABLE, THE COVERED PERSON'S
AUTHORIZED REPRESENTATIVE, IN WRITING WHETHER THE REQUEST IS
COMPLETE AND ELIGIBLE FOR EXTERNAL REVIEW.
(2) IF THE REQUEST:
(I) IS NOT COMPLETE, THE INSURER SHALL INFORM THE
COVERED PERSON AND, IF APPLICABLE, THE COVERED PERSON'S
AUTHORIZED REPRESENTATIVE AND THE DEPARTMENT IN WRITING
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AND INCLUDE IN THE NOTICE WHAT INFORMATION OR MATERIALS
ARE NEEDED TO MAKE THE REQUEST COMPLETE.
(II) IS NOT ELIGIBLE FOR EXTERNAL REVIEW, THE
INSURER SHALL INFORM THE COVERED PERSON AND, IF
APPLICABLE, THE COVERED PERSON'S AUTHORIZED
REPRESENTATIVE AND THE DEPARTMENT IN WRITING AND INCLUDE
IN THE NOTICE THE REASONS FOR THE REQUEST'S
INELIGIBILITY.
(3) NOTIFICATION PROVIDED UNDER PARAGRAPH (2) SHALL BE
PROVIDED IN A FORM SPECIFIED BY THE DEPARTMENT AND INCLUDE A
STATEMENT INFORMING THE COVERED PERSON AND, IF APPLICABLE,
THE COVERED PERSON'S AUTHORIZED REPRESENTATIVE OF AN
INSURER'S INITIAL DETERMINATION THAT THE REQUEST IS
INELIGIBLE FOR EXTERNAL REVIEW AND THAT THE EXTERNAL REVIEW
REQUEST MAY BE APPEALED TO THE DEPARTMENT.
(4) NOTWITHSTANDING AN INSURER'S INITIAL DETERMINATION
THAT THE REQUEST IS INELIGIBLE FOR REVIEW, THE DEPARTMENT MAY
DETERMINE, BASED UPON THE TERMS OF THE COVERED PERSON'S
HEALTH INSURANCE POLICY, THAT THE REQUEST IS ELIGIBLE FOR
EXTERNAL REVIEW UNDER SECTION 2164.5. THE DETERMINATION SHALL
BE BINDING ON THE INSURER AND THE COVERED PERSON AND MAY BE
APPEALED TO THE COMMISSIONER. CONSIDERATION OF THE APPEAL MAY
NOT DELAY OR TERMINATE THE EXTERNAL REVIEW.
(5) WHEN A REQUEST IS DETERMINED TO BE ELIGIBLE FOR
EXTERNAL REVIEW, THE INSURER SHALL NOTIFY THE DEPARTMENT, THE
COVERED PERSON AND, IF APPLICABLE, THE COVERED PERSON'S
AUTHORIZED REPRESENTATIVE.
(D) PROCEDURE FOR REVIEW OF REQUESTS ELIGIBLE FOR EXTERNAL
REVIEW.--
(1) WITHIN ONE BUSINESS DAY OF THE DATE OF RECEIPT OF
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NOTICE THAT A REQUEST IS ELIGIBLE FOR EXTERNAL REVIEW
FOLLOWING THE PRELIMINARY REVIEW CONDUCTED UNDER SUBSECTION
(C), THE DEPARTMENT SHALL:
(I) ASSIGN AN IRO TO CONDUCT THE EXTERNAL REVIEW
FROM THE LIST OF APPROVED IROS COMPILED AND MAINTAINED BY
THE DEPARTMENT UNDER SECTION 2164.9 AND NOTIFY THE
INSURER OF THE NAME OF THE ASSIGNED IRO.
(II) NOTIFY IN WRITING THE COVERED PERSON AND, IF
APPLICABLE, THE COVERED PERSON'S AUTHORIZED
REPRESENTATIVE OF THE REQUEST'S ELIGIBILITY AND
ACCEPTANCE FOR EXTERNAL REVIEW. THE NOTIFICATION SHALL
INCLUDE A STATEMENT THAT THE COVERED PERSON, OR THE
COVERED PERSON'S AUTHORIZED REPRESENTATIVE, MAY SUBMIT IN
WRITING TO THE ASSIGNED IRO, WITHIN FIVE BUSINESS DAYS OF
THE DATE OF RECEIPT OF THE NOTICE PROVIDED UNDER
SUBPARAGRAPH (I), ADDITIONAL INFORMATION THAT THE IRO
SHALL CONSIDER WHEN CONDUCTING THE EXTERNAL REVIEW. THE
IRO MAY ACCEPT AND CONSIDER ADDITIONAL INFORMATION
SUBMITTED AFTER FIVE BUSINESS DAYS.
(2) WITHIN ONE BUSINESS DAY OF THE RECEIPT OF THE NOTICE
OF ASSIGNMENT TO CONDUCT THE EXTERNAL REVIEW UNDER PARAGRAPH
(1), THE ASSIGNED IRO SHALL:
(I) SELECT ONE OR MORE CLINICAL REVIEWERS UNDER
PARAGRAPH (3) TO CONDUCT THE EXTERNAL REVIEW.
(II) BASED ON THE OPINION OR OPINIONS OF THE
CLINICAL REVIEWER OR REVIEWERS, MAKE A DECISION TO UPHOLD
OR REVERSE THE ADVERSE BENEFIT DETERMINATION OR FINAL
ADVERSE BENEFIT DETERMINATION.
(3) IN SELECTING A CLINICAL REVIEWER, THE ASSIGNED IRO
SHALL SELECT A PHYSICIAN OR OTHER HEALTH CARE PROVIDER WHO
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MEETS THE MINIMUM QUALIFICATIONS DESCRIBED IN SECTION 2611.1
AND, THROUGH CLINICAL EXPERIENCE IN THE PAST THREE YEARS, HAS
EXPERTISE IN THE TREATMENT OF THE COVERED PERSON'S CONDITION
AND IS KNOWLEDGEABLE ABOUT THE RECOMMENDED OR REQUESTED
HEALTH CARE SERVICE. THE COVERED PERSON, THE COVERED PERSON'S
AUTHORIZED REPRESENTATIVE AND, IF APPLICABLE, THE INSURER MAY
NOT CHOOSE OR CONTROL THE CHOICE OF THE PHYSICIAN OR OTHER
HEALTH CARE PROVIDER TO BE SELECTED TO CONDUCT THE EXTERNAL
REVIEW.
(4) IN ACCORDANCE WITH SUBSECTION (E), EACH CLINICAL
REVIEWER SHALL PROVIDE A WRITTEN OPINION TO THE ASSIGNED IRO
REGARDING WHETHER THE RECOMMENDED OR REQUESTED HEALTH CARE
SERVICE SHOULD BE COVERED.
(5) THE ASSIGNED CLINICAL REVIEWER IS NOT BOUND BY A
DECISION OR CONCLUSION REACHED DURING THE INSURER'S INTERNAL
CLAIMS AND APPEAL PROCESS UNDER SECTION 2164.
(E) FORWARDING OF REQUIRED DOCUMENTS.--
(1) WITHIN FIVE BUSINESS DAYS OF THE DATE OF RECEIPT OF
THE NOTICE PROVIDED UNDER SUBSECTION (D)(1), THE INSURER, OR
A UTILIZATION REVIEW ORGANIZATION DESIGNATED BY THE INSURER,
SHALL PROVIDE TO THE ASSIGNED IRO THE DOCUMENTS AND
INFORMATION CONSIDERED IN MAKING THE ADVERSE BENEFIT
DETERMINATION OR THE FINAL ADVERSE BENEFIT DETERMINATION.
(2) EXCEPT AS PROVIDED IN PARAGRAPH (3), FAILURE BY THE
INSURER, OR BY A UTILIZATION REVIEW ORGANIZATION DESIGNATED
BY THE INSURER, TO PROVIDE THE DOCUMENTS AND INFORMATION
WITHIN THE TIME PERIOD SPECIFIED IN PARAGRAPH (1) MAY NOT
DELAY THE CONDUCT OF THE EXTERNAL REVIEW.
(3) IF THE INSURER, OR A UTILIZATION REVIEW ORGANIZATION
DESIGNATED BY THE INSURER, FAILS TO PROVIDE THE DOCUMENTS AND
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INFORMATION WITHIN THE TIME PERIOD SPECIFIED IN PARAGRAPH
(1), THE ASSIGNED IRO MAY TERMINATE THE EXTERNAL REVIEW AND
MAKE A DECISION TO REVERSE THE ADVERSE BENEFIT DETERMINATION
OR FINAL ADVERSE BENEFIT DETERMINATION. WITHIN 24 HOURS UPON
MAKING THE DECISION, THE IRO SHALL NOTIFY THE DEPARTMENT, THE
INSURER, THE COVERED PERSON, AND, IF APPLICABLE, THE COVERED
PERSON'S AUTHORIZED REPRESENTATIVE.
(F) REVIEW OF INFORMATION.--
(1) EACH CLINICAL REVIEWER SELECTED UNDER SUBSECTION (D)
SHALL REVIEW ALL OF THE INFORMATION AND DOCUMENTS RECEIVED
UNDER SUBSECTION (E) AND OTHER INFORMATION SUBMITTED IN
WRITING BY THE COVERED PERSON OR COVERED PERSON'S AUTHORIZED
REPRESENTATIVE UNDER SUBSECTION (D)(1)(II).
(2) WITHIN ONE BUSINESS DAY OF RECEIPT OF INFORMATION
SUBMITTED BY THE COVERED PERSON OR COVERED PERSON'S
AUTHORIZED REPRESENTATIVE UNDER SUBSECTION (D)(1)(II), THE
ASSIGNED IRO SHALL FORWARD THE INFORMATION TO THE INSURER.
(G) RECONSIDERATION BY INSURER.--
(1) UPON RECEIPT OF THE INFORMATION, IF ANY, REQUIRED TO
BE FORWARDED UNDER SUBSECTION (F)(2), THE INSURER MAY
RECONSIDER AN ADVERSE BENEFIT DETERMINATION OR FINAL ADVERSE
BENEFIT DETERMINATION THAT IS THE SUBJECT OF THE EXTERNAL
REVIEW.
(2) RECONSIDERATION BY THE INSURER OF AN ADVERSE BENEFIT
DETERMINATION OR FINAL ADVERSE BENEFIT DETERMINATION UNDER
PARAGRAPH (1) MAY NOT DELAY OR TERMINATE THE EXTERNAL REVIEW.
(3) THE EXTERNAL REVIEW MAY BE TERMINATED WITHOUT AN IRO
DETERMINATION ONLY IF THE INSURER DECIDES, UPON COMPLETION OF
RECONSIDERATION, TO REVERSE THE ADVERSE BENEFIT DETERMINATION
OR FINAL ADVERSE BENEFIT DETERMINATION AND PROVIDE COVERAGE
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OR PAYMENT FOR THE RECOMMENDED HEALTH CARE SERVICE THAT IS
THE SUBJECT OF THE EXTERNAL REVIEW.
(4) WITHIN ONE BUSINESS DAY OF MAKING THE DECISION TO
REVERSE THE INSURER'S ADVERSE BENEFIT DETERMINATION OR FINAL
ADVERSE BENEFIT DETERMINATION, AS PROVIDED IN PARAGRAPH (3),
THE INSURER SHALL NOTIFY THE DEPARTMENT, THE ASSIGNED IRO,
THE COVERED PERSON, AND, IF APPLICABLE, THE COVERED PERSON'S
AUTHORIZED REPRESENTATIVE, IN WRITING OF THE INSURER'S
DECISION.
(5) THE ASSIGNED IRO SHALL TERMINATE THE EXTERNAL REVIEW
UPON RECEIPT OF THE NOTICE FROM THE INSURER UNDER PARAGRAPH
(4).
(H) CLINICAL REVIEW PROCESS.--
(1) EXCEPT AS PROVIDED IN PARAGRAPH (3), WITHIN 20 DAYS
OF BEING SELECTED IN ACCORDANCE WITH SUBSECTION (D) TO
CONDUCT THE EXTERNAL REVIEW, EACH CLINICAL REVIEWER SHALL
PROVIDE AN OPINION TO THE ASSIGNED IRO REGARDING WHETHER THE
RECOMMENDED OR REQUESTED HEALTH CARE SERVICE SHOULD BE
COVERED.
(2) EXCEPT FOR AN OPINION PROVIDED UNDER PARAGRAPH (3),
A CLINICAL REVIEWER'S OPINION SHALL BE IN WRITING AND INCLUDE
THE FOLLOWING INFORMATION:
(I) A DESCRIPTION OF THE COVERED PERSON'S MEDICAL
CONDITION.
(II) A DESCRIPTION OF THE INDICATORS RELEVANT TO
DETERMINING WHETHER THERE IS SUFFICIENT EVIDENCE TO
DEMONSTRATE THAT:
(A) THE RECOMMENDED OR REQUESTED HEALTH CARE
SERVICE IS MORE LIKELY THAN NOT TO BE BENEFICIAL TO
THE COVERED PERSON THAN ANY AVAILABLE STANDARD HEALTH
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CARE SERVICE.
(B) THE ADVERSE RISKS OF THE RECOMMENDED OR
REQUESTED HEALTH CARE SERVICE WOULD NOT BE
SUBSTANTIALLY INCREASED OVER THE ADVERSE RISKS OF
AVAILABLE STANDARD HEALTH CARE SERVICE.
(III) A DESCRIPTION AND ANALYSIS OF MEDICAL OR
SCIENTIFIC EVIDENCE CONSIDERED IN REACHING THE OPINION.
(IV) A DESCRIPTION AND ANALYSIS OF AN EVIDENCE-BASED
STANDARD.
(V) INFORMATION ON WHETHER THE REVIEWER'S RATIONALE
FOR THE OPINION IS BASED ON SUBSECTION (I)(5)(I) OR (II).
(3) THE FOLLOWING SHALL APPLY:
(I) FOR AN EXPEDITED EXTERNAL REVIEW, A CLINICAL
REVIEWER SHALL PROVIDE AN OPINION ORALLY OR IN WRITING TO
THE ASSIGNED IRO AS EXPEDITIOUSLY AS THE COVERED PERSON'S
MEDICAL CONDITION OR CIRCUMSTANCES REQUIRE, BUT IN NO
EVENT MORE THAN FIVE CALENDAR DAYS AFTER BEING SELECTED
IN ACCORDANCE WITH SUBSECTION (D).
(II) IF THE OPINION PROVIDED UNDER SUBPARAGRAPH (I)
IS NOT IN WRITING, WITHIN 48 HOURS OF THE DATE THE
OPINION WAS PROVIDED, THE CLINICAL REVIEWER SHALL PROVIDE
WRITTEN CONFIRMATION OF THE OPINION TO THE ASSIGNED IRO
AND INCLUDE THE INFORMATION REQUIRED UNDER PARAGRAPH (2).
(I) FACTORS TO BE CONSIDERED.--IN ADDITION TO THE DOCUMENTS
AND INFORMATION PROVIDED UNDER SUBSECTION (A)(2) OR (E), A
CLINICAL REVIEWER SELECTED UNDER SUBSECTION (D), TO THE EXTENT
THE INFORMATION OR DOCUMENTS ARE AVAILABLE AND THE REVIEWER
CONSIDERS APPROPRIATE, SHALL CONSIDER THE FOLLOWING IN REACHING
AN OPINION UNDER SUBSECTION (H):
(1) THE COVERED PERSON'S MEDICAL RECORDS.
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(2) THE ATTENDING HEALTH CARE PROVIDER'S RECOMMENDATION.
(3) CONSULTING REPORTS FROM APPROPRIATE HEALTH CARE
PROVIDERS AND OTHER DOCUMENTS SUBMITTED BY THE INSURER, THE
COVERED PERSON, AND, IF APPLICABLE, THE COVERED PERSON'S
AUTHORIZED REPRESENTATIVE OR TREATING PROVIDER.
(4) THE TERMS OF COVERAGE UNDER THE COVERED PERSON'S
HEALTH INSURANCE POLICY TO ENSURE THAT THE IRO'S DECISION IS
NOT CONTRARY TO THE TERMS.
(5) WHETHER EITHER OF THE FOLLOWING IS SATISFIED:
(I) THE RECOMMENDED OR REQUESTED HEALTH CARE SERVICE
HAS BEEN APPROVED BY THE UNITED STATES FOOD AND DRUG
ADMINISTRATION, IF APPLICABLE, FOR THE CONDITION.
(II) MEDICAL OR SCIENTIFIC EVIDENCE OR EVIDENCE-
BASED STANDARDS DEMONSTRATE THAT:
(A) THE EXPECTED BENEFIT OF THE RECOMMENDED OR
REQUESTED HEALTH CARE SERVICE IS MORE LIKELY THAN NOT
TO BE BENEFICIAL TO THE COVERED PERSON THAN ANY
AVAILABLE STANDARD HEALTH CARE SERVICE.
(B) THE ADVERSE RISKS OF THE RECOMMENDED OR
REQUESTED HEALTH CARE SERVICE WOULD NOT BE
SUBSTANTIALLY INCREASED OVER THE ADVERSE RISKS OF AN
AVAILABLE STANDARD HEALTH CARE SERVICE.
(J) NOTICE OF DECISION.--
(1) WITHIN 20 DAYS OF THE DATE THE ASSIGNED IRO RECEIVES
THE OPINION OF A CLINICAL REVIEWER, THE ASSIGNED IRO SHALL
PROVIDE WRITTEN NOTICE OF THE ASSIGNED IRO'S DECISION TO
UPHOLD OR REVERSE THE ADVERSE BENEFIT DETERMINATION TO:
(I) THE COVERED PERSON.
(II) IF APPLICABLE, THE COVERED PERSON'S AUTHORIZED
REPRESENTATIVE.
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(III) THE INSURER.
(IV) THE DEPARTMENT.
(2) IF A MAJORITY OF THE CLINICAL REVIEWERS RECOMMEND
THAT:
(I) THE RECOMMENDED OR REQUESTED HEALTH CARE SERVICE
BE COVERED, THE IRO SHALL MAKE A DECISION TO REVERSE THE
INSURER'S ADVERSE BENEFIT DETERMINATION OR FINAL ADVERSE
BENEFIT DETERMINATION.
(II) THE RECOMMENDED OR REQUESTED HEALTH CARE
SERVICE NOT BE COVERED, THE IRO SHALL MAKE A DECISION TO
UPHOLD THE INSURER'S ADVERSE BENEFIT DETERMINATION OR
FINAL ADVERSE BENEFIT DETERMINATION.
(3) IF THE CLINICAL REVIEWERS ARE EVENLY DIVIDED AS TO
WHETHER THE RECOMMENDED OR REQUESTED HEALTH CARE SERVICE
SHOULD BE COVERED:
(I) THE IRO SHALL OBTAIN THE OPINION OF AN
ADDITIONAL CLINICAL REVIEWER IN ORDER FOR THE IRO TO MAKE
A DECISION BASED ON THE OPINIONS OF A MAJORITY OF THE
CLINICAL REVIEWERS.
(II) THE ADDITIONAL CLINICAL REVIEWER SELECTED SHALL
USE THE SAME INFORMATION TO REACH AN OPINION AS THE
CLINICAL REVIEWERS WHO HAVE ALREADY SUBMITTED THEIR
OPINION.
(III) THE SELECTION OF THE ADDITIONAL CLINICAL
REVIEWER MAY NOT EXTEND THE TIME WITHIN WHICH THE
ASSIGNED IRO IS REQUIRED TO MAKE A DECISION.
(4) THE IRO SHALL INCLUDE THE FOLLOWING IN THE NOTICE
PROVIDED UNDER PARAGRAPH (1):
(I) A GENERAL DESCRIPTION OF THE REASON FOR THE
REQUEST FOR EXTERNAL REVIEW.
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(II) THE WRITTEN OPINION OF EACH CLINICAL REVIEWER,
INCLUDING THE RECOMMENDATION OF EACH CLINICAL REVIEWER AS
TO WHETHER THE RECOMMENDED OR REQUESTED HEALTH CARE
SERVICE SHOULD BE COVERED AND THE RATIONALE FOR THE
REVIEWER'S RECOMMENDATION.
(III) THE DATE THE IRO WAS ASSIGNED BY THE
DEPARTMENT TO CONDUCT THE EXTERNAL REVIEW.
(IV) THE DATE OF THE EXTERNAL REVIEW.
(V) THE DATE OF THE IRO'S DECISION.
(VI) THE PRINCIPAL REASON OR REASONS FOR THE IRO'S
DECISION.
(VII) THE RATIONALE FOR THE IRO'S DECISION.
(5) UPON RECEIPT OF A NOTICE OF A DECISION UNDER
PARAGRAPH (1) REVERSING THE ADVERSE BENEFIT DETERMINATION OR
FINAL ADVERSE BENEFIT DETERMINATION, THE INSURER SHALL,
WITHIN 24 HOURS, APPROVE THE COVERAGE THAT WAS THE SUBJECT OF
THE ADVERSE BENEFIT DETERMINATION OR FINAL ADVERSE BENEFIT
DETERMINATION.
(K) ASSIGNMENT OF IRO.--THE DEPARTMENT SHALL ASSIGN, ON A
RANDOM BASIS, AN APPROVED IRO AMONG THOSE QUALIFIED TO CONDUCT
THE PARTICULAR EXTERNAL REVIEW BASED ON THE NATURE OF THE HEALTH
CARE SERVICE THAT IS THE SUBJECT OF THE ADVERSE BENEFIT
DETERMINATION OR FINAL ADVERSE BENEFIT DETERMINATION, AND SHALL
CONSIDER THE CONFLICT-OF-INTEREST CONCERNS UNDER SECTION
2164.10(D).
SECTION 2164.8. BINDING NATURE OF EXTERNAL REVIEW DECISION.
(A) BINDING ON INSURER.--AN EXTERNAL REVIEW DECISION SHALL
BE BINDING ON THE INSURER, EXCEPT TO THE EXTENT THE INSURER HAS
OTHER REMEDIES AVAILABLE UNDER APPLICABLE STATE LAW.
(B) BINDING ON COVERED PERSON.--AN EXTERNAL REVIEW DECISION
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SHALL BE BINDING ON A COVERED PERSON, EXCEPT TO THE EXTENT THE
COVERED PERSON HAS OTHER REMEDIES AVAILABLE UNDER APPLICABLE
FEDERAL AND STATE LAW.
(C) FINALITY OF DECISION.--NEITHER THE COVERED PERSON NOR
THE COVERED PERSON'S AUTHORIZED REPRESENTATIVE MAY FILE A
SUBSEQUENT REQUEST FOR EXTERNAL REVIEW INVOLVING THE SAME
ADVERSE BENEFIT DETERMINATION OR FINAL ADVERSE BENEFIT
DETERMINATION FOR WHICH THE COVERED PERSON HAS ALREADY RECEIVED
AN EXTERNAL REVIEW DECISION UNDER THIS SUBARTICLE.
SECTION 2164.9. DEPARTMENT APPROVAL OF INDEPENDENT REVIEW
ORGANIZATIONS.
(A) GENERAL RULE.--THE DEPARTMENT MAY APPROVE AN IRO
ELIGIBLE TO BE ASSIGNED TO CONDUCT EXTERNAL REVIEWS UNDER THIS
SUBDIVISION.
(B) ELIGIBILITY REQUIREMENTS.--TO BE ELIGIBLE FOR APPROVAL
BY THE DEPARTMENT UNDER THIS SECTION TO CONDUCT EXTERNAL REVIEWS
UNDER THIS SUBDIVISION, AN IRO MUST:
(1) EXCEPT AS OTHERWISE PROVIDED IN THIS SECTION, BE
ACCREDITED BY A NATIONALLY RECOGNIZED PRIVATE ACCREDITING
ENTITY THAT THE DEPARTMENT HAS DETERMINED TO POSSESS IRO
ACCREDITATION STANDARDS THAT ARE EQUIVALENT TO OR EXCEED THE
MINIMUM QUALIFICATIONS FOR THE IROS ESTABLISHED UNDER SECTION
2611.1.
(2) SUBMIT AN APPLICATION FOR APPROVAL IN ACCORDANCE
WITH SUBSECTION (D).
(3) IDENTIFY THE IRO'S PROPOSED FEES FOR EXTERNAL
REVIEWS.
(C) FORM OF APPLICATION.--THE DEPARTMENT SHALL DEVELOP AN
APPLICATION FORM FOR INITIALLY APPROVING AND FOR RENEWING THE
APPROVAL OF IROS TO CONDUCT EXTERNAL REVIEWS.
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(D) CONSIDERATION OF APPLICATION.--
(1) AN IRO SEEKING APPROVAL TO CONDUCT EXTERNAL REVIEWS
UNDER THIS SUBDIVISION SHALL SUBMIT THE APPLICATION FORM AND
INCLUDE WITH THE FORM ALL DOCUMENTATION AND INFORMATION
NECESSARY FOR THE DEPARTMENT TO DETERMINE WHETHER THE IRO
SATISFIES THE MINIMUM QUALIFICATIONS ESTABLISHED UNDER
SECTION 2164.10.
(2) THE DEPARTMENT MAY APPROVE AN IRO THAT IS NOT
ACCREDITED BY A NATIONALLY RECOGNIZED PRIVATE ACCREDITING
ENTITY IF THERE ARE NO ACCEPTABLE NATIONALLY RECOGNIZED
PRIVATE ACCREDITING ENTITIES PROVIDING IRO ACCREDITATION.
(3) THE DEPARTMENT MAY CHARGE THE IRO AN APPLICATION FEE
TO BE SUBMITTED WITH AN APPLICATION FOR APPROVAL OR FOR
RENEWAL.
(4) THE DEPARTMENT MAY DECLINE TO CERTIFY AN IRO IF THE
IRO'S PROPOSED FEES FOR EXTERNAL REVIEWS ARE DETERMINED BY
THE DEPARTMENT TO BE UNREASONABLE.
(E) DURATION OF APPROVAL.--
(1) AN APPROVAL SHALL BE VALID FOR TWO YEARS UNLESS THE
DEPARTMENT DETERMINES BEFORE THE APPROVAL EXPIRES THAT THE
IRO NO LONGER SATISFIES THE MINIMUM QUALIFICATIONS
ESTABLISHED UNDER SECTION 2164.10.
(2) IF THE DEPARTMENT DETERMINES THAT AN IRO IS NO
LONGER ACCREDITED OR NO LONGER SATISFIES THE MINIMUM
REQUIREMENTS ESTABLISHED UNDER SECTION 2164.10, THE
DEPARTMENT MAY TERMINATE THE APPROVAL OF THE IRO AND REMOVE
THE IRO FROM THE LIST OF IROS APPROVED TO CONDUCT EXTERNAL
REVIEWS UNDER THIS SUBDIVISION.
(F) LIST OF APPROVED IROS.--THE DEPARTMENT SHALL MAINTAIN
AND PERIODICALLY UPDATE A LIST OF APPROVED IROS. THE DEPARTMENT
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SHALL PERIODICALLY TRANSMIT NOTICE A LIST OF APPROVED IROS TO
THE LEGISLATIVE REFERENCE BUREAU FOR PUBLICATION IN THE
PENNSYLVANIA BULLETIN.
(G) NO PROHIBITION.--NOTHING IN THIS SECTION OR IN SECTION
2164.10 SHALL PROHIBIT AN ENTITY CERTIFIED AS A UTILIZATION
REVIEW ENTITY FROM BEING APPROVED AS AN IRO.
SECTION 2164.10. MINIMUM QUALIFICATIONS FOR INDEPENDENT REVIEW
ORGANIZATIONS.
(A) REQUIREMENTS FOR DEPARTMENT APPROVAL.--TO BE APPROVED
UNDER SECTION 2164.9 TO CONDUCT EXTERNAL REVIEWS AND EXTERNAL
GRIEVANCES, AN IRO MUST ESTABLISH AND MAINTAIN WRITTEN POLICIES
AND PROCEDURES THAT GOVERN ALL ASPECTS OF BOTH THE STANDARD AND
EXPEDITED ADVERSE BENEFIT DETERMINATION EXTERNAL REVIEW AND
EXTERNAL GRIEVANCE REVIEW REQUIRED BY SECTIONS 2162, 2162.6 AND
2162.7 THAT INCLUDE, AT A MINIMUM:
(1) A QUALITY ASSURANCE MECHANISM IN PLACE THAT ENSURES:
(I) THAT AN EXTERNAL REVIEW IS CONDUCTED WITHIN THE
SPECIFIED TIME PERIOD AND THAT REQUIRED NOTICES ARE
PROVIDED IN A TIMELY MANNER.
(II) THE SELECTION OF QUALIFIED AND IMPARTIAL
CLINICAL REVIEWERS TO CONDUCT EXTERNAL REVIEW ON BEHALF
OF THE IRO, AND SUITABLE MATCHING OF REVIEWERS TO
SPECIFIC CASES.
(III) THAT AN IRO EMPLOYS OR CONTRACTS WITH AN
ADEQUATE NUMBER OF CLINICAL REVIEWERS TO SUITABLY MATCH
REVIEWERS TO SPECIFIC CASES.
(IV) THE CONFIDENTIALITY OF MEDICAL AND TREATMENT
RECORDS AND CLINICAL REVIEW CRITERIA.
(V) THAT A PERSON EMPLOYED BY OR UNDER CONTRACT WITH
THE IRO ADHERES TO THE REQUIREMENTS OF THIS SUBDIVISION.
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(VI) THAT THE IRO AND ITS ASSIGNED CLINICAL
REVIEWERS ARE UNBIASED IN THE CONDUCT OF AN EXTERNAL
REVIEW.
(2) A TOLL-FREE TELEPHONE SERVICE TO RECEIVE INFORMATION
24 HOURS PER DAY, 7 DAYS PER WEEK, RELATED TO EXTERNAL
REVIEWS, THAT IS CAPABLE OF ACCEPTING, RECORDING OR PROVIDING
APPROPRIATE INSTRUCTION TO INCOMING TELEPHONE CALLERS DURING
OTHER-THAN-NORMAL BUSINESS HOURS.
(3) AN AGREEMENT TO MAINTAIN AND PROVIDE TO THE
DEPARTMENT THE INFORMATION DESCRIBED IN SECTION 2164.12.
(B) QUALIFICATIONS OF CLINICAL REVIEWER.--A CLINICAL
REVIEWER ASSIGNED BY AN IRO TO CONDUCT EXTERNAL REVIEW MUST BE A
PHYSICIAN OR OTHER APPROPRIATE HEALTH CARE PROVIDER WHO MEETS
THE FOLLOWING MINIMUM QUALIFICATIONS:
(1) HAS EXPERTISE IN THE TREATMENT OF THE COVERED
PERSON'S OR ENROLLEE'S MEDICAL CONDITION THAT IS THE SUBJECT
OF THE EXTERNAL REVIEW.
(2) IS KNOWLEDGEABLE ABOUT THE RECOMMENDED HEALTH CARE
SERVICE THROUGH RECENT OR CURRENT ACTUAL CLINICAL EXPERIENCE
TREATING PATIENTS WITH THE SAME OR SIMILAR MEDICAL CONDITION
OF THE COVERED PERSON OR ENROLLEE.
(3) HOLDS A NONRESTRICTED LICENSE IN A STATE OR
COMMONWEALTH OF THE UNITED STATES AND, FOR A PHYSICIAN, A
CURRENT CERTIFICATION FROM A RECOGNIZED AMERICAN MEDICAL
SPECIALTY BOARD IN THE AREA OR AREAS OF MEDICINE APPROPRIATE
TO THE SUBJECT OF THE EXTERNAL REVIEW.
(4) HAS NO HISTORY OF DISCIPLINARY ACTIONS OR SANCTIONS,
INCLUDING LOSS OF STAFF PRIVILEGES OR PARTICIPATION
RESTRICTIONS, THAT HAVE BEEN TAKEN OR ARE PENDING BY A
HOSPITAL, GOVERNMENTAL AGENCY OR UNIT OR REGULATORY BODY THAT
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RAISE A SUBSTANTIAL QUESTION AS TO THE CLINICAL REVIEWER'S
PHYSICAL, MENTAL OR PROFESSIONAL COMPETENCE OR MORAL
CHARACTER.
(C) PROHIBITED RELATIONSHIPS.--IN ADDITION TO THE
REQUIREMENTS UNDER SUBSECTION (A), AN IRO MAY NOT OWN OR
CONTROL, BE A SUBSIDIARY OF OR IN ANY WAY BE OWNED OR CONTROLLED
BY OR EXERCISE CONTROL WITH AN INSURER OR MA OR CHIP MANAGED
CARE PLAN, A NATIONAL, STATE OR LOCAL TRADE ASSOCIATION OF
INSURERS OR MA OR CHIP MANAGED CARE PLANS, OR HEALTH CARE
PROVIDERS.
(D) CONFLICTS OF INTEREST.--
(1) IN ADDITION TO THE REQUIREMENTS UNDER THIS SECTION,
TO BE APPROVED UNDER SECTIONS 2162, 2162.6 OR 2162.7 TO
CONDUCT AN EXTERNAL REVIEW OF A SPECIFIED CASE, NEITHER THE
IRO SELECTED TO CONDUCT THE EXTERNAL REVIEW NOR A CLINICAL
REVIEWER ASSIGNED BY THE IRO TO CONDUCT THE EXTERNAL REVIEW
MAY HAVE A MATERIAL PROFESSIONAL, FAMILIAL OR FINANCIAL
CONFLICT OF INTEREST WITH ANY OF THE FOLLOWING:
(I) THE INSURER OR MA OR CHIP MANAGED CARE PLAN THAT
IS THE SUBJECT OF THE EXTERNAL REVIEW.
(II) THE COVERED PERSON OR ENROLLEE WHOSE TREATMENT
IS THE SUBJECT OF THE EXTERNAL REVIEW OR THE COVERED
PERSON'S OR ENROLLEE'S AUTHORIZED REPRESENTATIVE.
(III) AN OFFICER, DIRECTOR OR MANAGEMENT EMPLOYEE OF
THE INSURER OR MA OR CHIP MANAGED CARE PLAN THAT IS THE
SUBJECT OF THE EXTERNAL REVIEW.
(IV) THE HEALTH CARE PROVIDER, THE HEALTH CARE
PROVIDER'S MEDICAL GROUP OR INDEPENDENT PRACTICE
ASSOCIATION RECOMMENDING THE HEALTH CARE SERVICE THAT IS
THE SUBJECT OF THE EXTERNAL REVIEW.
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(V) THE FACILITY AT WHICH THE RECOMMENDED HEALTH
CARE SERVICE WOULD BE PROVIDED.
(VI) THE DEVELOPER OR MANUFACTURER OF THE PRINCIPAL
DRUG, DEVICE, PROCEDURE OR OTHER THERAPY BEING
RECOMMENDED FOR THE COVERED PERSON OR ENROLLEE WHOSE
TREATMENT IS THE SUBJECT OF THE EXTERNAL REVIEW.
(2) IN DETERMINING WHETHER AN IRO OR CLINICAL REVIEWER
OF THE IRO HAS A MATERIAL PROFESSIONAL, FAMILIAL OR FINANCIAL
CONFLICT OF INTEREST FOR PURPOSES OF PARAGRAPH (1), THE
DEPARTMENT SHALL TAKE INTO CONSIDERATION SITUATIONS WHERE AN
APPARENT CONFLICT OF INTEREST UNDER PARAGRAPH (1) IS NOT
MATERIAL.
(E) ACCREDITATION.--
(1) AN IRO THAT IS ACCREDITED BY A NATIONALLY RECOGNIZED
PRIVATE ACCREDITING ENTITY THAT POSSESSES INDEPENDENT REVIEW
ACCREDITATION STANDARDS THAT THE DEPARTMENT HAS DETERMINED
ARE EQUIVALENT TO OR EXCEED THE MINIMUM QUALIFICATIONS OF
THIS SECTION SHALL BE PRESUMED TO BE IN COMPLIANCE WITH THIS
SECTION TO BE ELIGIBLE FOR APPROVAL UNDER SECTION 2164.9.
(2) THE DEPARTMENT SHALL INITIALLY AND PERIODICALLY
REVIEW THE IRO ACCREDITATION STANDARDS OF A NATIONALLY
RECOGNIZED PRIVATE ACCREDITING ENTITY TO DETERMINE WHETHER
THE ENTITY'S STANDARDS ARE, AND CONTINUE TO BE, EQUIVALENT TO
OR EXCEEDING THE MINIMUM QUALIFICATIONS ESTABLISHED UNDER
THIS SECTION. THE DEPARTMENT MAY ACCEPT A REVIEW CONDUCTED BY
THE NAIC FOR THE PURPOSES OF THE DETERMINATION UNDER THIS
PARAGRAPH.
(3) UPON REQUEST, A NATIONALLY RECOGNIZED PRIVATE
ACCREDITING ENTITY SHALL MAKE ITS CURRENT IRO ACCREDITATION
STANDARDS AVAILABLE TO THE DEPARTMENT OR THE NAIC IN ORDER
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FOR THE DEPARTMENT TO DETERMINE IF THE ENTITY'S STANDARDS
EXCEED OR ARE EQUIVALENT TO THE MINIMUM QUALIFICATIONS
ESTABLISHED UNDER THIS SECTION. THE DEPARTMENT MAY EXCLUDE A
PRIVATE ACCREDITING ENTITY THAT IS NOT REVIEWED BY THE NAIC.
SECTION 2164.11. HOLD HARMLESS FOR INDEPENDENT REVIEW
ORGANIZATIONS.
NO IRO, CLINICAL REVIEWER WORKING ON BEHALF OF AN IRO OR AN
EMPLOYEE, AGENT OR CONTRACTOR OF AN IRO MAY BE HELD LIABLE FOR
DAMAGES TO A PERSON FOR AN OPINION RENDERED, OR ACT OR OMISSION
PERFORMED, WITHIN THE SCOPE OF THE ORGANIZATION'S OR PERSON'S
DUTIES UNDER THE LAW DURING OR UPON COMPLETION OF AN EXTERNAL
REVIEW CONDUCTED UNDER THIS SUBDIVISION, UNLESS THE OPINION WAS
RENDERED, OR ACT OR OMISSION PERFORMED, IN BAD FAITH OR INVOLVED
GROSS NEGLIGENCE.
SECTION 2164.12. EXTERNAL REVIEW REPORTING REQUIREMENTS.
(A) RECORDKEEPING BY IROS.--
(1) AN IRO ASSIGNED UNDER THIS SUBDIVISION TO CONDUCT AN
EXTERNAL REVIEW SHALL MAINTAIN WRITTEN RECORDS IN THE
AGGREGATE FOR THE ENTIRE COMMONWEALTH AND FOR EACH INSURER OR
MA OR CHIP MANAGED CARE PLAN, ON ALL REQUESTS FOR WHICH THE
IRO CONDUCTED AN EXTERNAL REVIEW DURING A CALENDAR YEAR.
(2) AN IRO REQUIRED TO MAINTAIN WRITTEN RECORDS UNDER
PARAGRAPH (1) ON ALL REQUESTS FOR EXTERNAL REVIEW FOR WHICH
THE IRO WAS ASSIGNED TO CONDUCT AN EXTERNAL REVIEW SHALL
SUBMIT TO THE DEPARTMENT, UPON REQUEST, A REPORT IN THE
FORMAT SPECIFIED BY THE DEPARTMENT.
(3) THE REPORT SHALL INCLUDE IN THE AGGREGATE, FOR THE
ENTIRE COMMONWEALTH AND FOR EACH INSURER OR MA OR CHIP
MANAGED CARE PLAN:
(I) THE TOTAL NUMBER OF REQUESTS FOR EXTERNAL
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REVIEW.
(II) THE NUMBER OF REQUESTS FOR EXTERNAL REVIEW
RESOLVE AND, OF THOSE RESOLVED, THE NUMBER RESOLVED
UPHOLDING THE ADVERSE BENEFIT DETERMINATION OR FINAL
ADVERSE BENEFIT DETERMINATION AND THE NUMBER RESOLVED
REVERSING THE ADVERSE BENEFIT DETERMINATION OR FINAL
ADVERSE BENEFIT DETERMINATION.
(III) THE AVERAGE LENGTH OF TIME FOR EXTERNAL REVIEW
REQUEST RESOLUTION.
(IV) A SUMMARY OF THE TYPES OF COVERAGES OR CASES
FOR WHICH AN EXTERNAL REVIEW WAS SOUGHT, PROVIDED IN A
FORMAT SPECIFIED BY THE DEPARTMENT.
(V) THE NUMBER OF EXTERNAL REVIEWS UNDER SECTIONS
2164.5 AND 2164.7 THAT WERE TERMINATED AS THE RESULT OF A
RECONSIDERATION BY THE INSURER OF THE ADVERSE BENEFIT
DETERMINATION OR FINAL ADVERSE BENEFIT DETERMINATION
AFTER THE RECEIPT OF ADDITIONAL INFORMATION FROM THE
COVERED PERSON OR THE COVERED PERSON'S AUTHORIZED
REPRESENTATIVE.
(VI) OTHER INFORMATION THE DEPARTMENT MAY REQUEST OR
REQUIRE.
(4) THE IRO SHALL RETAIN THE WRITTEN RECORDS REQUIRED
UNDER THIS SUBSECTION FOR AT LEAST THREE YEARS.
(B) RECORDKEEPING BY INSURERS.--
(1) AN INSURER SHALL MAINTAIN WRITTEN RECORDS IN THE
AGGREGATE, FOR THE ENTIRE COMMONWEALTH, FOR EACH TYPE OF
HEALTH INSURANCE POLICY OFFERED BY THE INSURER, ON ALL
REQUESTS FOR EXTERNAL REVIEW AS TO WHICH THE INSURER RECEIVES
NOTICE FROM THE DEPARTMENT UNDER THIS SUBARTICLE.
(2) AN INSURER REQUIRED TO MAINTAIN WRITTEN RECORDS
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UNDER PARAGRAPH (1) SHALL SUBMIT TO THE DEPARTMENT, UPON
REQUEST, A REPORT IN THE FORMAT SPECIFIED BY THE DEPARTMENT.
(3) THE REPORT SHALL INCLUDE IN THE AGGREGATE, FOR THE
ENTIRE COMMONWEALTH AND FOR EACH TYPE OF HEALTH INSURANCE
POLICY OFFERED BY THE INSURER:
(I) THE TOTAL NUMBER OF REQUESTS FOR EXTERNAL
REVIEW.
(II) OF THE TOTAL NUMBER OF REQUESTS FOR EXTERNAL
REVIEW REPORTED UNDER SUBPARAGRAPH (I), THE NUMBER OF
REQUESTS DETERMINED ELIGIBLE FOR EXTERNAL REVIEW.
(III) OTHER INFORMATION THE DEPARTMENT MAY REQUEST
OR REQUIRE.
(4) THE INSURER SHALL RETAIN THE WRITTEN RECORDS
REQUIRED UNDER THIS SUBSECTION FOR AT LEAST THREE YEARS.
SECTION 2164.13. FUNDING OF EXTERNAL REVIEW.
(A) COST.--THE INSURER AGAINST WHICH A REQUEST FOR STANDARD
EXTERNAL REVIEW OR EXPEDITED EXTERNAL REVIEW UNDER SECTION
2164.5, 2164.6 OR 2164.7 IS FILED SHALL PAY THE COST OF THE IRO
TO CONDUCT THE EXTERNAL REVIEW.
(B) FEES.--THE FEES CHARGED BY AN IRO SHALL BE REASONABLE
AND CUSTOMARY. THE DEPARTMENT SHALL ANNUALLY TRANSMIT NOTICE OF
THE FEES FOR THE TYPES OF ADVERSE BENEFIT DETERMINATIONS UNDER
REVIEW TO THE LEGISLATIVE REFERENCE BUREAU FOR PUBLICATION IN
THE PENNSYLVANIA BULLETIN.
(C) NO FEE.--A COVERED PERSON OR THE COVERED PERSON'S
AUTHORIZED REPRESENTATIVE MAY NOT BE CHARGED A FEE IN ORDER TO
FILE A REQUEST FOR EXTERNAL REVIEW.
SECTION 2164.14. AVAILABILITY OF FORMS.
(A) GENERAL RULE.--THE DEPARTMENT SHALL MAKE AVAILABLE, IN
AN ELECTRONIC FORMAT AND, UPON REQUEST, IN PRINT FORMAT, ANY
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APPLICABLE FORMS ADOPTED BY THE DEPARTMENT RELATED TO AN ADVERSE
BENEFIT DETERMINATION REQUEST, NOTICE OF INITIAL DETERMINATION
BY INSURER, HEALTH CARE PROVIDER CERTIFICATION FOR EXPEDITED
REVIEW, INSURER ANNUAL REPORT, IRO INTERNAL REPORT AND OTHER
FORMS SPECIFIED BY THIS SUBDIVISION.
(B) LOCATION OF FORMS.--FORMS DESCRIBED IN SUBSECTION (A)
SHALL BE POSTED ON THE DEPARTMENT'S PUBLICLY ACCESSIBLE INTERNET
WEBSITE.
(C) AMENDMENT AND REVISION.--IF FORMS DESCRIBED IN
SUBSECTION (A) ARE AMENDED OR REVISED, THE DEPARTMENT SHALL
TRANSMIT NOTICE OF THE CHANGES TO THE LEGISLATIVE REFERENCE
BUREAU FOR PUBLICATION IN THE PENNSYLVANIA BULLETIN.
SECTION 8. SECTION 2166, SUBDIVISION (K) HEADING OF ARTICLE
XXI AND SECTIONS 2171, 2181 AND 2182 OF THE ACT ARE AMENDED TO
READ:
SECTION 2166. PROMPT PAYMENT OF CLAIMS.--(A) [A LICENSED]
AN INSURER OR [A] MA OR CHIP MANAGED CARE PLAN SHALL PAY A CLEAN
CLAIM SUBMITTED BY A HEALTH CARE PROVIDER OR COVERED PERSON
WITHIN FORTY-FIVE (45) DAYS OF RECEIPT OF THE CLEAN CLAIM.
(B) IF [A LICENSED] AN INSURER OR [A] MA OR CHIP MANAGED
CARE PLAN FAILS TO REMIT THE PAYMENT AS PROVIDED UNDER
SUBSECTION (A), INTEREST AT TEN PER CENTUM (10%) PER ANNUM SHALL
BE ADDED TO THE AMOUNT OWED ON THE CLEAN CLAIM. INTEREST SHALL
BE CALCULATED BEGINNING THE DAY AFTER THE REQUIRED PAYMENT DATE
AND ENDING ON THE DATE THE CLAIM IS PAID. THE [LICENSED] INSURER
OR MA OR CHIP MANAGED CARE PLAN SHALL NOT BE REQUIRED TO PAY ANY
INTEREST CALCULATED TO BE LESS THAN TWO ($2) DOLLARS.
(K) [HEALTH CARE PROVIDER AND MANAGED CARE PLAN
PROTECTION] CONSCIENCE PROTECTION.
SECTION 2171. [HEALTH CARE PROVIDER AND MANAGED CARE PLAN]
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CONSCIENCE PROTECTION.--(A) [A] AN INSURER OR MA OR CHIP
MANAGED CARE PLAN SHALL NOT EXCLUDE, DISCRIMINATE AGAINST OR
PENALIZE ANY HEALTH CARE PROVIDER FOR ITS REFUSAL TO ALLOW,
PERFORM, PARTICIPATE IN OR REFER FOR HEALTH CARE SERVICES WHEN
THE REFUSAL OF THE HEALTH CARE PROVIDER IS BASED ON MORAL OR
RELIGIOUS GROUNDS AND THAT PROVIDER MAKES ADEQUATE INFORMATION
AVAILABLE TO [ENROLLEES] COVERED PERSONS ENROLLEES OR, IF
APPLICABLE, PROSPECTIVE [ENROLLEES] COVERED PERSONS.
(B) NO PUBLIC INSTITUTION, PUBLIC OFFICIAL OR PUBLIC AGENCY
MAY TAKE DISCIPLINARY ACTION AGAINST, DENY LICENSURE OR
CERTIFICATION OR PENALIZE ANY PERSON, ASSOCIATION OR CORPORATION
ATTEMPTING TO ESTABLISH A [PLAN] HEALTH ARE COVERAGE ARRANGEMENT
OR OPERATING, EXPANDING OR IMPROVING AN EXISTING INSURER OR MA
OR CHIP MANAGED CARE PLAN BECAUSE THE PERSON, ASSOCIATION OR
CORPORATION REFUSES TO PROVIDE ANY PARTICULAR FORM OF HEALTH
CARE SERVICES OR OTHER SERVICES OR SUPPLIES COVERED BY OTHER
INSURERS OR MA OR CHIP MANAGED CARE PLANS WHEN THE REFUSAL IS
BASED ON MORAL OR RELIGIOUS GROUNDS.
SECTION 2181. DEPARTMENTAL POWERS AND DUTIES.--(A) [THE
DEPARTMENT SHALL REQUIRE THAT RECORDS] RECORDS AND DOCUMENTS
SUBMITTED TO [A] AN INSURER OR MA OR CHIP MANAGED CARE PLAN OR
UTILIZATION REVIEW ENTITY AS PART OF ANY COMPLAINT [OR],
GRIEVANCE, INTERNAL APPEALS OR ADVERSE BENEFIT DETERMINATION
SHALL BE MADE AVAILABLE TO THE DEPARTMENT, UPON REQUEST, FOR
PURPOSES OF ENFORCEMENT OR COMPLIANCE WITH THIS ARTICLE.
(B) THE DEPARTMENT SHALL COMPILE DATA RECEIVED FROM [A] AN
INSURER OR MA OR CHIP MANAGED CARE PLAN ON AN ANNUAL BASIS
REGARDING THE NUMBER, TYPE AND DISPOSITION OF COMPLAINTS [AND],
GRIEVANCES, INTERNAL APPEALS AND ADVERSE BENEFITS DETERMINATIONS
FILED WITH [A] AN INSURER OR MA OR CHIP MANAGED CARE PLAN UNDER
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THIS ARTICLE.
(C) THE DEPARTMENT SHALL ISSUE GUIDELINES IDENTIFYING THOSE
PROVISIONS OF THIS ARTICLE THAT EXCEED OR ARE NOT INCLUDED IN
THE "STANDARDS FOR THE ACCREDITATION OF MANAGED CARE
ORGANIZATIONS" PUBLISHED BY THE NATIONAL COMMITTEE FOR QUALITY
ASSURANCE. THESE GUIDELINES SHALL BE PUBLISHED IN THE
PENNSYLVANIA BULLETIN AND UPDATED AS NECESSARY. COPIES OF THE
GUIDELINES SHALL BE MADE AVAILABLE TO INSURERS, MA OR CHIP
MANAGED CARE PLANS, HEALTH CARE PROVIDERS AND COVERED PERSONS
AND ENROLLEES UPON REQUEST.
(D) THE DEPARTMENT [AND THE INSURANCE DEPARTMENT] SHALL
ENSURE COMPLIANCE WITH THIS ARTICLE. THE [APPROPRIATE]
DEPARTMENT [SHALL] MAY INVESTIGATE POTENTIAL VIOLATIONS OF THE
ARTICLE BASED UPON INFORMATION RECEIVED FROM COVERED PERSONS,
ENROLLEES, HEALTH CARE PROVIDERS AND OTHER SOURCES [IN ORDER TO
ENSURE COMPLIANCE WITH THIS ARTICLE].
[(E) THE DEPARTMENT AND THE INSURANCE DEPARTMENT SHALL
PROMULGATE SUCH REGULATIONS AS MAY BE NECESSARY TO CARRY OUT THE
PROVISIONS OF THIS ARTICLE.]
(F) THE DEPARTMENT [IN COOPERATION WITH THE INSURANCE
DEPARTMENT] SHALL SUBMIT AN ANNUAL REPORT TO THE GENERAL
ASSEMBLY REGARDING THE IMPLEMENTATION, OPERATION AND ENFORCEMENT
OF THIS ARTICLE.
SECTION 2182. PENALTIES AND SANCTIONS.--(A) THE DEPARTMENT
[OR THE INSURANCE DEPARTMENT, AS APPROPRIATE,] MAY IMPOSE A
CIVIL PENALTY OF UP TO FIVE THOUSAND ($5,000) DOLLARS FOR A
VIOLATION OF THIS ARTICLE.
(B) [A] AN INSURER OR MA OR CHIP MANAGED CARE PLAN SHALL BE
SUBJECT TO THE ACT OF JULY 22, 1974 (P.L.589, NO.205), KNOWN AS
THE "UNFAIR INSURANCE PRACTICES ACT."
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(C) THE DEPARTMENT [OR THE INSURANCE DEPARTMENT] MAY
MAINTAIN AN ACTION IN THE NAME OF THE COMMONWEALTH FOR AN
INJUNCTION TO PROHIBIT ANY ACTIVITY WHICH VIOLATES THE
PROVISIONS OF THIS ARTICLE.
(D) THE DEPARTMENT MAY ISSUE AN ORDER TEMPORARILY
PROHIBITING [A] AN INSURER OR MA OR CHIP MANAGED CARE PLAN WHICH
VIOLATES THIS ARTICLE FROM ENROLLING NEW [MEMBERS] COVERED
PERSONS OR ENROLLEES.
(E) THE DEPARTMENT MAY REQUIRE [A] AN INSURER OR MA OR CHIP
MANAGED CARE PLAN TO DEVELOP AND ADHERE TO A PLAN OF CORRECTION
APPROVED BY THE DEPARTMENT. THE DEPARTMENT SHALL MONITOR
COMPLIANCE WITH THE PLAN OF CORRECTION. THE PLAN OF CORRECTION
SHALL BE AVAILABLE TO COVERED PERSONS OR ENROLLEES OF THE
INSURER OR MA OR CHIP MANAGED CARE PLAN UPON REQUEST.
[(F) IN NO EVENT SHALL THE DEPARTMENT AND THE INSURANCE
DEPARTMENT IMPOSE A PENALTY FOR THE SAME VIOLATION.]
SECTION 9. THE ACT IS AMENDED BY ADDING A SECTION TO READ:
SECTION 2184. REGULATIONS.--THE DEPARTMENT MAY PROMULGATE
REGULATIONS AS NECESSARY AND APPROPRIATE TO CARRY OUT THE
PROVISIONS OF THIS ARTICLE.
SECTION 10. SECTIONS 2191 AND 2192(4) OF THE ACT ARE AMENDED
TO READ:
SECTION 2191. COMPLIANCE WITH NATIONAL ACCREDITING
STANDARDS.--NOTWITHSTANDING ANY OTHER PROVISION OF THIS ARTICLE
TO THE CONTRARY, THE DEPARTMENT SHALL GIVE CONSIDERATION TO [A]
AN INSURER'S OR MA OR CHIP MANAGED CARE PLAN'S DEMONSTRATED
COMPLIANCE WITH THE STANDARDS AND REQUIREMENTS SET FORTH IN THE
"STANDARDS FOR THE ACCREDITATION OF MANAGED CARE ORGANIZATIONS"
PUBLISHED BY THE NATIONAL COMMITTEE FOR QUALITY ASSURANCE OR
OTHER DEPARTMENT-APPROVED QUALITY REVIEW ORGANIZATIONS IN
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DETERMINING COMPLIANCE WITH THE SAME OR SIMILAR PROVISIONS OF
THIS ARTICLE. THE INSURER OR MA OR CHIP MANAGED CARE PLAN,
HOWEVER, SHALL REMAIN SUBJECT TO AND SHALL COMPLY WITH ANY OTHER
PROVISIONS OF THIS ARTICLE THAT EXCEED OR ARE NOT INCLUDED IN
THE STANDARDS OF THE NATIONAL COMMITTEE FOR QUALITY ASSURANCE OR
OTHER DEPARTMENT-APPROVED QUALITY REVIEW ORGANIZATIONS.
SECTION 2192. EXCEPTIONS.--THIS ARTICLE SHALL NOT APPLY TO
ANY OF THE FOLLOWING:
* * *
(4) THE FEE-FOR-SERVICE PROGRAMS OPERATED BY THE DEPARTMENT
OF [PUBLIC WELFARE] HUMAN SERVICES UNDER TITLE XIX OF THE SOCIAL
SECURITY ACT (49 STAT. 620, 42 U.S.C. ยง 1396 ET SEQ.).
SECTION 11. REPEALS ARE AS FOLLOWS:
(1) THE GENERAL ASSEMBLY DECLARES THAT THE REPEALS UNDER
PARAGRAPH (2) ARE NECESSARY TO EFFECTUATE THIS ACT.
(2) THE FOLLOWING ACTS AND PARTS OF ACTS ARE REPEALED TO
THE EXTENT SPECIFIED:
(I) SECTION 630(E) AND (F) OF THE ACT, INSOFAR AS
THEY ARE INCONSISTENT WITH THIS ACT.
(II) THE ACT OF DECEMBER 29, 1972 (P.L.1701,
NO.364), KNOWN AS THE HEALTH MAINTENANCE ORGANIZATION
ACT, INSOFAR AS IT IS INCONSISTENT WITH THIS ACT.
(III) 40 PA.C.S. CH. 61, INSOFAR AS IT IS
INCONSISTENT WITH THIS ACT.
(IV) 40 PA.C.S. CH. 63, INSOFAR AS IT IS
INCONSISTENT WITH THIS ACT.
(V) ALL OTHER PARTS OF THIS ACT ARE REPEALED INSOFAR
AS THEY ARE INCONSISTENT WITH THIS ACT.
SECTION 12. CONTINUATION IS AS FOLLOWS:
(1) EXCEPT AS OTHERWISE REQUIRED TO COMPLY WITH THIS
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ACT, ACTIVITIES INITIATED UNDER ARTICLE XXI OF THE ACT PRIOR
TO THE EFFECTIVE DATE OF THIS SECTION SHALL CONTINUE AND
REMAIN IN FULL FORCE AND EFFECT AND MAY BE COMPLETED UNDER
ARTICLE XXI OF THE ACT ON AND AFTER THE EFFECTIVE DATE OF
THIS SECTION.
(2) CONTRACTS AND OBLIGATIONS ENTERED INTO UNDER ARTICLE
XXI OF THE ACT PRIOR TO THE EFFECTIVE DATE OF THIS SECTION
SHALL NOT BE AFFECTED OR IMPAIRED BY THIS ACT.
(3) ORDERS, REGULATIONS, RULES AND DECISIONS OF THE
DEPARTMENT OF HEALTH WHICH WERE MADE UNDER ARTICLE XXI OF THE
ACT PRIOR TO THE EFFECTIVE DATE OF THIS SECTION AND WHICH ARE
IN EFFECT ON THE EFFECTIVE DATE OF THIS SECTION SHALL REMAIN
IN FULL FORCE AND EFFECT AND SHALL BE ENFORCED BY THE
DEPARTMENT UNTIL REVOKED, VACATED OR MODIFIED BY THE
DEPARTMENT UNDER ARTICLE XXI OF THE ACT.
SECTION 13. THIS ACT SHALL TAKE EFFECT AS FOLLOWS:
(1) THE FOLLOWING PROVISIONS SHALL TAKE EFFECT
IMMEDIATELY:
(I) SECTION 11 OF THIS ACT.
(II) SECTION 12 OF THIS ACT.
(III) THIS SECTION.
(2) THE ADDITION OF SECTION 2153 OF THE ACT SHALL TAKE
EFFECT JANUARY 1, 2023.
(3) THE REMAINDER OF THIS ACT SHALL TAKE EFFECT JANUARY
1, 2024.
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