PRINTER'S NO. 779
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No.
661
Session of
2017
INTRODUCED BY GREENLEAF, YUDICHAK, TARTAGLIONE AND BREWSTER,
MAY 2, 2017
REFERRED TO BANKING AND INSURANCE, MAY 2, 2017
AN ACT
Amending Title 40 (Insurance) of the Pennsylvania Consolidated
Statutes, in regulation of insurers and related persons
generally, providing for external review.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Part II of Title 40 of the Pennsylvania
Consolidated Statutes is amended by adding a chapter to read:
CHAPTER 39
EXTERNAL REVIEW
Sec.
3901. Definitions.
3902. Applicability of chapter.
3903. Notice of right to external review.
3904. Request for external review.
3905. Exhaustion of internal grievance process.
3906. Standard external review.
3907. Expedited external review.
3908. External review of experimental or investigational
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treatment adverse benefit determinations.
3909. Binding nature of external review decision.
3910. Department approval of independent review organizations.
3911. Minimum qualifications for independent review
organizations.
3912. Hold harmless for independent review organizations.
3913. External review reporting requirements.
3914. Funding of external review.
3915. Disclosure requirements.
3916. Severability.
3917. Regulations.
3918. Availability of forms.
§ 3901. Definitions.
The following words and phrases when used in this chapter
shall have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Adverse benefit determination." A determination by an
insurer or a utilization review organization designated by the
insurer that a health care service has been reviewed and, based
upon the information provided, does not meet the insurer'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.
"Ambulatory review." Utilization review of health care
services performed or provided in an outpatient setting.
"Authorized representative." One of the following:
(1) a person to whom a covered person has given express
written consent to represent the covered person in an
external review;
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(2) a person authorized by law to provide substituted
consent for a covered person; or
(3) a family member of a covered person or covered
person's treating health care professional only when the
covered person is unable to provide consent.
"Case management." A coordinated set of activities conducted
for individual patient management of serious, complicated,
protracted or other health conditions.
"Certification." A determination by an insurer or a
utilization review organization designated by the insurer that a
covered benefit has been reviewed and, based upon the
information provided, satisfies the insurer's requirements for
medical necessity, appropriateness, health care setting, level
of care and effectiveness.
"Clinical review criteria." The set of written screening
procedures, decision abstracts, clinical protocols and practice
guidelines used by an insurer to determine the necessity and
appropriateness of health care services.
"Commissioner." The Insurance Commissioner of the
Commonwealth.
"Concurrent review." A review by a utilization review
organization of all reasonably necessary supporting information,
which review occurs during a covered person'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 to which a covered
person is entitled under the terms of a health benefit plan.
"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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"Discharge planning." The formal process for determining,
prior to discharge from a facility, the coordination and
management of care that a patient will receive following the
discharge.
"Emergency service." A health care service provided to a
covered person after the sudden onset of a medical condition
that manifests itself by acute symptoms of sufficient severity
or severe pain 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 detrimental
consequences to the health of the covered person or, with
respect to a pregnant woman, the health of the woman or her
unborn child. This term includes:
(1) Emergency medical services, including those rendered
by an EMS agency as those terms are defined in 35 Pa.C.S. §
8103 (relating to definitions).
(2) A health care service that a health care provider
determines is necessary to evaluate and, if necessary,
stabilize the condition of a covered person so that the
covered person may be transported without suffering
detrimental consequences or aggravating the covered person's
condition.
(3) If a covered person is admitted to a facility, a
health care service rendered prior to discharge.
"Evidence-based standard." Interventions and treatment
approaches that have been proven effective through appropriate
empirical analysis.
"Facility." A health care setting or an institution
providing health care services, including:
(1) A general, special, psychiatric or rehabilitation
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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 physician office or clinic.
"Final adverse benefit determination." An adverse benefit
determination that has been upheld by an insurer or a
utilization review organization designated by the insurer at the
completion of the insurer's internal grievance process
procedures as specified in section 2161 of the Insurance Company
Law or 45 CFR 147.136(b) (relating to internal claims and
appeals and external review processes).
"Health care provider." A health service doctor as defined
in section 6302 (relating to definitions).
"Health care services." A covered treatment, admission,
procedure, medical supply and equipment or other service,
including behavioral health, prescribed or otherwise provided or
proposed to be provided by a health care provider to a covered
person for the diagnosis, prevention, treatment, cure or relief
of a health condition, illness, injury or disease.
"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.
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(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 dental only policy.
(9) A vision only policy.
(10) A workers' compensation policy.
(11) An automobile medical payment policy under 75
Pa.C.S. (relating to vehicles).
(12) Any other similar policies providing for limited
benefits.
"Independent review organization" or "IRO." An entity that
conducts independent external review of adverse benefit
determinations and final adverse benefit determinations.
"Insurance Company Law." The act of May 17, 1921 (P.L.682,
No.284), known as The Insurance Company Law of 1921.
"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) Section 630, Article XXIV or any other provision of
the Insurance Company Law.
(2) The act of December 29, 1972 (P.L.1701, No.364),
known as the Health Maintenance Organization Act.
(3) A provision of Chapter 61 (relating to hospital plan
corporations) or 63 (relating to professional health services
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plan corporations).
"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. § 1395x(t)(2)).
(4) One of the following standard reference compendia:
(i) The American Hospital Formulary Service-Drug
Information.
(ii) Drug Facts and Compensation.
(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:
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(i) The Federal 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 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) through
(5).
"NAIC." The National Association of Insurance Commissioners.
"Prospective review." Utilization review conducted prior to
an admission or a course of treatment.
"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:
(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; or
(3) payment for the provision of health care services to
an individual.
"Retrospective review." Review of medical necessity
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conducted after health care services have been provided to a
covered person, 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.
"Second opinion." An opportunity or requirement to obtain a
clinical evaluation by a provider other than the one originally
making a recommendation for a proposed health care service to
assess the clinical necessity and appropriateness of the initial
proposed health care service.
"Utilization review." A set of formal techniques designed to
monitor the use of, or evaluate the clinical necessity,
appropriateness, efficacy or efficiency of, health care
services, procedures or settings, which techniques may include
ambulatory review, prospective review, second opinion,
certification, concurrent review, case management discharge
planning or retrospective review.
"Utilization review organization." An entity that conducts
utilization review, other than an insurer performing utilization
review for the insurer's own health insurance policies.
§ 3902. Applicability of chapter.
This chapter applies as follows:
(1) For a health insurance policy for which either rates
or forms are required to be filed with the Federal Government
or the department, this chapter shall apply to a policy for
which a form or rate is first filed on or after 180 days
after the date of enactment.
(2) For a health insurance policy for which neither
rates nor forms are required to be filed with the Federal
Government or the department, this chapter shall apply to a
policy issued or renewed on or after 60 days after the date
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of enactment of this chapter.
§ 3903. 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 3906 (relating to standard
external review), 3907 (relating to expedited external review)
or 3908 (relating to external review of experimental or
investigational treatment adverse benefit determinations) at the
same time the insurer sends written notice of:
(1) an adverse benefit determination upon completion of
the insurer's utilization review process specified in section
2152 of the Insurance Company Law; or
(2) a final adverse benefit determination.
(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 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
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review of a grievance involving an adverse benefit
determination under section 2161(e) of the Insurance
Company Law or 45 CFR 147.136(b)(2)(ii)(B) (relating to
internal claims and appeals and external review
processes) 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 a
grievance involving an adverse benefit determination
under section 2161(e) of the Insurance Company Law or 45
CFR 147.136(b)(2)(ii)(B). The IRO assigned to conduct the
expedited external review will determine whether the
covered person is required to complete the expedited
review of the grievance prior to conducting the expedited
external review. The request may be filed under section
3907 or 3908 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 physician
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 a grievance under the
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insurer's internal grievance process under section 2161
of the Insurance Company Law or 45 CFR 147.136(b)(2), but
will be considered to have exhausted the insurer's
internal grievance process for purposes of section 3905
(relating to exhaustion of internal grievance process)
and may immediately file a request for external review
under section 3904 (relating to request for external
review) 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
grievance with the insurer.
(B) The covered person or the covered person's
authorized representative has not requested or agreed
to a delay.
(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 3906 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 3907; or
(ii) if the final adverse benefit determination
concerns:
(A) an admission, availability of care,
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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 3907;
(B) a denial of coverage based on a
determination that the recommended or requested
health care services are 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 3908; or
(C) a written certification by the treating
physician that the recommended or requested health
care services that are 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 3908.
(4) A copy of the description of both the standard and
expedited external review procedures required by section 3915
(relating to disclosure requirements), highlighting 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
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purposes of conducting an external review under this chapter,
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.
§ 3904. Request for external review.
(a) Form of request.--
(1) Except for a request for an expedited external
review under section 3907 (relating to expedited external
review), 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.
§ 3905. Exhaustion of internal grievance process.
(a) Requirement to exhaust internal grievance process.--
(1) Except as provided in subsection (b), a request for
external review under section 3906 (relating to standard
external review), 3907 (relating to expedited external
review) or 3908 (relating to external review of experimental
or investigational treatment adverse benefit determinations)
or a request for retrospective review under section 2152 of
the Insurance Company Law or 45 CFR 147.136 (relating to
internal claims and appeals and external review processes)
may not be made until the covered person has exhausted the
insurer's internal grievance process under section 2161 of
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the Insurance Company Law or 45 CFR 147.136(b)(2).
(2) A covered person is considered to have exhausted the
insurer's internal grievance process for purposes of this
section if the covered person or the covered person's
authorized representative:
(i) Has filed a grievance involving an adverse
benefit determination under section 2161 of the Insurance
Company Law or 45 CFR 147.136(b)(2).
(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 grievance from the insurer within 30 days following
the date the covered person or the covered person's
authorized representative filed the grievance with the
insurer.
(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 review of a grievance involving an adverse benefit
determination under section 2161(e) of the Insurance Company
Law or 45 CFR 147.136(b)(2)(ii)(B), 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 3907, if the covered person has a
medical condition for which the time frame for completion
of an expedited review of the grievance involving an
adverse benefit determination under section 2161(e) of
the Insurance Company Law or 45 CFR 147.136(b)(2)(ii)(B)
would seriously jeopardize the life or health of the
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covered person or would jeopardize the covered person's
ability to regain maximum function; or
(ii) under section 3908, if 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, and
the covered person's treating physician 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.
(2) Upon receipt of a request for an expedited external
review under paragraph (1), the IRO conducting the external
review in accordance with the provisions of section 3907 or
3908 shall determine whether the covered person is required
to complete the expedited review process under section
2161(e) of the Insurance Company Law or 45 CFR 147.136(b)(2)
(ii)(B) 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 grievance review process under
section 2161(e) of the Insurance Company Law or 45 CFR
147.136(b)(2)(ii)(B), the IRO shall immediately notify the
covered person and, if applicable, the covered person's
authorized representative that the IRO will not proceed with the
expedited external review under section 3907 until the insurer
has completed the expedited grievance review process and the
covered person's grievance remains unresolved.
(d) Waiver of exhaustion requirement.--A request for
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external review of an adverse benefit determination may be made
before the covered person has exhausted the insurer's internal
grievance procedures under section 2161 of the Insurance Company
Law or 45 CFR 147.136(b)(2), 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 3906
or 3908.
§ 3906. Standard external review.
(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 3903 (relating to
notice of right to external review).
(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 by 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 by the health insurance policy at the time
the health care service was provided.
(2) The health care service that is the subject of the
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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 grievance process under section 2161 of the
Insurance Company Law or 45 CFR 147.136(b)(2) (relating to
internal claims and appeals and external review processes),
unless the covered person is not required to exhaust the
insurer's internal grievance process under section 3905
(relating to exhaustion of internal grievance process).
(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 3903(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.
(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
and include in the notice what information or materials
are needed to make the request complete; or
(ii) is not eligible for external review, the
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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 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
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. An appeal to the commissioner
shall be subject to 2 Pa.C.S. Ch. 5 Subch. A (relating to
practice and procedure of Commonwealth agencies).
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
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the department under section 3910 (relating to department
approval of independent review organizations) 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) The assigned IRO shall not be bound by a decision or
conclusion reached during the insurer's utilization review
process under section 2152 of the Insurance Company Law or
the insurer's internal grievance process under section 2161
of the Insurance Company Law or 45 CFR 147.136(b)(2).
(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
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(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)(3).
(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.--
(1) Upon receipt of the information, if any, required to
be forwarded under subsection (f)(2), the insurer may
reconsider its adverse benefit determination or final adverse
benefit determination that is the subject of the external
review.
(2) Reconsideration by the insurer of its 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
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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.
(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
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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 of the IRO's clinical reviewer or
reviewers after considering the information under paragraphs
(1) through (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 its 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) 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 its decision.
(v) The principal reason or reasons for its
decision, including what applicable evidence-based
standards were considered in reaching its decision.
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(vi) The rationale for its decision.
(vii) References to the evidence or documentation,
including evidence-based standards, considered in
reaching its 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
immediately 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 3911(d)
(relating to minimum qualifications for independent review
organizations).
§ 3907. Expedited external review.
(a) Request for review.--Except as provided in subsection
(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:
(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
of a grievance involving an adverse benefit determination
under section 2161(e) of the Insurance Company Law or 45
CFR 147.136(b)(2)(ii)(B) (relating to internal claims and
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appeals and external review processes) 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 review of a grievance involving an adverse
benefit determination under section 2161(e) of the
Insurance Company Law or 45 CFR 147.136(b)(2)(ii)(B).
(2) A final adverse benefit determination if:
(i) the covered person has a medical condition for
which the time frame for completion of a standard
external review under section 3906 (relating to standard
external review) would seriously jeopardize the life or
health of the covered person or would jeopardize the
covered person's ability to regain maximum function; or
(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
review, the department shall immediately send a copy of the
request to the insurer.
(2) Immediately upon receipt of a request under
paragraph (1), the insurer shall determine whether the
request meets the reviewability requirements under section
3906(b). The insurer shall immediately notify the department,
the covered person and, if applicable, the covered person's
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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 3906(b). The department's decision shall
be binding on the insurer and the covered person and may be
appealed to the commissioner. An appeal to the commissioner
shall be subject to 2 Pa.C.S. Ch. 5 Subch. A (relating to
practice and procedure of Commonwealth agencies).
Consideration of an appeal may not delay or terminate the
external review.
(5) Upon receipt of the notice that the request meets
reviewability requirements, the department shall immediately
assign an IRO to conduct the expedited external review from
the list of approved IROs compiled and maintained by the
department under section 3910 (relating to department
approval of independent review organizations). The department
shall immediately notify the insurer of the name of the
assigned IRO.
(6) In reaching a decision in accordance with subsection
(e), the assigned IRO shall not be bound by a decision or
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conclusion reached during the insurer's utilization review
process under section 2152 of the Insurance Company Law or
the insurer's internal grievance process under section 2161
of the Insurance Company Law or CFR 147.136(b)(2).
(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 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 by one of
the following methods:
(1) electronically;
(2) by telephone;
(3) by facsimile; or
(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.
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(5) The most appropriate practice guidelines, which
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) through (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 3906(b), the assigned IRO shall
provide notice of its 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 its
decision to uphold or reverse the adverse benefit
determination or the final adverse benefit determination to:
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(i) The covered person.
(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 its decision.
(v) The principal reason or reason for the IRO's
decision, including applicable evidence-based standards
considered in reaching its decision.
(vi) The rationale for its decision.
(vii) References to the evidence or documentation,
including evidence-based standards, considered in
reaching its 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
immediately 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
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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 subject of the adverse benefit
determination or final adverse benefit determination, and shall
consider the conflict-of-interest concerns under section 3911(d)
(relating to minimum qualifications for independent review
organizations).
§ 3908. 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 3903 (relating to notice
of right to external review) 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 physician 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 immediately. With respect to notice
of an insurer's eligibility determination:
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(i) Upon notice of the request for expedited
external review, the insurer shall immediately determine
whether the request meets the reviewability requirements
of subsection (b). The insurer shall immediately 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 chapter. The
department's decision shall be binding on the insurer and the
covered person and may be appealed to the commissioner. An
appeal to the commissioner shall be subject 2 Pa.C.S. Ch. 5
Subch. A (relating to practice and procedure of Commonwealth
agencies). Consideration of an appeal may not delay or
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terminate the external review.
(4) Upon receipt of a notice under paragraph (2), the
department shall immediately assign an IRO to review the
expedited request from the list of approved IROs compiled and
maintained by the department under section 3910 (relating to
department approval of independent review organizations) 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; or
(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 by the
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health insurance policy at the time the health care
services were provided.
(ii) The recommended or requested health care
services that are the subject of the adverse benefit
determination or final adverse benefit determination:
(A) Are a covered benefit under the covered
person's health insurance policy, except for the
insurer's determination that the health care services
are experimental or investigational for a particular
medical condition.
(B) Are not explicitly listed as an excluded
benefit under the covered person's health insurance
policy.
(iii) The covered person's treating physician 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 by the insurer that are more
beneficial than the recommend or requested health
care services described in subparagraph (iv).
(iv) The covered person's treating physician:
(A) has recommended health care services that
the physician certifies, in writing, are likely to be
more beneficial to the covered person, in the
physician's opinion, than available standard health
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care services; or
(B) who 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, 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;
(v) The covered person has exhausted the insurer's
internal grievance process under section 2161 of the
Insurance Company Law or 45 CFR 147.136(b)(2) (relating
to internal claims and appeals and external review
processes), unless the covered person is not required to
exhaust the insurer's internal grievance process under
section 3905 (relating to exhaustion of internal
grievance process).
(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 3903(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.
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(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
and include in the notice what information or materials
are needed to make the request complete; or
(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 3906(b) (relating to standard
external review). The determination shall be binding on the
insurer and the covered person and may be appealed to the
commissioner. An appeal to the commissioner shall be subject
to 2 Pa.C.S. Ch. 5 Subch. A. Consideration of the appeal may
not delay or terminate the external review.
(5) When a request is determined to be eligible for
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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
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 3910 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; and
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(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
meets the minimum qualifications described in section 3911
(relating to minimum qualifications for independent review
organizations) and, through clinical experience in the past
three years, is an expert in the treatment of the covered
person's condition and is knowledgeable about the recommended
or requested health care services. 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
services should be covered.
(5) The assigned clinical reviewer is not bound by a
decision or conclusion reached during the insurer's
utilization review process under section 2152 of the
Insurance Company Law or the insurer's internal grievance
process under section 2161 of the Insurance Company Law or 45
CFR 147.136(b)(2).
(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
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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 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
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. Immediately 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
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reconsider its adverse benefit determination or final adverse
benefit determination that is the subject of the external
review.
(2) Reconsideration by the insurer of its 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
its reconsideration, to reverse its 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 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 services should be
covered.
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(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
services are more likely than not to be beneficial to
the covered person than any available standard health
care services.
(B) The adverse risks of the recommended or
requested health care services would not be
substantially increased over the adverse risks of
available standard health care services.
(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)
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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.
(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 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.
(5) Whether:
(i) the recommended or requested health care
services have been approved by the United States Food and
Drug Administration, if applicable, for the condition; or
(ii) medical or scientific evidence or evidence-
based standards demonstrate that:
(A) The expected benefits of the recommended or
requested health care services are more likely than
not to be beneficial to the covered person than any
available standard health care services.
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(B) The adverse risks of the recommended or
requested health care services would not be
substantially increased over the adverse risks of
available standard health care services.
(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.
(iii) The insurer.
(iv) The department.
(2) If a majority of the clinical reviewers recommend
that:
(i) The recommended or requested health care
services 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
services not be covered, the IRO shall make a decision to
uphold the insurer's adverse benefit determination or
final adverse benefit determination.
(3) In the event that the clinical reviewers are evenly
divided as to whether the recommended or requested health
care services 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
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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.
(ii) The written opinion of each clinical reviewer,
including the recommendation of each clinical reviewer as
to whether the recommended or requested health care
services 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 its decision.
(vi) The principal reason or reasons for its
decision.
(vii) The rationale for its 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
immediately approve the coverage that was the subject of the
adverse benefit determination or final adverse benefit
determination.
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(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 services that are the subject of the adverse benefit
determination or final adverse benefit determination, and shall
consider the conflict-of-interest concerns under section 3911.
§ 3909. Binding nature of external review decision.
(a) Binding 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
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 chapter.
§ 3910. Department approval of independent review
organizations.
(a) General rule.--The department shall approve IROs
eligible to be assigned to conduct external reviews under this
chapter.
(b) Eligibility requirements.--In order to be eligible for
approval by the department under this section to conduct
external reviews under this chapter, the IRO must:
(1) Except as otherwise provided in this section, be
accredited by a nationally recognized private accrediting
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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
3911 (relating to minimum qualifications for independent
review organizations).
(2) Submit an application for approval in accordance
with subsection (d).
(c) Form of application.--The department shall develop an
application form for initially approving and for reapproving
IROs to conduct external reviews.
(d) Consideration of application.--
(1) An IRO seeking to be approved to conduct external
review under this chapter 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 3911.
(2) The department may approve the IRO that is not
accredited by a nationally recognized private accrediting
entity as required by subsection (b)(1) if there are no
acceptable nationally recognized private accrediting entities
providing IRO accreditation.
(3) The department may charge an application fee that
IROs must submit to the department with an application for
approval and reapproval.
(e) Duration of approval.--
(1) An approval is valid for two years unless the
department determines before the approval expires that the
IRO no longer satisfies the minimum qualifications
established under section 3911.
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(2) If the department determines that an IRO is no
longer accredited or no longer satisfies the minimum
requirements established under section 3911, the department
shall terminate the approval of the IRO and remove the IRO
from the list of IROs approved to conduct external reviews
under this chapter that is maintained by the department under
subsection (f).
(f) List of approved IROs.--The department shall maintain
and periodically update a list of approved IROs.
§ 3911. Minimum qualifications for independent review
organizations.
(a) Requirements for department approval.--To be approved
under section 3910 (relating to department approval of
independent review organizations) to conduct external reviews,
an IRO must establish and maintain written policies and
procedures that govern all aspects of both the standard external
review and the expedited external review required by this
chapter 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
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records and clinical review criteria.
(v) That a person employed by or under contract with
the IRO adheres to the requirements of this chapter.
(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, which service 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 3913
(relating to external review reporting requirements).
(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) Is an expert in the treatment of the covered
person's medical condition that is the subject of the
external review.
(2) Is knowledgeable about the recommended health care
services through recent or current actual clinical experience
treating patients with the same or similar medical condition
of the covered person.
(3) Holds a nonrestricted license in a state or
commonwealth of the United States and, for physicians, 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.
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(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
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, a national, State or
local trade association of insurers or health care providers.
(d) Conflicts of interest.--
(1) In addition to the requirements under this section,
to be approved under section 3910 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 that is the subject of the external
review.
(ii) The covered person whose treatment is the
subject of the external review or the covered person's
authorized representative.
(iii) An officer, director or management employee of
the insurer 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 services that
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are subject of the external review.
(v) The facility at which the recommended health
care services would be provided.
(vi) The developer or manufacturer of the principal
drug, device, procedure or other therapy being
recommended for the covered person whose treatment is the
subject of the external review.
(2) In determining whether an IRO or a 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 3910.
(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
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standards available to the department or the NAIC in order
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.
§ 3912. 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 chapter, unless the opinion was
rendered, or act or omission performed, in bad faith or involved
gross negligence.
§ 3913. External review reporting requirements.
(a) Recordkeeping by IROs.--
(1) An IRO assigned under this chapter to conduct an
external review shall maintain written records in the
aggregate for both the entire Commonwealth and for the
insurer, 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, both for
the entire Commonwealth and for the insurer:
(i) The total number of requests for external
review.
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(ii) The number of requests for external review
resolve and, of those involved, the number resolved
upholding the adverse benefit determination or final
adverse benefit determination and the number of 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 as provided in
the format required by the department.
(v) The number of external reviews under section
3906(g) (relating to standard external review) and
3908(g) (relating to external review of experimental or
investigational treatment adverse benefit determinations)
that was 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 covered
person's authorized representative.
(vi) Other information the department requests or
requires.
(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, both for the entire Commonwealth and 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 chapter.
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(2) An insurer required to maintain written records
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, both 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 requests or
requires.
(4) The insurer shall retain the written records
required under this subsection for at least three years.
§ 3914. Funding of external review.
The insurer against which a request for standard external
review or expedited external review under section 3906 (relating
to standard external review), 3907 (relating to expedited
external review) or 3908 (relating to external review of
experimental or investigational treatment adverse benefit
determinations) is filed shall pay the cost of the IRO to
conduct the external review.
§ 3915. Disclosure requirements.
(a) Disclosure to covered persons.--
(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.
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(2) The disclosure required by paragraph (1) shall be in
a format as prescribed by the department.
(b) Required contents of disclosure.--The description of
procedures required under subsection (a) shall include:
(1) 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
with the department.
(2) The telephone number and address of the department.
(3) 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.
(4) 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.
§ 3916. Severability.
If any provision of this chapter or the application of the
provision to a person or circumstance is held invalid, the
remainder of the chapter and the application of the provision to
persons or circumstances other than those to which the provision
is held invalid is not affected.
§ 3917. Regulations.
The department may promulgate regulations as may be necessary
and appropriate to carry out the provisions of this chapter.
§ 3918. Availability of forms.
The department shall make available, in an electronic format
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and, upon request, a print format, the applicable forms adopted
by the department related to an external review request, notice
of initial determination by insurer, physician certification for
expedited review, insurer annual report, IRO internal report or
other forms required by this chapter. Forms may be posted on the
department's publicly accessible Internet website. Notice shall
be published in the Pennsylvania Bulletin of the availability of
amended forms if revisions are made.
Section 2. Repeals are as follows:
(1) The General Assembly declares that the repeal under
paragraph (2) is necessary to effectuate the addition of 40
Pa.C.S. Ch. 39.
(2) Section 2162 of the act of May 17, 1921 (P.L.682,
No.284), known as The Insurance Company Law of 1921.
(3) All other acts and parts of acts are repealed
insofar as they are inconsistent with the addition of 40
Pa.C.S. Ch. 39.
Section 3. This act shall take effect in 180 days.
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