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Sub. H. B. No. 218 As Enrolled
(129th General Assembly)
(Substitute House Bill Number 218)
AN ACT
To amend sections 1751.11, 1751.33, 1751.35, 1751.66,
1751.77, 1751.78, 1751.811, 1751.83, 1751.87,
1751.89, 3901.045, 3923.60, and 4731.36; to enact
sections 3922.01 to 3922.23; and to repeal
sections 1751.831, 1751.84, 1751.85, 1751.88,
3901.80, 3901.81, 3901.82, 3901.83, 3901.84,
3923.66, 3923.67, 3923.68, 3923.681, 3923.69,
3923.70, 3923.75, 3923.76, 3923.77, 3923.78, and
3923.79 of the Revised Code to use the compendia
adopted by the United States Department of Health
and Human Services to determine whether an insurer
may exclude coverage for off-label drug usage and
to revise the external review process used by
health plan issuers.
Be it enacted by the General Assembly of the State of Ohio:
SECTION 1. That sections 1751.11, 1751.33, 1751.35, 1751.66,
1751.77, 1751.78, 1751.811, 1751.83, 1751.87, 1751.89, 3901.045,
3923.60, and 4731.36 be amended and sections 3922.01, 3922.02,
3922.03, 3922.04, 3922.05, 3922.06, 3922.07, 3922.08, 3922.09,
3922.10, 3922.11, 3922.12, 3922.13, 3922.14, 3922.15, 3922.16,
3922.17, 3922.18, 3922.19, 3922.20, 3922.21, 3922.22, and 3922.23
of the Revised Code be enacted to read as follows:
Sec. 1751.11. (A) Every subscriber of a health insuring
corporation is entitled to an evidence of coverage for the health
care plan under which health care benefits are provided.
(B) Every subscriber of a health insuring corporation that
offers basic health care services is entitled to an identification
card or similar document that specifies the health insuring
corporation's name as stated in its articles of incorporation, and
any trade or fictitious names used by the health insuring
corporation. The identification card or document shall list at
least one toll-free telephone number that provides the subscriber
with access, to information on a twenty-four-hours-per-day,
seven-days-per-week basis, as to how health care services may be
obtained. The identification card or document shall also list at
least one toll-free number that, during normal business hours,
provides the subscriber with access to information on the coverage
available under the subscriber's health care plan and information
on the health care plan's internal and external review processes.
(C) No evidence of coverage, or amendment to the evidence of
coverage, shall be delivered, issued for delivery, renewed, or
used, until the form of the evidence of coverage or amendment has
been filed by the health insuring corporation with the
superintendent of insurance. If the superintendent does not
disapprove the evidence of coverage or amendment within sixty days
after it is filed it shall be deemed approved, unless the
superintendent sooner gives approval for the evidence of coverage
or amendment. With respect to an amendment to an approved evidence
of coverage, the superintendent only may disapprove provisions
amended or added to the evidence of coverage. If the
superintendent determines within the sixty-day period that any
evidence of coverage or amendment fails to meet the requirements
of this section, the superintendent shall so notify the health
insuring corporation and it shall be unlawful for the health
insuring corporation to use such evidence of coverage or
amendment. At any time, the superintendent, upon at least thirty
days' written notice to a health insuring corporation, may
withdraw an approval, deemed or actual, of any evidence of
coverage or amendment on any of the grounds stated in this
section. Such disapproval shall be effected by a written order,
which shall state the grounds for disapproval and shall be issued
in accordance with Chapter 119. of the Revised Code.
(D) No evidence of coverage or amendment shall be delivered,
issued for delivery, renewed, or used:
(1) If it contains provisions or statements that are
inequitable, untrue, misleading, or deceptive;
(2) Unless it contains a clear, concise, and complete
statement of the following:
(a) The health care services and insurance or other benefits,
if any, to which an enrollee is entitled under the health care
plan;
(b) Any exclusions or limitations on the health care
services, type of health care services, benefits, or type of
benefits to be provided, including copayments and deductibles;
(c) An enrollee's personal financial obligation for
noncovered services;
(d) Where and in what manner general information and
information as to how health care services may be obtained is
available, including a toll-free telephone number;
(e) The premium rate with respect to individual and
conversion contracts, and relevant copayment and deductible
provisions with respect to all contracts. The statement of the
premium rate, however, may be contained in a separate insert.
(f) The method utilized by the health insuring corporation
for resolving enrollee complaints;
(g) The utilization review, internal review, and external
review procedures established under sections 1751.77 to 1751.85
1751.83 and Chapter 3922. of the Revised Code.
(3) Unless it provides for the continuation of an enrollee's
coverage, in the event that the enrollee's coverage under the
group policy, contract, certificate, or agreement terminates while
the enrollee is receiving inpatient care in a hospital. This
continuation of coverage shall terminate at the earliest
occurrence of any of the following:
(a) The enrollee's discharge from the hospital;
(b) The determination by the enrollee's attending physician
that inpatient care is no longer medically indicated for the
enrollee; however, nothing in division (D)(3)(b) of this section
precludes a health insuring corporation from engaging in
utilization review as described in the evidence of coverage.
(c) The enrollee's reaching the limit for contractual
benefits;
(d) The effective date of any new coverage.
(4) Unless it contains a provision that states, in substance,
that the health insuring corporation is not a member of any
guaranty fund, and that in the event of the health insuring
corporation's insolvency, an enrollee is protected only to the
extent that the hold harmless provision required by section
1751.13 of the Revised Code applies to the health care services
rendered;
(5) Unless it contains a provision that states, in substance,
that in the event of the insolvency of the health insuring
corporation, an enrollee may be financially responsible for health
care services rendered by a provider or health care facility that
is not under contract to the health insuring corporation, whether
or not the health insuring corporation authorized the use of the
provider or health care facility.
(E) Notwithstanding divisions (C) and (D) of this section, a
health insuring corporation may use an evidence of coverage that
provides for the coverage of beneficiaries enrolled in medicare
pursuant to a medicare contract, or an evidence of coverage that
provides for the coverage of beneficiaries enrolled in the federal
employees health benefits program pursuant to 5 U.S.C.A. 8905, or
an evidence of coverage that provides for the coverage of medicaid
recipients, or an evidence of coverage that provides for the
coverage of beneficiaries under any other federal health care
program regulated by a federal regulatory body, or an evidence of
coverage that provides for the coverage of beneficiaries under any
contract covering officers or employees of the state that has been
entered into by the department of administrative services, if both
of the following apply:
(1) The evidence of coverage has been approved by the United
States department of health and human services, the United States
office of personnel management, the Ohio department of job and
family services, or the department of administrative services.
(2) The evidence of coverage is filed with the superintendent
of insurance prior to use and is accompanied by documentation of
approval from the United States department of health and human
services, the United States office of personnel management, the
Ohio department of job and family services, or the department of
administrative services.
Sec. 1751.33. (A) Each health insuring corporation shall
provide to its subscribers a description of the health insuring
corporation, its method of operation, its service area, its most
recent provider list, its complaint procedure established pursuant
to section 1751.19 of the Revised Code, and a description of its
utilization review, internal review, and external review processes
established under sections 1751.77 to 1751.85 1751.83 and Chapter
3922. of the Revised Code. A health insuring corporation may
satisfy this requirement by delivering to its subscribers a
document that identifies a web site where the subscriber may view
this information. At the request of the subscriber, a health
insuring corporation shall provide this information in hard copy
by mail. A health insuring corporation providing basic health care
services or supplemental health care services shall provide this
information annually. A health insuring corporation providing only
specialty health care services shall provide this information
biennially.
(B) Each health insuring corporation, upon the request of a
subscriber, shall make available its most recent statutory
financial statement.
Sec. 1751.35. (A) The superintendent of insurance may
suspend or revoke any certificate of authority issued to a health
insuring corporation under this chapter if the superintendent
finds that:
(1) The health insuring corporation is operating in
contravention of its articles of incorporation, its health care
plan or plans, or in a manner contrary to that described in and
reasonably inferred from any other information submitted under
section 1751.03 of the Revised Code, unless amendments to such
submissions have been filed and have taken effect in compliance
with this chapter.
(2) The health insuring corporation fails to issue evidences
of coverage in compliance with the requirements of section 1751.11
of the Revised Code.
(3) The contractual periodic prepayments or premium rates
used do not comply with the requirements of section 1751.12 of the
Revised Code.
(4) The health insuring corporation enters into a contract,
agreement, or other arrangement with any health care facility or
provider, that does not comply with the requirements of section
1751.13 of the Revised Code, or the corporation fails to provide
an annual certificate as required by section 1751.13 of the
Revised Code.
(5) The superintendent determines, after a hearing conducted
in accordance with Chapter 119. of the Revised Code, that the
health insuring corporation no longer meets the requirements of
section 1751.04 of the Revised Code.
(6) The health insuring corporation is no longer financially
responsible and may reasonably be expected to be unable to meet
its obligations to enrollees or prospective enrollees.
(7) The health insuring corporation has failed to implement
the complaint system that complies with the requirements of
section 1751.19 of the Revised Code.
(8) The health insuring corporation, or any agent or
representative of the corporation, has advertised, merchandised,
or solicited on its behalf in contravention of the requirements of
section 1751.31 of the Revised Code.
(9) The health insuring corporation has unlawfully
discriminated against any enrollee or prospective enrollee with
respect to enrollment, disenrollment, or price or quality of
health care services.
(10) The continued operation of the health insuring
corporation would be hazardous or otherwise detrimental to its
enrollees.
(11) The health insuring corporation has submitted false
information in any filing or submission required under this
chapter or any rule adopted under this chapter.
(12) The health insuring corporation has otherwise failed to
substantially comply with this chapter or any rule adopted under
this chapter.
(13) The health insuring corporation is not operating a
health care plan.
(14) The health insuring corporation has failed to comply
with any of the requirements of sections 1751.77 to 1751.88
1751.87 or Chapter 3922. of the Revised Code.
(B) A certificate of authority shall be suspended or revoked
only after compliance with the requirements of Chapter 119. of the
Revised Code.
(C) When the certificate of authority of a health insuring
corporation is suspended, the health insuring corporation, during
the period of suspension, shall not enroll any additional
subscribers or enrollees except newborn children or other newly
acquired dependents of existing subscribers or enrollees, and
shall not engage in any advertising or solicitation whatsoever.
(D) When the certificate of authority of a health insuring
corporation is revoked, the health insuring corporation, following
the effective date of the order of revocation, shall conduct no
further business except as may be essential to the orderly
conclusion of the affairs of the health insuring corporation. The
health insuring corporation shall engage in no further advertising
or solicitation whatsoever. The superintendent, by written order,
may permit such further operation of the health insuring
corporation as the superintendent may find to be in the best
interest of enrollees, to the end that enrollees will be afforded
the greatest practical opportunity to obtain continuing health
care coverage.
Sec. 1751.66. (A) No individual or group health insuring
corporation policy, contract, or agreement that provides coverage
for prescription drugs shall limit or exclude coverage for any
drug approved by the United States food and drug administration on
the basis that the drug has not been approved by the United States
food and drug administration for the treatment of the particular
indication for which the drug has been prescribed, provided the
drug has been recognized as safe and effective for treatment of
that indication in one or more of the standard medical reference
compendia specified in division (B)(1) of this section adopted by
the United States department of health and human services under 42
U.S.C. 1395x(t)(2), as amended, or in medical literature that
meets the criteria specified in division (B)(2) of this section.
(B)(1) The compendia accepted for purposes of division (A) of
this section are the following:
(a) The "AMA drug evaluations," a publication of the American
medical association;
(b) The "AHFS (American hospital formulary service) drug
information," a publication of the American society of health
system pharmacists;
(c) "Drug information for the health care provider," a
publication of the United States pharmacopoeia convention.
(2) Medical literature may be accepted for purposes of
division (A) of this section only if all of the following apply:
(a)(1) Two articles from major peer-reviewed professional
medical journals have recognized, based on scientific or medical
criteria, the drug's safety and effectiveness for treatment of the
indication for which it has been prescribed;
(b)(2) No article from a major peer-reviewed professional
medical journal has concluded, based on scientific or medical
criteria, that the drug is unsafe or ineffective or that the
drug's safety and effectiveness cannot be determined for the
treatment of the indication for which it has been prescribed;
(c)(3) Each article meets the uniform requirements for
manuscripts submitted to biomedical journals established by the
international committee of medical journal editors or is published
in a journal specified by the United States department of health
and human services pursuant to Section 1861(t)(2)(B) of the
"Social Security Act," 107 Stat. 591 (1993), 42 U.S.C. 1395
(x)(t)(2)(B), as amended, as accepted peer-reviewed medical
literature.
(C) Coverage of a drug required by division (A) of this
section includes medically necessary services associated with the
administration of the drug.
(D) Division (A) of this section shall not be construed to do
any of the following:
(1) Require coverage for any drug if the United States food
and drug administration has determined its use to be
contraindicated for the treatment of the particular indication for
which the drug has been prescribed;
(2) Require coverage for experimental drugs not approved for
any indication by the United States food and drug administration;
(3) Alter any law with regard to provisions limiting the
coverage of drugs that have not been approved by the United States
food and drug administration;
(4) Require reimbursement or coverage for any drug not
included in the drug formulary or list of covered drugs specified
in a health insuring corporation contract;
(5) Prohibit a health insuring corporation from limiting or
excluding coverage of a drug, provided that the decision to limit
or exclude coverage of the drug is not based primarily on the
coverage of drugs required by this section.
(E) This section applies only to health insuring corporation
policies, contracts, and agreements that are described in division
(A) of this section and that are delivered, issued for delivery,
or renewed in this state on or after July 1, 1997.
Sec. 1751.77. As used in sections 1751.77 to 1751.88 1751.87
of the Revised Code, unless otherwise specifically provided or as
otherwise required pursuant to applicable federal law or
regulations:
(A) "Adverse determination" means a determination by a health
insuring corporation or its designee utilization review
organization that an admission, availability of care, continued
stay, or other health care service has been reviewed and, based
upon the information provided, the health care service does not
meet the requirements for benefit payment under the health
insuring corporation's policy, contract, or agreement, and
coverage is therefore denied, reduced, or terminated.
(B) "Ambulatory review" means utilization review of health
care services performed or provided in an outpatient setting.
(C) "Authorized person" means a parent, guardian, or other
person authorized to act on behalf of an enrollee with respect to
health care decisions.
(D) "Case management" means a coordinated set of activities
conducted for individual patient management of serious,
complicated, protracted, or other specified health conditions.
(E) "Certification" means a determination by a health
insuring corporation or its designee utilization review
organization that an admission, availability of care, continued
stay, or other health care service has been reviewed and, based
upon the information provided, the health care service satisfies
the requirements for benefit payment under the health insuring
corporation's policy, contract, or agreement.
(F) "Clinical peer" means a physician when an evaluation is
to be made of the clinical appropriateness of health care services
provided by a physician. If an evaluation is to be made of the
clinical appropriateness of health care services provided by a
provider who is not a physician, "clinical peer" means either a
physician or a provider holding the same license as the provider
who provided the health care services.
(G) "Clinical review criteria" means the written screening
procedures, decision abstracts, clinical protocols, and practice
guidelines used by a health insuring corporation to determine the
necessity and appropriateness of health care services.
(H) "Concurrent review" means utilization review conducted
during a patient's hospital stay or course of treatment.
(I) "Discharge planning" means the formal process for
determining, prior to a patient's discharge from a health care
facility, the coordination and management of the care that the
patient is to receive following discharge from a health care
facility.
(J) "Participating provider" means a provider or health care
facility that, under a contract with a health insuring corporation
or with its contractor or subcontractor, has agreed to provide
health care services to enrollees with an expectation of receiving
payment, other than coinsurance, copayments, or deductibles,
directly or indirectly from the health insuring corporation.
(K) "Physician" means a provider who holds a certificate
issued under Chapter 4731. of the Revised Code authorizing the
practice of medicine and surgery or osteopathic medicine and
surgery or a comparable license or certificate from another state.
(L) "Prospective review" means utilization review that is
conducted prior to an admission or a course of treatment.
(M) "Retrospective review" means utilization review of
medical necessity that is conducted after health care services
have been provided to a patient. "Retrospective review" does not
include the review of a claim that is limited to an evaluation of
reimbursement levels, veracity of documentation, accuracy of
coding, or adjudication of payment.
(N) "Second opinion" means an opportunity or requirement to
obtain a clinical evaluation by a provider other than the provider
originally making a recommendation for proposed health care
services to assess the clinical necessity and appropriateness of
the proposed health care services.
(O) "Utilization review" means a process used to monitor the
use of, or evaluate the clinical necessity, appropriateness,
efficacy, or efficiency of, health care services, procedures, or
settings. Areas of review may include ambulatory review,
prospective review, second opinion, certification, concurrent
review, case management, discharge planning, or retrospective
review.
(P) "Utilization review organization" means an entity that
conducts utilization review, other than a health insuring
corporation performing a review of its own health care plans.
Sec. 1751.78. (A)(1) Sections 1751.77 to 1751.88 1751.87 and
Chapter 3922. of the Revised Code apply to any health insuring
corporation that provides or performs utilization review services
in connection with its policies, contracts, and agreements
covering basic health care services and to any designee of the
health insuring corporation, or to any utilization review
organization that performs utilization review functions on behalf
of the health insuring corporation in connection with policies,
contracts, or agreements of the health insuring corporation
covering basic health care services.
(2) Nothing in sections 1751.77 to 1751.82 or section
1751.823 of the Revised Code shall be construed to require a
health insuring corporation to provide or perform utilization
review services in connection with health care services provided
under a policy, plan, or agreement of supplemental health care
services or specialty health care services.
(B)(1) Each health insuring corporation shall be responsible
for monitoring all utilization review and internal review
activities carried out by, or on behalf of, the health insuring
corporation and for ensuring that all requirements of sections
1751.77 to
1751.88 1751.87 and Chapter 3922. of the Revised Code,
and any rules adopted thereunder, are met. The health insuring
corporation shall also ensure that appropriate personnel have
operational responsibility for the conduct of the health insuring
corporation's utilization review program.
(2) If a health insuring corporation contracts to have a
utilization review organization or other entity perform the
utilization review functions required by sections 1751.77 to
1751.88 1751.87 and Chapter 3922. of the Revised Code, and any
rules adopted thereunder, the superintendent of insurance shall
hold the health insuring corporation responsible for monitoring
the activities of the utilization review organization or other
entity and for ensuring that the requirements of those sections
and rules are met.
Sec. 1751.811. In lieu of conducting a prospective,
concurrent, or retrospective review under section 1751.81 of the
Revised Code, providing a reconsideration under section 1751.82 of
the Revised Code, or conducting an internal review under section
1751.83 of the Revised Code, a health insuring corporation may
afford an enrollee an opportunity for an external review under
section
1751.84 3922.08 or 1751.85 3922.10 of the Revised Code. If
an external review is conducted pursuant to this section, the
health insuring corporation is not required to afford the enrollee
an opportunity for any of the reviews that were disregarded
pursuant to this section, including the external review that may
have resulted from a review that was disregarded pursuant to this
section, unless new clinical information is submitted to the
health insuring corporation.
Sec. 1751.83. A health insuring corporation shall establish
and maintain an internal review system that has been approved by
the superintendent of insurance. The system shall provide for
review by a clinical peer and include adequate and reasonable
procedures for review and resolution of appeals from enrollees
concerning adverse determinations made under section 1751.81 of
the Revised Code, including procedures for verifying and reviewing
appeals from enrollees whose medical conditions require expedited
review.
A health insuring corporation shall consider and provide a
written response to each request for an internal review not later
than sixty thirty days after receipt of the request, except that
if the seriousness of the enrollee's medical condition requires an
expedited review, the health insuring corporation shall provide
the written response not later than seven days after receipt of
the request or in accordance with applicable preemptive federal
laws or regulations. The response shall state the reason for the
health insuring corporation's decision, inform the enrollee of the
right to pursue a further review, and explain the procedures for
initiating the review, including the time frames within which the
enrollee must request the review, as specified in section 1751.84
or 1751.85 3922.02 of the Revised Code. Failure by a health
insuring corporation to provide a written response within the time
frames specified under this section shall be deemed a denial by
the health insuring corporation for purposes of requesting a an
external review under section 1751.831, 1751.84, or 1751.85
Chapter 3922. of the Revised Code.
If the health insuring corporation has denied, reduced, or
terminated coverage for a health care service on the grounds that
the service is not a service covered under the terms of the
enrollee's policy, contract, or agreement, the response shall
inform the enrollee of the right to request a review by the
superintendent of insurance under section 1751.831 Chapter 3922.
of the Revised Code. If the health insuring corporation has
denied, reduced, or terminated coverage for a health care service
on the grounds that the service is not medically necessary, the
response shall inform the enrollee of the right to request an
external review under
section 1751.84 Chapter 3922. of the Revised
Code, except that if the enrollee meets the criteria set forth in
division (A) of section 1751.85 of the Revised Code, the response
shall inform the enrollee of the right to request an external
review under section 1751.85 of the Revised Code.
The health insuring corporation shall make available to the
superintendent for inspection copies of all documents in the
health insuring corporation's possession related to reviews
conducted pursuant to this section, including medical records
related to those reviews, and of responses, for three years
following completion of the review.
Sec. 1751.87. Nothing in sections 1751.77 to 1751.85 1751.83
of the Revised Code shall be construed to create a cause of action
against any of the following:
(A) An an employer that provides health care benefits to
employees through a health insuring corporation;
(B) A clinical peer, medical expert, or independent review
organization that participates in an external review under section
1751.84 or 1751.85 of the Revised Code;
(C) A health insuring corporation that provides coverage for
benefits in accordance with division (F) of section 1751.84 of
division (C)(11) of section 1751.85 of the Revised Code.
Sec. 1751.89. Sections 1751.77 to 1751.85 1751.83 of the
Revised Code do not apply to either of the following:
(A) Coverage provided to beneficiaries enrolled in the
medicare+choice program operated under Title XVIII of the "Social
Security Act," 49 Stat. 620 (1935), 42 U.S.C.A. 301, as amended;
(B) Coverage provided to medicaid recipients;
(C) Coverage provided to participants of the children's
buy-in program.
Sec. 3901.045. (A) The superintendent of insurance may
receive documents and information, including otherwise
confidential or privileged documents and information, from local,
state, federal, and international regulatory and law enforcement
agencies, from local, state, and federal prosecutors, and from the
national association of insurance commissioners and its affiliates
and subsidiaries, provided that the superintendent maintains as
confidential or privileged any document or information received
with notice or the understanding that the document or information
is confidential or privileged under the laws of the jurisdiction
that is the source of the document or information.
(B) The superintendent may also receive documents and
information, including otherwise confidential or privileged
documents and information, from the chief deputy rehabilitator,
the chief deputy liquidator, other deputy rehabilitators and
liquidators, and from any other person employed by, or acting on
behalf of, the superintendent pursuant to Chapter 3901. or 3903.
of the Revised Code, provided that the superintendent maintains as
confidential or privileged any document or information received
with the notice or understanding that the document or information
is confidential or privileged, except that the superintendent may
share and disclose such a document or information when authorized
by other sections of the Revised Code.
(C) The superintendent has the authority to maintain as
confidential or privileged the documents and information received
pursuant to this section.
(D) The superintendent's authority to receive documents and
information under this section, from the persons and subject to
the conditions listed in this section, is not limited in any way
by section 1751.19, 3901.36, 3901.44, 3901.48, 3901.70, 3901.83,
3903.11, 3903.72, 3903.88, 3905.492, 3905.50, 3922.21, or 3999.36
of the Revised Code.
Sec. 3922.01. As used in this chapter:
(A) "Adverse benefit determination" means a decision by a
health plan issuer:
(1) To deny, reduce, or terminate a requested health care
service or payment in whole or in part, including all of the
following:
(a) A determination that the health care service does not
meet the health plan issuer's requirements for medical necessity,
appropriateness, health care setting, level of care, or
effectiveness, including experimental or investigational
treatments;
(b) A determination of an individual's eligibility for
individual health insurance coverage, including coverage offered
to individuals through a nonemployer group, to participate in a
plan or health insurance coverage;
(c) A determination that a health care service is not a
covered benefit;
(d) The imposition of an exclusion, including exclusions for
pre-existing conditions, source of injury, network, or any other
limitation on benefits that would otherwise be covered.
(2) Not to issue individual health insurance coverage to an
applicant, including coverage offered to individuals through a
nonemployer group;
(3) To rescind coverage on a health benefit plan.
(B) "Ambulatory review" has the same meaning as in section
1751.77 of the Revised Code.
(C) "Authorized representative" means an individual who
represents a covered person in an internal appeal or external
review process of an adverse benefit determination who is any of
the following:
(1) A person to whom a covered individual has given express,
written consent to represent that individual in an internal
appeals process or external review process of an adverse benefit
determination;
(2) A person authorized by law to provide substituted consent
for a covered individual;
(3) A family member or a treating health care professional,
but only when the covered person is unable to provide consent.
(D) "Best evidence" means evidence based on all of the
following sources, listed according to priority, as they are
available:
(1) Randomized clinical trials;
(2) Cohort studies or case-control studies;
(3) Case series;
(4) Expert opinion.
(E) "Covered person" means a policyholder, subscriber,
enrollee, member, or individual covered by a health benefit plan.
"Covered person" does include the covered person's authorized
representative with regard to an internal appeal or external
review in accordance with division (C) of this section. "Covered
person" does not include the covered person's representative in
any other context.
(F) "Covered benefits" or "benefits" means those health care
services to which a covered person is entitled under the terms of
a health benefit plan.
(G) "Emergency medical condition" has the same meaning as in
section 1753.28 of the Revised Code.
(H) "Emergency services" has the same meaning as in section
1753.28 of the Revised Code.
(I) "Evidence-based standard" means the conscientious,
explicit, and judicious use of the current best evidence, based on
a systematic review of the relevant research, in making decisions
about the care of individuals.
(J) "Facility" means an institution providing health care
services, or a health care setting, including hospitals and other
licensed inpatient centers, ambulatory, surgical, treatment,
skilled nursing, residential treatment, diagnostic, laboratory,
and imaging centers, and rehabilitation and other therapeutic
health settings.
(K) "Final adverse benefit determination" means an adverse
benefit determination that is upheld at the completion of a health
plan issuer's internal appeals process.
(L) "Health benefit plan" means a policy, contract,
certificate, or agreement offered by a health plan issuer to
provide, deliver, arrange for, pay for, or reimburse any of the
costs of health care services, including benefit plans marketed in
the individual or group market by all associations, whether bona
fide or non-bona fide. "Health benefit plan" also means a limited
benefit plan, except as follows. "Health benefit plan" does not
mean any of the following types of coverage: a policy, contract,
certificate, or agreement that covers only a specified accident,
accident only, credit, dental, disability income, long-term care,
hospital indemnity, medicare supplement, medicare, tricare,
specified disease, or vision care; coverage issued as a supplement
to liability insurance; insurance arising out of workers'
compensation or similar law; automobile medical payment insurance;
or insurance under which benefits are payable with or without
regard to fault and which is statutorily required to be contained
in any liability insurance policy or equivalent self-insurance; a
medicare supplement policy of insurance, as defined by the
superintendent of insurance by rule, coverage under a plan through
medicare, medicaid, or the federal employees benefit program; any
coverage issued under Chapter 55 of Title 10 of the United States
Code and any coverage issued as a supplement to that coverage.
(M) "Health care professional" means a physician,
psychologist, nurse practitioner, or other health care
practitioner licensed, accredited, or certified to perform health
care services consistent with state law.
(N) "Health care provider" or "provider" means a health care
professional or facility.
(O) "Health care services" means services for the diagnosis,
prevention, treatment, cure, or relief of a health condition,
illness, injury, or disease.
(P) "Health plan issuer" means an entity subject to the
insurance laws and rules of this state, or subject to the
jurisdiction of the superintendent of insurance, that contracts,
or offers to contract to provide, deliver, arrange for, pay for,
or reimburse any of the costs of health care services under a
health benefit plan, including a sickness and accident insurance
company, a health insuring corporation, a fraternal benefit
society, a self-funded multiple employer welfare arrangement, or a
nonfederal, government health plan. "Health plan issuer" includes
a third party administrator licensed under Chapter 3959. of the
Revised Code to the extent that the benefits that such an entity
is contracted to administer under a health benefit plan are
subject to the insurance laws and rules of this state or subject
to the jurisdiction of the superintendent.
(Q) "Health information" means information or data, whether
oral or recorded in any form or medium, and personal facts or
information about events or relationships that relates to all of
the following:
(1) The past, present, or future physical, mental, or
behavioral health or condition of a covered person or a member of
the covered person's family;
(2) The provision of health care services or health-related
benefits to a covered person;
(3) Payment for the provision of health care services to or
for a covered person.
(R) "Independent review organization" means an entity that is
accredited by a nationally recognized private accrediting
organization to conduct independent external reviews of adverse
benefit determinations and is accredited pursuant to section
3922.13 of the Revised Code.
(S) "Medical or scientific evidence" means evidence found in
any of the following sources:
(1) Peer-reviewed scientific studies published in, or
accepted for publication by, medical journals that meet nationally
recognized requirements for scientific manuscripts and that submit
most of their published articles for review by experts who are not
part of the editorial staff;
(2) Peer-reviewed medical literature, including literature
relating to therapies 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 and
elsevier science ltd. for indexing in excerpta medicus;
(3) Medical journals recognized by the secretary of health
and human services under section 1861(t)(2) of the federal social
security act;
(4) The following standard reference compendia:
(a) The American hospital formulary service drug information;
(b) Drug facts and comparisons;
(c) The American dental association accepted dental
therapeutics;
(d) 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 any of the following:
(a) The federal agency for health care research and quality;
(b) The national institutes of health;
(c) The national cancer institute;
(d) The national academy of sciences;
(e) The centers for medicare and medicaid services;
(f) The federal food and drug administration;
(g) Any national board recognized by the national institutes
of health for the purpose of evaluating the medical value of
health care services.
(6) Any other medical or scientific evidence that is
comparable.
(T) "Person" has the same meaning as in section 3901.19 of
the Revised Code.
(U) "Protected health information" means health information
related to the identity of an individual, or information that
could reasonably be used to determine the identity of an
individual.
(V) "Rescission" means a cancellation or discontinuance of
coverage that has a retroactive effect. "Rescission" does not
include a cancellation or discontinuance of coverage that has only
a prospective effect or a cancellation or discontinuance of
coverage that is effective retroactively to the extent it is
attributable to a failure to timely pay required premiums or
contributions towards the cost of coverage.
(W) "Retrospective review" means a review conducted after
services have been provided to a covered person.
(X) "Superintendent" means the superintendent of insurance.
(Y) "Utilization review" has the same meaning as in section
1751.77 of the Revised Code.
(Z) "Utilization review organization" has the same meaning as
in section 1751.77 of the Revised Code.
Sec. 3922.02. (A) A covered person may make a request for an
external review of an adverse benefit determination.
(B) All requests for external review shall be made in
writing, except when making a request for an expedited review
under section 3922.09 of the Revised Code, by the covered person
within one hundred eighty days of the date of the final adverse
benefit determination in a form prescribed by the superintendent.
Requests for an expedited review may be requested orally or by
electronic means. When an oral or electronic request for review is
made, written confirmation of the request must be submitted to the
health plan issuer no later than five days after the initial
request was made.
(C) An adverse benefit determination shall be eligible for
internal appeal or external review, regardless of how small the
cost of the requested health care service related to the adverse
benefit determination is.
Sec. 3922.03. (A) All health plan issuers shall implement an
internal appeal process under which a covered person may appeal an
adverse benefit determination. This process must be in compliance
with the Patient Protection and Affordable Care Act of 2010, Pub.
L. 111-148, 124 Stat. 119, as amended, and the associated
regulations, as well as any other applicable state rules or
federal regulations.
(B) Review of a final adverse benefit determination shall be
through an external review under section 3922.08, 3922.09, or
3922.10 of the Revised Code.
(C) All health plan issuers shall provide notice to covered
persons, pursuant to and in accordance with federal regulations,
of all internal appeal processes, external review processes, the
availability of any applicable office of health insurance
assistance, ombudsman program, or other similar program in this
state to assist consumers.
Sec. 3922.04. (A) Except as provided in division (E) of this
section, a health plan issuer is not required to grant a request
for a standard external review made under section 3922.08 or
3922.10 of the Revised Code until the covered person has exhausted
the health plan issuer's internal appeal process.
(B) An internal appeal process shall be considered exhausted
if a covered person has requested an internal appeal and has not
received a written decision from the health plan issuer within the
time frame required by 23 C.F.R. 2560.503-1 or the health plan
issuer fails to adhere to all requirements of the internal appeals
process.
(C) Notwithstanding division (B) of this section, the
internal appeals process will not be deemed exhausted based on de
minimis violations that do not cause, and are not likely to cause,
prejudice or harm to the covered person so long as the health plan
issuer demonstrates that the violation was for good cause or due
to matters beyond the control of the health plan issuer and that
the violation occurred in the context of an ongoing, good faith
exchange of information between the health plan issuer and the
covered person, and is not reflective of a pattern or practice of
noncompliance, except that:
(1) If the health plan issuer denies a request for external
review under this division, the covered person may request written
explanation from the health plan issuer, and the health plan
issuer shall provide the explanation within ten days, including a
specific description of its bases, if any, for asserting that the
delay should not cause the internal appeals process to be
considered exhausted;
(2) The covered person may request review by the
superintendent of the health plan issuer's explanation provided
under division (C)(1) of this section and if the superintendent
affirms the health plan issuer's explanation, the covered person
may, within ten days of the superintendent's notice of decision,
resubmit and pursue the internal appeal process. Time periods for
refiling the internal appeal shall begin to run upon receipt of
such notice by the covered person.
(D) Notwithstanding division (B) of this section, a covered
person shall not make a request for an external review of an
adverse benefit determination involving a retrospective review
determination made pursuant to a utilization review until the
covered person has exhausted the health plan issuer's internal
appeals process.
(E) A request for an external review of an adverse benefit
determination may be made before the covered person has exhausted
the health plan issuer's internal appeals procedures whenever the
health plan issuer agrees to waive the exhaustion requirement. If
the internal appeal process is waived, the covered person may file
a request in writing for a standard external review under section
3922.08 or 3922.10 of the Revised Code.
(F) Notwithstanding any other section in this chapter, health
plan issuers offering individual health insurance coverage,
including coverage offered to individuals through nonemployer
groups shall not require more than one level of internal appeal
before the individual may request an external review.
Sec. 3922.05. (A) A health plan issuer shall afford the
opportunity for an external review by an independent review
organization for an adverse benefit determination if the
determination involved a medical judgment or if the decision was
based on any medical information, pursuant to the following
sections:
(1) Section 3922.08 of the Revised Code for a standard
review;
(2) Section 3922.09 of the Revised Code for an expedited
review;
(3) Section 3922.10 of the Revised Code for reviews involving
experimental procedures.
(B) A health plan issuer shall afford the opportunity for an
external review by the superintendent of insurance for an adverse
benefit determination by the health plan issuer based on a
contractual issue that did not involve a medical judgment or any
medical information, pursuant to section 3922.11 of the Revised
Code.
(C) For an adverse benefit determination in which emergency
medical services have been determined to be not medically
necessary or appropriate after an external review pursuant to
division (A) of this section, the health plan issuer shall afford
the covered person the opportunity for an external review by the
superintendent of insurance, based on the prudent layperson
standard, pursuant to section 3922.11 of the Revised Code.
(D) Upon receipt of a request for an external review from a
covered person, the health plan issuer shall review it for
completeness as prescribed under any associated rules, policies,
or procedures adopted by the superintendent.
(1) If the request is complete, the health plan issuer shall
initiate an external review in accordance with any associated
rules, policies, or procedures adopted by the superintendent of
insurance and shall notify the covered person in writing, in a
form specified by the superintendent of insurance, that the
request is complete. This notification shall include both of the
following:
(a) The name and contact information for the assigned
independent review organization or the superintendent of
insurance, as applicable, for the purpose of submitting additional
information;
(b) Except for when an expedited request is made under
section 3922.09 or 3922.10 of the Revised Code, a statement that
the covered person may, with ten business days after the date of
receipt of the notice, submit, in writing, additional information
for either the independent review organization or the
superintendent of insurance to consider when conducting the
external review.
(2) If the request for an external review is not complete,
the health plan issuer shall, in accordance with any associated
rules, policies, or procedures adopted by the superintendent of
insurance, inform the covered person in writing, including what
information is needed to make the request complete.
(E)(1) If the health plan issuer denies a request for an
external review on the basis that the adverse benefit
determination is not eligible for an external review, the health
plan issuer shall notify the covered person in writing of both of
the following:
(a) The reason for the denial;
(b) That the denial may be appealed to the superintendent.
(2) If the health plan issuer denies a request for external
review on the basis that the adverse benefit determination is not
eligible for an external review, the covered person may appeal the
denial to the superintendent of insurance.
(3) Regardless of a determination made by a health plan
issuer, the superintendent of insurance may determine that a
request is eligible for external review. The superintendent's
determination shall be made in accordance with the terms of the
covered person's benefit plan and shall be subject to all
applicable provisions of this chapter.
(F)(1) If an external review of an adverse benefit
determination is granted, the superintendent, according to any
rules, policies, or procedures adopted by the superintendent shall
assign an independent review organization from the list of
organizations maintained by the superintendent under section
3922.13 of the Revised Code to conduct the external review and
shall notify the health plan issuer of the name of the assigned
independent review organization.
(2) The assignment of an approved independent review
organization shall be done on a random basis from those
independent review organizations qualified to conduct the review
in question based on the nature of the health care service that is
the subject of the adverse benefit determination.
(3) The superintendent of insurance shall not choose an
independent review organization with a conflict of interest, as
prescribed under section 3922.14 of the Revised Code.
(G) In its review of an adverse benefit determination under
section 3922.08, 3922.09, or 3922.10 of the Revised Code, an
assigned independent review organization is not bound by any
decisions or conclusions reached by the health plan issuer during
its utilization review process or internal appeals process. The
organization is not required to, but may, accept and consider
additional information submitted after the end of the
ten-business-day period described in division (D)(1)(b) of this
section.
(H)(1) An independent review organization assigned to review
an adverse benefit determination shall provide written notice of
its decision to either uphold or reverse the determination within
thirty days of receipt of a request for a standard review or a
standard review involving an experimental or investigational
treatment, or within seventy-two hours of receipt of an expedited
request.
(2) The written notice shall be sent to all of the following:
(a) The covered person;
(b) The health plan issuer;
(c) The superintendent of insurance.
(3) The written notification shall include all of the
following:
(a) A general description of the reason for the request for
external review;
(b) The date the independent review organization was assigned
by the superintendent of insurance to conduct the external review;
(c) The dates over which the external review was conducted;
(d) The date on which the independent review organization's
decision was made;
(e) The rationale for its decision;
(f) References to the evidence or documentation, including
any evidence-based standards used, that were considered in
reaching its decision.
(I) Upon receipt of a notice by an independent review
organization to reverse the adverse benefit determination, a
health plan issuer shall immediately provide coverage for the
health care service or services in question.
Sec. 3922.06. Except for when an expedited request is made
under section 3922.09 or 3922.10 of the Revised Code, an
independent review organization shall forward upon receipt a copy
of any information received from a covered person pursuant to
division (D)(1) of section 3922.05 of the Revised Code, as well as
any other information received from the covered person, to the
health plan issuer.
Upon receipt of that information or the information described
in division (K) of section 3922.10 of the Revised Code, a health
plan issuer may reconsider its adverse benefit determination and
provide coverage for the health service in question.
Reconsideration of an adverse benefit determination by a
health plan issuer receipt of information under this section shall
not delay or terminate an external review.
If a health plan issuer reverses an adverse benefit
determination under this section, the health plan issuer shall
notify, in writing and within one business day of making such a
decision, the covered person, the assigned independent review
organization, and the superintendent of insurance.
Upon receipt of such a notification, the assigned independent
review organization shall terminate the associated external
review.
Sec. 3922.07. In addition to the information provided under
division (D)(1)(b) of section 3922.05, division (B) of section
3922.08, division (C) of section 3922.09, and division (D) of
section 3922.10 of the Revised Code, an assigned independent
review organization, to the extent that such documents are
available and appropriate, shall consider all of the following
when conducting its review:
(A) The covered person's medical records;
(B) The attending health care professional's recommendation;
(C) Consulting reports from appropriate health care
professionals and other documents submitted by the health plan
issuer, covered person, or covered person's treating provider;
(D) The terms of coverage under the covered person's health
benefit plan to ensure that the independent review organization's
decision is not contrary to the terms of the plan;
(E) The most appropriate practice guidelines, including
evidence-based standards, and practice guidelines developed by the
federal government, and national or professional medical
societies, boards, and associations;
(F) Any applicable clinical review criteria developed and
used by the health plan issuer or its designated utilization
review organization;
(G) The opinion of the independent review organization's
clinical reviewer or reviewers after considering the other sources
described in this section.
Sec. 3922.08. (A) The provisions of this section apply only
to standard reviews, which are not expedited and do not involve an
experimental or investigational treatment.
(B) Within five days after the receipt of a request for an
external review that is complete and valid, the health plan issuer
shall provide to the assigned independent review organization all
documents and information considered in making the adverse benefit
determination.
(C) An external review shall not be delayed due to failure on
the part of the health plan issuer to provide the information
required under division (B) of this section.
(D)(1) An independent review organization may reverse an
adverse benefit determination if the information required under
division (B) of this section is not provided in the allotted time.
The independent review organization may also grant a request from
the health plan issuer for more time to provide the required
information.
(2) If an adverse benefit determination is reversed under
division (D)(1) of this section, the independent review
organization shall notify, within one business day of making the
decision, the covered person, the health plan issuer, and the
superintendent of insurance.
Sec. 3922.09. (A) A covered person may make a request for an
expedited external review, except as provided in division (J) of
this section:
(1) After an adverse benefit determination, if both of the
following apply:
(a) The covered person's treating physician certifies that
the adverse benefit determination involves a medical condition
that could seriously jeopardize the life or health of the covered
person if treated after the time frame of an expedited internal
review;
(b) The covered person has filed a request for an expedited
internal review.
(2) After a final adverse benefit determination, if either of
the following apply:
(a) The covered person's treating physician certifies that
the adverse benefit determination involves a medical condition
that could seriously jeopardize the life or health of the covered
person, or would jeopardize the covered person's ability to regain
maximum function, if treated after the time frame of a standard
external review;
(b) 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 yet been discharged from a facility.
(B) Immediately upon receipt of a request for an expedited
external review, the health plan issuer shall determine if the
request is complete under any associated rules, policies, or
procedures adopted by the superintendent of insurance and eligible
for expedited external review under division (B) of this section.
The health plan issuer shall immediately notify the covered person
of its determination in accordance with any associated rules,
policies, or procedures adopted by the superintendent of
insurance.
(C) If a request for an expedited review is complete and
eligible, the health plan issuer shall immediately provide or
transmit all necessary documents and information considered in
making the adverse benefit determination in question to the
assigned independent review organization electronically, or by
telephone, facsimile, or other available expeditious method.
(D) In addition to the information transmitted under division
(D) of this section, the assigned independent review organization
shall also consider relevant information as required under section
3922.07 of the Revised Code.
(E) As expeditiously as the covered person's medical
condition requires, but no more than seventy-two hours after being
assigned an expedited, external review, the assigned independent
review organization shall uphold or reverse the adverse benefit
determination.
(F) If a health plan issuer fails to provide the documents
and information as required in division (D) of this section, the
independent review organization shall not delay the external
review and may accordingly reverse the adverse benefit
determination.
(G) An independent review organization shall promptly notify
the covered person, health plan issuer, and superintendent of
insurance of any decision made under this section. If such a
notice is not made in writing, the independent review
organization, shall provide, within forty-eight hours of making
the decision, written confirmation, including the information
required under division (H)(3) of section 3922.05 of the Revised
Code, of its decision to the covered person, the health plan
issuer, and the superintendent of insurance.
(H) Upon receipt of a notice by an independent review
organization to reverse the adverse benefit determination, a
health plan issuer shall immediately provide coverage for the
health care service or services in question.
(I) An expedited, external review may not be provided for
retrospective final adverse benefit determinations.
Sec. 3922.10. The provisions of this section apply only to
external reviews that involve an experimental or investigational
treatment.
(A) A covered person may request an external review of an
adverse benefit determination based on the conclusion that a
requested health care service is experimental or investigational,
except when the requested health care service is explicitly listed
as an excluded benefit under the covered person's benefit plan.
(B) To be eligible for an external review under this section,
a covered person's treating physician shall certify that one of
the following situations is applicable:
(1) Standard health care services have not been effective in
improving the condition of the covered person;
(2) Standard health care services are not medically
appropriate for the covered person;
(3) There is no available standard health care services
covered by the health plan issuer that is more beneficial than
requested health care service.
(C)(1) A covered person may request orally or by electronic
means an expedited review under this section if the person's
treating physician certifies that the requested health care
service in question would be significantly less effective if not
promptly initiated.
(2) Immediately upon receipt of a request for an expedited
external review, the health plan issuer shall determine if the
request is complete under any associated rules, policies, or
procedures adopted by the superintendent of insurance and eligible
for expedited external review under division (B) of this section.
The health plan issuer shall immediately notify the covered person
of its determination in accordance with any associated rules
adopted by the superintendent of insurance.
(D) The health plan issuer shall provide to the assigned
independent review organization all documents and information
considered in making the adverse benefit determination within
whichever of the following applies:
(1) Within five days after the receipt of a request for an
external review;
(2) For an expedited external review, immediately by
telephone, facsimile, or any other available expeditious method.
(E) An independent review organization assigned by the
superintendent of insurance under division (F) of section 3922.05
of the Revised Code shall do both of the following:
(1) Select at least one clinical reviewer, pursuant to
divisions (F) and (G) of this section to conduct the external
review;
(2) Make a decision to uphold or reverse the adverse benefit
determination based upon the opinion of the clinical reviewer or
reviewers.
(F) In selecting clinical reviewers under division (E) of
this section, the assigned independent review organization shall
select physicians or other health care professionals who meet the
minimum qualifications described in section 3922.15 of the Revised
Code, and through clinical experience in the last three years, are
experts in the treatment of the covered person's condition and
have knowledge of the requested health care service.
(G) Neither the covered person, nor the health plan issuer,
shall choose or have any influence over the choice of the clinical
reviewer or reviewers chosen under division (E) of this section.
(H)(1) Each chosen clinical reviewer shall provide a written
opinion to the assigned independent review organization on whether
the adverse benefit determination should be upheld or reversed.
(2) In reaching such opinions, a clinical reviewer is not
bound by any conclusions reached by the health plan issuer during
a utilization review process or its internal appeals process.
(3) Any such opinion shall be in writing and shall include
all of the following information:
(a) A description of the covered person's condition;
(b) A description of the indicators relevant to determining
whether there is sufficient evidence to demonstrate that the
recommended or requested therapy is more likely than not to be
more beneficial to the covered person than any available standard
health care service, and that the adverse risks of the requested
health care service would not be substantially greater than those
of available standard health care services;
(c) A description and analysis of any medical or scientific
evidence considered in reaching the opinion;
(d) A description and analysis of any evidence-based standard
considered;
(e) Information on whether the reviewer's rationale for the
opinion is based on division (L)(2) or (L)(3) of this section.
(I) An external review shall not be delayed due to failure on
the part of the health plan issuer to provide the information
required under division (D) of this section.
(J)(1) An independent review organization may reverse an
adverse benefit determination, if the information required under
division (D) of this section is not provided in the allotted time.
The external review committee may also grant a request from the
health plan issuer for more time to provide the required
information.
(2) If an adverse benefit determination is reversed under
division (J)(1) of this section, the independent review
organization shall immediately notify the covered person, the
health plan issuer, and the superintendent of insurance.
(K)(1) Each clinical reviewer shall review all of the
information received pursuant to division (D) of this section, as
well as any other information submitted in writing by the covered
person pursuant to division (D) of section 3922.05 of the Revised
Code.
(2) In addition to the documents and information provided
pursuant to division (D) of this section and division (D) of
section 3922.05 of the Revised Code, each clinical reviewer shall
consider the following:
(a) Information required under section 3922.07 of the Revised
Code;
(b) Whether the requested health care service has been
approved by the federal food and drug administration, if
applicable, for the condition;
(c) Whether medical or scientific evidence, or evidence-based
standards, demonstrate that the expected benefits of the requested
health care service is more likely than not to be beneficial to
the covered person than any available standard health care
service, and that the adverse risks of the requested health care
service would not be substantially greater than those of available
standard health care services.
(L) Within one business day after the receipt of any such
information submitted by the covered person in accordance with
division (K)(1) of this section, the independent review
organization shall forward the information to the health plan
issuer. Upon receipt of any such forwarded information in
accordance with division (K)(1) of this section, a health plan
issuer may reconsider its adverse benefit determination under
section 3922.06 of the Revised Code.
(M)(1) Within thirty days after the date of receipt of a
request for a standard external review, or within seventy-two
hours of receipt of a request for an expedited external review,
the assigned independent review organization shall provide written
notice of its decision to uphold or reverse the adverse benefit
determination to the covered person, the health plan issuer, and
the superintendent of insurance.
(2)(a) If a majority of the clinical reviewers recommend that
the requested health care service should be covered, the
independent review organization shall make a decision to reverse
the health plan issuer's adverse benefit determination.
(b) If a majority of the clinical reviewers recommend that
the recommended or requested health care service or treatment
should not be covered, the independent review organization shall
make a decision to uphold the health plan issuer's adverse benefit
determination.
(c)(i) If the clinical reviewers are evenly split as to
whether the adverse benefit determination should be reversed or
upheld, the independent review organization shall obtain the
opinion of an additional clinical reviewer in order for the
independent review organization to make a decision based on the
opinions of a majority of the clinical reviewers pursuant to this
division.
(ii) The additional clinical reviewer selected shall use the
same information to reach an opinion as the clinical reviewers who
have already submitted their opinions pursuant to this section.
(iii) The selection of the additional clinical reviewer under
this division shall not extend the time within which the assigned
independent review organization is required to make a decision.
(3) The independent review organization shall include in the
notice provided pursuant to division (M)(1) of this section all of
the following:
(a) A general description of the reason for the request for
external review;
(b) The written opinion of each clinical reviewer, including
the recommendation of each clinical reviewer as to whether the
recommended or requested health care service or treatment should
be covered and the rationale for that recommendation;
(c) The date the independent review organization was assigned
by the superintendent to conduct the external review;
(d) The dates over which the external review was conducted;
(e) The date of its decision;
(f) The principal reason or reasons for its decision;
(g) The rationale for its decision.
(N) Upon receipt of a notice of a decision by an independent
review organization pursuant to division (M)(1) of this section
reversing the adverse benefit determination, a health plan issuer
shall immediately provide coverage of the requested health care
service in question.
Sec. 3922.11. (A) The superintendent of insurance shall
establish and maintain a system for receiving and reviewing
requests for external review for adverse benefit determinations
where the determination by the health plan issuer was based on a
contractual issue and did not involve a medical judgment or a
determination based on any medical information, except for
emergency services, as specified in division (C) of section
3922.05 of the Revised Code.
(B) A health plan issuer shall submit a request for external
review pursuant to division (B) or (C) of section 3922.05 of the
Revised Code to the superintendent, in accordance with any
associated rules, policies, or procedures adopted by the
superintendent of insurance.
(C) On receipt of a request from a health plan issuer, the
superintendent shall consider whether the health care service is a
service covered under the terms of the covered person's policy,
contract, certificate, or agreement, except that the
superintendent shall not conduct a review under this section
unless the covered person has exhausted the health plan issuer's
internal review process, pursuant to sections 3922.03 and 3922.04
of the Revised Code. The health plan issuer and covered person
shall provide the superintendent with any information required by
the superintendent that is in their possession and is germane to
the review.
(D) Unless the superintendent is not able to do so because
making the determination requires a medical judgement or a
determination based on medical information, the superintendent
shall determine whether the health care service at issue is a
service covered under the terms of the covered person's contract,
policy, certificate, or agreement. The superintendent shall notify
the covered person, and the health plan issuer of the
superintendent's determination.
(E) If the superintendent notifies the health plan issuer
that making the determination requires a medical judgement or a
determination based on medical information, the health plan issuer
shall initiate an external review under this chapter.
(F) If the superintendent determines that the health service
is a covered service, the health plan issuer shall cover the
service.
(G) If the superintendent determines that the health care
service is not a covered service, the health plan issuer is not
required to cover the service or afford the enrollee an external
review.
Sec. 3922.12. (A) An external review decision is binding on
the health plan issuer except to the extent the health plan issuer
has other remedies available under applicable state law, or unless
the superintendent of insurance determines that, due to the facts
and circumstances of an external review, a second external review
is required.
(B) An external review decision is binding on the covered
person except to the extent the covered person has other remedies
available under applicable federal or state law, or unless the
superintendent determines that, due to the facts and circumstances
of an external review, a second external review is required.
(C) A covered person may not file a subsequent request for
external review involving the same adverse benefit determination
for which the covered person has already received an external
review decision pursuant to this chapter, except in the event that
new medical or scientific evidence is submitted to the health plan
issuer.
Sec. 3922.13. The superintendent shall accredit independent
review organizations as prescribed by this section.
(A) The superintendent shall develop an application form to
accredit and renew accreditation of an independent review
organization.
(B) An independent review organization seeking to be
accredited by the superintendent, or to renew its accreditation,
shall submit the application form and include with the form all
documentation and information necessary for the superintendent to
determine if the independent review organization satisfies the
minimum qualifications established under section 3922.14 of the
Revised Code.
(C)(1) Except as provided in division (C)(2) of this section,
an independent review organization is eligible for accreditation
by the superintendent under this section only if it is accredited
by a nationally recognized private accrediting entity that the
superintendent has determined has accreditation standards that are
equivalent to or exceed the minimum qualifications for independent
review organizations under section 3922.14 of the Revised Code.
(2) The superintendent may approve independent review
organizations that are not accredited by a nationally recognized
private accrediting entity, if there are no acceptable nationally
recognized private accrediting entities providing independent
review organization accreditation.
(D) An independent review organization shall apply to renew
its accreditation on an annual basis.
(E) If the superintendent determines that an independent
review organization has lost its accreditation by a nationally
recognized private accrediting entity or no longer satisfies the
minimum requirements established under section 3922.14 of the
Revised Code, the superintendent shall revoke the independent
review organization's accreditation and shall remove the
independent review organization from the list of independent
review organizations approved to conduct external reviews.
(F) The superintendent shall maintain and periodically update
a list of accredited independent review organizations.
Sec. 3922.14. (A) To be accredited by the superintendent of
insurance to conduct external reviews under section 3922.13 of the
Revised Code, in addition to the requirements provided in section
3922.13 of the Revised Code and any associated rules adopted by
the superintendent, an independent review organization shall do
all of the following:
(1) Develop and maintain written policies and procedures that
govern all aspects of both the standard external review process
and the expedited external review process set forth in this
chapter, including a quality assurance mechanism that does all of
the following:
(a) Ensures that external reviews are conducted within the
time frames prescribed under this chapter and that the required
notices are provided in a timely manner;
(b) Ensures the selection of qualified and impartial
clinical reviewers to conduct external reviews on behalf of the
independent review organization;
(c) Ensures that chosen clinical reviewers are suitably
matched according to their area of expertise to specific cases and
that the independent review organization employs or contracts with
an adequate number of clinical reviewers to meet this requirement;
(d) Ensures the confidentiality of medical and treatment
records and clinical review criteria;
(e) Ensures that any person employed by, or who is under
contract with, the independent review organization adheres to the
requirements of this chapter.
(2) Maintain a toll-free telephone service to receive
information on a twenty-four-hour-a-day, seven-days-a-week basis
related to external reviews that is capable of accepting,
recording, and providing appropriate instruction to incoming
telephone callers during other than normal business hours;
(3) Agree to maintain and provide to the superintendent, upon
request and in accordance with any associated rules, policies, or
procedures adopted by the superintendent of insurance, the
information prescribed in section 3922.17 of the Revised Code.
(B) An independent review organization may not own or
control, be a subsidiary of or in any way be owned or controlled
by, or exercise control with a benefit plan, a national, state or
local trade association of benefit plans, or a national, state, or
local trade association of health care providers.
(C)(1) Neither the independent review organization selected
to conduct the external review nor any clinical reviewer assigned
by the independent organization to conduct the external review may
have a material, professional, familial, or financial affiliation
with any of the following:
(a) The health plan issuer that is the subject of the
external review, or any officer, director, or management employee
of the health plan issuer;
(b) The covered person whose treatment is the subject of the
external review;
(c) The health care provider, or the health care provider's
medical group or independent practice association, recommending
the health care service or treatment that is the subject of the
external review;
(d) The facility at which the recommended health care service
would be provided;
(e) 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) The superintendent may make a determination as to whether
an independent review organization or a clinical reviewer of the
independent review organization has a material professional,
familial, or financial conflict of interest for purposes of
division (C)(1) of this section. In making this determination, the
superintendent may take into consideration situations where an
independent review organization, or a clinical reviewer, may have
an apparent conflict of interest, but that the characteristics of
the relationship or connection in question are such that they do
not fall under the definition of conflict of interest provided
under division (D)(1) of this section. If the superintendent
determines that a conflict of interest exists, the superintendent
shall disallow an independent review organization or a clinical
reviewer from conducting the external review in question. Such
determinations related to conflicts of interest are the sole
discretion of the superintendent of insurance.
(D)(1) An independent review organization that is accredited
by a nationally recognized private accrediting entity that has
independent review accreditation standards that the superintendent
has determined are equivalent to or exceed the minimum
qualifications of this section shall be presumed in compliance
with this section to be eligible for accreditation by the
superintendent under section 3922.14 of the Revised Code.
(2) The superintendent shall initially review and
periodically review the independent review organization
accreditation standards of a nationally recognized private
accrediting entity to determine whether the entity's standards
are, and continue to be, equivalent to or exceed the minimum
qualifications established under this section. The superintendent
may accept a review conducted by the national association of
insurance commissioners for the purpose of the determination under
this division.
(3) Upon request, a nationally recognized, private
accrediting entity shall make its current independent review
organization accreditation standards available to the
superintendent or the national association of insurance
commissioners in order for the superintendent to determine if the
entity's standards are equivalent to or exceed the minimum
qualifications established under this section. The superintendent
may exclude any private accrediting entity that is not reviewed by
the national association of insurance commissioners.
(E) An independent review organization shall be unbiased in
its review of adverse benefit determinations and shall establish
and maintain written procedures to ensure that it is unbiased.
Sec. 3922.15. All clinical reviewers assigned by an
independent review organization to conduct external reviews shall
have the same license as the health care provider of the service
in question, and shall be physicians or other appropriate health
care providers who meet all of the following minimum
qualifications:
(A) Be an expert in the treatment of the medical condition
that is the subject of the external review;
(B) Be knowledgeable about the requested health care service
through clinical experience, within the last three years, treating
patients with the same, or a similar, medical condition;
(C) Hold a nonrestricted license in a state of the United
States and, for physicians, a current certification by a
recognized American medical specialty board in the area or areas
appropriate to the subject of the external review;
(D) Have no history of disciplinary actions or sanctions,
including loss of staff privileges or participation restrictions,
that have been taken or are pending by any hospital, governmental
agency or unit, or regulatory body that raise a question as to the
clinical reviewer's physical, mental, or professional competence
or moral character.
Sec. 3922.16. (A) Nothing in this chapter shall be construed
to create a cause of action against any of the following:
(1) An employer that provides health care benefits to
employees through a health plan issuer;
(2) A clinical reviewer, medical expert, or independent
review organization that participates in an external review under
this chapter;
(3) A health plan issuer that provides coverage for benefits
pursuant to this chapter.
(B) An independent review organization and any medical expert
or clinical reviewer an independent review organization uses in
conducting an external review under this chapter is not liable in
damages in a civil action for injury, death, or loss to person or
property and is not subject to professional disciplinary action
for making, in good faith, any finding, conclusion, or
determination required to complete the external review.
(C) This section does not grant immunity from civil liability
or professional disciplinary action to an independent review
organization, medical expert, or clinical peer for an action that
is outside the scope of authority granted under this chapter.
Sec. 3922.17. (A)(1) An independent review organization
assigned pursuant to sections 3922.08, 3922.09, or 3922.10 of the
Revised Code to conduct an external review shall maintain written
records in accordance with the associated rules established by the
superintendent, in the aggregate by state, and by the health plan
issuer, on all external reviews requested and conducted during a
calendar year.
Each independent review organization shall submit this
information to the superintendent, upon request, in a report in
the format specified by the superintendent that shall include, in
the aggregate by state and for each health plan issuer, all of the
following:
(a) The total number of requests for external review;
(b) The number of requests for external review resolved and,
of those resolved, the number upholding and the number reversing
an adverse benefit determination;
(c) The average length of time for a resolution;
(d) A summary of the types of requested health care services
or cases for which an external review was sought;
(e) The number of external reviews that were terminated as
the result of a reconsideration by the health plan issuer of an
adverse benefit determination after the receipt of additional
information from the covered person under section 3922.05 of the
Revised Code;
(f) The costs associated with external reviews, including the
amounts charged by the independent review organization to conduct
the reviews;
(g) The medical specialty, or the type, of clinical reviewer
used to conduct each external review, as related to the specific
medical condition of the covered person;
(h) Any other information the superintendent may request or
require.
(2) The independent review organization shall retain the
written records required under division (A)(1) of this section for
at least three years.
(B) A health plan issuer shall maintain written records on
all requests made for an external review under this chapter and
shall provide all such information as required by any associated
rules, policies, or procedures adopted by the superintendent of
insurance. A health plan issuer shall maintain written records on
all requests for external review for at least three years.
(C) The superintendent shall compile and annually publish the
information collected under this section and report the
information to the governor, the speaker and minority leader of
the house of representatives, the president and minority leader of
the senate, and the chairs and ranking minority members of the
house and senate committees with jurisdiction over health and
insurance issues.
Sec. 3922.18. The health plan issuer against which a request
for a standard external review or an expedited external review is
filed shall pay the cost of the external review, including the
cost of any external review that is required at the direction of
the superintendent.
If the superintendent determines that, due to the facts and
circumstances of an external review, a second external review is
required, the health plan issuer shall pay the costs of the second
review.
Sec. 3922.19. (A) Each health plan issuer shall include a
description of its external review procedures, including the
superintendent's contractual review, in, or attached to, the
policy, certificate, membership booklet, or outline of coverage,
or other evidence of coverage it provides to covered persons. This
disclosure shall be in a form prescribed by the superintendent in
any associated rules, policies, or procedures.
(B) The disclosure required by division (A) of this section
shall include a statement that informs the covered person of the
covered person's right to file a request for an external review of
an adverse benefit determination with the health plan issuer. The
statement shall do all of the following:
(1) Explain that external review is available when the
adverse benefit determination involves an issue of medical
necessity, appropriateness, health care setting, and level of care
or effectiveness;
(2) Include the telephone number and address of the
superintendent
(3) Inform the covered person that, when filing a request for
an external review, the covered person will be required to
authorize the release of the covered person's medical records as
necessary to conduct the external review.
(C)(1) When a health plan issuer notifies a covered person of
an adverse benefit determination, the health plan issuer shall
also notify the covered person, in writing, of the covered
person's right to request an external review, pursuant to section
3922.08, 3922.09, 3922.10, or 3922.11 of the Revised Code.
(2) As part of the written notice required under division
(C)(1) of this section, a health plan issuer shall include all of
the following:
(a) Information sufficient to identify the claim or health
care service involved, including the health care provider, and the
date of service and claim amount, if applicable;
(b) A description of the reason or reasons for the adverse
benefit determination, including the denial code, such as the
claim adjustment reason code and the remittance advice remark
code, and each code's corresponding meaning;
(c) A description of the health plan issuer's standard, if
any, that was used in making the determination;
(d) A description of the available internal appeals and
external review processes, including information regarding how to
initiate an appeal and an external review;
(e) Disclosure of the availability of assistance from the
superintendent with the internal appeals and external review
processes, including the web site, telephone number, and mailing
address of the superintendent's office of consumer services.
(3) In the case of a notice of a final adverse benefit
determination subsequent to an internal appeal, in addition to the
information required under division (C)(2) of this section, the
notice must also include a discussion of the decision.
(4) Any written notice provided under division (C) of this
section shall be in a form prescribed by the superintendent of
insurance.
(D) For an adverse benefit determination that is not a final
adverse benefit determination, the health plan issuer shall
include with the notice required under division (C) of this
section a statement informing the covered person of all of the
following:
(1) If the covered person's treating physician certifies in
writing that the covered person has a medical condition where the
time frame for completion of an expedited review of an internal
appeal involving an adverse benefit determination would seriously
jeopardize the life or health of the covered person or jeopardize
the covered person's ability to regain maximum function, the
covered person may file a request for an expedited external review
to be conducted simultaneously with the expedited internal appeal,
pursuant to section 3922.09 of the Revised Code.
(2) If the adverse benefit determination involves a denial of
coverage based on a determination that the recommended or
requested health care service or treatment is experimental or
investigational and the covered person's treating physician
certifies in writing that the recommended or requested health care
service or treatment that is the subject of the adverse benefit
determination would be significantly less effective if not
promptly initiated, the covered person may file a request for an
expedited external review to be conducted simultaneously with the
expedited internal appeal, pursuant to section 3922.09 or 3922.10
of the Revised Code.
(3) If the covered person has requested an internal appeal
and the health plan issuer has not issued a written decision to
the covered person within thirty days following the date the
covered person files the request, and the covered person has not
requested or agreed to a delay, the covered person may file a
request for external review pursuant to section 3922.08 of the
Revised Code and may be considered to have exhausted the health
plan issuer's internal appeals process for purposes of section
3922.04 of the Revised Code.
(E) For a final adverse benefit determination, the health
plan issuer shall include with the notice required under division
(C) of this section a statement informing the covered person of
all of the following:
(1) A written request for an external review must be
submitted to the health plan issuer within one hundred eighty days
after the date of the notice of final adverse benefit
determination;
(2) If the covered person's treating physician certifies in
writing that the covered person has a medical condition for which
the time frame for completion of a standard external review
pursuant to section 3922.08 of the Revised Code 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 may file a request for an expedited
external review pursuant to section 3922.09 of the Revised Code.
(3)(a) If the final adverse benefit determination concerns a
health care service for which the covered person received
emergency services, but has not been discharged from a facility,
the covered person may request an expedited external review
pursuant to section 3922.09 of the Revised Code.
(b) If the final adverse benefit determination concerns
denial of coverage based on a determination that the recommended
or requested health care service or treatment is experimental or
investigational, the covered person may file a request for an
external review to be conducted pursuant to section 3922.10 of the
Revised Code, or if the covered person's treating physician
certifies in writing 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 may
request an expedited external review to be conducted under section
3922.10 of the Revised Code.
(F)(1) In addition, any information required to be provided
under divisions (D) and (E) of this section, the health plan
issuer shall include a description of both the standard and
expedited external review procedures the health plan issuer is
required to produce pursuant to this chapter, highlighting in the
external review procedures the sections of the Revised Code that
give the covered person the opportunity to submit additional
information.
(2) The health plan issuer shall also include any forms used
to process an external review, including an authorization form, or
other document approved by the superintendent that complies with
the requirements of 45 C.F.R. 164.508, by which the covered
person, for purposes of conducting an external review under this
chapter, authorizes the health plan issuer and the covered
person's treating health care provider to disclose protected
health information, including medical records, concerning the
covered person that are related in any manner to the external
review.
Sec. 3922.20. Consistent with the Rules of Evidence, a
written decision or opinion prepared by an independent review
organization under this chapter shall be admissible in any civil
action related to the coverage decision that was the subject of
the decision or opinion. The independent review organization's
decision or opinion shall be presumed to be a scientifically valid
and accurate description of the state of medical knowledge at the
time it was written.
Consistent with the Rules of Evidence, any party to a civil
action related to a plan's decision involving an investigational
or experimental drug, device, or treatment may introduce into
evidence any applicable medicare reimbursement standards
established under Title XVIII of the "Social Security Act," 49
Stat. 620 (1935), 42 U.S.C.A. 301, as amended.
Sec. 3922.21. (A) When a record containing information
pertaining to the medical history, diagnosis, prognosis, or
medical condition of a covered person is provided to the
superintendent of insurance for any reason under this chapter or
sections 1751.77 to 1751.87 of the Revised Code, regardless of the
source, the superintendent shall maintain the confidentiality of
the record. The record in the superintendent's possession is not a
public record under section 149.43 of the Revised Code, except to
the extent that information from the record is used in preparing
reports under section 3922.17 of the Revised Code.
(B) Notwithstanding division (A) of this section, the
superintendent may share a record that is the subject of this
section in connection with the investigation or prosecution of any
illegal or criminal activity with the chief deputy rehabilitator,
the chief deputy liquidator, other deputy rehabilitators and
liquidators, and any other person employed by, or acting on behalf
of, the superintendent pursuant to Chapter 3901. or 3903. of the
Revised Code, with other local, state, federal, and international
regulatory and law enforcement agencies, with local, state, and
federal prosecutors, and with the national association of
insurance commissioners and its affiliates and subsidiaries,
provided that the recipient agrees to maintain the confidential or
privileged status of the confidential or privileged record and has
authority to do so.
(C) Nothing in this section shall prohibit the superintendent
from receiving records in accordance with section 3901.045 of the
Revised Code.
(D) The superintendent may enter into agreements governing
the sharing and use of records consistent with the requirements of
this section.
(E) No waiver of any applicable privilege or claim of
confidentiality in the records that are the subject of this
section shall occur as a result of sharing or receiving records as
authorized in divisions (B) and (C) of this section.
Sec. 3922.22. The superintendent may adopt rules under
Chapter 119. of the Revised Code to carry out the purposes of this
chapter and shall prescribe forms relating to notices, appeals,
and requests for external review under this chapter.
Sec. 3922.23. A violation of this chapter shall be an unfair
or deceptive act or practice under sections 3901.19 to 3901.26 of
the Revised Code. Additionally, health plan issuers holding a
certificate of authority from the superintendent are also subject
to the following:
(A) If, after notice and hearing, the superintendent of
insurance finds that a health plan issuer has failed to comply
with the requirements of this chapter, the superintendent may
suspend or revoke the health plan issuer's license to transact
business within the state.
(B)(1) In lieu of the suspension or revocation of a license
under division (A) of this section, the superintendent of
insurance, pursuant to an adjudication hearing initiated and
conducted in accordance with Chapter 119. of the Revised Code, or
by consent of the health plan issuer without an adjudication
hearing, may levy an administrative penalty. The administrative
penalty shall be in an amount determined by the superintendent,
but the administrative penalty shall not exceed one hundred
thousand dollars per violation. Additionally, the superintendent
may require the health plan issuer to correct any deficiency that
may be the basis for the suspension or revocation of the health
plan issuer's license. All penalties collected shall be paid into
the state treasury to the credit of the department of insurance
operating fund.
(2) If the superintendent for any reason has cause to believe
that any violation of the requirements of this chapter has
occurred or is threatened, the superintendent may give notice to
the health plan issuer and to the representatives or other persons
who appear to be involved in the suspected violation to arrange a
conference with the suspected violators or their authorized
representatives for the purpose of attempting to ascertain the
facts relating to the suspected violation, and, if it appears that
any violation has occurred or is threatened, to arrive at an
adequate and effective means of correcting or preventing the
violation.
Proceedings shall not be covered by any formal procedural
requirements, and may be conducted in the manner the
superintendent may consider appropriate under the circumstances.
(3)(a) The superintendent may issue an order directing a
health plan issuer or a representative of the issuer to cease and
desist from engaging in any act or practice in violation of the
requirements of this chapter. Within thirty days after service of
the order to cease and desist, the respondent may request a
hearing on the question of whether acts or practices in violation
of those sections have occurred. Such hearings shall be conducted
in accordance with Chapter 119. of the Revised Code and judicial
review shall be available as provided by that chapter.
(b) If the superintendent has reasonable cause to believe
that an order has been violated in whole or in part, the
superintendent may request the attorney general to commence and
prosecute any appropriate action or proceeding in the name of the
state against the violators in the court of common pleas of
Franklin county. The court in any such action or proceeding may
levy civil penalties, not to exceed one hundred thousand dollars
per violation, in addition to any other appropriate relief,
including requiring a violator to pay the expenses reasonably
incurred by the superintendent in enforcing the order. The
penalties and fees collected shall be paid into the state treasury
to the credit of the department of insurance operating fund.
Sec. 3923.60. (A) Notwithstanding section 3901.71 of the
Revised Code, no group or individual policy of sickness and
accident insurance that provides coverage for prescription drugs
shall limit or exclude coverage for any drug approved by the
United States food and drug administration on the basis that the
drug has not been approved by the United States food and drug
administration for the treatment of the particular indication for
which the drug has been prescribed, provided the drug has been
recognized as safe and effective for treatment of that indication
in one or more of the standard medical reference compendia
specified in division (B)(1) of this section adopted by the United
States department of health and human services under 42 U.S.C.
1395x(t)(2), as amended, or in medical literature that meets the
criteria specified in division (B)(2) of this section.
(B)(1) The compendia accepted for purposes of division (A) of
this section are the following:
(a) The "AMA drug evaluations," a publication of the American
medical association;
(b) The "AHFS (American hospital formulary service) drug
information," a publication of the American society of health
system pharmacists;
(c) "Drug information for the health care provider," a
publication of the United States pharmacopeia convention.
(2) Medical literature may be accepted for purposes of
division (A) of this section only if all of the following apply:
(a)(1) Two articles from major peer-reviewed professional
medical journals have recognized, based on scientific or medical
criteria, the drug's safety and effectiveness for treatment of the
indication for which it has been prescribed;
(b)(2) No article from a major peer-reviewed professional
medical journal has concluded, based on scientific or medical
criteria, that the drug is unsafe or ineffective or that the
drug's safety and effectiveness cannot be determined for the
treatment of the indication for which it has been prescribed;
(c)(3) Each article meets the uniform requirements for
manuscripts submitted to biomedical journals established by the
international committee of medical journal editors or is published
in a journal specified by the United States department of health
and human services pursuant to section 1861(t)(2)(B) of the
"Social Security Act," 107 Stat. 591 (1993), 42 U.S.C.
1395x(t)(2)(B), as amended, as acceptable peer-reviewed medical
literature.
(C) Coverage of a drug required by division (A) of this
section includes medically necessary services associated with the
administration of the drug.
(D) Division (A) of this section shall not be construed to do
any of the following:
(1) Require coverage for any drug if the United States food
and drug administration has determined its use to be
contraindicated for the treatment of the particular indication for
which the drug has been prescribed;
(2) Require coverage for experimental drugs not approved for
any indication by the United States food and drug administration;
(3) Alter any law with regard to provisions limiting the
coverage of drugs that have not been approved by the United States
food and drug administration;
(4) Require reimbursement or coverage for any drug not
included in the drug formulary or list of covered drugs specified
in a policy of sickness and accident insurance;
(5) Prohibit a policy of sickness and accident insurance from
limiting or excluding coverage of a drug, provided that the
decision to limit or exclude coverage of the drug is not based
primarily on the coverage of drugs required by this section.
(E) This section, as amended, applies only to policies of
sickness and accident insurance that are described in division (A)
of this section and that are delivered, issued for delivery, or
renewed in this state on or after the effective date of this
amendment.
Sec. 4731.36. (A) Sections 4731.01 to 4731.47 of the Revised
Code shall not prohibit service in case of emergency, domestic
administration of family remedies, or provision of assistance to
another individual who is self-administering drugs.
Sections 4731.01 to 4731.47 of the Revised Code shall not
apply to any of the following:
(1) A commissioned medical officer of the United States armed
forces, as defined in section 5903.11 of the Revised Code, or an
employee of the veterans administration of the United States or
the United States public health service in the discharge of the
officer's or employee's professional duties;
(2) A dentist authorized under Chapter 4715. of the Revised
Code to practice dentistry when engaged exclusively in the
practice of dentistry or when administering anesthetics in the
practice of dentistry;
(3) A physician or surgeon in another state or territory who
is a legal practitioner of medicine or surgery therein when
providing consultation to an individual holding a certificate to
practice issued under this chapter who is responsible for the
examination, diagnosis, and treatment of the patient who is the
subject of the consultation, if one of the following applies:
(a) The physician or surgeon does not provide consultation in
this state on a regular or frequent basis.
(b) The physician or surgeon provides the consultation
without compensation of any kind, direct or indirect, for the
consultation.
(c) The consultation is part of the curriculum of a medical
school or osteopathic medical school of this state or a program
described in division (A)(2) of section 4731.291 of the Revised
Code.
(4) A physician or surgeon in another state or territory who
is a legal practitioner of medicine or surgery therein and
provided services to a patient in that state or territory, when
providing, not later than one year after the last date services
were provided in another state or territory, follow-up services in
person or through the use of any communication, including oral,
written, or electronic communication, in this state to the patient
for the same condition;
(5) A physician or surgeon residing on the border of a
contiguous state and authorized under the laws thereof to practice
medicine and surgery therein, whose practice extends within the
limits of this state. Such practitioner shall not either in person
or through the use of any communication, including oral, written,
or electronic communication, open an office or appoint a place to
see patients or receive calls within the limits of this state.
(6) A board, committee, or corporation engaged in the conduct
described in division (A) of section 2305.251 of the Revised Code
when acting within the scope of the functions of the board,
committee, or corporation;
(7) The conduct of an independent review organization
accredited by the superintendent of insurance under section
3901.80 3922.13 of the Revised Code for the purpose of external
reviews conducted under
sections 1751.84, 1751.85, 3923.67,
3923.68, 3923.76, and 3923.77 Chapter 3922. of the Revised Code.
(B) Sections 4731.51 to 4731.61 of the Revised Code do not
apply to any graduate of a podiatric school or college while
performing those acts that may be prescribed by or incidental to
participation in an accredited podiatric internship, residency, or
fellowship program situated in this state approved by the state
medical board.
(C) This chapter does not apply to an acupuncturist who
complies with Chapter 4762. of the Revised Code.
(D) This chapter does not prohibit the administration of
drugs by any of the following:
(1) An individual who is licensed or otherwise specifically
authorized by the Revised Code to administer drugs;
(2) An individual who is not licensed or otherwise
specifically authorized by the Revised Code to administer drugs,
but is acting pursuant to the rules for delegation of medical
tasks adopted under section 4731.053 of the Revised Code;
(3) An individual specifically authorized to administer drugs
pursuant to a rule adopted under the Revised Code that is in
effect on the effective date of this amendment, as long as the
rule remains in effect, specifically authorizing an individual to
administer drugs.
(E) The exemptions described in divisions (A)(3), (4), and
(5) of this section do not apply to a physician or surgeon whose
certificate to practice issued under this chapter is under
suspension or has been revoked or permanently revoked by action of
the state medical board.
SECTION 2. That existing sections 1751.11, 1751.33, 1751.35,
1751.66, 1751.77, 1751.78, 1751.811, 1751.83, 1751.87, 1751.89,
3901.045, 3923.60, and 4731.36 and sections 1751.831, 1751.84,
1751.85, 1751.88, 3901.80, 3901.81, 3901.82, 3901.83, 3901.84,
3923.66, 3923.67, 3923.68, 3923.681, 3923.69, 3923.70, 3923.75,
3923.76, 3923.77, 3923.78, and 3923.79 of the Revised Code are
hereby repealed.
SECTION 3. This act, other than the amendments to sections
1751.66 and 3923.60 of the Revised Code, shall apply to health
benefit plans, as defined in section 3922.01 of the Revised Code
as enacted in this act, in effect and under which requests for
external review of adverse benefit determinations are submitted on
or after January 1, 2012.
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