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PRIOR PRINTER'S NO. 453
PRINTER'S NO. 948
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No.
225
Session of
2021
INTRODUCED BY PHILLIPS-HILL, MARTIN, J. WARD, MENSCH, COLLETT,
MUTH, KANE, STEFANO, AUMENT, CAPPELLETTI, BAKER, BROOKS,
BOSCOLA, HUTCHINSON, SABATINA, TOMLINSON, LAUGHLIN,
MASTRIANO, SANTARSIERO AND KEARNEY, MARCH 18, 2021
SENATOR DiSANTO, BANKING AND INSURANCE, AS AMENDED,
JUNE 23, 2021
AN ACT
Amending the act of May 17, 1921 (P.L.682, No.284), entitled "An
act relating to insurance; amending, revising, and
consolidating the law providing for the incorporation of
insurance companies, and the regulation, supervision, and
protection of home and foreign insurance companies, Lloyds
associations, reciprocal and inter-insurance exchanges, and
fire insurance rating bureaus, and the regulation and
supervision of insurance carried by such companies,
associations, and exchanges, including insurance carried by
the State Workmen's Insurance Fund; providing penalties; and
repealing existing laws," in quality healthcare
accountability and protection, further providing for
definitions, for responsibilities of managed care plans,
providing for preauthorization standards and for
preauthorization costs, further providing for continuity of
care, providing for step therapy protocols, further providing
for required disclosure, for operational standards and
providing for preauthorization and adverse determinations,
for appeals, for access requirements in service areas, for
uniform preauthorization form, for preauthorization
exemptions and for data collection and reporting; and making
an editorial change.
AMENDING THE ACT OF MAY 17, 1921 (P.L.682, NO.284), ENTITLED "AN
ACT RELATING TO INSURANCE; AMENDING, REVISING, AND
CONSOLIDATING THE LAW PROVIDING FOR THE INCORPORATION OF
INSURANCE COMPANIES, AND THE REGULATION, SUPERVISION, AND
PROTECTION OF HOME AND FOREIGN INSURANCE COMPANIES, LLOYDS
ASSOCIATIONS, RECIPROCAL AND INTER-INSURANCE EXCHANGES, AND
FIRE INSURANCE RATING BUREAUS, AND THE REGULATION AND
SUPERVISION OF INSURANCE CARRIED BY SUCH COMPANIES,
ASSOCIATIONS, AND EXCHANGES, INCLUDING INSURANCE CARRIED BY
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THE STATE WORKMEN'S INSURANCE FUND; PROVIDING PENALTIES; AND
REPEALING EXISTING LAWS," IN QUALITY HEALTHCARE
ACCOUNTABILITY AND PROTECTION, FURTHER PROVIDING FOR
DEFINITIONS AND FOR RESPONSIBILITIES OF MANAGED CARE PLANS,
PROVIDING FOR PREAUTHORIZATION REVIEW STANDARDS AND FOR
PREAUTHORIZATION COSTS, FURTHER PROVIDING FOR CONTINUITY OF
CARE, PROVIDING FOR STEP THERAPY, FURTHER PROVIDING FOR
REQUIRED DISCLOSURE AND FOR OPERATIONAL STANDARDS AND
PROVIDING FOR INITIAL REVIEW OF PREAUTHORIZATION REQUESTS AND
ADVERSE DETERMINATIONS, FOR PREAUTHORIZATION DENIAL
GRIEVANCES AND FOR ACCESS REQUIREMENTS IN SERVICE AREAS; AND
MAKING AN EDITORIAL CHANGE.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. The General Assembly finds that:
(1) Preauthorization of medical treatment, testing and
procedures was initially designed to reduce unnecessary cost
placed on insurers, insureds and providers.
(2) The process of preauthorization and the process to
appeal a preauthorization decision has not been updated in 20
years.
(3) The current preauthorization process has become
overly expansive, to the point where it is interfering with
the patient-provider relationship by inserting a third party
into the treatment decision-making process.
(4) The basic minimum requirements of this act are
necessary to ensure that the patient-provider relationship
remains paramount in making any decision on the course of
treatment.
Section 2. It is the intent of the General Assembly to
create clear definitions, notice requirements and processes for
the determination of authorizing insurance coverage for medical
treatment, procedures and testing prior to the patient receiving
the treatment, procedure and testing.
Section 3. The definitions of "emergency service,"
"enrollee," "grievance," "health care service," "prospective
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utilization review," "retrospective utilization review,"
"utilization review" and "utilization review entity" in section
2102 of the act of May 17, 1921 (P.L.682, No.284), known as The
Insurance Company Law of 1921, are amended and the section is
amended by adding definitions to read:
Section 2102. Definitions.--As used in this article, the
following words and phrases shall have the meanings given to
them in this section:
* * *
"Administrative defect." Any deficiency, error, mistake or
missing information other than medical necessity that serves as
the basis of an adverse determination issued by a utilization
review entity as justification to deny preauthorization.
"Adverse determination." A decision made by a utilization
review entity from a preauthorization request that:
(1) the health care services furnished or proposed to an
insured are not medically necessary or result from an
administrative denial; or
(2) denies, reduces or terminates benefit coverage.
The term includes a decision to deny a step therapy exception
request under section 2118. The term does not include a decision
to deny, reduce or terminate services that are not covered for
reasons other than their medical necessity or experimental or
investigational nature.
* * *
"Appeal." A formal request, either orally or in writing, to
reconsider a determination not to authorize a health care
service prior to the service being provided. This does not
include a grievance filed under section 2161, relating to
reconsideration of a decision made after coverage has been
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provided.
"Appeal procedure." A formal process that permits an
insured, attending physician or his designee, facility or health
care practitioner on an insured's behalf to appeal an adverse
determination rendered by the utilization review entity or its
designee utilization review entity or agent.
"Authorization." A determination by a utilization review
entity that:
(1) A health care service has been reviewed and, based on
the information provided, satisfies the utilization review
entity's requirements for medical necessity.
(2) The health care service reviewed is a covered service.
(3) Payment will be made for the health care service.
* * *
"Clinical criteria." Policies, screening procedures,
determination rules, determination abstracts, clinical
protocols, practice guidelines and medical protocols that are
specified in a written document available for peer-to-peer
review by a peer within the same profession and specialty and
subject to challenge by an insured, a provider or a provider
organization when used as a basis to withhold preauthorization,
deny or otherwise modify coverage and that is used by a
utilization review entity to determine the medical necessity of
health care services. The criteria shall:
(1) Be based on nationally recognized standards.
(2) Be developed in accordance with the current standards of
national accreditation entities.
(3) Reflect community standards of care.
(4) Ensure quality of care and access to needed health care
services.
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(5) Be evidence-based or based on generally accepted expert
consensus standards.
(6) Be sufficiently flexible to allow deviations from norms
when justified on a case-by-case basis.
(7) Be evaluated and updated if necessary at least annually.
"Clinical practice guidelines." A systematically developed
statement to assist in decision-making by health care providers
and enrollees relating to appropriate health care for specific
clinical circumstances and conditions.
* * *
"Emergency service." Any health care service provided to an
enrollee, including prehospital transportation or treatment by
emergency medical services providers, after the sudden onset of
a medical condition that manifests itself by acute symptoms of
sufficient severity or severe pain such that a prudent layperson
who possesses an average knowledge of health and medicine could
reasonably expect the absence of immediate medical attention to
result in:
(1) placing the health of the enrollee or, with respect to a
pregnant woman, the health of the woman or her unborn child in
serious jeopardy;
(2) serious impairment to bodily functions; or
(3) serious dysfunction of any bodily organ or part.
Emergency transportation and related emergency service provided
by a licensed ambulance service shall constitute an emergency
service.
["Enrollee." Any policyholder, subscriber, covered person or
other individual who is entitled to receive health care services
under a managed care plan.]
"Expedited appeal." A formal request, either orally or in
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writing, to reconsider an adverse determination not to authorize
emergency health care services or urgent health care services.
"Final adverse determination." An adverse determination that
has been upheld by a utilization review entity at the completion
of the utilization review entity's internal appeals process.
"Grievance." As provided in subdivision (i), a request by an
[enrollee] insured or a health care provider, with the written
consent of the [enrollee] insured, to have a managed care plan
or utilization review entity reconsider a decision solely
concerning the medical necessity and appropriateness of a health
care service after the service has been provided to the insured.
If the managed care plan is unable to resolve the matter, a
grievance may be filed regarding the decision that:
(1) disapproves full or partial payment for a requested
health care service;
(2) approves the provision of a requested health care
service for a lesser scope or duration than requested; or
(3) disapproves payment for the provision of a requested
health care service but approves payment for the provision of an
alternative health care service.
The term [does] shall not include a complaint.
* * *
"Health care service." Any [covered] treatment, admission,
procedure, test used to aid in diagnosis or the provision of the
applicable treatment, pharmaceutical product, medical supplies
and equipment or other services, including behavioral health[,
prescribed] or otherwise provided or proposed to be provided by
a health care provider to an enrollee under a managed care plan
contract.
* * *
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"Medically necessary health care services." Health care
services that a prudent health care provider would provide to a
patient for the purpose of preventing, diagnosing or treating an
illness, injury, disease or its symptoms in a manner that is:
(1) in accordance with generally accepted standards of
medical practice based on clinical criteria;
(2) appropriate in terms of type, frequency, extent, site
and duration pursuant to clinical criteria; and
(3) not primarily for the economic benefit of the health
plans and purchasers or for the convenience of the patient,
treating physician or other health care provider.
"Medication assisted treatment" or "MAT." The use of
medications approved by the United States Food and Drug
Administration, including methadone, buprenorphine, alone or in
combination with naloxone, or naltrexone, in combination with
counseling and behavioral therapies, to provide a comprehensive
approach to the treatment of substance use disorders.
"NCPDP SCRIPT Standard." The National Council for
Prescription Drug 10 Programs SCRIPT Standard Version 201310,
the most recent standard adopted by the Department of Health and
Human Services or a subsequently related version, provided that
the new version is backwards-compatible to the current version
adopted by the Department of Health and Human Services. The
NCPDP SCRIPT Standard applies to the provision of pharmaceutical
or pharmacological products.
"Nonurgent health care service." A health care service
provided to an enrollee that is not considered an emergency
service or an urgent health care service.
* * *
"Preauthorization" or "prior authorization." The process by
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which a utilization review entity managed care organization or
health care insurer determines the medical necessity of
otherwise covered health care services prior to authorizing
coverage and the rendering of the health care services,
including, but not limited to, preadmission review, pretreatment
review, utilization and case management. The term includes a
health insurer's or utilization review entity's requirement that
an insured or health care practitioner notify the health insurer
or utilization review agent prior to providing a health care
service. This determination and any appeal therefrom shall be
conducted prior to the delivery or provision of a health care
service and result in a decision to approve or deny payment for
the health care service.
* * *
["Prospective utilization review." A review by a utilization
review entity of all reasonably necessary supporting information
that occurs prior to the delivery or provision of a health care
service and results in a decision to approve or deny payment for
the health care service.]
* * *
"Retrospective utilization [review."] review" or
"retrospective review." A review by a utilization review entity
of all reasonably necessary supporting information which occurs
following delivery or provision of a health care service and
results in a decision to approve or deny payment for the health
care service[.], but may not be used to review a decision to
approve payment for health care services through
preauthorization.
* * *
"Urgent health care service." A health care service deemed
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by a provider to require expedited preauthorization review in
the event a delay may jeopardize life or health of the insured
or a delay in treatment could:
(1) negatively affect the ability of the insured to regain
maximum function; or
(2) subject the insured to severe pain that cannot be
adequately managed without receiving the care or treatment that
is the subject of the utilization review as quickly as possible.
The term shall not include an emergency service or nonurgent
health care service.
"Utilization review." A system of prospective, concurrent or
retrospective utilization review performed by a utilization
review entity of the medical necessity and appropriateness of
health care services prescribed, provided or proposed to be
provided to an enrollee. The term includes preauthorization, but
does not include any of the following:
(1) Requests for clarification of coverage, eligibility or
health care service verification.
(2) A health care provider's internal quality assurance or
utilization review process unless the review results in denial
of payment for a health care service.
"Utilization review entity." Any entity certified pursuant
to subdivision (h) that performs utilization review on behalf of
a managed care plan. The term includes:
(1) an employer with employes in this Commonwealth who are
covered under a health benefit plan or health insurance policy;
(2) an insurer that writes health insurance policies,
including preferred provider organizations defined in section
630;
(3) pharmacy benefits managers responsible for managing
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access of insureds to available pharmaceutical or
pharmacological care;
(4) any other individual or entity that provides, offers to
provide or administers hospital, outpatient, medical or other
health benefits to an individual treated by a health care
provider in this Commonwealth under a policy, plan or contract;
or
(5) a health insurer if the health insurer performs
utilization review.
Section 4. Section 2111 of the act is amended by adding
paragraphs to read:
Section 2111. Responsibilities of Managed Care Plans.--A
managed care plan shall do all of the following:
* * *
(14) Make updates to its enrollment eligibility information
within thirty (30) days of receiving updated enrollment
information. Updates in enrollment eligibility may occur due to
new enrollments, coordination of benefits or termination of
benefits. If a managed care plan fails to update eligibility
information in a timely manner, the managed care plan may not
deny payment due to enrollment information being inaccurate for
a date of service if current eligibility information was
available. In the event of a retroactive termination or a
determination that an enrollee was ineligible for benefits, a
health plan may recover any payments made in error within thirty
(30) days of the date of service.
(15) When establishing rules pertaining to the timely filing
of health care provider claims, provide that a health care
provider's filing requirement will commence based on the
following, whichever occurs latest:
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(i) the time of patient discharge; or
(ii) when authorization or approval is confirmed by the
managed care plan.
Section 5. The act is amended by adding sections to read:
Section 2114. Preauthorization Standards.--(a) No later
than one hundred eighty (180) days after the effective date of
this section, preauthorization requests shall be accessible to
health care providers and accepted by insurers, managed care
organizations and utilization review organizations
electronically through a secure electronic transmission
platform. The electronic preauthorization requirements under
this subsection shall not apply:
(1) under circumstances when electronic transmission is not
available to be issued or received due to a temporary
technological or electrical failure and, in the instance of a
temporary technological failure, a practitioner shall, within
seventy-two (72) hours, seek to correct any cause for the
failure that is reasonably within the practitioner's control.
(2) when a practitioner who or health care facility that
does not have either of the following:
(i) Internet access; or
(ii) an electronic health record system.
(b) NCPDP SCRIPT Standard shall be acceptable for
pharmaceutical or pharmacological care, subject to the terms and
limitations under subsection (a).
(c) Any restriction that a utilization review entity places
on the preauthorization of health care services shall be:
(1) based on the medical necessity of those services and on
clinical criteria;
(2) applied consistently; and
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(3) disclosed by the managed care plan or utilization review
entity pursuant to section 2136.
(d) Adverse determinations and final adverse determinations
made by a utilization review entity or agent thereof shall be
based on clinical criteria.
(e) A utilization review entity shall not deny coverage of a
health care service solely based on the grounds that the health
care service does not meet clinical criteria.
(f) Preauthorization shall not be required:
(1) where a medication, including noncontrolled generic
medication or procedure prescribed for a patient is customary
and properly indicated or is a treatment for the clinical
indication as supported by peer-reviewed medical publications;
or
(2) for the provision of MAT for the treatment of an opioid-
use disorder.
(f.1) A managed care plan may not deny preauthorization for
a health care service for an insured currently managed with an
established treatment regimen or for continuity of care. The
continued care may not be subject to concurrent review if the
treatment regimen or continuity of care follows from a previous
preauthorization approval.
(g) If a provider contacts a utilization review entity
seeking preauthorization, a medically necessary health care
service and the utilization review entity, through any agent,
contractor, employe or representative informs the provider that
preauthorization is not required for the particular service that
is sought, coverage for the service shall be deemed approved.
(h) No later than one hundred eighty (180) days after the
effective date of this section, the payer shall accept and
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respond to preauthorization requests under the pharmacy benefit
through a secure electronic transmission using the NCPDP SCRIPT
Standard ePA transactions.
Section 2115. Preauthorization Costs.--(a) In the event
that an insured is covered by more than one health plan that
requires preauthorization:
(1) If preauthorization for a health care service has
been approved by a primary insurer, then a secondary insurer
or defined benefits plan may not refuse payment for health
care services solely on the basis that the procedures of the
secondary insurer for preauthorization were not followed.
(2) Nothing in this section shall be construed to
preclude a secondary insurer or defined benefits plan from
preauthorizing a health care service that may have been
denied preauthorization by a primary insurer.
(b) An appeal of an adverse determination or external review
of a final adverse determination shall be provided without
charge to the insured or insured's health care provider.
Section 6. Section 2117 of the act is amended by adding
subsections to read:
Section 2117. Continuity of Care.--* * *
(g) If the appeal of an adverse determination of a
preauthorization request concerns ongoing health care services
that are being provided pursuant to an initially authorized
admission or course of treatment, the health care services shall
be continued to be paid and provided without liability to the
insured or insured's health care provider until the latest of:
(1) thirty (30) days following the insured or insured's
health care provider's receipt of a notice of final adverse
determination satisfying the requirements of this act, if the
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decision on adverse determination has been appealed through an
external review proceeding;
(2) the duration of treatment; or
(3) sixty (60) days.
(h) The insured shall receive services for the longest
possible time calculated under this section.
(i) The insurer shall not be permitted to retroactively
review the decision to approve and provide health care services
through preauthorization, including preauthorizing for extending
the term or course of treatment.
(j) Notwithstanding any other provision of law, the insurer
shall not retroactively recover the cost of treatment either for
the initial period of treatment or the period of treatment
provided to the insured as part of the decision-making process
to authorize coverage of additional treatment periods.
Section 7. The act is amended by adding a section to read:
Section 2118. Step Therapy.--(a) The following shall apply:
(1) Clinical review criteria used to establish a step
therapy protocol shall be based on clinical practice guidelines
that:
(i) Recommend that the prescription drugs be taken in the
specific sequence required by the step therapy protocol.
(ii) Are developed and endorsed by a multidisciplinary panel
of experts that manages conflicts of interest among the members
of the writing and review groups by:
(A) Requiring members to disclose any potential conflict of
interests with entities, including insurers, health plans and
pharmaceutical manufacturers and recuse themselves from voting
if the member has a conflict of interest.
(B) Using a methodologist to work with writing groups to
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provide objectivity in data analysis and ranking of evidence
through the preparation of evidence tables and facilitating
consensus.
(C) Offering opportunities for public review and comments.
(iii) Are based on high quality studies, research and
medical practice.
(iv) Are created by an explicit and transparent process
that:
(A) minimizes biases and conflicts of interest;
(B) explains the relationship between treatment options and
outcomes;
(C) rates the quality of the evidence supporting
recommendations; and
(D) considers relevant patient subgroups and preferences.
(v) Are continually updated through a review of new
evidence, research and newly developed treatments.
(2) In the absence of clinical guidelines that meet the
requirements under paragraph (1) , peer reviewed publications may
be substituted.
(3) When establishing a step therapy protocol, a utilization
review agent shall also take into account the needs of atypical
patient populations and diagnoses when establishing clinical
review criteria.
(4) An insurer, pharmacy benefit manager or utilization
review organization shall:
(i) upon written request, provide all specific written
clinical review criteria relating to the particular condition or
disease, including clinical review criteria relating to a step
therapy protocol override determination; and
(ii) make the clinical review criteria and other clinical
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information available on its publicly accessible Internet
website and to a health care professional on behalf of an
insured upon written request.
(5) This subsection shall not be construed to require
insurers, health plans or the Commonwealth to set up a new
entity to develop clinical review criteria used for step therapy
protocols.
(b) The following shall apply:
(1) When coverage of a prescription drug for the treatment
of any medical condition is restricted for use by an insurer,
health plan or utilization review organization through the use
of a step therapy protocol, the patient and prescribing
practitioner shall have access to a clear, readily accessible
and convenient process to request a step therapy exception. An
insurer, health plan or utilization review organization may use
its existing medical exceptions process to satisfy this
requirement. The process shall be made easily accessible on the
publicly accessible Internet website of the insurer, health plan
or utilization review organization. An insurer, health plan or
utilization review organization must disclose all rules and
criteria related to the step therapy protocol upon request to
all prescribing practitioners, including the specific
information and documentation that must be submitted by a
prescribing practitioner or patient to be considered a complete
exception request.
(2) A step therapy exception shall be granted if:
(i) The required prescription drug is contraindicated or
will likely cause an adverse reaction by or physical or mental
harm to the patient.
(ii) The required prescription drug is expected to be
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ineffective based on the known clinical characteristics of the
patient and the known characteristics of the prescription drug
regimen.
(iii) The patient has tried the required prescription drug
while under the patient's current or previous health insurance
or health benefit plan, or another prescription drug in the same
pharmacologic class or with the same mechanism of action, and
the prescription drug was discontinued due to lack of efficacy
or effectiveness, diminished effect or an adverse event.
(iv) The required prescription drug is not in the best
interest of the patient, based on medical necessity.
(v) The patient is stable on a prescription drug selected by
the patient's health care provider for the medical condition
under consideration while on a current or previous health
insurance or health benefit plan.
(3) Upon the granting of a step therapy exception, the
insurer, health plan or utilization review organization shall
authorize coverage for the prescription drug prescribed by the
patient's treating health care provider.
(4) The insurer, health plan or utilization review
organization shall grant or deny a step therapy exception
request or an appeal within seventy-two (72) hours of receipt.
The following shall apply:
(i) In cases where exigent circumstances exist, an insurer,
health plan or utilization review organization shall respond
within twenty-four (24) hours of receipt.
(ii) If a request for a step therapy override exception is
incomplete or additional clinically relevant information is
required, the insurer, health plan or utilization review
organization shall notify the prescribing practitioner within
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seventy-two (72) hours of submission, or twenty-four (24) hours
in exigent circumstances, what additional or clinically relevant
information is required in order to approve or deny the step
therapy exception request or appeal under this section.
(iii) Once the requested information is submitted, the
applicable time period to grant or deny a step therapy exception
request or appeal shall apply.
(iv) Should a determination or request for incomplete or
clinically relevant information by an insurer, health plan or
utilization review organization not be received by the
prescribing practitioner within the time allotted, the exception
or appeal shall be deemed granted.
(v) In the event of a denial, the insurer, health plan or
utilization review organization must inform the patient of a
potential appeal process.
(5) Any step therapy exception under this subsection shall
be eligible for appeal by an insured.
(6) This subsection shall not be construed to prevent:
(i) An insurer, health plan or utilization review
organization from requiring a patient to try an AB-rated generic
equivalent or interchangeable biological product, as defined in
42 U.S.C. ยง 262(i)(3) (relating to regulation of biological
products) , unless the requirement meets any of the criteria
under this subsection for a step therapy exception request,
prior to providing coverage for the equivalent branded
prescription drug;
(ii) An insurer, health plan or utilization review
organization from requiring a pharmacist to effect substitutions
of prescription drugs consistent with the laws of this
Commonwealth .
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(iii) A health care provider from prescribing a prescription
drug that is determined to be medically appropriate.
(c) Notwithstanding any provision of law to the contrary,
the Insurance Department shall promulgate any regulations
necessary to enforce this section.
(d) An insurer, health plan or a utilization review
organization shall annually report to the Insurance Department,
in a format prescribed by the Insurance Department:
(i) the number of step therapy exception requests received
by exception;
(ii) the type of health care providers or the medical
specialties of the health care providers submitting step therapy
exception requests;
(iii) the number of step therapy exception requests by
exception that were denied and the reasons for the denials;
(iv) the number of step therapy exception requests by
exception that were approved;
(v) the number of step therapy exception requests by
exception that were initially denied and then appealed;
(vi) the number of step therapy exception requests by
exception that were initially denied and then subsequently
reversed by internal appeals or external reviews; and
(vii) the medical conditions for which patients are granted
exceptions due to the likelihood that switching from the
prescription drug will likely cause an adverse reaction by or
physical or mental harm to the insured.
(e) As used in this section, the following words and phrases
shall have the meanings given to them in this subsection unless
the context clearly indicates otherwise:
"Clinical practice guidelines." A systematically developed
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statement to assist decision making by health care providers and
patient decisions about appropriate healthcare for specific
clinical circumstances and conditions.
"Clinical review criteria." The written screening
procedures, decision abstracts, clinical protocols and practice
guidelines used by an insurer, health plan or utilization review
organization to determine the medical necessity and
appropriateness of healthcare services.
"Medically necessary." Health services and supplies that
under the applicable standard of care are appropriate:
(1) to improve or preserve health, life or function;
(2) to slow the deterioration of health, life or
function; or
(3) for the early screening, prevention, evaluation,
diagnosis or treatment of a disease, condition, illness or
injury.
"Step therapy exception." When a step therapy protocol
should be overridden in favor of immediate coverage of the
health care provider's selected prescription drug.
"Step therapy protocol." A protocol, policy or program that
establishes the specific sequence in which prescription drugs
for a specified medical condition and medically appropriate for
a particular patient are covered by an insurer or health plan.
"Utilization review organization." An entity that conducts
utilization review, other than an insurer or health plan
performing utilization review for its own health benefit plans.
Section 8. Article XXI, Subdivision (f) subheading of the
act is amended to read:
(f) Information for Enrollees and Health Care Providers.
Section 9. Section 2136 of the act is amended by adding a
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subsection to read:
Section 2136. Required Disclosure.--* * *
(c) If a utilization review entity intends to implement a
new preauthorization requirement or restriction or amend an
existing requirement or restriction, the utilization review
entity shall provide contracted health care providers and
insureds with written notice of the new or amended requirement
or amendment not less than sixty (60) days before the
requirement or restriction is implemented. The notice shall be
in writing which may be satisfied by any of the following:
(1) certified mail return receipt requested;
(2) electronic mail read receipt requested;
(3) p ublication on the publicly accessible Internet
website of the insurer with an electronic mail message to
providers and insureds that identifies the location of the
publication on the website;
(4) web-exchange, provided that an electronic mail
message on how to access the web-exchange is sent to the
providers and insured; or
(5) any other contractually agreed upon method,
specifying the details of the communication which include
some proof of receipt by the providers and insureds.
Section 10. Section 2152(a)(4) and (6) of the act are
amended and the section is amended by adding subsections to
read:
Section 2152. Operational Standards.--(a) A utilization
review entity shall do all of the following:
* * *
(4) Conduct utilization reviews based on the medical
necessity and appropriateness of the health care service being
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reviewed and provide notification within the following time
frames:
(i) A prospective utilization review decision shall be
communicated within two (2) business days of the receipt of all
supporting information reasonably necessary to complete the
review.
(ii) A concurrent utilization review decision shall be
communicated within one (1) business day of the receipt of all
supporting information reasonably necessary to complete the
review.
(iii) A retrospective utilization review decision shall be
communicated within thirty (30) days of the receipt of all
supporting information reasonably necessary to complete the
review.
(iv) A utilization review entity shall allow an insured and
the insured's health care provider a minimum of one (1) business
day following an inpatient admission pursuant to an emergency
health care service or urgent health care service to notify the
utilization review entity of the admission and any health care
services performed.
* * *
(6) Provide all decisions in writing to include the basis
and clinical rationale for the decision. For adverse
determinations of preauthorization decisions, a utilization
review entity shall provide all decisions to the insured and the
insured's health care provider, which decisions shall also
include instructions concerning how an appeal may be perfected.
Utilization review entities may not retroactively review the
medical necessity of a preauthorization that has been previously
approved or granted.
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