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PRINTER'S NO. 1099
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
225
Session of
2021
INTRODUCED BY MENTZER, ISAACSON, HOHENSTEIN, SCHLEGEL CULVER,
ZIMMERMAN, D. MILLER, GILLEN, THOMAS, KAUFFMAN, MARSHALL,
TOMLINSON, MALONEY, MALAGARI, OTTEN, O'MARA, EMRICK, MULLINS,
DUNBAR, KAUFER, KLUNK, SAYLOR, FEE, MIHALEK, ECKER, RAPP,
ORTITAY, DOWLING AND MARKOSEK, APRIL 1, 2021
REFERRED TO COMMITTEE ON INSURANCE, APRIL 1, 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 health care
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, 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.
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
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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
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
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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
provided. The calculation of any deadline shall not commence
until written confirmation of an appeal is received. Nothing in
this definition precludes written confirmation of the appeal to
be submitted electronically or by facsimile.
"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
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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.
(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
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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
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
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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.
* * *
"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
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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 backward-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." As follows:
(1) Formerly known as a prospective utilization review.
(2) The process by 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 preadmission review, pretreatment
review, utilization and case management.
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(3) 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.
(4) The term may be used interchangeably with the term
"prior authorization."
* * *
["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.
* * *
"Step therapy exception." A step therapy protocol that is
overridden in favor of immediate coverage of the health care
provider's selected prescription drug.
"Step therapy protocol." A protocol, policy or program that
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establishes the specific sequence in which medically appropriate
prescription drugs for a specified medical condition are used by
a particular patient and are covered by a managed care plan.
"Urgent health care service." A health care service deemed
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 does 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 any of the following:
(1) An employer with employes in this Commonwealth who are
covered under a health benefit plan or health insurance policy.
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(2) An insurer that writes health insurance policies,
including preferred provider organizations defined in section
630.
(3) Pharmacy benefits managers responsible for managing
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.
(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 ninety
(90) days of the date of service.
(15) When establishing rules pertaining to the timely filing
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of health care provider claims, provide that a health care
provider's filing requirement will commence based on the
following, whichever occurs latest:
(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, prior authorization 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 do not apply:
(1) Under circumstances when electronic transmission is not
available to be issued or received due to a temporary
technological or electrical failure. 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 control of the
practitioner.
(2) When a practitioner or health care facility does not
have any of the following:
(i) Internet access.
(ii) An electronic health record system.
(b) NCPDP SCRIPT Standard shall be acceptable for
pharmaceutical or pharmacological care, subject to the terms and
limitations of subsection (a).
(c) Any restriction that a utilization review entity places
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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
(3) disclosed by the managed care plan or utilization review
entity in accordance with 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.
(g) 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 shall also not be subject to concurrent review if
the treatment regimen or continuity of care follows from a
previous preauthorization approval.
(h) 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
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preauthorization is not required for the particular service that
is sought, coverage for the service shall be deemed approved.
(i) No later than one hundred eighty (180) days after the
effective date of this section, the payer shall accept and
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, a secondary insurer or defined
benefits plan shall 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
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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
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) Clinical review criteria
used to establish a step therapy protocol shall be based on
clinical practice guidelines that:
(1) Recommend that the prescription drugs be taken in the
specific sequence required by the step therapy protocol.
(2) 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:
(i) Requiring members to disclose any potential conflict of
interest with an entity, including an insurer, health plan and
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pharmaceutical manufacturer, and recuse themselves from voting
if they have a conflict of interest.
(ii) Using a methodologist to work with writing groups to
provide objectivity in data analysis and ranking of evidence
through the preparation of evidence tables and facilitating
consensus.
(iii) Offering opportunities for public review and comments.
(3) Are based on high-quality studies, research and medical
practice.
(4) Are created by an explicit and transparent process that:
(i) Minimizes biases and conflicts of interest.
(ii) Explains the relationship between treatment options and
outcomes.
(iii) Rates the quality of evidence supporting
recommendations.
(iv) Considers relevant patient subgroups and preferences.
(5) Are continually updated through a review of new
evidence, research and newly developed treatments.
(6) Use peer-reviewed publications in the absence of
clinical guidelines that meet the requirements of this act.
(b) When establishing a step therapy protocol, a utilization
review agent shall also take into account the needs of atypical
patient population and diagnoses when establishing clinical
review criteria.
(c) An insurer, pharmacy benefit manager or utilization
review organization shall:
(1) Upon written request, provide all specific written or
clinical review criteria relating to the particular condition or
disease, including clinical review criteria relating to a step
therapy protocol override determination.
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(2) Make available clinical review criteria and other
clinical information on the publicly accessible Internet website
of the insurer, pharmacy benefit manager or utilization review
organization and to a health care professional on behalf of an
insured upon written request.
(d) This section shall not be construed to require an
insurer, health plan or the Commonwealth to establish a new
entity to develop clinical review criteria used for step therapy
protocols.
(e) When coverage of a prescription drug for the treatment
of a 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 available on the
publicly accessible Internet website of the insurer, health plan
or utilization review organization. An insurer, health plan or
utilization review organization shall 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.
(f) A step therapy exception shall be expeditiously granted
if:
(1) The required prescription drug is contraindicated or
likely will cause an adverse reaction by, or physical or mental
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harm to, the patient.
(2) The required prescription drug is expected to be
ineffective based on the known clinical characteristics of the
patient and the known characteristics of the prescription drug
regimen.
(3) The patient has tried the required prescription drug
while under the current or a 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.
(4) The required prescription drug is not in the best
interests of the patient based on medical necessity.
(5) 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 .
(g) 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.
(h) 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.
In situations where exigent circumstances exist, the insurer,
health plan or utilization review organization shall respond
within twenty-four (24) hours of receipt. 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
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prescribing practitioner within seventy-two (72) hours of
submission, or twenty-four (24) hours in exigent circumstances,
of the additional or clinically relevant information required to
approve or deny the step therapy exception request or appeal
pursuant to the criteria disclosed in this section. Once the
requested information is submitted, the applicable time period
to grant or deny a step therapy exception request or appeal
shall apply. If a determination or request for incomplete or
clinically relevant information by an insurer, health plan or
utilization review organization is not received by the
prescribing practitioner within the time allotted, the exception
or appeal shall be deemed granted. In the event of a denial, the
insurer, health plan or utilization review organization shall
inform the patient of a potential appeal process.
(i) Any step therapy exception, as defined under this
section, shall be eligible for appeal by an insured.
(j) This section shall not be construed to prevent :
(1) 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 by
42 U.S.C. ยง 262(i)(3) (relating to regulation of biological
products), unless the requirement meets any of the criteria
under this section pursuant to a step therapy exception request
submitted under this section, prior to providing coverage for
the equivalent branded prescription drug.
(2) An insurer, health plan or utilization review
organization from requiring a pharmacist to effect substitutions
of prescription drugs consistent with State law.
(3) A health care provider from prescribing a prescription
drug that is determined to be medically appropriate.
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(k) Notwithstanding any other provision of law, the
Insurance Department shall promulgate regulations necessary to
enforce this section.
(l) On an annual basis, an insurer, health plan or
utilization review organization shall report to the Insurance
Department, in a format prescribed by the Insurance Department,
the following:
(1) The number of step therapy exception requests received
by exception as provided in this section, including:
(i) The number that were denied and the reason for the
denial.
(ii) The number that were approved.
(iii) The number that were initially denied and then
appealed.
(iv) The number that were initially denied and then
subsequently reversed by internal appeal or external review.
(2) The type of health care providers or the medical
specialties of the health care providers submitting step therapy
exception requests.
(3) 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 or
physical or mental harm to the insured.
(m) Notwithstanding any other definition under this act, as
used in this section, the following words and phrases shall have
the meanings given to them in this subsection:
"Clinical practice guidelines." A systematically developed
statement to assist decision making by health care providers and
patient decisions about appropriate health care for specific
clinical circumstances and conditions.
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"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 health care 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." A step therapy protocol that
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 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
subsection to read:
Section 2136. Required Disclosure.--* * *
(c) If a utilization review entity intends to implement a
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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. The requirement that the notice shall be in writing
may be satisfied by any of the following:
(1) Certified mail, return receipt requested.
(2) Electronic mail, read receipt requested.
(3) Publication on the 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
insureds.
(5) Any other contractually agreed-upon method that
specifies 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
reviewed and provide notification within the following time
frames:
(i) A prospective utilization review decision shall be
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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.
* * *
(9) Post to the utilization review entity's publicly
accessible Internet website:
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(i) A current list of services and supplies requiring
preauthorization.
(ii) Written clinical criteria for preauthorization
decisions.
(10) Ensure that a preauthorization shall be valid for one
hundred eighty (180) days or the duration of treatment,
whichever is greater, from the date the health care provider
receives the preauthorization so long as the insured is a member
of the plan. A duration of fewer than one hundred eighty (18 0)
days may be approved upon an agreement between a provider and
payer.
(11) When performing preauthorization, only request copies
of medical records if a difficulty develops in determining the
medical necessity of a health care service. In that case, the
utilization review agent may only request the necessary and
relevant sections of the medical record.
(12) Not deny preauthorization nor delay preauthorization
for administrative defects. In the event an administrative
defect is discovered, a managed care plan shall allow a health
care provider the opportunity to remedy the administrative
defect within thirty (30) days of receiving notice.
* * *
(e) Failure by a utilization review entity to comply with
deadlines and other requirements specified for preauthorization
shall result in the health care service subject to review to be
deemed preauthorized and paid by the managed care plan.
(f) A utilization review entity shall approve claims for
health care services for which a preauthorization was required
and received from the managed care plan prior to the rendering
of the health care services, unless one of the following occurs:
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(1) The enrollee was not eligible for coverage at the time
the health care service was rendered. A managed care plan may
not deny payment for a claim on this basis if the enrollee's
coverage was retroactively terminated more than one hundred
twenty (120) days after the date of service, provided the claim
is submitted timely. If the claim is submitted after the timely
filing deadline, the managed care plan shall have no more than
thirty (30) days after the claim is received to deny the claim
on the basis the enrollee was not eligible for coverage on the
date of the health care service.
(2) The preauthorization was based on materially inaccurate
or incomplete information provided by the enrollee, the
enrollee's designee or the health care provider, such that if
the correct or complete information had been provided, the
preauthorization would not have been granted.
(3) There is a reasonable basis supported by material facts
available for review that the enrollee, the enrollee's designee
or the health care provider has engaged in fraud or abuse.
Section 11. The act is amended by adding sections to read:
Section 2161.1. Preauthorization and Adverse
Determinations.-- (a) A utilization review entity shall ensure
that:
(1) Preauthorizations are made by a qualified licensed
health care provider who has knowledge of the items, services,
products, tests or procedures submitted for preauthorization.
(2) Adverse determinations are made by a physician. The
reviewing physician must possess a current and valid
nonrestricted license to practice medicine in this Commonwealth
and be board certified. However, the insurer shall make
available a physician in a like specialty if the review requires
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a peer-to-peer review in the specialty or sub-specialty or the
review is requested by the submitting provider. A utilization
review entity may seek approval from the Insurance Commissioner
to use a reviewing physician that is not board-certified due to
unavailability or difficulty in finding a board-certified
reviewing physician in a given specialty. The Insurance
Commissioner shall develop a form and parameters for the
requests and shall transmit all requests as notices to the
Legislative Reference Bureau for publication in the Pennsylvania
Bulletin. The Insurance Commissioner shall provide at least ten
(10) days for comment before rendering a decision, which
decision shall be transmitted to the Legislative Reference
Bureau as a separate notice for publication in the Pennsylvania
Bulletin.
(b) Notification of a preauthorization shall be accompanied
by a unique preauthorization number and indicate:
(1) The specific health care services preauthorized.
(2) The next date for review.
(3) The total number of days approved.
(4) The date of admission or initiation of services, if
applicable.
(c) Neither the utilization review entity nor the payer or
health insurer that has retained the utilization review entity
may retroactively deny coverage for emergency or nonemergency
care that had been preauthorized when the care was provided, if
the information provided was accurate.
(d) In the event a health care provider obtains
preauthorization for one (1) service but the service provided is
not an exact match to the service that was preauthorized, but
the service does not materially depart from the service that was
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preauthorized, a health plan shall not deny payment for the
service only if:
(1) the date of service differs by less than thirty (30)
days;
(2) the physician or health care provider rendering the
service differs from the physician or health care provider that
was indicated on the preauthorization, but is otherwise licensed
and qualified to provide the preauthorized service; or
(3) the service provided is different than what was
preauthorized but is commonly and appropriately a substitute
based on common procedural terminology.
(e) If the denial of preauthorization is conditioned upon
incomplete information or administrative error, the health plan
shall allow the health care provider to resubmit the claim with
corrected information for appropriate reimbursement within
thirty (30) days of receiving notice.
(f) (1) If a utilization review entity questions the
medical necessity of a health care service, the utilization
review entity shall notify the insured's health care provider
that medical necessity is being questioned and provide the basis
of the challenge in sufficient detail to allow the provider to
meaningfully address the concern of the utilization review
entity prior to issuing an adverse determination.
(2) The insured's health care provider or the health care
provider's designee and the insured or insured's designee shall
have the right to discuss the medical necessity of the health
care service with the utilization review physician.
(3) A utilization review entity questioning medical
necessity of a health care service which may result in an
adverse determination shall make the reviewing physician or a
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physician who is part of a team making the decision available
telephonically between the hours of seven (7) o'clock
antemeridian and seven (7) o'clock postmeridian.
(g) When making a determination based on medical necessity,
a utilization review entity shall base the determination on an
insured's presenting symptoms, diagnosis and information
available through the course of treatment or at the time of
admission or presentation at the emergency department.
(h) In the event a utilization review entity determines an
alternative level of care is appropriate, the utilization review
entity shall provide and cite the specific criteria used as the
basis for the level of care determination to the health care
provider , prior to denial to enable a meaningful peer-to-peer
review. If, after the peer-to-peer review has been completed,
denial remains the determination, the health care provider shall
have the right to appeal the determination.
(i) A utilization review entity may not issue an adverse
determination for a procedure due to lack of preauthorization if
the procedure is medically necessary or clinically appropriate
for the patient's medical condition and rendered at the same
time as a related procedure for which preauthorization was
required and received.
(j) A utilization review entity shall make a
preauthorization or adverse determination and notify the insured
and the insured's health care practitioner as follows:
(1) For nonurgent health care services, within seventy-two
(72) hours of obtaining all the necessary information to make
the preauthorization or adverse determination.
(2) For urgent health care services, within twenty-four (24)
hours of obtaining all the necessary information to make the
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preauthorization or adverse determination.
(k) No utilization review entity may require
preauthorization for an emergency service, including
postevaluation and poststabilization services.
Section 2161.2. Appeals.-- (a) An insured or the insured's
health care provider may request an expedited appeal of an
adverse determination via telephone, facsimile, electronic mail
or other expeditious method. Within one (1) day of receiving an
expedited appeal and all information necessary to decide the
appeal, the utilization review entity shall provide the insured
and the insured's health care provider written confirmation of
the expedited review determination.
(b) An appeal shall be reviewed only by a physician who
satisfies any of the following conditions:
(1) Is board certified in the same specialty as a health
care practitioner who typically manages the medical condition or
disease.
(2) Is currently in active practice, provided that if
circumstances so justify or the provider seeking
preauthorization specifically requests a health care provider
actively engaged in the specialty who typically manages the
medical condition or disease, such a physician shall be made
available for the review.
(3) Is knowledgeable of, and has experience in, providing
the health care services under appeal.
(4) Is under contract with a utilization review entity to
perform reviews of appeals and payment of fees due under the
contract, but the performance and payment is not subject to or
contingent upon the outcome of the appeal.
The physician may also be subject to a provider agreement
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with the insurer as a provider, but may not receive any other
fee or compensation from the insurer. The physician's receipt of
compensation from the utilization review entity shall not be
considered by the physician in determining the conclusion
reached by the physician. The physician shall at all times
render independent and accurate medical judgment in reaching an
opinion or conclusion. Failure to comply with this provision
shall render the physician subject to licensure disciplinary
action by the appropriate State licensing board.
(5) Not involved in making the adverse determination.
(6) Familiar with all known clinical aspects of the health
care services under review, including all pertinent medical
records provided to the utilization review entity by the
insured's health care provider and any relevant record provided
to the utilization review entity by a health care facility.
(c) The utilization review entity shall ensure that appeal
procedures satisfy the following requirements:
(1) The insured and the insured's health care provider may
challenge the adverse determination and have the right to appear
in person before the physician who reviews the adverse
determination.
(2) The utilization review entity shall provide the insured
and the insured's health care provider with written notice of
the time and place concerning where the review meeting will take
place. Notice shall be given to the insured's health care
provider at least fifteen (15) days in advance of the review
meeting.
(3) If the insured or the insured's health care provider
appear in person, the utilization review entity shall offer the
insured or insured's health care provider the opportunity to
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communicate with the reviewing physician, at the utilization
review entity's expense, by conference call, videoconferencing
or other available technology.
(4) The physician performing the review of the appeal shall
consider all information, documentation or other material
submitted in connection with the appeal without regard to
whether the information was considered in making the adverse
determination.
(d) The following deadlines shall apply to the utilization
review entities:
(1) A utilization review entity shall decide an expedited
appeal and notify the insured and the insured's health care
provider of the determination within three (3) days after
receiving a notice of expedited appeal by the insured or the
insured's health care provider and all information necessary to
decide the appeal.
(2) A utilization review entity shall issue a written
determination concerning a nonexpedited appeal not later than
thirty (30) days after receiving a notice of appeal from an
insured or insured's health care provider and all information
necessary to decide the appeal.
(e) Written notice of final adverse determinations shall be
provided to the insured and the insured's health care provider.
(f) If the insured or the insured's health care provider or
a designee on behalf of either the insured or the insured's
health care provider has satisfied all necessary requirements
for the appeal of an adverse determination through the
preauthorization process and the appeal has resulted in a
continued adverse determination either based on lack of medical
necessity or an administrative defect, the insured, the
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insured's health care provider or a designee on behalf of either
the insured or the insured's health care provider or a designee
may file a consumer complaint with the Insurance Department. The
complaint shall be adjudicated without unnecessary delay and a
determination shall be issued by the Insurance Department with
appropriate sanctions, if applicable, pursuant to the authority
given to the Insurance Department.
(g) To the extent that an insured, an insured's health care
provider or a designee on behalf of either the insured or the
insured's health care provider or a designee files a consumer
complaint with the department or the Office of Attorney General
pursuant to their authority to receive such complaints, a copy
of the complaint filed with either the department or the Office
of Attorney General shall be forwarded to the Insurance
Department and the copy shall serve as a new consumer complaint
to be adjudicated pursuant to the terms of this section and all
other applicable law.
(h) Nothing in this section shall be construed to preclude
the ability of an insured or an insured's designee to file a
separate consumer complaint with the Insurance Department for
failure to comply with the requirements of this act as it
applies to preauthorization processes or denial of health
insurance coverage generally.
Section 2195. Access Requirements in Service Areas.-- If a
patient's safe discharge is delayed for any reason, including
lack of available posthospitalization services such as skilled
nursing facilities, home health services and postacute
rehabilitation, the managed care plan shall reimburse the
hospital for each subsequent date of service at the greater of
the contracted rate with the managed care plan for the current
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level of care and service or the full diagnostic related group
payment divided by the mean length of stay for the particular
diagnostic related group.
Section 2196. Uniform Preauthorization Form.--(a) Within
three (3) months of the effective date of this section, the
Insurance Department shall convene a panel to develop a uniform
preauthorization form that all health care providers in this
Commonwealth shall use to request preauthorization and that all
health insurers shall accept as sufficient to request
preauthorization of health care services.
(b) The panel shall consist of not fewer than ten (10)
persons. Equal representation shall be afforded to the
physician, health care facility, employer, health insurer and
consumer protection communities within this Commonwealth.
(c) Within one (1) year of the effective date of this
section, the panel shall conclude development of the uniform
preauthorization form and the Insurance Department shall make
the uniform preauthorization form available to health care
providers in this Commonwealth and utilization review entities
and agents.
Section 2197. Preauthorization Exemptions.-- A health care
service that has been provided following approval through the
preauthorization procedures provided by the insurer or which
have been disclosed as not subject to preauthorization
procedures shall not be subject to retrospective review or
concurrent review based on medical necessity related to the
preauthorization.
Section 2198. Data Collection and Reporting.--(a) The
Insurance Department shall maintain and collect data on the
number of appeals filed by enrollees, enrollee designees and
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health care providers with utilization review entities.
(b) The Insurance Department shall, on an annual basis,
publish a report, which shall be posted on the department's
publicly accessible Internet website. The Insurance Department
shall serve a copy of the report on the Banking and Insurance
Committee of the Senate and the Insurance Committee of the House
of Representatives. The report shall identify the following data
elements by place and type of service:
(1) The total number of appeals filed against utilization
review entities.
(2) The number and percentage of appeals filed against each
utilization review entity.
(3) The total number of appeals found in favor of
utilization review entities.
(4) The number and percentage of appeals found in favor of
each managed care plan.
(5) The total number of appeals found in favor of the
enrollee, designee or health care provider.
(6) The number and percentage of appeals found in favor of
the enrollee, designee or health care provider against each
managed care plan.
(c) The Insurance Department shall evaluate, monitor and
track health plan statistics per the information gathered in
subsection (a) and investigate negative trends and outliers and
shall facilitate meetings between health care providers and
managed care plans to discuss and resolve disputes.
Section 12. Nothing in this act shall be construed to
preclude an insurer from developing a program exempting a health
care provider from preauthorization protocols.
Section 13. This act shall take effect in 60 days.
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