PRINTER'S NO. 2133
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
1754
Session of
2023
INTRODUCED BY MULLINS, CUTLER, STURLA, STENDER, DONAHUE, BURGOS,
MADDEN, FREEMAN, BOROWSKI, SANCHEZ AND CERRATO,
OCTOBER 16, 2023
REFERRED TO COMMITTEE ON INSURANCE, OCTOBER 16, 2023
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 casualty insurance, providing
for coverage for biomarker testing.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. The act of May 17, 1921 (P.L.682, No.284), known
as The Insurance Company Law of 1921, is amended by adding a
section to read:
Section 635.9. Coverage for Biomarker Testing.--(a) An
insurer or medical assistance or Children's Health Insurance
Program managed care plan that amends, delivers or renews a
health insurance policy or an agreement with the Department of
Human Services on or after January 1, 2024, shall include
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
biomarker testing as a covered benefit.
(b) Biomarker testing shall be covered for the purposes of
diagnosis, treatment, appropriate management or ongoing
monitoring of an insured or enrollee's disease or condition when
the test is supported by medical and scientific evidence,
including, but not limited to, any of the following:
(1) labeled indications for an FDA-approved or cleared test;
(2) indicated tests for an FDA-approved drug;
(3) warnings and precautions on FDA-approved drug labels;
(4) Centers for Medicare and Medicaid Services National
Coverage Determinations or Medicare Administrative Contractor
Local Coverage Determinations; or
(5) nationally recognized clinical practice guidelines and
consensus statements.
(b.1) The information obtained through biomarker testing is
to be used only for the purposes specified in subsection (b) and
is protected by the Health Insurance Portability and
Accountability Act of 1996 (Public Law 104-191, 110 Stat. 1936).
The information shall not be used for any other purpose by an
insurer.
(c) Biomarker testing covered under subsections (a) and (b)
shall be provided in a manner that limits disruptions in care,
including the need for multiple biopsies or biospecimen samples.
(d) If prior authorization is required for biomarker
testing, an insurer or medical assistance or Children's Health
Insurance Program managed care plan shall approve or deny a
prior authorization request and notify the enrollee, the
enrollee's health care provider and any entity requesting
authorization of the service within 72 hours for nonurgent
requests or within 24 hours for urgent requests.
20230HB1754PN2133 - 2 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
(e) The patient and prescribing practitioner shall have
access to clear, readily accessible and convenient processes to
request an exception to a coverage policy or an adverse
utilization review determination of a health insurer, nonprofit
health service plan and health maintenance organization. The
process shall be made readily accessible on the health
insurer's, nonprofit health service plan's or health maintenance
organization's publicly accessible Internet website.
(f) An insurer shall submit a report to the Insurance
Department and a medical assistance or Children's Health
Insurance Program managed care plan shall submit to the
Department of Human Services by January 31 of the following
year, the following data from the preceding calendar year in a
form and manner prescribed by the respective department, which
the respective department shall publish to the President pro
tempore of the Senate, the Speaker of the House of
Representatives, the members of the Banking and Insurance
Committee of the Senate and the members of the Insurance
Committee of the House of Representatives:
(1) The number of exception requests received by exception.
(2) The type of health care providers or the medical
specialties of the health care providers submitting exception
requests.
(3) The number of exception requests by exception that were
denied and the reasons for the denials.
(4) The number of exception requests by exception that were
approved.
(5) The number of exception requests by exception that were
initially denied and then appealed.
(6) The number of exception requests by exception that were
20230HB1754PN2133 - 3 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
initially denied and then subsequently reversed by internal
appeals or external reviews.
(7) The medical conditions for which patients are granted
exceptions due to the likelihood that not receiving biomarker
testing will likely result in treatment decisions that could
cause an adverse reaction or physical harm to the insured.
(g) 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:
"Biomarker." A characteristic that is objectively measured
and evaluated as an indicator of normal biological processes,
pathogenic processes or pharmacologic responses to a specific
therapeutic intervention, including known gene-drug interactions
for medications being considered for use or already being
administered. The term includes gene mutations, characteristics
of genes or protein expression.
"Biomarker testing." The analysis of a patient's tissue,
blood or other biospecimen for the presence of a biomarker. The
term includes single-analyte tests, multi-plex panel tests,
protein expression and whole exome, whole genome and whole
transcriptome sequencing.
"Consensus statements." Statements developed by an
independent, multidisciplinary panel of experts utilizing a
transparent methodology and reporting structure and with a
conflict-of-interest policy. These statements should be aimed at
specific clinical circumstances and base the statements on the
best available evidence for the purpose of optimizing the
outcomes of clinical care.
"Covered benefit." A health care service as specified in the
terms of a health insurance policy or an agreement with the
20230HB1754PN2133 - 4 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
Department of Human Services.
"Health insurance policy." A policy, subscriber contract,
certificate or plan issued by an insurer that provides medical
or health care coverage. The term does not include any of the
following:
(1) An accident only policy.
(2) A credit only policy.
(3) A long-term care or disability income policy.
(4) A specified disease policy.
(5) A Medicare supplement policy.
(6) A TRICARE policy, including a Civilian Health and
Medical Program of the Uniformed Services (CHAMPUS) supplement
policy.
(7) A fixed indemnity policy.
(8) A hospital indemnity policy.
(9) A worker's compensation policy.
(10) An automobile medical payment policy under 75 Pa.C.S.
(relating to vehicles).
(11) A homeowner's insurance policy.
(12) Any other similar policies providing for limited
benefits.
(13) A dental only policy.
(14) A vision only policy.
"Insurer." An entity licensed by the Insurance Department
that offers, issues or renews a health insurance policy and
governed under any of the following:
(1) Section 630 and Article XXIV of this act.
(2) The act of December 29, 1972 (P.L.1701, No.364), known
as the Health Maintenance Organization Act.
(3) 40 Pa.C.S. Ch. 61 (relating to hospital plan
20230HB1754PN2133 - 5 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
corporations).
(4) 40 Pa.C.S. Ch. 63 (relating to professional health
services plan corporations).
"Medical assistance" or "Children's Health Insurance Program
managed care plan." A health care plan that uses a gatekeeper
to manage the utilization of health care services, including
biomarker testing, by medical assistance or children's health
insurance program enrollees and integrates the financing and
delivery of health care services, including biomarker testing.
"Nationally recognized clinical practice guidelines."
Evidence-based clinical practice guidelines developed by
independent organizations or medical professional societies
utilizing a transparent methodology and reporting structure and
with a conflict-of-interest policy. Clinical practice guidelines
establish standards of care informed by a systemic review of
evidence and an assessment of the benefits and risks of
alternative care options and include recommendations intended to
optimize patient care.
Section 2. This act shall apply as follows:
(1) For health insurance policies for which either rates
or forms are required to be filed with the Federal Government
or the Insurance Department, the addition of section 635.9 of
the act shall apply to any policy for which a form or rate is
first filed on or after the effective date of this section.
(2) For health insurance policies for which neither
rates nor forms are required to be filed with the Federal
Government or the Insurance Department, the addition of
section 635.9 of the act shall apply to any policy issued or
renewed on or after 120 days after the effective date of this
section.
20230HB1754PN2133 - 6 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
Section 3. This act shall take effect in 60 days.
20230HB1754PN2133 - 7 -
1