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PRINTER'S NO. 4103
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
2679
Session of
2018
INTRODUCED BY BOYLE, KRUEGER-BRANEKY, DAVIS, DEAN, SCHLOSSBERG,
THOMAS, SIMS, HILL-EVANS, GALLOWAY, RABB, McCARTER, FRANKEL,
DAVIDSON, DALEY, KINSEY, STURLA, BRIGGS, SOLOMON, ROZZI,
BULLOCK, TAI AND ROEBUCK, SEPTEMBER 26, 2018
REFERRED TO COMMITTEE ON INSURANCE, SEPTEMBER 26, 2018
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 prior authorization, copayment, coinsurance and
dispensing requirements for contraceptive drugs, devices,
products and related medical or counseling services, for
coverage for voluntary male sterilization and for drug
formularies.
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
sections to read:
Section 635.8. Prior Authorization, Copayment, Coinsurance
and Dispensing Requirements for Contraceptive Drugs, Devices,
Products and Related Medical or Counseling Services.--(a) The
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following shall apply regarding coverage:
(1) Subject to paragraphs (2) and (3), an insurer that
issues, delivers or renews a health insurance policy in this
Commonwealth on or after the effective date of this section
shall provide coverage for all FDA-approved contraceptive drugs,
devices, products and related medical or counseling services,
including those prescribed by the insured's provider or as
otherwise authorized under Federal or State law.
(2) This subsection does not apply to an organization that
requests and receives an exclusion from coverage under paragraph
(3).
(3) The following shall apply to a religious employer:
(i) Subject to subparagraph (iii), a religious employer may
request and an insurer shall grant the request for an exclusion
from coverage under a health insurance policy for coverage of an
FDA-approved contraceptive drug, device, product or related
medical or counseling service which is contrary to the
employer's religious tenets if the employer:
(A) is a not-for-profit organization that has the purpose of
inculcating religious values;
(B) primarily employs individuals who share the religious
tenets of the employer; and
(C) primarily serves individuals who share the religious
tenets of the employer.
(ii) A religious employer granted an exclusion under
subparagraph (i) shall provide written notice to prospective
insureds prior to their enrollment in the health insurance
policy, listing the contraceptive drugs, devices, products and
related medical or counseling services which the employer
refuses to cover for religious reasons.
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(iii) The exclusion from coverage under this paragraph shall
not apply to an FDA-approved contraceptive drug, device, product
or related medical or counseling service which is used for
purposes other than birth control.
(b) An insurer may not impose any restriction or delay on
the coverage required under this section, including, but not
limited to, a prior authorization requirement for a
contraceptive drug, device, product or related medical or
counseling service that is:
(1) approved by the FDA; and
(2) either:
(i) obtained under a prescription written by an authorized
prescriber, including for purposes other than birth control or
which are necessary to preserve the life or health of an
insured; or
(ii) for medical or counseling services which are necessary
for the effective use of contraception.
(c) The following shall apply regarding a cost-sharing
mechanism requirement:
(1) Except as provided in paragraph (2), an insurer may not
apply a copayment, coinsurance, deductible or another cost-
sharing mechanism requirement for a contraceptive drug, device
or product that is:
(i) approved by the FDA; and
(ii) either:
(A) obtained under a prescription written by an authorized
prescriber, including for purposes other than birth control; or
(B) for medical or counseling services which are necessary
for the effective use of contraception.
(2) An insurer may apply a copayment, coinsurance,
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deductible or another cost-sharing mechanism requirement for a
contraceptive drug, device or product that, according to the
FDA, is a therapeutic equivalent to another contraceptive drug,
device or product that is available under the same policy or
contract without a copayment, coinsurance or deductible, if the
copayment, coinsurance or deductible is not greater than it
would be for another prescription contraceptive drug, device or
product covered under the same policy. If the insured's
provider, acting within the provider's scope of practice,
determines that none of the methods designated by the health
insurance policy are medically appropriate for the insured's
medical or personal history, the health insurance policy shall
also provide coverage for another FDA-approved, medically
appropriate prescription contraceptive method prescribed by the
insured's provider without a copayment, coinsurance, deductible
or another cost-sharing mechanism.
(d) The following shall apply regarding dispensing:
(1) Except as provided in paragraph (2), an insurer shall
provide coverage for a single dispensing to an insured of a
supply of prescription contraceptives for up to a twelve-month
period.
(2) An insurer shall provide coverage for a supply of
prescription contraceptives that is for less than a twelve-month
period if:
(i) the insured requests a lesser dispensing of the
contraceptive drug, device or product at one time; or
(ii) the prescribing provider instructs that the insured
receive a lesser dispensing of the contraceptive drug, device or
product at one time.
(e) An insurer:
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(1) Shall provide coverage without a prescription for all
contraceptive drugs, devices and products approved by the FDA
and available by prescription and over the counter.
(2) May not apply a copayment, coinsurance, deductible or
another cost-sharing requirement for a contraceptive drug
dispensed without a prescription under paragraph (1) that
exceeds the copayment or coinsurance requirement for the
contraceptive drug dispensed under a prescription.
(f) The following shall apply regarding enforcement:
(1) An applicant or insured who believes that the applicant
or insured has been adversely affected by an act or practice of
an insurer in violation of this act may file any of the
following:
(i) A complaint with the Insurance Commissioner, who shall
handle the complaint consistent with 2 Pa.C.S. (relating to
administrative law and procedure) and address a violation
through means appropriate to the nature and extent of the
violation, which may include a cease and desist order,
injunctive relief, restitution, suspension or revocation of a
certificate of authority or license, civil penalties,
reimbursement of costs or reasonable attorney fees incurred by
the aggrieved individual in bringing the complaint, or any
combination of these.
(ii) A civil action against the insurer in a State court of
original jurisdiction, which, upon proof of the violation of
this section by a preponderance of the evidence, shall award
appropriate relief, including temporary, preliminary or
permanent injunctive relief, compensatory or punitive damages,
the costs of suit, reasonable attorney fees and reasonable fees
for the aggrieved individual's expert witnesses. At any time
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prior to the rendering of final judgment, the aggrieved
individual may elect to recover, in lieu of actual damages, an
award of statutory damages in the amount of five thousand
dollars ($5,000) for each violation.
(g) As used in this section:
"Authorized prescriber" means a person who is licensed,
registered or otherwise lawfully authorized to distribute,
dispense or administer a controlled substance, other drug,
device or product in the course of professional practice or
research in this Commonwealth, excluding veterinarians.
"FDA" means the United States Food and Drug Administration.
"Health insurance policy" means:
(1) An individual or group health insurance policy,
subscriber contract, certificate or plan which provides medical
or health care coverage by a health care facility or licensed
health care provider which is offered by or is governed under
this act or any of the following:
(i) Subarticle (f) of Article IV of the act of June 13, 1967
(P.L.31, No.21), known as the "Human Services Code."
(ii) The act of December 29, 1972 (P.L.1701, No.364), known
as the "Health Maintenance Organization Act."
(iii) The act of May 18, 1976 (P.L.123, No.54), known as the
"Individual Accident and Sickness Insurance Minimum Standards
Act."
(iv) A nonprofit corporation subject to 40 Pa.C.S. Ch. 61
(relating to hospital plan corporations) or 63 (relating to
professional health services plan corporations).
(2) The term does not include any of the following:
(i) A health benefit plan that is a grandfathered health
plan, as defined in section 1251 of the Patient Protection and
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Affordable Care Act (Public Law 111-148, 42 U.S.C. § 18011).
(ii) Any of the following types of insurance or a
combination of any of the following types of insurance:
(A) Accident only.
(B) Fixed indemnity.
(C) Limited benefit.
(D) Credit.
(E) Dental.
(F) Vision.
(G) Specified disease.
(H) Medicare supplement.
(I) Civilian Health and Medical Program of the Uniformed
Services (CHAMPUS) supplement.
(J) Long-term care or disability income.
(K) Workers' compensation.
(L) Automobile medical payment.
"Insurer" means an entity that issues an individual or group
health insurance policy.
"Medical or counseling services" include, but are not limited
to:
(1) Examinations, procedures and medical and counseling
services which are provided on an inpatient or outpatient basis.
(2) Services for initial and periodic comprehensive physical
examinations. Coverage for the examinations shall be consistent
with the recommendations of the appropriate medical specialty
organizations and shall be made under terms and conditions
applicable to other coverage.
(3) Medical, laboratory and radiology services warranted by
initial and periodic comprehensive physical examinations or by
the history, physical findings or risk factors, including
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medical services necessary for the insertion and removal of any
contraceptive drug, device or product and individual or group
family planning counseling.
"P rescription contraceptive drug, device or product" includes
all regimes of over-the-counter and prescription contraceptive
drugs and all regimes of prescription contraceptive devices
approved by the FDA and any generic equivalent approved as
substitutable by the FDA. The term excludes male condoms.
"Therapeutic equivalent" means a drug, device or product
which:
(1) can be expected to have the same clinical effect and
safety profile when administered to a patient under the
conditions specified in the labeling;
(2) is FDA-approved as safe and effective;
(3) is a pharmaceutical equivalent in that it:
(i) contains identical amounts of the same active drug
ingredient in the same dosage form and route of administration;
and
(ii) meets compendial or other applicable standards of
strength, quality, purity and identity;
(4) is bioequivalent in that it:
(i) does not present a known or potential bioequivalence
problem and meets an acceptable in vitro standard; or
(ii) is shown to meet an appropriate bioequivalence standard
if it does present a known or potential bioequivalence problem;
(5) is adequately labeled; and
(6) is manufactured in compliance with current good
manufacturing practice regulations.
Section 635.9. Coverage for Voluntary Male Sterilization.--
(a) The following shall apply regarding coverage:
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(1) Subject to paragraphs (2) and (3), an insurer that
issues, delivers or renews a health insurance policy in this
Commonwealth on or after the effective date of this section
shall provide coverage for voluntary male sterilization in
accordance with the provisions of this section.
(2) This subsection does not apply to an organization that
requests and receives an exclusion from coverage under paragraph
(3).
(3) The following shall apply to a religious employer:
(i) A religious employer may request and an insurer shall
grant the request for an exclusion from coverage under a health
insurance policy for coverage of an FDA-approved contraceptive
drug, device, product or related medical or counseling service
which is contrary to the employer's religious tenets if the
employer:
(A) is a not-for-profit organization that has the purpose of
inculcating religious values;
(B) primarily employs individuals who share the religious
tenets of the employer; and
(C) primarily serves individuals who share the religious
tenets of the employer.
(ii) A religious employer granted an exclusion under
subparagraph (i) shall provide written notice to prospective
insureds prior to their enrollment in the health insurance
policy, listing the contraceptive drugs, devices, products and
medical or counseling services which the employer refuses to
cover for religious reasons.
(b) An insurer that provides coverage for voluntary male
sterilization under a health insurance policy that is issued,
delivered or renewed in this Commonwealth on or after the
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effective date of this section may not apply a copayment,
coinsurance requirement or deductible to coverage for voluntary
male sterilization.
(c) The following shall apply regarding enforcement:
(1) An applicant or insured who believes that the applicant
or insured has been adversely affected by an act or practice of
an insurer in violation of this act may file any of the
following:
(i) A complaint with the Insurance Commissioner, who shall
handle the complaint consistent with 2 Pa.C.S. (relating to
administrative law and procedure) and address a violation
through means appropriate to the nature and extent of the
violation, which may include a cease and desist order,
injunctive relief, restitution, suspension or revocation of a
certificate of authority or license, civil penalties,
reimbursement of costs or reasonable attorney fees incurred by
the aggrieved individual in bringing the complaint, or any
combination of these.
(ii) A civil action against the insurer in a State court of
original jurisdiction, which, upon proof of the violation of
this section by a preponderance of the evidence, shall award
appropriate relief, including temporary, preliminary or
permanent injunctive relief, compensatory or punitive damages,
the costs of suit, reasonable attorney fees and reasonable fees
for the aggrieved individual's expert witnesses. At any time
prior to the rendering of final judgment, the aggrieved
individual may elect to recover, in lieu of actual damages, an
award of statutory damages in the amount of five thousand
dollars ($5,000) for each violation.
(d) As used in this section:
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"Health insurance policy" means "health insurance policy" as
that term is defined in section 635.8(g).
"Insurer" means "insurer" as that term is defined in section
635.8(g).
Section 635.10. Drug Formularies.--(a) An insurer that
issues, delivers or renews a health insurance policy in this
Commonwealth on or after the effective date of this section
shall provide coverage for prescription drugs, devices, products
and related medical or counseling services in accordance with
the provisions of this section.
(b) Each insurer that limits its coverage of prescription
drugs, devices, products or related medical or counseling
services to those in a formulary shall establish and implement
an easily accessible, transparent and sufficiently expedient
process by which a member may receive a prescription drug,
device, product or related medical or counseling services not in
the insurer's formulary in accordance with this section.
(c) The procedure shall provide for coverage for a
prescription drug, device or product that is not in the
formulary if, in the judgment of the authorized prescriber, any
of the following apply:
(1) There is no equivalent prescription drug, device or
product in the insurer's formulary.
(2) An equivalent prescription drug, device or product in
the insurer's formulary:
(i) has been ineffective in treating the disease or
condition of the member; or
(ii) has caused or is likely to cause an adverse reaction or
other harm to the member.
(3) For a contraceptive prescription drug, device or
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product, the prescription drug, device or product that is not on
the formulary is medically necessary for the member to adhere to
the appropriate use of the prescription drug or device.
(d) The following shall apply regarding enforcement:
(1) An applicant or insured who believes that the applicant
or insured has been adversely affected by an act or practice of
an insurer in violation of this act may file any of the
following:
(i) A complaint with the Insurance Commissioner, who shall
handle the complaint consistent with 2 Pa.C.S. (relating to
administrative law and procedure) and address a violation
through means appropriate to the nature and extent of the
violation, which may include a cease and desist order,
injunctive relief, restitution, suspension or revocation of a
certificate of authority or license, civil penalties,
reimbursement of costs or reasonable attorney fees incurred by
the aggrieved individual in bringing the complaint, or any
combination of these.
(ii) A civil action against the insurer in a State court of
original jurisdiction, which, upon proof of the violation of
this section by a preponderance of the evidence, shall award
appropriate relief, including temporary, preliminary or
permanent injunctive relief, compensatory or punitive damages,
the costs of suit, reasonable attorney fees and reasonable fees
for the aggrieved individual's expert witnesses. At any time
prior to the rendering of final judgment, the aggrieved
individual may elect to recover, in lieu of actual damages, an
award of statutory damages in the amount of five thousand
dollars ($5,000) for each violation.
(e) As used in this section:
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"Authorized prescriber" means "authorized prescriber" as that
term is defined in section 635.8(g).
"Formulary" means a list of prescription drugs, devices or
products that are covered by an insurer.
"Health insurance policy" means "health insurance policy" as
that term is defined in section 635.8(g), except that paragraph
(2)(i) of that definition shall not apply.
"Insurer" means "insurer" as that term is defined in section
635.8(g).
"Medical or counseling services" means "medical or counseling
services" as that term is defined in section 635.8(g).
"Member" means an individual entitled to health care benefits
for prescription drugs, devices or products under a health
insurance policy issued or delivered in this Commonwealth by an
insurer. The term includes a subscriber.
Section 2. If a provision of this act or its application to
any person, entity or circumstance is held invalid, the
invalidity shall not affect other provisions or applications of
this act that can be given effect without the invalid provision
or application, and to this end the provisions of this act shall
be severable.
Section 3. This act shall take effect in 180 days.
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