PRINTER'S NO. 125
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
161
Session of
2017
INTRODUCED BY DeLUCA, PICKETT, FRANKEL, D. COSTA, PASHINSKI,
MILLARD, COX, DONATUCCI, CALTAGIRONE, GODSHALL, WATSON,
FABRIZIO, McNEILL, KORTZ, DALEY, PYLE, THOMAS, MATZIE,
SOLOMON AND STURLA, JANUARY 23, 2017
REFERRED TO COMMITTEE ON INSURANCE, JANUARY 23, 2017
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 pharmaceutical cost transparency.
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 635.8. Pharmaceutical Cost Transparency.--(a) This
section shall apply to a prescription drug that has one or more
of the following:
(1) An average wholesale price of five thousand dollars
($5,000) or more annually.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
(2) An average wholesale price of five thousand dollars
($5,000) or more per course of treatment.
(3) An average wholesale price that has increased by fifty
per centum (50%) or more over the past five years.
(4) An average wholesale price that has increased by twenty-
five per centum (25%) or more over the past twelve months.
(b) A health insurance policy or government program
providing benefits for a prescription drug described under
subsection (a) may not be required to provide the benefits if
the Insurance Department finds that the manufacturer of the
prescription drug has not filed a report on the prescription
drug as required under subsection (c).
(c) On or before March 1 of each year, a manufacturer of a
prescription drug described under subsection (a) shall file with
the Insurance Department the following information on a form
prescribed by the Insurance Department:
(1) The costs for the production of the drug, including the
following:
(i) The research and development costs paid by the
manufacturer, and separately, the research and development costs
paid by any predecessor in the development of the drug.
(ii) The costs of clinical trials and other regulatory costs
paid by the manufacturer, and separately, the costs of clinical
trials and other regulatory costs paid by any predecessor in the
development of the drug.
(iii) The costs for materials, manufacturing and
administration attributable to the drug.
(iv) The costs paid by any entity other than the
manufacturer or predecessor for research and development,
including, but not limited to, any amount from Federal, State or
20170HB0161PN0125 - 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
other governmental programs or any form of subsidies, grants or
other support.
(v) The other costs to acquire the drug, including costs for
the purchase of patents, licensing or acquisition of a corporate
entity owning rights to the drug while in development, or all of
the costs under this subparagraph.
(vi) The marketing and advertising costs for the promotion
of the drug directly to consumers, including, but not limited
to:
(A) Costs associated with coupons or discounts, that are
directed to consumers and the amount redeemed.
(B) Marketing and advertising costs for promotion of the
drug directly or indirectly to prescribers.
(C) Any other advertising for the drug.
(D) Any payments or contributions to providers not employed
on a full-time basis by the manufacturer, regardless of whether
the payments or contributions are connected to a particular
drug.
(2) The filing under this subsection must be audited and
certified by an independent third-party auditor prior to filing.
(3) A cumulative annual history of average wholesale price
increases for the drug expressed as percentages, including the
months each average wholesale price increase took effect.
(4) The profit attributable to the drug as represented in
dollars and represented as a percentage of the total company
profits that were derived from the sale of the drug.
(5) A description of the manufacturers' patient prescription
assistance programs, including, but not limited to:
(i) The amount of financial assistance provided.
(ii) The amount of financial assistance provided to
20170HB0161PN0125 - 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
residents of this Commonwealth.
(iii) The average amount of assistance per resident of this
Commonwealth and for which drugs the assistance was provided.
(iv) The parameters and qualifications for the patient
prescription assistance programs.
(6) Any payments or financial incentives, direct or
indirect, to hospitals, health care providers or physicians
attributable to the drug described under subsection (a),
including, but not limited to, speaking fees, dinners, research,
consulting, charitable donations, grants or other incentives.
(c) The Insurance Department may promulgate regulations as
may be necessary and appropriate to carry out the provisions of
this section.
(d) This section shall apply as follows:
(1) For a health insurance policy for which either rates or
forms are required to be filed with the Federal Government or
the Insurance Department, this section shall apply to any policy
for which a form or rate is first permitted to be used on or
after 180 days following the effective date of this section.
(2) For a health insurance policy for which neither rates
nor forms are required to be filed with the Federal Government
or the Insurance Department, this section shall apply to any
policy issued or renewed on or after 180 days following the
effective date of this section.
(e) As used in this section:
(1) "Government program" means any of the following:
(i) The Commonwealth's medical assistance program
established under the act of June 13, 1967 (P.L.31, No.21),
known as the Human Services Code.
(ii) The program for comprehensive health care for uninsured
20170HB0161PN0125 - 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
children established under Article XXIII-A.
(iii) The program of pharmaceutical assistance for the
elderly established under Chapter 5 of the act of August 26,
1971 (P.L.351, No.91), known as the State Lottery Law.
(2) "Health insurance policy" means 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:
(i) An accident only policy.
(ii) A credit only policy.
(iii) A long-term care or disability income policy.
(iv) A specified disease policy.
(v) A Medicare supplement policy.
(vi) A TRICARE policy, including a Civilian Health and
Medical Program of the Uniformed Services (CHAMPUS) supplement
policy.
(vii) A fixed indemnity policy.
(viii) A dental only policy.
(ix) A vision only policy.
(x) A workers' compensation policy.
(xi) An automobile medical payment policy under 75 Pa.C.S.
(relating to vehicles).
(xii) Any other similar policies providing for limited
benefits.
(3) "Insurer" means an entity licensed by the Insurance
Department with accident and health authority to issue a policy,
subscriber contract, certificate or plan that provides medical
or health care coverage that is offered or governed under any of
the following:
(i) This act, including section 630 and Article XXIV.
20170HB0161PN0125 - 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
(ii) The act of December 29, 1972 (P.L.1701, No.364), known
as the Health Maintenance Organization Act.
(iii) 40 Pa.C.S. Ch. 61 (relating to hospital plan
corporations) or 63 (relating to professional health services
plan corporations).
(4) "Prescription" means a written or oral order issued by a
duly licensed medical practitioner in the course of the
practitioner's professional practice for a controlled substance,
other drug or device or medication that is dispensed for use by
a consumer.
Section 2. This act shall take effect in 60 days.
20170HB0161PN0125 - 6 -
1
2
3
4
5
6
7
8
9
10
11