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Legislation Document
SPONSOR:
Sen. Pinkney
DELAWARE STATE SENATE
153rd GENERAL ASSEMBLY
SENATE AMENDMENT NO. 1
TO
HOUSE SUBSTITUTE NO. 1
FOR
HOUSE BILL NO. 200
AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
after line 5 and before line 6 by adding the following and redesignating accordingly:
(2) “Essential support services” include all of the following:
a. HIV testing.
b. Hepatitis B and C testing.
c. Kidney function assessment through creatinine testing and calculated estimated creatinine clearance or glomerular filtration rate.
d. Pregnancy testing.
e. Sexually transmitted infection screening and counseling.
f. Adherence counseling.
(3) “FDA” means the United States Food and Drug Administration.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
on lines 7 through 8 by deleting “
includes prescribing PrEP and PEP to individuals who are at increased risk of HIV acquisition.
” as it appears therein and inserting in lieu thereof “
means as defined in § 3371 of this title.
”
.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
after line 12 and before line 13 by adding the following:
(8) “Therapeutic equivalent” means a PrEP or a PEP that is all of the following:
a. Approved as safe and effective.
b. Pharmaceutically equivalent to another PrEP or another PEP because it contains an identical amount of the same active drug ingredient in the same dosage form and route of administration and meets compendial or other applicable standards of strength, quality, purity, and identity.
c. Assigned, by the FDA, the same therapeutic equivalence code as another PrEP or another PEP.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
after line 16 and before line 17 by adding the following:
c.
Medically necessary e
ssential support services.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
on line 17 by deleting “
The
” as it appears therein and inserting in lieu thereof “
Except as otherwise provided in paragraph (b)(3) of this section,
the
”.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
after line 21 and before line 22 by adding the following:
(3)a. If the FDA has approved 1 or more therapeutic equivalents of a PrEP or a PEP, a health benefit plan is not required to cover all of the therapeutic equivalent versions of that PrEP or that PEP, so long as at least 1 therapeutic equivalent version of that PrEP and at least 1 therapeutic equivalent version of that PEP are covered without cost-sharing, prior authorization, or step therapy requirements. For purposes of this section, a long-acting version of a PrEP or a PEP is not therapeutically equivalent to another long-acting version of a PrEP or a PEP with a different duration.
b. If there is a therapeutic equivalent of a PrEP or a PEP, a health benefit plan may provide coverage for more than 1 version of that PrEP or that PEP and may impose cost-sharing, prior authorization, or step therapy requirements, so long as at least 1 version of that PrEP and at least 1 version of that PEP in the same method of administration is covered without cost-sharing, prior authorization, or step therapy requirements. But a health benefit plan must provide coverage for a particular PrEP or a particular PEP without cost-sharing, prior authorization, or step therapy requirements, regardless of whether the PrEP or the PEP has a therapeutic equivalent, if a covered individual’s treating health-care provider recommends that particular PrEP or that particular PEP based on a medical determination regarding that covered individual.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
after line 40 and before line 41 by adding the following and redesignating accordingly:
(2) “Essential support services” include all of the following:
a. HIV testing.
b. Hepatitis B and C testing.
c. Kidney function assessment through creatinine testing and calculated estimated creatinine clearance or glomerular filtration rate.
d. Pregnancy testing.
e. Sexually transmitted infection screening and counseling.
f. Adherence counseling.
(3) “FDA” means the United States Food and Drug Administration.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
on lines 42 through 43 by deleting “
includes prescribing PrEP and PEP to individuals who are at increased risk of HIV acquisition.
” as it appears therein and inserting in lieu thereof “
means as defined in § 3581 of this title.
”
.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
after line 47 and before line 48 by adding the following:
(8) “Therapeutic equivalent” means a PrEP or a PEP that is all of the following:
a. Approved as safe and effective.
b. Pharmaceutically equivalent to another PrEP or another PEP because it contains an identical amount of the same active drug ingredient in the same dosage form and route of administration and meets compendial or other applicable standards of strength, quality, purity, and identity.
c. Assigned, by the FDA, the same therapeutic equivalence code as another PrEP or another PEP.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
after line 51 and before line 52 by adding the following:
c.
Medically necessary e
ssential support services.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
on line 52 by deleting “
The
” as it appears therein and inserting in lieu thereof “
Except as otherwise provided in paragraph (b)(3) of this section,
the
”.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
after line 56 and before line 57 by adding the following:
(3)a. If the FDA has approved 1 or more therapeutic equivalents of a PrEP or a PEP, a health benefit plan is not required to cover all of the therapeutic equivalent versions of that PrEP or that PEP, so long as at least 1 therapeutic equivalent version of that PrEP and at least 1 therapeutic equivalent version of that PEP are covered without cost-sharing, prior authorization, or step therapy requirements. For purposes of this section, a long-acting version of a PrEP or a PEP is not therapeutically equivalent to another long-acting version of a PrEP or a PEP with a different duration.
b. If there is a therapeutic equivalent of a PrEP or a PEP, a health benefit plan may provide coverage for more than 1 version of that PrEP or that PEP and may impose cost-sharing, prior authorization, or step therapy requirements, so long as at least 1 version of that PrEP and at least 1 version of that PEP in the same method of administration is covered without cost-sharing, prior authorization, or step therapy requirements. But a health benefit plan must provide coverage for a particular PrEP or a particular PEP without cost-sharing, prior authorization, or step therapy requirements, regardless of whether the PrEP or the PEP has a therapeutic equivalent, if a covered individual’s treating health-care provider recommends that particular PrEP or that particular PEP based on a medical determination regarding that covered individual.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
after line 75 and before line 76 by adding the following and redesignating accordingly:
(2) “Essential support services” include all of the following:
a. HIV testing.
b. Hepatitis B and C testing.
c. Kidney function assessment through creatinine testing and calculated estimated creatinine clearance or glomerular filtration rate.
d. Pregnancy testing.
e. Sexually transmitted infection screening and counseling.
f. Adherence counseling.
(3) “FDA” means the United States Food and Drug Administration.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
on lines 77 through 78 by deleting “
includes prescribing PrEP and PEP to individuals who are at increased risk of HIV acquisition.
” as it appears therein and inserting in lieu thereof “
means as defined in § 3581 of Title 18.
”
.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
after line 82 and before line 83 by adding the following:
(8) “Therapeutic equivalent” means a PrEP or a PEP that is all of the following:
a. Approved as safe and effective.
b. Pharmaceutically equivalent to another PrEP or another PEP because it contains an identical amount of the same active drug ingredient in the same dosage form and route of administration and meets compendial or other applicable standards of strength, quality, purity, and identity.
c. Assigned, by the FDA, the same therapeutic equivalence code as another PrEP or another PEP.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
after line 85 and before line 86 by adding the following:
c.
Medically necessary e
ssential support services.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
on line 86 by deleting “
The
” as it appears therein and inserting in lieu thereof “
Except as otherwise provided in paragraph (b)(3) of this section,
the
”.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
after line 90 and before line 91 by adding the following:
(3)a. If the FDA has approved 1 or more therapeutic equivalents of a PrEP or a PEP, the plan is not required to cover all of the therapeutic equivalent versions of that PrEP or that PEP, so long as at least 1 therapeutic equivalent version of that PrEP and at least 1 therapeutic equivalent version of that PEP are covered without cost-sharing, prior authorization, or step therapy requirements. For purposes of this section, a long-acting version of a PrEP or a PEP is not therapeutically equivalent to another long-acting version of a PrEP or a PEP with a different duration.
b. If there is a therapeutic equivalent of a PrEP or a PEP, the plan may provide coverage for more than 1 version of that PrEP or that PEP and may impose cost-sharing, prior authorization, or step therapy requirements, so long as at least 1 version of that PrEP and at least 1 version of that PEP in the same method of administration is covered without cost-sharing, prior authorization, or step therapy requirements. But the plan must provide coverage for a particular PrEP or a particular PEP without cost-sharing, prior authorization, or step therapy requirements, regardless of whether the PrEP or the PEP has a therapeutic equivalent, if a covered individual’s treating health-care provider recommends that particular PrEP or that particular PEP based on a medical determination regarding that covered individual.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
after line 95 and before line 96 by adding the following and redesignating accordingly:
(2) “Essential support services” include all of the following:
a. HIV testing.
b. Hepatitis B and C testing.
c. Kidney function assessment through creatinine testing and calculated estimated creatinine clearance or glomerular filtration rate.
d. Pregnancy testing.
e. Sexually transmitted infection screening and counseling.
f. Adherence counseling.
(3) “FDA” means the United States Food and Drug Administration.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
on lines 97 through 98 by deleting “
includes prescribing PrEP and PEP to individuals who are at increased risk of HIV acquisition.
” as it appears therein and inserting in lieu thereof “
means as defined in § 3581 of Title 18.
”
.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
after line 102 and before line 103 by adding the following:
(8) “Therapeutic equivalent” means a PrEP or a PEP that is all of the following:
a. Approved as safe and effective.
b. Pharmaceutically equivalent to another PrEP or another PEP because it contains an identical amount of the same active drug ingredient in the same dosage form and route of administration and meets compendial or other applicable standards of strength, quality, purity, and identity.
c. Assigned, by the FDA, the same therapeutic equivalence code as another PrEP or another PEP.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
after line 105 and before line 106 by adding the following:
c.
Medically necessary e
ssential support services.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
on line 106 by deleting “
To
” as it appears therein and inserting in lieu thereof “
Except as otherwise provided in paragraph (b)(3) of this section and to
”.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
after line 110 and before line 111 by adding the following:
(3)a. If the FDA has approved 1 or more therapeutic equivalents of a PrEP or a PEP, a health benefit plan is not required to cover all of the therapeutic equivalent versions of that PrEP or that PEP, so long as at least 1 therapeutic equivalent version of that PrEP and at least 1 therapeutic equivalent version of that PEP are covered without cost-sharing, prior authorization, or step therapy requirements. For purposes of this section, a long-acting version of a PrEP or a PEP is not therapeutically equivalent to another long-acting version of a PrEP or a PEP with a different duration.
b. If there is a therapeutic equivalent of a PrEP or a PEP, a health benefit plan may provide coverage for more than 1 version of that PrEP or that PEP and may impose cost-sharing, prior authorization, or step therapy requirements, so long as at least 1 version of that PrEP and at least 1 version of that PEP in the same method of administration is covered without cost-sharing, prior authorization, or step therapy requirements. But a health benefit plan must provide coverage for a particular PrEP or a particular PEP without cost-sharing, prior authorization, or step therapy requirements, regardless of whether the PrEP or the PEP has a therapeutic equivalent, if a recipient’s treating health-care provider recommends that particular PrEP or that particular PEP based on a medical determination regarding that recipient.
FURTHER AMEND House Substitute No. 1 for House Bill No. 200,
as amended,
on line 112 by deleting “2027.” as it appears therein and inserting in lieu thereof “
2026.”
.
SYNOPSIS
This Amendment amends House Substitute No. 1 for House Bill No. 200, as amended by making all of the following changes:
1. Adding a definition of “essential services” which include testing and counseling services related to providing PEP and PrEP treatment.
2. Adding a definition of “FDA” to shorthand references, added by this Amendment, to the United States Food and Drug Administration.
3. Changing the definition of “medically necessary” to references the definition in Chapter 33, Subchapter II and Chapter 35, Subchapter V of Title 18, relating to pre-authorization transparency. The updated definition is commonly used for other health coverage mandates.
4. Adds a definition of “therapeutic equivalent” of a PrEP or PEP medication.
5. Adding medically necessary essential services to the list of required coverage.
6. Specifying that, if there are 1 or more FDA-approved therapeutic equivalent medications for a PEP medication or a PrEP medication, a health plan, policy, certificate, or contract is not required to cover all therapeutic equivalent versions of that PEP medication or that PrEP medication, so long as at least 1 therapeutic equivalent of that PEP medication and at least 1 therapeutic equivalent version of that PrEP medication is covered without cost-sharing, prior authorization, and step therapy requirements. For the purposes of the coverage requirement, a long-acting version of a PEP medication or a PrEP medication is not the therapeutic equivalent of another long-acting version of a PEP medication or a PrEP medication with a different duration
7. Allowing a health plan, certificate, policy, or contract to cover more than 1 therapeutic equivalent of a PEP medication or a PrEP medication and impose cost-sharing, prior authorization, and step therapy requirements, so long as at least 1 version of that PEP medication and at least 1 version of that PrEP medication in the same method of administration is covered without cost-sharing, prior authorization, and step therapy requirements. But a health plan, certificate, policy, or contract must provide a PEP medication or a PrEP medication without cost-sharing, prior authorization, or step therapy requirements, regardless of whether there is a therapeutic equivalent, if a covered individual’s or recipient’s treating health-care provider recommends that particular PEP medication or that particular PrEP medication based on a medical determination regarding that covered individual or recipient.
8. Changing the applicability date so that the coverage requirement applies to all policies, contracts, or certificates, that are issued, renewed, modified, altered, amended, or reissued after December 31, 2026.
Author: Senator Pinkney