[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5506 Introduced in House (IH)]
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118th CONGRESS
1st Session
H. R. 5506
To amend titles XVIII and XIX of the Social Security Act and title 10,
United States Code, to provide no-cost coverage for the preventive
distribution of opioid overdose reversal drugs.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 14, 2023
Ms. Pettersen (for herself, Ms. Schrier, and Ms. Budzinski) introduced
the following bill; which was referred to the Committee on Energy and
Commerce, and in addition to the Committees on Ways and Means, and
Armed Services, for a period to be subsequently determined by the
Speaker, in each case for consideration of such provisions as fall
within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To amend titles XVIII and XIX of the Social Security Act and title 10,
United States Code, to provide no-cost coverage for the preventive
distribution of opioid overdose reversal drugs.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Hospitals As Naloxone Distribution
Sites Act'' or the ``HANDS Act''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) Opioid use disorder is a treatable brain disease from
which people can recover.
(2) Individuals living with opioid use disorder, those who
use opioids for chronic pain, and those who use illicit
substances that may be contaminated with fentanyl or other
illicit additives are at high risk for fatal overdose.
(3) Individuals at-risk of overdose are frequently cared
for in emergency departments and hospitals, making these
locations ideal places to screen and intervene. In addition,
medical providers have the knowledge and ability to provide
medically accurate information, but also treat the disease of
addiction once a person is ready for treatment.
(4) Overdose deaths are preventable with lifesaving opioid
overdose reversal medications like naloxone. Two-thirds of
fatal overdoses have a witness, who can intervene and prevent
overdose death if they have access to opioid antagonists.
(5) Just as individuals with life-threatening allergies
should carry an EpiPen, individuals and close contacts of those
with opioid use disorder should carry an opioid overdose
reversal medication.
(6) While over the counter (OTC) access to reversal agents
may increase their availability to certain populations, the
hurdles to access these medications for many of the most at-
risk patients will still remain. These hurdles include out of
pocket costs, transportation or access to pharmacies or other
areas carrying OTC naloxone, stigma by pharmacy staff,
addiction-related compromised executive function, and more.
Therefore, hospitals are uniquely positioned as a point of
distribution to best serve those who would most benefit.
(7) It is the intent of Congress to increase access for all
individuals with opioid use disorder, and other risk factors,
to opioid overdose reversal medication so that if they
experience an overdose, they will have a second chance. As long
as there is breath, there is hope for recovery.
SEC. 3. NO-COST COVERAGE OF PREVENTIVE OPIOID OVERDOSE REVERSAL DRUGS.
(a) Coverage Under Medicare.--
(1) Coverage.--Section 1861(s)(2) of the Social Security
Act (42 U.S.C. 1395x(s)(2)) is amended--
(A) in subparagraph (JJ), by adding ``and'' after
the semicolon at the end; and
(B) by adding at the end the following new
subparagraph:
``(KK) a preventive opioid overdose reversal drug
(as defined in subsection (nnn)) furnished on or after
January 1, 2024;''.
(2) Preventive opioid overdose reversal drug defined.--
Section 1861 of the Social Security Act (42 U.S.C. 1395x) is
amended by adding at the end the following new subsection:
``(nnn) Preventive Opioid Overdose Reversal Drug.--The term
`preventive opioid overdose reversal drug' means an opioid overdose
reversal drug that is furnished by a physician, nurse practitioner,
physician assistant, or other attending clinical personnel (as
determined by the Secretary by regulation) to an individual who is an
inpatient of a hospital, critical access hospital, or rural emergency
hospital, or is a patient of the emergency department of such a
hospital or an ambulatory surgical center, but only if--
``(1) such physician, nurse practitioner, physician
assistant, or attending clinical professional determines that
such individual is at risk for an opioid overdose; and
``(2) such drug is furnished at the time such individual is
discharged from the hospital or leaves the emergency department
or ambulatory surgical center, as the case may be, together
with instructions for the administration of such drug.''.
(3) Prohibition of cost sharing.--Section 1833 of the
Social Security Act (42 U.S.C. 1395l) is amended--
(A) in subsection (a)(1)--
(i) in subparagraph (S)(i), by striking
``subparagraph (EE),'' and inserting
``subparagraphs (EE) and (II),'';
(ii) in subparagraph (GG), by striking
``and'' at the end; and
(iii) by inserting ``, and (II) with
respect to a preventive opioid overdose
reversal drug (as defined in section 1861(nnn))
furnished on or after January 1, 2024, the
amounts paid shall be 100 percent of the lesser
of the actual charges for such drug or the
amount determined under section 1842(o)''
before the semicolon at the end; and
(B) in subsection (b)--
(i) by striking ``, and (13)'' and
inserting ``(13)''; and
(ii) by striking ``section 1861(n)..'' and
inserting ``section 1861(n), and (14) such
deductible shall not apply with respect to a
preventive opioid reversal drug (as defined in
section 1861(nnn)) furnished on or after
January 1, 2024.''.
(4) Prohibition of cost sharing for medicare advantage
plans.--Section 1852(a)(1)(B) of the Social Security Act (42
U.S.C. 1395w-22(a)(1)(B)) is amended--
(A) in clause (iv)--
(i) by redesignating subclause (VIII) as
subclause (IX); and
(ii) by inserting after subclause (VII) the
following new subclause:
``(VIII) A preventive opioid
reversal drug (as defined in section
1861(nnn)).''; and
(B) in clause (v), by striking ``and (VI)'' and
inserting ``(VI), and (VIII)''.
(b) Coverage Under Medicaid.--
(1) Mandatory coverage.--
(A) In general.--Section 1902(a)(10)(A) of the
Social Security Act (42 U.S.C. 1396a(a)(10)(A)) is
amended by striking ``and (30)'' and inserting ``(30),
and (31)''.
(B) Alternative benefit plans.--Section 1937(b) of
the Social Security Act (42 U.S.C. 1396u-7(b)) is
amended by adding at the end the following new
paragraph:
``(9) Preventive opioid overdose reversal drugs.--
Notwithstanding the previous provisions of this section, a
State may not provide for medical assistance through enrollment
of an individual with benchmark coverage or benchmark-
equivalent coverage under this section unless, beginning on
January 1, 2024, such coverage includes (and does not impose
any deduction, cost sharing, or similar charge for) preventive
opioid overdose reversal drugs described in section
1861(nnn)).''.
(2) Inclusion in medical assistance.--
(A) In general.--Section 1905(a) of the Social
Security Act (42 U.S.C. 1396d(a)) is amended--
(i) in paragraph (30), by striking ``and''
at the end;
(ii) by redesignating paragraph (31) as
paragraph (32); and
(iii) by inserting after paragraph (30) the
following new paragraph:
``(31) beginning January 1, 2024, preventive opioid
overdose reversal drugs described in section 1861(nnn); and''.
(3) Application of rebate requirements.--Section 1927 of
the Social Security Act (42 U.S.C. 1396r-8) is amended--
(A) in subsection (d)(7), by adding at the end the
following new subparagraph:
``(F) Preventive opioid overdose reversal drugs
described in section 1861(nnn) that are furnished as
medical assistance in accordance with section
1905(a)(31) and section 1902(a)(10)(A).''; and
(B) in subsection (k)(4)--
(i) by striking ``If a State plan'' and
inserting:
``(A) In general.--If a State plan''; and
(ii) by adding at the end the following new
subparagraph:
``(B) Preventive opioid overdose reversal drugs.--
Beginning January 1, 2024, in applying paragraph (2)(A)
to a preventive opioid overdose reversal drug described
in section 1861(nnn), such drug shall be deemed a
prescribed drug for purposes of section 1905(a)(12).''.
(4) Prohibition of cost sharing.--
(A) In general.--Section 1916 of the Social
Security Act (42 U.S.C. 1396o) is amended--
(i) in subsection (a)(2)--
(I) in subparagraph (I), by
striking ``or'' at the end;
(II) in subparagraph (J), by
striking ``; and'' at the end and
inserting ``, or''; and
(III) by adding at the end the
following new subparagraph:
``(K) beginning January 1, 2024, preventive opioid
overdose reversal drugs described in section 1861(nnn);
and''; and
(ii) in subsection (b)(2)--
(I) in subparagraph (I), by
striking ``or'' at the end;
(II) in subparagraph (J), by
striking ``; and'' at the end and
inserting ``, or''; and
(III) by adding at the end the
following new subparagraph:
``(K) beginning January 1, 2024, preventive opioid
overdose reversal drugs described in section 1861(nnn);
and''.
(B) Application to alternative cost sharing.--
Section 1916A(b)(3)(B) of the Social Security Act (42
U.S.C. 1396o-1(b)(3)(B)) is amended by adding at the
end the following new clause:
``(xv) Beginning January 1, 2024,
preventive opioid overdose reversal drugs
described in section 1861(nnn).''.
(c) Coverage Under TRICARE.--Section 1074g of title 10, United
States Code, is amended as follows:
(1) In subsection (a)(6), by adding at the end the
following new subparagraph:
``(D) Notwithstanding subparagraphs (A) through (C), beginning on
January 1, 2024, an eligible covered beneficiary shall not be required
to pay a cost-sharing amount for a preventive opioid overdose reversal
drug.''.
(2) In subsection (i), by adding at the end the following
new paragraph:
``(5) The term `preventive opioid overdose reversal drug'
has the meaning given such term in section 1861 of the Social
Security Act (42 U.S.C. 1395x).''.
SEC. 4. REGULATORY GUIDANCE.
Not later than 1 year after the date of the enactment of this Act,
the Commissioner of Food and Drugs shall issue guidance for State
boards of pharmacy, nursing, and medicine with respect to--
(1) enhancing safe and effective hospital-based dispensing
and distribution of opioid overdose reversal drugs; and
(2) eliminating barriers to such dispensing and
distribution.
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