[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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