I 118th CONGRESS 1st Session H. R. 5506 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.

1. Short title This Act may be cited as the Hospitals As Naloxone Distribution Sites Act or the HANDS Act . 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. 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 ). . 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.