NOPAIN Act

I 116TH CONGRESS 1ST SESSION H. R. 5172 To amend title XVIII of the Social Security Act to combat the opioid crisis by promoting access to non-opioid treatments in the hospital outpatient setting. IN THE HOUSE OF REPRESENTATIVES NOVEMBER 19, 2019 Ms. SEWELL of Alabama (for herself, Mr. MCKINLEY, and Mr. BRINDISI) in- troduced the following bill; which was referred to the Committee on En- ergy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdic- tion of the committee concerned A BILL To amend title XVIII of the Social Security Act to combat the opioid crisis by promoting access to non-opioid treat- ments in the hospital outpatient setting. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Non-Opioids Prevent 4 Addiction In the Nation Act’’ or the ‘‘NOPAIN Act’’. 5 SEC. 2. FINDINGS. 6 Congress finds the following: 7 VerDate Sep 11 2014 20:52 Dec 02, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H5172.IH H5172 jbell on DSKJLSW7X2PROD with BILLS 2 •HR 5172 IH (1) The United States is undergoing an epi- 1 demic of addiction and deaths caused by prescription 2 drug overdoses. According to the Centers for Disease 3 Control and Prevention (CDC), opioids are the main 4 driver of drug overdose deaths accounting for 47,600 5 overdose deaths in 2017. Every day, over 130 people 6 die in the United States from opioid overdoses. 7 (2) Additionally, the CDC estimates that the 8 economic costs associated with prescription opioid 9 misuse exceeds $78 billion annually. These costs in- 10 clude those associated with healthcare, lost produc- 11 tivity, addiction treatment, and the criminal justice 12 system. 13 (3) Certain non-opioid treatments and services 14 can be successful in replacing, delaying, or reducing 15 the use of opioids to treat postsurgical pain. 16 (4) The Substance Use-Disorder Prevention 17 that Promotes Opioid Recovery and Treatment 18 (SUPPORT) for Patients and Communities Act was 19 enacted on October 24, 2018. This law requires that 20 CMS review payments under Medicare’s Outpatient 21 Prospective Payment System (OPPS) and ASC Pay- 22 ment System with a goal of ensuring there are not 23 financial incentives to use opioids instead of non- 24 opioid alternatives. Additionally, the bill requires 25 VerDate Sep 11 2014 23:12 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5172.IH H5172 jbell on DSKJLSW7X2PROD with BILLS 3 •HR 5172 IH CMS to ‘‘consider the extent to which payment pol- 1 icy revisions (such as the creation of additional 2 groups of covered OPD services to classify sepa- 3 rately those procedures that utilize opioids and non- 4 opioid alternatives for pain management) would re- 5 duce payment incentives to use opioids instead of 6 non-opioid alternatives for pain management.’’ 7 (5) Pursuant to section 319 of the Public 8 Health Service Act, the Acting Secretary for the 9 U.S. Department of Health & Human Services de- 10 termined on October 26, 2017, that a public health 11 emergency exists as a result of the consequences of 12 the opioid crisis, and the Secretary renewed this de- 13 termination on October 16, 2019. 14 (6) The President’s Commission on Combating 15 Drug Addiction and the Opioid Crisis was estab- 16 lished on March 29, 2017. The Commission rec- 17 ommended that CMS examine payment policies for 18 certain drugs that function specifically as non-opioid 19 pain management treatments. According to the 20 Commission’s report, ‘‘. . . the current CMS pay- 21 ment policy for ‘supplies’ related to surgical proce- 22 dures creates unintended incentives to prescribe 23 opioid medications to patients for postsurgical pain 24 instead of administering non-opioid pain medica- 25 VerDate Sep 11 2014 01:25 Nov 28, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5172.IH H5172 jbell on DSKJLSW7X2PROD with BILLS 4 •HR 5172 IH tions. Under current policies, CMS provides one all- 1 inclusive bundled payment to hospitals for all ‘sur- 2 gical supplies,’ which includes hospital administered 3 drug products intended to manage patients’ post- 4 surgical pain. This policy results in the hospitals re- 5 ceiving the same fixed fee from Medicare whether 6 the surgeon administers a non-opioid medication or 7 not.’’ 8 (7) The Pain Management Best Practices 9 Inter-Agency Task Force was authorized by section 10 101 of the Comprehensive Addiction and Recovery 11 Act of 2016. The Task Force consisted of Federal 12 agency representatives as well as experts and rep- 13 resentatives from a broad group of invested stake- 14 holders and was convened to issue recommendations 15 for identifying and addressing gaps and inconsist- 16 encies for managing acute pain. In the Task Force’s 17 Final Report on Best Practices: Updates, Gaps, In- 18 consistencies and Recommendations, the following 19 gap was identified: ‘‘Multimodal, non-opioid thera- 20 pies are underutilized in the perioperative, inflam- 21 matory, musculoskeletal, and neuropathic injury set- 22 tings.’’ The report also states that ‘‘Non-opioids 23 should be used as first-line therapy whenever clini- 24 VerDate Sep 11 2014 23:12 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5172.IH H5172 jbell on DSKJLSW7X2PROD with BILLS 5 •HR 5172 IH cally appropriate in the inpatient and outpatient set- 1 tings.’’ 2 (8) Research shows that despite ongoing efforts 3 to end the opioid crisis, patients continue to receive 4 large quantities of opioids to treat postsurgical pain. 5 One 2018 study showed that 12 percent of patients 6 who had a soft tissue or orthopedic operation in the 7 year prior reported that they had become addicted 8 or dependent on opioids. Further research shows 9 that patients receiving an opioid prescription after 10 short-stay surgeries have a 44 percent increased risk 11 of opioid use. 12 (9) CMS has reiterated its position in rule- 13 making that it is appropriate to pay separately for 14 certain non-opioid pain management treatments that 15 function as surgical supplies in the ASC setting, it 16 is clear that direction from Congress is necessary to 17 modify Medicare’s outpatient policies with the goal 18 of encouraging access to non-opioid treatments and 19 services to address the opioid crisis. 20 SEC. 3. ACCESS TO NON-OPIOID TREATMENTS FOR PAIN. 21 (a) IN GENERAL.—Section 1833(t) of the Social Se- 22 curity Act (42 U.S.C. 1395l(t)) is amended— 23 (1) in paragraph (2)(E), by inserting ‘‘and sep- 24 arate payments for non-opioid treatments under 25 VerDate Sep 11 2014 23:12 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H5172.IH H5172 jbell on DSKJLSW7X2PROD with BILLS 6 •HR 5172 IH paragraph (16)(G),’’ after ‘‘payments under para- 1 graph (6)’’; and 2 (2) in paragraph (16), by adding at the end the 3 following new subparagraph: 4 ‘‘(G) ACCESS TO NON-OPIOID TREATMENTS 5 FOR PAIN.— 6 ‘‘(i) IN GENERAL.—Notwithstanding 7 any other provision of this subsection, with 8 respect to a covered OPD service (or group 9 of services) furnished on or after January 10 1, 2020, and before January 1, 2025, the 11 Secretary shall not package, and shall 12 make a separate payment as specified in 13 clause (ii) for, a non-opioid treatment (as 14 defined in clause (iii)) furnished as part of 15 such service (or group of services). 16 ‘‘(ii) AMOUNT OF PAYMENT.—The 17 amount of the payment specified in this 18 clause is, with respect to a non-opioid 19 treatment that is— 20 ‘‘(I) a drug or biological product, 21 the amount of payment for such drug 22 or biological determined under section 23 1847A; or 24 VerDate Sep 11 2014 23:12 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5172.IH H5172 jbell on DSKJLSW7X2PROD with BILLS 7 •HR 5172 IH ‘‘(II) a medical device, the 1 amount of the hospital’s charges for 2 the device, adjusted to cost. 3 ‘‘(iii) DEFINITION OF NON-OPIOID 4 TREATMENT.—A ‘non-opioid treatment’ 5 means— 6 ‘‘(I) a drug or biological product 7 that is indicated to produce analgesia 8 without acting upon the body’s opioid 9 receptors; or 10 ‘‘(II) an implantable, reusable, or 11 disposable medical device cleared or 12 approved by the Administrator for 13 Food and Drugs for the intended use 14 of managing or treating pain; 15 that has demonstrated the ability to re- 16 place or reduce opioid consumption in a 17 clinical trial or through clinical data pub- 18 lished in a peer-reviewed journal, as deter- 19 mined by the Secretary.’’. 20 (b) AMBULATORY SURGICAL CENTER PAYMENT SYS- 21 TEM.—Section 1833(i)(2)(D) of the Social Security Act 22 (42 U.S.C. 1395l(i)(2)(D)) is amended— 23 (1) by aligning the margins of clause (v) with 24 the margins of clause (iv); 25 VerDate Sep 11 2014 23:12 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H5172.IH H5172 jbell on DSKJLSW7X2PROD with BILLS 8 •HR 5172 IH (2) by redesignating clause (vi) as clause (vii); 1 and 2 (3) by inserting after clause (v) the following 3 new clause: 4 ‘‘(vi) In the case of surgical services 5 furnished on or after January 1, 2020, and 6 before January 1, 2025, the payment sys- 7 tem described in clause (i) shall provide for 8 a separate payment for a non-opioid treat- 9 ment (as defined in clause (iii) of sub- 10 section (t)(16)(G)) furnished as part of 11 such services in the amount specified in 12 clause (ii) of such subsection.’’. 13 (c) EVALUATION OF THERAPEUTIC SERVICES FOR 14 PAIN MANAGEMENT.— 15 (1) REPORT TO CONGRESS.—Not later than 1 16 year after the date of the enactment of this Act, the 17 Secretary of Health and Human Services (in this 18 subsection referred to as the ‘‘Secretary’’), acting 19 through the Administrator of the Centers for Medi- 20 care & Medicaid Services, shall submit to Congress 21 a report identifying— 22 (A) limitations, gaps, barriers to access, or 23 deficits in Medicare coverage or reimbursement 24 for restorative therapies, behavioral approaches, 25 VerDate Sep 11 2014 23:12 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H5172.IH H5172 jbell on DSKJLSW7X2PROD with BILLS 9 •HR 5172 IH and complementary and integrative health serv- 1 ices that are identified in the Pain Management 2 Best Practices Inter-Agency Task Force Report 3 and that have demonstrated the ability to re- 4 place or reduce opioid consumption; and 5 (B) recommendations to address the limi- 6 tations, gaps, barriers to access, or deficits 7 identified under subparagraph (A) to improve 8 Medicare coverage and reimbursement for such 9 therapies, approaches, and services. 10 (2) PUBLIC CONSULTATION.—In developing the 11 report described in paragraph (1), the Secretary 12 shall consult with relevant stakeholders as deter- 13 mined appropriate by the Secretary. 14 (3) EXCLUSIVE TREATMENT.—Any drug, bio- 15 logical product, or medical device that is a non- 16 opioid treatment (as defined in section 17 1833(t)(16)(G)(iii) of the Social Security Act, as 18 added by subsection (a)) shall not be considered a 19 therapeutic service for the purpose of the report de- 20 scribed in paragraph (1). 21 Æ VerDate Sep 11 2014 23:12 Nov 27, 2019 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6301 E:\BILLS\H5172.IH H5172 jbell on DSKJLSW7X2PROD with BILLS