Title: NOPAIN Act
Policy area: Health

Summary:
Non-Opioids Prevent Addiction In the Nation Act or the NOPAIN Act
This bill temporarily establishes separate payments for certain non-opioid treatments under the Medicare prospective payment system for hospital outpatient department services and the payment system for ambulatory surgical center services. The bill applies to pain management treatments that are able to replace or reduce opioid consumption, as shown through clinical trials or data.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5172 Introduced in House (IH)]

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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) 
 introduced the following bill; which was referred to the Committee on 
   Energy 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 
                jurisdiction 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 treatments in the hospital 
                          outpatient setting.

    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 ``Non-Opioids Prevent Addiction In the 
Nation Act'' or the ``NOPAIN Act''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) The United States is undergoing an epidemic of 
        addiction and deaths caused by prescription drug overdoses. 
        According to the Centers for Disease Control and Prevention 
        (CDC), opioids are the main driver of drug overdose deaths 
        accounting for 47,600 overdose deaths in 2017. Every day, over 
        130 people die in the United States from opioid overdoses.
            (2) Additionally, the CDC estimates that the economic costs 
        associated with prescription opioid misuse exceeds $78 billion 
        annually. These costs include those associated with healthcare, 
        lost productivity, addiction treatment, and the criminal 
        justice system.
            (3) Certain non-opioid treatments and services can be 
        successful in replacing, delaying, or reducing the use of 
        opioids to treat postsurgical pain.
            (4) The Substance Use-Disorder Prevention that Promotes 
        Opioid Recovery and Treatment (SUPPORT) for Patients and 
        Communities Act was enacted on October 24, 2018. This law 
        requires that CMS review payments under Medicare's Outpatient 
        Prospective Payment System (OPPS) and ASC Payment System with a 
        goal of ensuring there are not financial incentives to use 
        opioids instead of non-opioid alternatives. Additionally, the 
        bill requires CMS to ``consider the extent to which payment 
        policy revisions (such as the creation of additional groups of 
        covered OPD services to classify separately those procedures 
        that utilize opioids and non-opioid alternatives for pain 
        management) would reduce payment incentives to use opioids 
        instead of non-opioid alternatives for pain management.''
            (5) Pursuant to section 319 of the Public Health Service 
        Act, the Acting Secretary for the U.S. Department of Health & 
        Human Services determined on October 26, 2017, that a public 
        health emergency exists as a result of the consequences of the 
        opioid crisis, and the Secretary renewed this determination on 
        October 16, 2019.
            (6) The President's Commission on Combating Drug Addiction 
        and the Opioid Crisis was established on March 29, 2017. The 
        Commission recommended that CMS examine payment policies for 
        certain drugs that function specifically as non-opioid pain 
        management treatments. According to the Commission's report, 
        ``. . . the current CMS payment policy for `supplies' related 
        to surgical procedures creates unintended incentives to 
        prescribe opioid medications to patients for postsurgical pain 
        instead of administering non-opioid pain medications. Under 
        current policies, CMS provides one all-inclusive bundled 
        payment to hospitals for all `surgical supplies,' which 
        includes hospital administered drug products intended to manage 
        patients' postsurgical pain. This policy results in the 
        hospitals receiving the same fixed fee from Medicare whether 
        the surgeon administers a non-opioid medication or not.''
            (7) The Pain Management Best Practices Inter-Agency Task 
        Force was authorized by section 101 of the Comprehensive 
        Addiction and Recovery Act of 2016. The Task Force consisted of 
        Federal agency representatives as well as experts and 
        representatives from a broad group of invested stakeholders and 
        was convened to issue recommendations for identifying and 
        addressing gaps and inconsistencies for managing acute pain. In 
        the Task Force's Final Report on Best Practices: Updates, Gaps, 
        Inconsistencies and Recommendations, the following gap was 
        identified: ``Multimodal, non-opioid therapies are 
        underutilized in the perioperative, inflammatory, 
        musculoskeletal, and neuropathic injury settings.'' The report 
        also states that ``Non-opioids should be used as first-line 
        therapy whenever clinically appropriate in the inpatient and 
        outpatient settings.''
            (8) Research shows that despite ongoing efforts to end the 
        opioid crisis, patients continue to receive large quantities of 
        opioids to treat postsurgical pain. One 2018 study showed that 
        12 percent of patients who had a soft tissue or orthopedic 
        operation in the year prior reported that they had become 
        addicted or dependent on opioids. Further research shows that 
        patients receiving an opioid prescription after short-stay 
        surgeries have a 44 percent increased risk of opioid use.
            (9) CMS has reiterated its position in rulemaking that it 
        is appropriate to pay separately for certain non-opioid pain 
        management treatments that function as surgical supplies in the 
        ASC setting, it is clear that direction from Congress is 
        necessary to modify Medicare's outpatient policies with the 
        goal of encouraging access to non-opioid treatments and 
        services to address the opioid crisis.

SEC. 3. ACCESS TO NON-OPIOID TREATMENTS FOR PAIN.

    (a) In General.--Section 1833(t) of the Social Security Act (42 
U.S.C. 1395l(t)) is amended--
            (1) in paragraph (2)(E), by inserting ``and separate 
        payments for non-opioid treatments under paragraph (16)(G),'' 
        after ``payments under paragraph (6)''; and
            (2) in paragraph (16), by adding at the end the following 
        new subparagraph:
                    ``(G) Access to non-opioid treatments for pain.--
                            ``(i) In general.--Notwithstanding any 
                        other provision of this subsection, with 
                        respect to a covered OPD service (or group of 
                        services) furnished on or after January 1, 
                        2020, and before January 1, 2025, the Secretary 
                        shall not package, and shall make a separate 
                        payment as specified in clause (ii) for, a non-
                        opioid treatment (as defined in clause (iii)) 
                        furnished as part of such service (or group of 
                        services).
                            ``(ii) Amount of payment.--The amount of 
                        the payment specified in this clause is, with 
                        respect to a non-opioid treatment that is--
                                    ``(I) a drug or biological product, 
                                the amount of payment for such drug or 
                                biological determined under section 
                                1847A; or
                                    ``(II) a medical device, the amount 
                                of the hospital's charges for the 
                                device, adjusted to cost.
                            ``(iii) Definition of non-opioid 
                        treatment.--A `non-opioid treatment' means--
                                    ``(I) a drug or biological product 
                                that is indicated to produce analgesia 
                                without acting upon the body's opioid 
                                receptors; or
                                    ``(II) an implantable, reusable, or 
                                disposable medical device cleared or 
                                approved by the Administrator for Food 
                                and Drugs for the intended use of 
                                managing or treating pain;
                        that has demonstrated the ability to replace or 
                        reduce opioid consumption in a clinical trial 
                        or through clinical data published in a peer-
                        reviewed journal, as determined by the 
                        Secretary.''.
    (b) Ambulatory Surgical Center Payment System.--Section 
1833(i)(2)(D) of the Social Security Act (42 U.S.C. 1395l(i)(2)(D)) is 
amended--
            (1) by aligning the margins of clause (v) with the margins 
        of clause (iv);
            (2) by redesignating clause (vi) as clause (vii); and
            (3) by inserting after clause (v) the following new clause:
                            ``(vi) In the case of surgical services 
                        furnished on or after January 1, 2020, and 
                        before January 1, 2025, the payment system 
                        described in clause (i) shall provide for a 
                        separate payment for a non-opioid treatment (as 
                        defined in clause (iii) of subsection 
                        (t)(16)(G)) furnished as part of such services 
                        in the amount specified in clause (ii) of such 
                        subsection.''.
    (c) Evaluation of Therapeutic Services for Pain Management.--
            (1) Report to congress.--Not later than 1 year after the 
        date of the enactment of this Act, the Secretary of Health and 
        Human Services (in this subsection referred to as the 
        ``Secretary''), acting through the Administrator of the Centers 
        for Medicare & Medicaid Services, shall submit to Congress a 
        report identifying--
                    (A) limitations, gaps, barriers to access, or 
                deficits in Medicare coverage or reimbursement for 
                restorative therapies, behavioral approaches, and 
                complementary and integrative health services that are 
                identified in the Pain Management Best Practices Inter-
                Agency Task Force Report and that have demonstrated the 
                ability to replace or reduce opioid consumption; and
                    (B) recommendations to address the limitations, 
                gaps, barriers to access, or deficits identified under 
                subparagraph (A) to improve Medicare coverage and 
                reimbursement for such therapies, approaches, and 
                services.
            (2) Public consultation.--In developing the report 
        described in paragraph (1), the Secretary shall consult with 
        relevant stakeholders as determined appropriate by the 
        Secretary.
            (3) Exclusive treatment.--Any drug, biological product, or 
        medical device that is a non-opioid treatment (as defined in 
        section 1833(t)(16)(G)(iii) of the Social Security Act, as 
        added by subsection (a)) shall not be considered a therapeutic 
        service for the purpose of the report described in paragraph 
        (1).
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