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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4981 Referred in Senate (RFS)]

<DOC>
114th CONGRESS
  2d Session
                                H. R. 4981

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                              May 12, 2016

     Received; read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 AN ACT

 
To amend the Controlled Substances Act to improve access to opioid use 
                          disorder treatment.

    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 ``Opioid Use Disorder Treatment 
Expansion and Modernization Act''.

SEC. 2. FINDING.

    The Congress finds that opioid use disorder has become a public 
health epidemic that must be addressed by increasing awareness and 
access to all treatment options for opioid use disorder, overdose 
reversal, and relapse prevention.

SEC. 3. OPIOID USE DISORDER TREATMENT MODERNIZATION.

    (a) In General.--Section 303(g)(2) of the Controlled Substances Act 
(21 U.S.C. 823(g)(2)) is amended--
            (1) in subparagraph (B), by striking clauses (i), (ii), and 
        (iii) and inserting the following:
            ``(i) The practitioner is a qualifying practitioner (as 
        defined in subparagraph (G)).
            ``(ii) With respect to patients to whom the practitioner 
        will provide such drugs or combinations of drugs, the 
        practitioner has the capacity to provide directly, by referral, 
        or in such other manner as determined by the Secretary--
                    ``(I) all schedule III, IV, and V drugs, as well as 
                unscheduled medications approved by the Food and Drug 
                Administration, for the treatment of opioid use 
                disorder, including such drugs and medications for 
                maintenance, detoxification, overdose reversal, and 
                relapse prevention, as available; and
                    ``(II) appropriate counseling and other appropriate 
                ancillary services.
            ``(iii)(I) The total number of such patients of the 
        practitioner at any one time will not exceed the applicable 
        number. Except as provided in subclause (II), the applicable 
        number is 30.
            ``(II) The applicable number is 100 if, not sooner than 1 
        year after the date on which the practitioner submitted the 
        initial notification, the practitioner submits a second 
        notification to the Secretary of the need and intent of the 
        practitioner to treat up to 100 patients.
            ``(III) The Secretary may by regulation change such total 
        number.
            ``(IV) The Secretary may exclude from the applicable number 
        patients to whom such drugs or combinations of drugs are 
        directly administered by the qualifying practitioner in the 
        office setting.
            ``(iv) If the Secretary by regulation increases the total 
        number of patients which a qualifying practitioner is permitted 
        to treat pursuant to clause (iii)(II), the Secretary shall 
        require such a practitioner to obtain a written agreement from 
        each patient, including the patient's signature, that the 
        patient--
                    ``(I) will receive an initial assessment and 
                treatment plan and periodic assessments and treatment 
                plans thereafter;
                    ``(II) will be subject to medication adherence and 
                substance use monitoring;
                    ``(III) understands available treatment options, 
                including all drugs approved by the Food and Drug 
                Administration for the treatment of opioid use 
                disorder, including their potential risks and benefits; 
                and
                    ``(IV) understands that receiving regular 
                counseling services is critical to recovery.
            ``(v) The practitioner will comply with the reporting 
        requirements of subparagraph (D)(i)(IV).'';
            (2) in subparagraph (D)--
                    (A) in clause (i), by adding at the end the 
                following:
            ``(IV) The practitioner reports to the Secretary, at such 
        times and in such manner as specified by the Secretary, such 
        information and assurances as the Secretary determines 
        necessary to assess whether the practitioner continues to meet 
        the requirements for a waiver under this paragraph.'';
                    (B) in clause (ii), by striking ``Upon receiving a 
                notification under subparagraph (B)'' and inserting 
                ``Upon receiving a determination from the Secretary 
                under clause (iii) finding that a practitioner meets 
                all requirements for a waiver under subparagraph (B)''; 
                and
                    (C) in clause (iii)--
                            (i) by inserting ``and shall forward such 
                        determination to the Attorney General'' before 
                        the period at the end of the first sentence; 
                        and
                            (ii) by striking ``physician'' and 
                        inserting ``practitioner'';
            (3) in subparagraph (G)--
                    (A) by amending clause (ii)(IV) to read as follows:
                    ``(IV) The physician has, with respect to the 
                treatment and management of opiate-dependent patients, 
                completed not less than 8 hours of training (through 
                classroom situations, seminars at professional society 
                meetings, electronic communications, or otherwise) that 
                is provided by the American Society of Addiction 
                Medicine, the American Academy of Addiction Psychiatry, 
                the American Medical Association, the American 
                Osteopathic Association, the American Psychiatric 
                Association, or any other organization that the 
                Secretary determines is appropriate for purposes of 
                this subclause. Such training shall address--
                            ``(aa) opioid maintenance and 
                        detoxification;
                            ``(bb) appropriate clinical use of all 
                        drugs approved by the Food and Drug 
                        Administration for the treatment of opioid use 
                        disorder;
                            ``(cc) initial and periodic patient 
                        assessments (including substance use 
                        monitoring);
                            ``(dd) individualized treatment planning; 
                        overdose reversal; relapse prevention;
                            ``(ee) counseling and recovery support 
                        services;
                            ``(ff) staffing roles and considerations;
                            ``(gg) diversion control; and
                            ``(hh) other best practices, as identified 
                        by the Secretary.''; and
                    (B) by adding at the end the following:
            ``(iii) The term `qualifying practitioner' means--
                    ``(I) a qualifying physician, as defined in clause 
                (ii); or
                    ``(II) during the period beginning on the date of 
                the enactment of the Opioid Use Disorder Treatment 
                Expansion and Modernization Act and ending on the date 
                that is 3 years after such date of enactment, a 
                qualifying other practitioner, as defined in clause 
                (iv).
            ``(iv) The term `qualifying other practitioner' means a 
        nurse practitioner or physician assistant who satisfies each of 
        the following:
                    ``(I) The nurse practitioner or physician assistant 
                is licensed under State law to prescribe schedule III, 
                IV, or V medications for the treatment of pain.
                    ``(II) The nurse practitioner or physician 
                assistant satisfies one or more of the following:
                            ``(aa) Has completed not fewer than 24 
                        hours of initial training addressing each of 
                        the topics listed in clause (ii)(IV) (through 
                        classroom situations, seminars at professional 
                        society meetings, electronic communications, or 
                        otherwise) provided by the American Society of 
                        Addiction Medicine, the American Academy of 
                        Addiction Psychiatry, the American Medical 
                        Association, the American Osteopathic 
                        Association, the American Nurses Credentialing 
                        Center, the American Psychiatric Association, 
                        the American Association of Nurse 
                        Practitioners, the American Academy of 
                        Physician Assistants, or any other organization 
                        that the Secretary determines is appropriate 
                        for purposes of this subclause.
                            ``(bb) Has such other training or 
                        experience as the Secretary determines will 
                        demonstrate the ability of the nurse 
                        practitioner or physician assistant to treat 
                        and manage opiate-dependent patients.
                    ``(III) The nurse practitioner or physician 
                assistant is supervised by or works in collaboration 
                with a qualifying physician, if the nurse practitioner 
                or physician assistant is required by State law to 
                prescribe medications for the treatment of opioid use 
                disorder in collaboration with or under the supervision 
                of a physician.
        The Secretary may review and update the requirements for being 
        a qualifying other practitioner under this clause.''; and
            (4) in subparagraph (H)--
                    (A) in clause (i), by inserting after subclause 
                (II) the following:
            ``(III) Such other elements of the requirements under this 
        paragraph as the Secretary determines necessary for purposes of 
        implementing such requirements.''; and
                    (B) by amending clause (ii) to read as follows:
    ``(ii) Not later than 1 year after the date of enactment of the 
Opioid Use Disorder Treatment Expansion and Modernization Act, the 
Secretary shall update the treatment improvement protocol containing 
best practice guidelines for the treatment of opioid-dependent patients 
in office-based settings. The Secretary shall update such protocol in 
consultation with experts in opioid use disorder research and 
treatment.''.
    (b) Recommendation of Revocation or Suspension of Registration in 
Case of Substantial Noncompliance.--The Secretary of Health and Human 
Services may recommend to the Attorney General that the registration of 
a practitioner be revoked or suspended if the Secretary determines, 
according to such criteria as the Secretary establishes by regulation, 
that a practitioner who is registered under section 303(g)(2) of the 
Controlled Substances Act (21 U.S.C. 823(g)(2)) is not in substantial 
compliance with the requirements of such section, as amended by this 
Act.
    (c) Opioid Defined.--Section 102(18) of the Controlled Substances 
Act (21 U.S.C. 802(18)) is amended by inserting ``or `opioid''' after 
``The term `opiate'''.
    (d) Reports to Congress.--
            (1) In general.--Not later than 2 years after the date of 
        enactment of this Act and not less than over every 5 years 
        thereafter, the Secretary of Health and Human Services, in 
        consultation with the Drug Enforcement Administration and 
        experts in opioid use disorder research and treatment, shall--
                    (A) perform a thorough review of the provision of 
                opioid use disorder treatment services in the United 
                States, including services provided in opioid treatment 
                programs and other specialty and nonspecialty settings; 
                and
                    (B) submit a report to the Congress on the findings 
                and conclusions of such review.
            (2) Contents.--Each report under paragraph (1) shall 
        include an assessment of--
                    (A) compliance with the requirements of section 
                303(g)(2) of the Controlled Substances Act (21 U.S.C. 
                823(g)(2)), as amended by this Act;
                    (B) the measures taken by the Secretary of Health 
                and Human Services to ensure such compliance;
                    (C) whether there is further need to increase or 
                decrease the number of patients a waivered practitioner 
                is permitted to treat, as provided for by the amendment 
                made by subsection (a)(1);
                    (D) the extent to which, and proportions with 
                which, the full range of Food and Drug Administration-
                approved treatments for opioid use disorder are used in 
                routine health care settings and specialty substance 
                use disorder treatment settings;
                    (E) access to, and use of, counseling and recovery 
                support services, including the percentage of patients 
                receiving such services;
                    (F) changes in State or local policies and 
                legislation relating to opioid use disorder treatment;
                    (G) the use of prescription drug monitoring 
                programs by practitioners who are permitted to dispense 
                narcotic drugs to individuals pursuant to a waiver 
                under section 303(g)(2) of the Controlled Substances 
                Act (21 U.S.C. 823(g)(2));
                    (H) the findings resulting from inspections by the 
                Drug Enforcement Administration of practitioners 
                described in subparagraph (G); and
                    (I) the effectiveness of cross-agency collaboration 
                between Department of Health and Human Services and the 
                Drug Enforcement Administration for expanding effective 
                opioid use disorder treatment.

SEC. 4. SENSE OF CONGRESS.

    It is the Sense of Congress that, with respect to the total number 
of patients that a qualifying physician (as defined in subparagraph 
(G)(iii) of section 303(g)(2) of the Controlled Substances Act (21 
U.S.C. 823(g)(2)) can treat at any one time pursuant to such section, 
the Secretary of Health and Human Services should consider raising such 
total number to 250 patients following a third notification to the 
Secretary of the need and intent of the physician to treat up to 250 
patients that is submitted to the Secretary not sooner than 1 year 
after the date on which the physician submitted to the Secretary a 
second notification to treat up to 100 patients.

SEC. 5. PARTIAL FILLS OF SCHEDULE II CONTROLLED SUBSTANCES.

    (a) In General.--Section 309 of the Controlled Substances Act (21 
U.S.C. 829) is amended by adding at the end the following:
    ``(f) Partial Fills of Schedule II Controlled Substances.--
            ``(1) Partial fills.--
                    ``(A) In general.--A prescription for a controlled 
                substance in schedule II may be partially filled if--
                            ``(i) it is not prohibited by State law;
                            ``(ii) the prescription is written and 
                        filled in accordance with the Controlled 
                        Substances Act (21 U.S.C. 801 et seq.), 
                        regulations prescribed by the Attorney General, 
                        and State law;
                            ``(iii) the partial fill is requested by 
                        the patient or the practitioner that wrote the 
                        prescription; and
                            ``(iv) the total quantity dispensed in all 
                        partial fillings does not exceed the total 
                        quantity prescribed.
                    ``(B) Other circumstances.--A prescription for a 
                controlled substance in schedule II may be partially 
                filled in accordance with section 1306.13 of title 21, 
                Code of Federal Regulations (as in effect on the date 
                of enactment of the Reducing Unused Medications Act of 
                2016).
            ``(2) Remaining portions.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), remaining portions of a partially 
                filled prescription for a controlled substance in 
                schedule II--
                            ``(i) may be filled; and
                            ``(ii) shall be filled not later than 30 
                        days after the date on which the prescription 
                        is written.
                    ``(B) Emergency situations.--In emergency 
                situations, as described in subsection (a), the 
                remaining portions of a partially filled prescription 
                for a controlled substance in schedule II--
                            ``(i) may be filled; and
                            ``(ii) shall be filled not later than 72 
                        hours after the prescription is issued.''.
    (b) Rule of Construction.--Nothing in this section shall be 
construed to affect the authority of the Attorney General to allow a 
prescription for a controlled substance in schedule III, IV, or V of 
section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) to 
be partially filled.

            Passed the House of Representatives May 11, 2016.

            Attest:

                                                 KAREN L. HAAS,

                                                                 Clerk.
```