H.R. 4981 — what changed

“(i) The practitioner is a qualifying practitioner (as defined in subparagraph (G)).

changed “(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 providing the contact information for the nearest applicable practitioner—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 subclauses (II) and (III), 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.

changed “(III) The applicable number is 250 if the practitioner is a qualifying physician meeting the requirement of subclause (VI) and, not sooner than 1 year after the date on which the practitioner physician submitted a second notification under subclause (II), the practitioner submits a third notification to the Secretary of the need and intent of the practitioner physician to treat up to 250 patients.

“(IV) The Secretary may by regulation change such total number.

“(V) 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.

changed “(VI) For purposes of subclause (III), a qualifying physician meets the requirement of this subclause if the practitioner or physician—

“(aa) holds a special certification in addiction psychiatry or addiction medicine as described in clause (ii) from the American Board of Medical Specialties, the American Board of Addiction Medicine, the American Osteopathic Association, the American Society of Addiction Medicine, or such other organization as the Secretary determines to be appropriate for purposes of this subclause; or

changed “(bb) completes at least has completed not fewer than 24 hours of training, with respect to the treatment and management of opiate-dependent patients, addressing the topics listed in subparagraph (G)(ii)(IV).

changed “(iv) In the case of a third notification under clause (iii)(III), the practitioner qualifying physician maintains and implements a diversion control plan that contains specific measures to reduce the likelihood of the diversion of controlled substances prescribed by the practitioner physician for the treatment of opioid use disorder.

changed “(v) In the case of a third notification under clause (iii)(III), the practitioner qualifying physician obtains 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;

changed “(II) will be subject to medication adherence and substance use monitoring; andmonitoring;

changed “(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.benefits; and

added “(IV) understands that receiving regular counseling services is critical to recovery.

“(vi) The practitioner will comply with the reporting requirements of subparagraph (D)(i)(IV).”

“(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.”

“(IV) The physician has, with respect to the treatment and management of opiate-dependent patients, completed not less than eight 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.”

“(iii) The term qualifying practitioner means—

“(I) a qualifying physician, as defined in clause (ii); or

“(II) 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 1 or more of the following:

changed “(aa) Has completed not fewer than 24 hours of initial training addressing each of the topics listed in clause (ii)(IV) (through classroom situations, seminar 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.

changed “(III) If required The nurse practitioner or physician assistant is supervised by State law, or works in collaboration with a qualifying physician, if the nurse practitioner or physician assistant prescribes 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.”

“(III) Such other elements of the requirements under this paragraph as the Secretary determines necessary for purposes of implementing such requirements.”

“(ii) Not later than one 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.”