SEC. 2. FEDERAL LICENSURE OF PHARMACEUTICAL REP-
RESENTATIVES 
WHO 
PROMOTE 
CERTAIN 
OPIOIDS. 
Subchapter E of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is 
amended by adding at the end the following: 
‘‘SEC. 569E. FEDERAL LICENSURE OF PHARMACEUTICAL 
REPRESENTATIVES WHO PROMOTE CERTAIN 
OPIOIDS. 
‘‘(a) IN GENERAL.—The Secretary, in consultation 
with the Attorney General, shall establish a licensure pro-
gram for pharmaceutical representatives described in sub-
section (b). 
‘‘(b) LICENSURE PROGRAM.— 
‘‘(1) REQUIREMENT.—Beginning on July 1, 
2021, no individual described in paragraph (2) may 
engage in the marketing or promoting of opioid 
drugs unless such individual is licensed under this 
section. 
‘‘(2) INDIVIDUALS
REQUIRED
TO
OBTAIN
LI-
CENSURE.—An individual required to obtain a li-
cense under this section is any individual who, on 
behalf of a drug manufacturer, engaged, on more 
than 15 days in a calendar year, in the marketing 
or promotion to health care professionals, including 
educational or sales communications, meetings or 
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paid events, and the provision of goods, gifts, and 
samples, of any opioid drug (other than methadone) 
that is listed in schedule II of section 202(c) of the 
Controlled Substances Act. 
‘‘(3) LICENSURE PERIOD.—Each license issued 
under this section shall be valid for 3 years, and 
may be renewed for additional 3-year periods. 
‘‘(c) REQUIREMENTS.—An individual required to ob-
tain a license under this section shall— 
‘‘(1) submit to the Secretary, at such time and 
in such manner as the Secretary may require— 
‘‘(A) such information as the Secretary 
may require; and 
‘‘(B) a registration fee in the amount of 
$3,000; 
‘‘(2) certify that such individual has completed 
training on ethics, pharmaceutical marketing regula-
tions, the ‘CDC Guidelines for Prescribing Opioids 
for Chronic Pain’, published by the Centers for Dis-
ease Control and Prevention in 2016 (or any suc-
cessor document) or the ‘FDA Blueprint for Pre-
scriber Education for Extended-Release and Long- 
Acting Opioid Analgesics’, and applicable Federal 
laws pertaining to drug marketing, labeling, and 
clinical trials, as the Secretary may require; 
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‘‘(3) certify that such individual will not engage 
in any illegal, fraudulent, misleading, or other decep-
tive marketing of schedule II opioid drugs; and 
‘‘(4) file with the Secretary annual reports dis-
closing the names of providers visited and any drug 
samples or gifts such individual gives any such pro-
vider. 
‘‘(d) 
MANUFACTURER
REPORTING
REQUIRE-
MENTS.—The manufacturer who employs or contracts 
with any individual required to obtain a license under this 
section shall include in reports required under section 
1128G of the Social Security Act the name of each such 
licensed individual that provides payments or other trans-
fers of value required to be reported under such section 
1128G that relates to an opioid drug that is listed in 
schedule II of the Controlled Substances Act.’’. 
SEC. 3. WITHDRAWAL OF APPROVAL OF CERTAIN OPIOIDS. 
(a) IN GENERAL.—Notwithstanding any other provi-
sion of law, any ultra-high-dose opioid shall be considered 
a drug that presents an imminent hazard to the public 
health within the meaning of section 505(e) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)), and 
the Secretary of Health and Human Services shall sus-
pend the approval of such drug, in accordance with such 
section 505(e). 
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(b) DEFINITION.—In this section, the term ‘‘ultra- 
high-dose opioid’’ means an opioid drug for which the 
daily dosage provided for in the approved label exceeds 
the morphine milligram equivalents per day outlined in the 
report entitled ‘‘CDC Guidelines for Prescribing Opioids 
for Chronic Pain’’, published by the Centers for Disease 
Control and Prevention in 2016 (or any successor docu-
ment). 
SEC. 4. CONTINUING MEDICAL EDUCATION AND PRESCRIP-
TION DRUG MONITORING PROGRAM REG-
ISTRATION FOR PRESCRIBERS. 
Section 303 of the Controlled Substances Act (21 
U.S.C. 823) is amended— 
(1) by redesignating subsection (k) as sub-
section (l); and 
(2) by inserting after subsection (j) the fol-
lowing: 
‘‘(k)(1) The Attorney General shall not register, or 
renew the registration of, a practitioner under subsection 
(f) who is licensed under State law to prescribe controlled 
substances in schedule II, III, or IV, unless the practi-
tioner submits to the Attorney General, for each such reg-
istration or renewal request, a written certification that— 
‘‘(A)(i) the practitioner has, during the 1-year 
period preceding the registration or renewal request, 
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completed a training program described in para-
graph (2); or 
‘‘(ii) the practitioner, during the applicable reg-
istration period, will not prescribe such controlled 
substances in amounts in excess of a 72-hour supply 
(for which no refill is available); and 
‘‘(B) the practitioner has registered with the 
prescription drug monitoring program of the State 
in which the practitioner practices, if the State has 
such program. 
‘‘(2) A training program described in this paragraph 
is a training program that— 
‘‘(A) follows the best practices for pain manage-
ment, as described in the ‘Guideline for Prescribing 
Opioids for Chronic Pain’ as published by the Cen-
ters for Disease Control and Prevention in 2016, or 
any successor thereto, or the ‘FDA Blueprint for 
Prescriber Education for Extended-Release and 
Long-Acting Opioid Analgesics’ as published by the 
Food and Drug Administration in 2017, or any suc-
cessor thereto; 
‘‘(B) includes information on— 
‘‘(i) recommending non-opioid and non- 
pharmacological therapy; 
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‘‘(ii) establishing treatment goals and eval-
uating patient risks; 
‘‘(iii) prescribing the lowest dose and few-
est number of pills considered effective; 
‘‘(iv) addictive and overdose risks of 
opioids; 
‘‘(v) diagnosing and managing substance 
use disorders, including linking patients to evi-
dence-based treatment; 
‘‘(vi) identifying narcotics-seeking behav-
iors; and 
‘‘(vii) using prescription drug monitoring 
programs; and 
‘‘(C) is approved by the Secretary.’’. 
SEC. 5. REPORT ON PRESCRIBER EDUCATION COURSES 
FOR MEDICAL AND DENTAL STUDENTS. 
Each school of medicine, school of osteopathic medi-
cine, and school of dentistry participating in a program 
under title IV of the Higher Education Act of 1965 (20 
U.S.C. 1070a et seq.), as a condition for such participa-
tion, shall submit an annual report to the Secretary of 
Education and the Secretary of Health and Human Serv-
ices on any prescriber education courses focused specifi-
cally on pain management and responsible opioid pre-
scribing practices that such school requires students to 
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take, and whether such courses are consistent with the 
most recently published version of the ‘‘Guideline for Pre-
scribing Opioids for Chronic Pain’’ of the Centers for Dis-
ease Control and Prevention or the ‘‘FDA Blueprint for 
Prescriber Education for Extended-Release and Long-Act-
ing Opioid Analgesics’’, as published by the Food and 
Drug Administration in 2017. The Secretary of Education 
and the Secretary of Health and Human Services shall 
compile the reports submitted by such schools and submit 
an annual summary of such reports to Congress. 
SEC. 6. REQUIREMENTS UNDER PRESCRIPTION DRUG MON-
ITORING PROGRAMS. 
(a) IN GENERAL.—Beginning 1 year after the date 
of enactment of this Act, each State that receives funding 
under any of the programs described in subsection (c) 
shall— 
(1) require practitioners, or their designees, in 
the State to consult the database of the prescription 
drug monitoring program before writing prescrip-
tions for controlled substances (as such term is de-
fined in section 102 of the Controlled Substances 
Act (21 U.S.C. 802)) in schedule II, III, or IV 
under section 202 of such Act (21 U.S.C. 812); 
(2) require dispensers of controlled substances 
in schedule II, III, or IV, or their designees, to input 
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data into the database of the prescription drug mon-
itoring program within 24 hours of filling a quali-
fying prescription, as required by the Attorney Gen-
eral and the Secretary of Health and Human Serv-
ices, including patient identifier information, the na-
tional drug code of the dispensed drug, date of dis-
pensing the drug, quantity and dosage of the drug 
dispensed, form of payment, Drug Enforcement Ad-
ministration registration number of the practitioner, 
Drug Enforcement Administration registration num-
ber of the dispenser; 
(3) allow practitioners and dispensers to des-
ignate other appropriate individuals to act as agents 
of such practitioners and dispensers for purposes of 
obtaining and inputing data from the database for 
purposes of complying with paragraphs (1) and (2), 
as applicable; 
(4) provide informational materials for practi-
tioners and dispensers to identify and refer patients 
with possible substance use disorders to professional 
treatment specialists; 
(5) establish formal data sharing agreements to 
foster electronic connectivity with the prescription 
drug monitoring programs of each State (if such 
State has such a program) with which the State 
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shares a border, to facilitate the exchange of infor-
mation through an established technology architec-
ture that ensures common data standards, privacy 
protection, and secure and streamlined information 
sharing; 
(6) authorize direct access to the State’s data-
base of the prescription drug monitoring program to 
all State law enforcement agencies, State boards re-
sponsible for the licensure, regulation, or discipline 
of practitioners, pharmacists, or other persons au-
thorized to prescribe, administer, or dispense con-
trolled substances; and 
(7) in order to enhance accountability in pre-
scribing and dispensing patterns, not fewer than 4 
times per year, proactively provide informational re-
ports on aggregate trends and individual outliers, 
based on information available through the State 
prescription drug monitoring program to— 
(A) the State entities and persons de-
scribed in paragraph (6); and 
(B) the Medicaid agency and the depart-
ment of public health of the State. 
(b) TRANSPARENCY IN PRESCRIBING PRACTICES AND 
INTERVENTION FOR HIGH PRESCRIBERS.— 
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(1) STATE
REPORTING
REQUIREMENT.—Each 
State that receives funding under any of the pro-
grams described in subsection (c) shall, twice per 
year, submit to the Secretary of Health and Human 
Services and the Administrator of the Drug Enforce-
ment Administration— 
(A) a list of all practitioners and dis-
pensers who, in the applicable reporting period, 
have prescribed or dispensed schedule II, III, or 
IV opioids in the State; 
(B) the amount of schedule II, III, or IV 
opioids that were prescribed and dispensed by 
each individual practitioner and dispenser de-
scribed in subparagraph (A); and 
(C) any additional information that the 
Secretary and Administrator may require to 
support surveillance and evaluation of trends in 
prescribing or dispensing of schedule II, III, or 
IV opioids, or to identify possible non-medical 
use and diversion of such substances. 
(2) ANNUAL REPORT.—Not later than 1 year 
after the date of enactment of this Act, and annually 
thereafter, the Secretary of Health and Human 
Services, in consultation with the Administrator of 
the Drug Enforcement Administration, the Secretary 
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of Defense, the Secretary of Veterans Affairs, and 
the Director of the Indian Health Service, shall sub-
mit to Congress, and make public, a report identi-
fying outliers among the medical specialties and geo-
graphic areas with the highest rates of opioid pre-
scribing in the Nation, by zip code. 
(3) DEVELOPMENT OF ACTION PLAN.— 
(A) INITIAL PLAN.—Not later than 1 year 
after the date of enactment of this Act, the Sec-
retary of Health and Human Services, in con-
sultation with the Administrator of the Drug 
Enforcement Administration, the Secretary of 
Defense, the Secretary of Veterans Affairs, and 
the Director of the Indian Health Service, shall 
submit to Congress a plan of action, including 
warning letters and enforcement mechanisms, 
for addressing outliers in opioid prescribing 
practices and ensuring an adequate Federal re-
sponse to protect the public health. 
(B) UPDATED
PLAN.—The Secretary of 
Health and Human Services shall submit to 
Congress updates to the plan of action de-
scribed in subparagraph (A), as such Secretary, 
in consultation with the heads of agencies de-
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(7) the State Opioid Response Grant program 
described under the heading ‘‘SUBSTANCE
ABUSE 
TREATMENT’’ under the heading ‘‘SUBSTANCE 
ABUSE AND MENTAL HEALTH SERVICES ADMINIS-
TRATION’’ of title II of division A of the Further 
Consolidated Appropriations Act, 2020 (Public Law 
116–94). 
(d) DEFINITIONS.—In this section, the terms ‘‘dis-
penser’’ and ‘‘practitioner’’ have the meanings given such 
terms in section 102 of the Controlled Substances Act (21 
U.S.C. 802). 
SEC. 7. INTEROPERABILITY OF CERTIFIED HEALTH INFOR-
MATION TECHNOLOGY. 
Section 3001(c)(5) of the Public Health Service Act 
(42 U.S.C. 300jj–11(c)(5)) is amended by adding at the 
end the following: 
‘‘(F) INTEROPERABILITY.—Beginning on 
January 1, 2021, the National Coordinator 
shall not certify electronic health records as 
health information technology that is in compli-
ance with applicable certification criteria under 
this paragraph unless such technology is inter-
operable with the prescription drug monitoring 
programs of each State that, at the time of the 
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request for such certification, has such a pro-
gram.’’. 
SEC. 8. STUDIES RELATED TO OVERDOSE DISCHARGE AND 
FOLLOW-UP POLICIES. 
(a) STUDY.—Not later than January 1, 2021, the 
Secretary of Health and Human Services shall— 
(1) conduct a study on the scope and cir-
cumstances of non-fatal opioid overdoses, the policies 
and procedures that States, health care systems, and 
first responders have implemented; and 
(2) in partnership with stakeholder organiza-
tions with subject matter expertise, establish guide-
lines for hospital procedures following non-fatal 
opioid overdose and the administration of overdose 
reversal medication. 
(b) STUDY AND DEVELOPMENT OF QUALITY MEAS-
URES UNDER MEDICARE RELATED TO OPIOID ABUSE 
AND SUBSTANCE USE DISORDER.—Section 1890A(e) of 
the Social Security Act (42 U.S.C. 1395aaa–1(e)) is 
amended— 
(1) by striking ‘‘MEASURES.—The Adminis-
trator’’ and inserting ‘‘MEASURES.— 
‘‘(1) IN GENERAL.—The Administrator’’; and 
(2) by adding at the end the following new 
paragraph: 
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‘‘(2) STUDY AND DEVELOPMENT OF QUALITY 
MEASURES RELATED TO OPIOID ABUSE AND SUB-
STANCE USE DISORDER.—Beginning not later than 
1 year after the date of enactment of this para-
graph, the Administrator of the Center for Medicare 
& Medicaid Services shall study, and through con-
tracts develop, in coordination with appropriate sub-
ject matter organizations (such as the entity with a 
contract under section 1890), for use under this Act, 
quality measures related to standards of care for 
treating individuals with non-fatal opioid overdose, 
discharge procedures, and linkages to appropriate 
substance use disorder treatment and community 
support services.’’. 
SEC. 9. MEDICAID OPIOID DRUG MAPPING TOOL. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services shall create an interactive opioid drug 
mapping tool, which shall be made publicly available on 
the internet website of the Centers for Medicare & Med-
icaid Services, showing prescribing practices of providers 
that participate in State Medicaid programs and geo-
graphic comparisons, at the State, county, and ZIP code 
levels, of de-identified opioid prescription claims made 
under State Medicaid programs under title XIX of the So-
cial Security Act (42 U.S.C. 1396 et seq.). 
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(b) COLLECTION OF DATA FROM STATES.—The Sec-
retary of Health and Human Services may request from 
States such data as the Secretary determines necessary 
to create the opioid mapping tool described in subsection 
(a). 
SEC. 10. NATIONAL ACADEMIES STUDY. 
(a) STUDY.—The Secretary of Health and Human 
Services shall enter into a contract with the National 
Academies of Science, Engineering, and Medicine (re-
ferred to in this section as the ‘‘National Academies’’) to 
carry out a study on the addition of coverage under the 
Medicare program under title XVIII of the Social Security 
Act of alternative treatment modalities (such as integra-
tive medicine, including acupuncture and exercise therapy, 
neural stimulation, biofeedback, radiofrequency ablation, 
and trigger point injections) furnished to Medicare bene-
ficiaries who suffer from acute or chronic lower back pain. 
Such study shall, pursuant to the contract under this 
paragraph, include an analysis of— 
(1) scientific research on the short-term and 
long-term impact of the addition of such coverage on 
clinical efficacy for pain management of such bene-
ficiaries; 
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(2) whether the lack of Medicare coverage for 
alternative treatment modalities impacts the volume 
of opioids prescribed for beneficiaries; and 
(3) the cost to the Medicare program of the ad-
dition of such coverage to treat pain and mitigate 
the progression of chronic pain, as weighed against 
the cost of opioid use disorder, overdose, readmis-
sion, subsequent surgeries, and utilization and ex-
penditures under parts B and D of such title. 
(b) REPORT.—Not later than 1 year after the date 
of enactment of this Act, pursuant to the contract under 
subsection (a), the National Academies shall submit to 
Congress a report on the study under subsection (a). 
(c) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there are authorized to be appropriated 
such sums as may be necessary. 
SEC. 11. EXCISE TAX ON OPIOID PAIN RELIEVERS. 
(a) IN GENERAL.—Subchapter E of chapter 32 of the 
Internal Revenue Code of 1986 is amended by adding at 
the end the following new section: 
‘‘SEC. 4192. OPIOID PAIN RELIEVERS. 
‘‘(a) IN GENERAL.—There is hereby imposed on the 
manufacturer or producer of any taxable active opioid a 
tax equal to the amount determined under subsection (b). 
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‘‘(b) AMOUNT DETERMINED.—The amount deter-
mined under this subsection with respect to a manufac-
turer or producer for a calendar year is 1 cent per milli-
gram of taxable active opioid in the production or manu-
facturing quota determined for such manufacturer or pro-
ducer for the calendar year under section 306 of the Con-
trolled Substances Act (21 U.S.C. 826). 
‘‘(c) TAXABLE ACTIVE OPIOID.—For purposes of this 
section— 
‘‘(1) IN GENERAL.—The term ‘taxable active 
opioid’ means any controlled substance (as defined 
in section 102 of the Controlled Substances Act (21 
U.S.C. 802), as in effect on the date of the enact-
ment of this section) manufactured in the United 
States which is opium, an opiate, or any derivative 
thereof. 
‘‘(2) EXCLUSIONS.— 
‘‘(A) OTHER INGREDIENTS.—In the case 
of a product that includes a taxable active 
opioid and another ingredient, subsection (a) 
shall apply only to the portion of such product 
that is a taxable active opioid. 
‘‘(B) DRUGS USED IN ADDICTION TREAT-
MENT.—The term ‘taxable active opioid’ shall 
not include any controlled substance (as so de-
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fined) which is used exclusively for the treat-
ment of opioid addiction as part of a medica-
tion-assisted treatment.’’. 
(b) CLERICAL AMENDMENTS.— 
(1) The heading of subchapter E of chapter 32 
of the Internal Revenue Code of 1986 is amended by 
striking 
‘‘Medical 
Devices’’ 
and 
inserting 
‘‘Other Medical Products’’. 
(2) The table of subchapters for chapter 32 of 
such Code is amended by striking the item relating 
to subchapter E and inserting the following new 
item: 
‘‘SUBCHAPTER E. OTHER MEDICAL PRODUCTS’’. 
(3) The table of sections for subchapter E of 
chapter 32 of such Code is amended by adding at 
the end the following new item: 
‘‘Sec. 4192. Opioid pain relievers.’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply to calendar years beginning after 
the date of the enactment of this Act. 
SEC. 12. OPIOID CONSUMER ABUSE REDUCTION PROGRAM. 
(a) OPIOID TAKE-BACK PROGRAM.—Section 302 of 
the Controlled Substances Act (21 U.S.C. 822) is amend-
ed by adding at the end the following: 
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‘‘(h)(1) The Attorney General shall establish a na-
tional take-back program for the safe and environmentally 
responsible disposal of controlled substances. 
‘‘(2) In establishing the take-back program required 
under paragraph (1), the Attorney General— 
‘‘(A) shall consult with the Secretary and the 
Administrator of the Environmental Protection 
Agency; and 
‘‘(B) may coordinate with States, law enforce-
ment agencies, water resource management agencies, 
manufacturers, practitioners, pharmacists, public 
health entities, transportation and incineration serv-
ice contractors, and other entities and individuals, as 
appropriate. 
‘‘(3) The take-back program established under para-
graph (1)— 
‘‘(A) shall— 
‘‘(i) ensure appropriate geographic dis-
tribution so as to provide— 
‘‘(I) reasonably convenient and equi-
table access to permanent take-back loca-
tions, including not less than 1 disposal 
site for every 25,000 residents and not less 
than 1 physical disposal site per town, city, 
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county, or other unit of local government, 
where possible; and 
‘‘(II) periodic collection events and 
mail-back programs, including public no-
tice of such events and programs, as a sup-
plement to the permanent take-back loca-
tions described in subclause (I), particu-
larly in areas in which the provision of ac-
cess to such locations at the level described 
in that subclause is not possible; 
‘‘(ii) establish a process for the accurate 
cataloguing and reporting of the quantities of 
controlled substances collected; and 
‘‘(iii) include a public awareness campaign 
and education of practitioners and pharmacists; 
and 
‘‘(B) may work in coordination with State and 
locally implemented public and private take-back 
programs. 
‘‘(4) From time to time, beginning in the second cal-
endar year that begins after the date of enactment of this 
subsection, the Secretary of the Treasury shall transfer 
from the general fund of the Treasury an amount equal 
to one-half of the total amount of taxes collected under 
section 4192 of the Internal Revenue Code of 1986 to the 
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Attorney General to carry out this subsection. Amounts 
transferred under this subparagraph shall remain avail-
able until expended.’’. 
(b) FUNDING OF SUBSTANCE ABUSE PROGRAMS.— 
From time to time, beginning in the second calendar year 
that begins after the date of enactment of this Act, the 
Secretary of the Treasury shall transfer from the general 
fund of the Treasury an amount equal to one-half of the 
total amount of taxes collected under section 4192 of the 
Internal Revenue Code of 1986, as added by this Act, to 
the Director of the Center for Substance Abuse Treatment 
of the Substance Abuse and Mental Health Services Ad-
ministration for programs of the Center, including the 
Block Grants for Prevention and Treatment of Substance 
Abuse program under subpart II of part B of title XIX 
of the Public Health Service Act (42 U.S.C. 300x–21 et 
seq.) and Programs of Regional and National Significance. 
Amounts transferred under this subsection shall remain 
available until expended. 
SEC. 13. GAO STUDY. 
Not later than 1 year after the date of enactment 
of this Act, the Comptroller General of the United States 
shall— 
(1) conduct a study examining the coverage of-
fered under commercial health insurance plans and 
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kjohnson on DSK79L0C42PROD with BILLS