Nursing Home Resident Pain Relief Act of 2011 - Amends the Controlled Substances Act to authorize a medical practitioner to enter into an agreement with the administrator of an institutional long-term care facility (facility) authorizing the administrator to designate qualified individuals to act as facility designees for the purpose of dispensing a controlled substance to facility residents.
Authorizes an administrator to delegate the authority to act as a facility designee to a qualified health care professional who is directly employed by, and subject to the supervision and control of, the facility.
Requires an administrator to: (1) maintain a list of all practitioners who have entered into such an authorizing agreement and all facility designees of each practitioner, and (2) provide the list to all pharmacies to which the facility submits prescriptions and to each such practitioner.
Authorizes a practitioner who is providing or supervising medical care to a facility resident to issue an oral prescription for the resident for a controlled substance that is a prescription drug. Allows the oral prescription to be communicated through a facility designee acting under an authorizing agreement. Requires the facility designee to promptly create a document that reduces such an oral prescription to writing and to transmit the written document to a pharmacy for dispensing.
Allows: (1) an oral prescription for a schedule II controlled substance to be issued through or transmitted by a facility designee during an emergency situation only, limited to an amount adequate to treat the patient during that situation; and (2) a schedule II controlled substance to be dispensed for treatment of a facility resident in a non-emergency situation if the prescription is in writing and signed by the practitioner.
Requires each practitioner who issues such an oral prescription to a facility designee to: (1) create a contemporaneous record of the prescription, and (2) maintain the record in a written or electronic log at the registered location of the practitioner. Directs the Attorney General to specify the contents and retention requirements for such record.
Requires: (1) a pharmacy, not later than 72 hours after dispensing a controlled substance pursuant to such an oral prescription, to transmit a copy of the prescription document received from the facility designee, clearly marked as having been dispensed, to the prescribing practitioner; and (2) the practitioner to certify the prescription's accuracy by physically affixing his or her signature to it and to return it to the pharmacy within 5 business days. Sets forth actions that the pharmacy must take if it does not receive an endorsed prescription within that period, including notifying the Drug Enforcement Administration (DEA).
Requires each facility to: (1) maintain a written or electronic logbook of each instance in which a facility designee memorializes and transmits an oral prescription for a controlled substance to a pharmacy on behalf of a practitioner; (2) keep the logbook and copies of specified associated documents on its premises; and (3) retain copies of specified documents for five years. Requires every registrant who prescribes a controlled substance for a facility resident to maintain the prescribing log.
Applies civil and criminal penalties for the distribution or dispensing of a controlled substance in violation of such Act to distribution or dispensing by such a facility. Sets forth penalties for violations of recordkeeping requirements.
[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 1560 Introduced in Senate (IS)]
112th CONGRESS
1st Session
S. 1560
To enhance access to controlled substances for residents of
institutional long-term care facilities, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
September 14, 2011
Mr. Kohl introduced the following bill; which was read twice and
referred to the Committee on the Judiciary
_______________________________________________________________________
A BILL
To enhance access to controlled substances for residents of
institutional long-term care facilities, and for other purposes.
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 ``Nursing Home Resident Pain Relief
Act of 2011''.
SEC. 2. DEFINITIONS.
Section 102 of the Controlled Substances Act (21 U.S.C. 802) is
amended--
(1) in paragraph (3), by adding at the end the following:
``Solely for purposes of section 309(f), the term `agent'
includes a facility designee.''; and
(2) by adding at the end the following:
``(57) The term `institutional long-term care facility'
means--
``(A) a facility certified to participate in the
Medicare or Medicaid programs as a nursing facility, as
defined in section 1919(a) of the Social Security Act
(42 U.S.C. 1396r(a));
``(B) a skilled nursing facility, as defined in
section 1819(a) of the Social Security Act (42 U.S.C.
1395i-3(a)); or
``(C) any other entity of a type designated by the
Attorney General by regulation.
``(58) The term `administrator of an institutional long-
term care facility' means--
``(A) a corporation, company, partnership, or other
entity that--
``(i) owns, operates, or manages an
institutional long-term care facility; and
``(ii) may be held liable, by law or by
consent, for the acts or omissions of the
facility designees who are delegated authority
by the institutional long-term care facility in
connection with the dispensing of controlled
substances, including liability for any civil
penalties authorized under part D of this
title; and
``(B) an individual who--
``(i) has been designated as a co-
administrator by an entity described in
subparagraph (A);
``(ii) is responsible for managing,
supervising, or overseeing the care provided to
residents of the institutional long-term care
facility or the work of the employees of the
institutional long-term care facility; and
``(iii) can be held personally liable,
along with the entity described in subparagraph
(A), at law or by consent, for the acts or
omissions of the facility designees of the
institutional long-term care facility in
connection with the dispensing of controlled
substances, including liability for any civil
penalties authorized under section 402.''.
SEC. 3. ORAL COMMUNICATION OF PRESCRIPTION INFORMATION FOR RESIDENTS OF
INSTITUTIONAL LONG-TERM CARE FACILITIES.
Section 309 of the Controlled Substances Act (21 U.S.C. 829) is
amended--
(1) in subsection (a), in the first sentence, by inserting
``except as provided in subsection (f) and'' after ``without
the written prescription of a practitioner''; and
(2) by adding at the end the following:
``(f) Controlled Substances Dispensed to Residents of Institutional
Long-Term Care Facilities Through the Use of Facility Designees.--
``(1) Definitions.--In this subsection--
``(A) the term `authorizing agreement' means a
written agreement--
``(i) between--
``(I) an individual practitioner
providing medical care to, or
supervising medical care being provided
to, a resident of an institutional
long-term care facility whose care is
provided or supervised by the
practitioner; and
``(II) an administrator of the
institutional long-term care facility;
``(ii) that authorizes the administrator to
designate 1 or more qualified individuals to
act as facility designees for the purpose of
dispensing a controlled substance to the
resident; and
``(iii) that includes a written
authorization from the practitioner, in a form
and manner specified by the Attorney General,
that specifies whether the scope of the
authorization is for--
``(I) controlled substances in
schedule II only; or
``(II) all controlled substances,
regardless of schedule; and
``(B) the term `facility designee' means an
individual designated by the administrator to whom the
authority to act as an agent of a practitioner is
delegated under paragraph (3)(A).
``(2) Authorization.--
``(A) In general.--A practitioner may enter into an
authorizing agreement with an administrator of an
institutional long-term care facility if the
administrator has--
``(i) adopted written policies and
procedures that specify the duties and
responsibilities of a facility designee and
that require documentation of the acceptance of
the duties and responsibilities by a facility
designee, consistent with the authorizing
agreement; and
``(ii) provided copies of the policies and
procedures adopted under clause (i) to the
practitioner and to each facility designee.
``(B) Rescission of authority.--A practitioner may
in writing, at any time--
``(i) rescind the authorizing agreement;
``(ii) rescind the authority of a facility
designee; or
``(iii) modify the scope of the
authorization of a facility designee.
``(3) Delegation of authority.--
``(A) In general.--Under an authorizing agreement,
an administrator of an institutional long-term care
facility may, in accordance with the policies and
procedures described in paragraph (2)(A)(i) delegate,
in writing, the authority to act as a facility designee
to 1 or more health care professionals who are
qualified under subparagraph (B).
``(B) Requirements for qualification.--To qualify
to be a facility designee under subparagraph (A), a
health care professional shall be--
``(i) directly employed by, and subject to
the supervision and control of, the
institutional long-term care facility;
``(ii) lawfully acting within the scope of
the employment of the individual; and
``(iii) be a registered nurse, advanced
practice nurse, physician's assistant, or
equivalent professional who is licensed,
certified, registered, or otherwise permitted
to provide professional nursing or health care
by the jurisdiction in which the individual is
employed.
``(C) Requirement.--A written delegation of
authority under subparagraph (A) shall specify, at the
option of the practitioner, and in accordance with the
authorizing agreement, whether the scope of the
authorization is for--
``(i) schedule II controlled substances
only; or
``(ii) all controlled substances,
regardless of schedule.
``(D) Service as a facility designee.--A facility
designee shall act in accordance with the policies and
procedures described in paragraph (2)(A)(i).
``(E) List of authorizing agreements and facility
designees.--
``(i) In general.--An administrator of an
institutional long-term care facility shall
establish and maintain a current list of--
``(I) all practitioners who have
entered into an authorizing agreement
with the administrator; and
``(II) all facility designees of
each practitioner described in
subclause (I) that are employees of the
institutional long-term care facility.
``(ii) Requirements.--The list required
under clause (i) shall--
``(I) be--
``(aa) dated upon
establishment and each time the
list is updated; and
``(bb) made readily
available in appropriate places
on the premises of the
institutional long-term care
facility to ensure proper
notice of which employees of
the institutional long-term
care facility are facility
designees for which
practitioners; and
``(II) include--
``(aa) the name and address
of the institutional long-term
care facility and the
administrator of the
institutional long-term care
facility;
``(bb) the name of each
practitioner who has entered
into an authorizing agreement
with the administrator of the
institutional long-term care
facility; and
``(cc) for each
practitioner listed under item
(bb)--
``(AA) the name of
each facility designee;
and
``(BB) whether
practitioner is
providing authorization
for schedule II
controlled substances
only or all controlled
substances, regardless
of schedule.
``(iii) Distribution of list.--An
administrator of an institutional long-term
care facility shall provide the list
established under clause (i) to--
``(I) all pharmacies to which the
institutional long-term care facility
submits prescriptions for dispensing;
and
``(II) each practitioner who has
entered into an authorizing agreement
with the administrator of the
institutional long-term care facility.
``(iv) Updates.--The administrator of an
institutional long-term care facility shall
promptly update and redistribute a list
established under clause (i) if--
``(I) there are any changes to the
information required to be included in
the list under clause (ii); or
``(II) the authority of any
facility designee on the list is
rescinded or modified under paragraph
(2)(B).
``(F) Prohibition of redelegation of authority.--A
facility designee may not redelegate any aspect of the
authorization of the practitioner to another
individual.
``(4) Transmission by a facility designee of a valid oral
prescription issued by practitioner.--
``(A) In general.--Except as provided in
subparagraph (D), a practitioner who is providing
medical care to, or supervising medical care being
provided to, a resident of an institutional long-term
care facility may issue an oral prescription for the
resident for a controlled substance which is a
prescription drug as determined under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), and the
oral prescription may be communicated through a
facility designee acting under the authorizing
agreement of the practitioner.
``(B) Policies.--A practitioner or a facility
designee acting under this subsection shall follow the
requirements of this subsection regardless of the
schedule of the controlled substance for which an oral
prescription is being communicated.
``(C) Requirements.--
``(i) Responsibilities of practitioner.--In
issuing an oral prescription under subparagraph
(A), a practitioner shall provide to the
facility designee--
``(I) the full name of the
resident;
``(II) the drug name, strength, and
dosage form;
``(III) the quantity prescribed;
``(IV) the directions for use; and
``(V) the name, address, and Drug
Enforcement Administration registration
number of the prescribing practitioner.
``(ii) Responsibilities of a facility
designee.--A facility designee that receives an
oral prescription issued under subparagraph (A)
shall promptly--
``(I) create a document that
reduces such oral prescription to
writing, which shall include--
``(aa) all of the
information provided by the
practitioner under clause (i);
``(bb) the legible full
name and signature of the
facility designee;
``(cc) the name and address
of the institutional long-term
care facility;
``(dd) the date and time
the facility designee received
the oral prescription; and
``(ee) an attestation by
the covered individual, under
penalty of perjury as provided
in section 1746 of title 28,
United States Code, that--
``(AA) the facility
designee has personally
spoken with the
prescribing
practitioner; and
``(BB) all the
information required
under clause (i) was
provided by the
practitioner and is
accurately and
completely recorded by
the facility designee
on the document; and
``(II) transmit the written
document, or a facsimile thereof, to a
pharmacy for dispensing.
``(iii) Prohibition.--A document described
in clause (ii)(I) may not be prepared, in whole
or in part, by a pharmacy.
``(iv) Facsimiles.--If a facility designee
transmits a written document described in
clause (ii)(I) by facsimile, the facsimile
shall serve as the original written
prescription and shall be maintained in
accordance with regulations promulgated by the
Attorney General.
``(D) Schedule ii controlled substances.--
``(i) In general.--An oral prescription for
a schedule II controlled substance shall only
be issued through or transmitted by a facility
designee under subparagraph (A) during an
emergency situation, as described in subsection
(a), and the quantity prescribed shall be
limited to an amount adequate to treat the
patient during the emergency situation.
``(ii) Non-emergency situations.--A
schedule II controlled substance may only be
dispensed for treatment of a resident of an
institutional long-term care facility in a non-
emergency situation if the prescription is in
writing and signed by the prescribing
individual practitioner, as described in
subsection (a).
``(E) Rule of construction.--Nothing in this
subsection shall be construed to--
``(i) preclude a practitioner from
issuing--
``(I) a prescription for a
controlled substance and transmitting
the prescription directly to the
pharmacy, as otherwise authorized in
subsections (a), (b), or (c) or by
regulations issued by the Attorney
General; or
``(II) a written prescription for a
controlled substance, signed by the
practitioner, and having the written
prescription transmitted to the
pharmacy through a duly authorized
agent of the practitioner (including a
facility designee), as otherwise
authorized by subsections (a), (b), or
(c) of this section or by regulations
issued by the Attorney General; or
``(ii) authorize a facility designee to
make any determination that underlies any
element of a prescription.
``(F) Rulemaking authority.--The Attorney General
may, by regulation, promulgate rules specifying
additional requirements with respect to the formatting,
content, and creation of the written document described
in subparagraph (C)(ii).
``(G) Record of oral prescriptions.--
``(i) In general.--Each practitioner who
issues an oral prescription to a facility
designee shall--
``(I) create a contemporaneous
record of the oral prescription; and
``(II) maintain the record in a
written or electronic log at the
registered location of the
practitioner, in accordance with
section 307.
``(ii) Contents and retention
requirements.--The Attorney General shall
specify by regulation the contents and
retention requirements for record required to
be kept under clause (i).
``(iii) Responsibility of the
practitioner.--A practitioner shall be
responsible for the creation of the
contemporaneous record of the oral prescription
required under clause (i)(I), and may not
delegate or assign any responsibilities under
clause (i), in whole or in part, to--
``(I) a pharmacy;
``(II) a facility designee; or
``(III) an institutional long-term
care facility (including an employee of
the institutional long-term care
facility).
``(H) Definition of oral prescription.--The
Attorney General may, if determined by the Attorney
General to be necessary, define by regulation the term
`oral prescription' for purposes of this subsection.
``(5) Pharmacy verification of oral prescriptions
transmitted by facility designees.--
``(A) In general.--Upon receiving an oral
prescription from a practitioner that was reduced to
writing and transmitted under paragraph (4), a pharmacy
shall--
``(i) determine whether the institutional
long-term care facility employee who
transmitted the prescription is a facility
designee for the prescribing practitioner for
the prescribed controlled substance based on
the most recent list of the facility designees
that the institutional long-term care facility
provided to the pharmacy under paragraph
(3)(E)(iii); and
``(ii) document the determination under
clause (i), which shall include a notation on
the prescription document to memorialize that
the cross-check was completed that includes--
``(I) the initials of the verifying
pharmacist; and
``(II) the date and time of the
verification.
``(B) Transmission to prescribing practitioner.--
Not later than 72 hours after a pharmacy dispenses a
controlled substance pursuant to an oral prescription
issued under paragraph (4), the pharmacy shall transmit
a copy of the prescription document that the pharmacy
received from the facility designee under paragraph
(4)(C)(ii), clearly marked as having been dispensed, to
the prescribing practitioner.
``(C) Practitioner requirement.--A practitioner
shall--
``(i) endorse, by physically affixing his
written signature to the copy of the
prescription the pharmacy transmitted to the
practitioner under subparagraph (B), if the
prescription was issued by the practitioner;
and
``(ii) not later than 5 business days after
receiving the copy of the prescription from the
pharmacy, return the prescription to the
pharmacy in accordance with subparagraph (E).
``(D) Endorsement of prescription.--By endorsing a
prescription under subparagraph (C), the practitioner--
``(i) attests that the oral prescription
memorialized and transmitted by a facility
designee was authorized by the practitioner
named on the prescription; and
``(ii) certifies that the prescription
information conveyed by the facility designee--
``(I) was accurate;
``(II) matches the information in
the record kept by the practitioner
under paragraph (4)(G); and
``(III) was based on determinations
and instructions made by the
practitioner.
``(E) Return of endorsed prescription to
pharmacy.--The practitioner may deliver a prescription
endorsed under subparagraph (C)(i) to the pharmacy in
person, by mail, by facsimile, or by other appropriate
means of delivery, except that if the practitioner uses
the mail for delivery, the prescription shall be
postmarked during the 5-business-day period described
in subparagraph (C)(ii).
``(F) Attachment of endorsement to prescription.--A
dispensing pharmacy shall attach a prescription
endorsed under subparagraph (C)(i) to the prescription
document that the pharmacy received from the facility
designee under paragraph (4)(C).
``(G) Noncompliance.--
``(i) In general.--If a pharmacy does not
receive an endorsed prescription required under
this paragraph from a practitioner within the
5-business-day period described in subparagraph
(C)(ii), the pharmacy--
``(I) may not dispense any
subsequent prescriptions for controlled
substances issued by or on behalf of
the practitioner for residents at the
institutional long-term care facility,
unless the prescription is a written
prescription issued directly by the
practitioner, until the required
endorsement of the oral prescription is
received; and
``(II) shall note the limitation
described in subclause (I) on the most
recent copy of the list that the
institutional long-term care facility
provided to the pharmacy under
paragraph (3)(E)(iii).
``(ii) Notice to dea.--A pharmacy shall
notify the nearest office of the Drug
Enforcement Administration if the pharmacy does
not receive an endorsed prescription from a
practitioner by the end of the 10-business-day
period beginning on the date on which the
pharmacy transmitted notice to the practitioner
under subparagraph (B).
``(6) Recordkeeping.--
``(A) In general.--Each institutional long-term
care facility shall--
``(i) maintain a readily retrievable
written or electronic logbook, in which it
records each instance in which a facility
designee memorializes and transmits an oral
prescription for a controlled substance to a
pharmacy on behalf of a practitioner under
paragraph (4); and
``(ii) keep, on the premises of the
institutional long-term care facility--
``(I) the logbook described in
clause (i); and
``(II) copies of--
``(aa) any authorizing
agreements;
``(bb) any policies and
procedures issued by the
institutional long-term care
facility under paragraph
(2)(A)(i);
``(cc) any notice of
rescission or modification of
the authority of a facility
designee;
``(dd) each list prepared
by the administrator of the
institutional long-term care
facility under paragraph
(3)(E); and
``(ee) all documents
created by facility designees
to reduce oral prescriptions to
writing, under paragraph
(4)(C)(ii)(I).
``(B) Retention of copies.--An institutional long-
term care facility shall--
``(i) retain a copy of any document
described in subparagraph (A)(ii)(II) until the
end of the 5-year period beginning on the date
on which the document was created; and
``(ii) whether retained in written or
electronic form, make available for inspection
and copying by the Attorney General under
section 510--
``(I) the logbook described in
subparagraph (A)(i); and
``(II) copies of the documents
described in subparagraph (A)(ii)(II).
``(C) Prohibition.--The logbook required under
subparagraph (A)(i) may not be prepared, maintained, or
updated, in whole or in part, by a pharmacy.
``(D) Contents of logbook.--The logbook shall
contain, at a minimum--
``(i) all of the information required under
paragraph (4)(C); and
``(ii) the name, address, and telephone
number of the pharmacy to which each
prescription was transmitted.
``(E) Rulemaking authority.--The Attorney General
may promulgate rules relating to the formatting,
content, and updating of the logbook required to be
kept under clause (A)(i).
``(7) Rule of construction.--Nothing in this subsection
shall be construed to allow an institutional long-term care
facility, or an administrator, employee, or agent of an
institutional long-term care facility, who is not a
practitioner, to prescribe, administer, dispense, distribute,
deliver, possess, maintain, stock, or otherwise use a
controlled substance except as expressly provided by this
title.''.
SEC. 4. PRACTITIONER RECORDKEEPING.
Section 307 of the Controlled Substances Act (21 U.S.C. 827) is
amended--
(1) in subsection (a)--
(A) in paragraph (2), by striking ``and'' at the
end;
(B) in paragraph (3), by striking ``inventory.''
and inserting ``inventory; and''; and
(C) by adding at the end the following:
``(4) every registrant who prescribes a controlled
substance for a patient residing at an institutional long-term
care facility under section 309(f) shall maintain the
prescribing log described in subsection (f)(2)(G) of that
section.''; and
(2) in subsection (c)(1)(A), by adding after ``treatment of
an individual'' the following: ``, or under section 309(f)''.
SEC. 5. PENALTIES.
(a) In General.--Section 402 of the Controlled Substances Act (21
U.S.C. 842) is amended--
(1) by amending subsection (a)(1) to read as follows:
``(1) who is subject to the requirements of part C,
including an institutional long-term care facility and an
administrator or employee of an institutional long-term care
facility who are subject to any of the requirements under
section 309(f), to distribute or dispense a controlled
substance, or to aid in the prescribing or dispensing of a
controlled substance, in violation of section 309;''; and
(2) in subsection (c)--
(A) in paragraph (1)--
(i) by amending subparagraph (B) to read as
follows:
``(B) In the case of a violation of paragraph (5)
or (10) of subsection (a) of this section, the civil
penalty for each violation shall not exceed $10,000,
except that if a person refuses or negligently fails to
make any record, report, notification, declaration, or
statement required by section 309(f), the civil penalty
for each violation shall be not less than $3,000 and
not more than $10,000.''; and
(ii) by adding at the end the following:
``(C) In the case of a violation of subsection
(a)(1), the civil penalty shall be not less than $5,000
for each violation.''; and
(B) in paragraph (2)--
(i) in subparagraph (A), by striking
``sentenced to imprisonment of not more than
one year'' and inserting ``sentenced to a term
of imprisonment of not more than 3 years''; and
(ii) in subparagraph (B), by striking ``2
years'' and inserting ``5 years''.
(b) Directive to the United States Sentencing Commission.--
(1) In general.--Pursuant to its authority under section
994 of title 28, United States Code, and in accordance with
this subsection, the United States Sentencing Commission shall
review and, if appropriate, amend the Federal Sentencing
Guidelines and policy statements to conform to the amendments
made by this Act.
(2) Requirements.--In carrying out this subsection, the
Commission shall--
(A) establish new guidelines and policy statements,
as warranted, in order to implement new or revised
criminal offenses created under this title;
(B) assure reasonable consistency with other
relevant directives and with other sentencing
guidelines;
(C) account for any additional aggravating or
mitigating circumstances that might justify exceptions
to the generally applicable sentencing ranges;
(D) make any necessary conforming changes to the
sentencing guidelines; and
(E) assure that the guidelines adequately meet the
purposes of sentencing under section 3553(a)(2) of
title 18, United States Code.
SEC. 6. RULE OF CONSTRUCTION.
Nothing in this Act or in the amendments made by this Act shall be
construed to alter or eliminate the requirements relating to electronic
prescriptions for controlled substances in effect on the date of
enactment of this Act, as established by the Attorney General.
<all>
Introduced in Senate
Sponsor introductory remarks on measure. (CR S5627-5628)
Read twice and referred to the Committee on the Judiciary.
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line