Bill Text: IN SB0407 | 2012 | Regular Session | Enrolled
Bill Title: Pharmacy matters.
Spectrum: Bipartisan Bill
Status: (Enrolled - Dead) 2012-03-20 - Signed by the Governor [SB0407 Detail]
Download: Indiana-2012-SB0407-Enrolled.html
PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana Constitution) is being amended, the text of the existing provision will appear in this style type, additions will appear in this style type, and deletions will appear in
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AN ACT to amend the Indiana Code concerning professions and occupations.
Be it enacted by the General Assembly of the State of Indiana:
(1) medical care to be provided to committed individuals, including treatment for mental retardation, alcoholism, and drug addiction;
(2) administration of medical facilities and health centers operated by the department;
(3) medical equipment, supplies, and devices to be available for medical care;
(4) provision of special diets to committed individuals;
(5) acquisition, storage, handling, distribution, and dispensing of all medication and drugs;
(6) the return of unused medications that meet the requirements of
(7) training programs and first aid emergency care for committed individuals and department personnel;
(8) medical records of committed individuals; and
(9) professional staffing requirements for medical care.
(b) The state department of health shall make an annual inspection of every health facility, health center, or hospital:
(1) operated by the department; and
(2) not accredited by a nationally recognized accrediting organization;
and report to the commissioner whether that facility, center, or hospital meets the requirements established by the state department of health. Any noncompliance with those requirements must be stated in writing to the commissioner, with a copy to the governor.
(c) For purposes of IC 4-22-2, the term "directive" as used in this section relates solely to internal policy and procedure not having the force of law.
(d) For purposes of subsection (a)(6), the department:
(1) shall return medication that belonged to a Medicaid recipient; and
(2) may return other unused medication;
to the pharmacy that dispensed the medication if the unused medication meets the requirements of
(e) The department may establish directives concerning the return of unused medical devices or medical supplies that are used for prescription drug therapy and that meet the requirements of
(f) A pharmacist or pharmacy that enters into an agreement with the department to accept the return of:
(1) unused medications that meet the requirements of
(2) unused medical devices or medical supplies that are used for prescription drug therapy and that meet the requirements of
may negotiate with the department a fee for processing the returns.
SECTION 2. IC 11-12-5-8, AS ADDED BY P.L.174-2011, SECTION 2, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2012]: Sec. 8. (a) This section applies to the return of:
(1) unused medications that meet the requirements of
(2) unused medical devices or medical supplies that are used for prescription drug therapy and that meet the requirements of
(b) The county sheriff:
(1) shall return medication that belonged to a Medicaid recipient; and
(2) may return other unused medication;
to the pharmacy that dispensed the medication if the unused medication meets the requirements of
(c) The county sheriff may return unused medical devices or medical supplies that are used for prescription drug therapy and that meet the requirements of
(d) A pharmacist or pharmacy that enters into an agreement with the county sheriff to accept the return of:
(1) unused medications that meet the requirements of
(2) unused medical devices or medical supplies that are used for prescription drug therapy and that meet the requirements of
may negotiate with the county sheriff a fee for processing the returns.
SECTION 3. IC 16-28-11-4, AS AMENDED BY P.L.174-2011, SECTION 3, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2012]: Sec. 4. (a) A health facility, county jail under IC 11-12-5-8, or department of correction facility under IC 11-10-3-4 that possesses unused medication that meets the requirements of
(1) shall return medication that belonged to a Medicaid recipient; and
(2) may return other unused medication;
to the pharmacy that dispensed the medication.
(b) An entity participating in a program under IC 25-26-23 may return unused medication to the pharmacy that dispensed the medication if the board of pharmacy adopts a rule allowing this procedure under IC 25-26-23-2.
SECTION 4. IC 25-26-13-17, AS AMENDED BY P.L.98-2006, SECTION 9, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2012]: Sec. 17. (a) The board shall establish classes of pharmacy permits as follows:
Type I. A retail permit for a pharmacy that provides pharmaceutical care to the general public by the dispensing of a drug or device.
Type II. An institutional permit for hospitals, clinics, health care facilities, sanitariums, nursing homes, or dispensaries that offer pharmaceutical care by dispensing a drug product to an inpatient under a drug order or to an outpatient of the institution under a prescription.
Type III. A permit for a pharmacy that is not:
(A) open to the general public; or
(B) located in an institution listed under a Type II permit;
and provides pharmaceutical care to a patient who is located in an institution or in the patient's home.
Type IV. A permit for a pharmacy not open to the general public that provides pharmaceutical care by dispensing drugs and devices to patients exclusively through the United States Postal Services or other parcel delivery service.
Type V. A permit for a pharmacy that engages exclusively in the preparation and dispensing of diagnostic or therapeutic radioactive drugs.
Type VI. A permit for a pharmacy open to the general public that provides pharmaceutical care by engaging in an activity under a Type I or Type III permit. A pharmacy that obtains a Type VI permit may provide services to:
(A) a home health care patient;
(B) a long term care facility; or
(C) a member of the general public.
(b)
(1) to:
(A) an employee, student, or volunteer of the hospital;
(B) a retiree who is participating in a retirement, pension, or benefit program administered by the hospital;
(C) an independent contractor who has an exclusive relationship with the hospital;
(D) a member of the hospital's governing board; or
(E) a member of the hospital's medical staff;
(2) to dependents of the individuals listed in subdivision (1);
for their own use.
(c) Nothing in this section prohibits a pharmacy holding a permit other than a Type IV permit from delivering drugs or devices through mail, parcel delivery, or hand delivery.
(d) Hospitals holding a Type II permit may operate remote locations within a reasonable distance of the licensed area, as determined by the
board, after:
(1) filing an application on a form prepared by the board;
(2) having each location inspected by the board; and
(3) obtaining approval from the board.
(e) Any applicable rule governing the practice of pharmacy in
Indiana shall apply to all permits under this section.
SECTION 5. IC 25-26-13-18, AS AMENDED BY P.L.1-2009,
SECTION 142, IS AMENDED TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2012]: Sec. 18. (a) To be eligible for issuance
of a pharmacy permit, an applicant must show to the satisfaction of the
board that:
(1) Persons at the location will engage in the bona fide practice of
pharmacy. The application must show the number of hours each
week, if any, that the pharmacy will be open to the general public.
(2) The pharmacy will maintain a sufficient stock of emergency
and frequently prescribed drugs and devices as to adequately
serve and protect the public health.
(3) Except as provided in section 19 of this chapter, a registered
pharmacist will be in personal attendance and on duty in the
licensed premises at all times when the practice of pharmacy is
being conducted and that the pharmacist will be responsible for
the lawful conduct of the pharmacy.
(4) One (1) pharmacist will have not more than four (4) Certified
pharmacy technicians or pharmacy technicians in training
certified under IC 25-26-19 must practice under the a licensed
pharmacist's immediate and personal supervision at any time. all
times. A pharmacist may not supervise more than six (6)
pharmacy technicians or pharmacy technicians in training at
any time. As used in this clause, subdivision, "immediate and
personal supervision" means within reasonable visual and vocal
distance of the pharmacist.
(5) The pharmacy will be located separate and apart from any area
containing merchandise not offered for sale under the pharmacy
permit. The pharmacy will:
(A) be stationary;
(B) be sufficiently secure, either through electronic or physical
means, or a combination of both, to protect the products
contained in the pharmacy and to detect and deter entry during
those times when the pharmacy is closed;
(C) be well lighted and ventilated with clean and sanitary
surroundings;
(D) be equipped with a sink with hot and cold running water
or some means for heating water, a proper sewage outlet, and
refrigeration;
(E) have a prescription filling area of sufficient size to permit
the practice of pharmacy as practiced at that particular
pharmacy; and
(F) have such additional fixtures, facilities, and equipment as
the board requires to enable it to operate properly as a
pharmacy in compliance with federal and state laws and
regulations governing pharmacies.
(b) Prior to opening a pharmacy after receipt of a pharmacy permit,
the permit holder shall submit the premises to a qualifying inspection
by a representative of the board and shall present a physical inventory
of the drug and all other items in the inventory on the premises.
(c) At all times, the wholesale value of the drug inventory on the
licensed items must be at least ten percent (10%) of the wholesale
value of the items in the licensed area.
SECTION 6. IC 25-26-13-25, AS AMENDED BY P.L.174-2011,
SECTION 4, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2012]: Sec. 25. (a) All original prescriptions, whether in
written or electronic format, shall be numbered and maintained in
numerical and chronological order, or in a manner approved by the
board and accessible for at least two (2) years in the pharmacy. A
prescription transmitted from a practitioner by means of
communication other than writing must immediately be reduced to
writing or recorded in an electronic format by the pharmacist. The files
shall be open for inspection to any member of the board or its duly
authorized agent or representative.
(b) A prescription may be electronically transmitted from the
practitioner by computer or another electronic device to a pharmacy
that is licensed under this article or any other state or territory. An
electronic data intermediary that is approved by the board:
(1) may transmit the prescription information between the
prescribing practitioner and the pharmacy;
(2) may archive copies of the electronic information related to the
transmissions as necessary for auditing and security purposes; and
(3) must maintain patient privacy and confidentiality of all
archived information as required by applicable state and federal
laws.
(c) Except as provided in subsection (d), a prescription for any drug,
the label of which bears either the legend, "Caution: Federal law
prohibits dispensing without prescription" or "Rx Only", may not be
refilled without written, electronically transmitted, or oral authorization
of a licensed practitioner.
(d) A prescription for any drug, the label of which bears either the
legend, "Caution: Federal law prohibits dispensing without
prescription" or "Rx Only", may be refilled by a pharmacist one (1)
time without the written, electronically transmitted, or oral
authorization of a licensed practitioner if all of the following conditions
are met:
(1) The pharmacist has made every reasonable effort to contact
the original prescribing practitioner or the practitioner's designee
for consultation and authorization of the prescription refill.
(2) The pharmacist believes that, under the circumstances, failure
to provide a refill would be seriously detrimental to the patient's
health.
(3) The original prescription authorized a refill but a refill would
otherwise be invalid for either of the following reasons:
(A) All of the authorized refills have been dispensed.
(B) The prescription has expired under subsection (g). (h).
(4) The prescription for which the patient requests the refill was:
(A) originally filled at the pharmacy where the request for a
refill is received and the prescription has not been transferred
for refills to another pharmacy at any time; or
(B) filled at or transferred to another location of the same
pharmacy or its affiliate owned by the same parent corporation
if the pharmacy filling the prescription has full access to
prescription and patient profile information that is
simultaneously and continuously updated on the parent
corporation's information system.
(5) The drug is prescribed for continuous and uninterrupted use
and the pharmacist determines that the drug is being taken
properly in accordance with IC 25-26-16.
(6) The pharmacist shall document the following information
regarding the refill:
(A) The information required for any refill dispensed under
subsection (e).
(B) The dates and times that the pharmacist attempted to
contact the prescribing practitioner or the practitioner's
designee for consultation and authorization of the prescription
refill.
(C) The fact that the pharmacist dispensed the refill without
the authorization of a licensed practitioner.
(7) The pharmacist notifies the original prescribing practitioner
of the refill and the reason for the refill by the practitioner's next
business day after the refill has been made by the pharmacist.
(8) Any pharmacist initiated refill under this subsection may not
be for more than the minimum amount necessary to supply the
patient through the prescribing practitioner's next business day.
However, a pharmacist may dispense a drug in an amount greater
than the minimum amount necessary to supply the patient through
the prescribing practitioner's next business day if:
(A) the drug is packaged in a form that requires the pharmacist
to dispense the drug in a quantity greater than the minimum
amount necessary to supply the patient through the prescribing
practitioner's next business day; or
(B) the pharmacist documents in the patient's record the
amount of the drug dispensed and a compelling reason for
dispensing the drug in a quantity greater than the minimum
amount necessary to supply the patient through the prescribing
practitioner's next business day.
(9) Not more than one (1) pharmacist initiated refill is dispensed
under this subsection for a single prescription.
(10) The drug prescribed is not a controlled substance.
A pharmacist may not refill a prescription under this subsection if the
practitioner has designated on the prescription form the words "No
Emergency Refill".
(e) When refilling a prescription, the refill record shall include:
(1) the date of the refill;
(2) the quantity dispensed if other than the original quantity; and
(3) the dispenser's identity on:
(A) the original prescription form; or
(B) another board approved, uniformly maintained, readily
retrievable record.
(f) The original prescription form or the other board approved
record described in subsection (e) must indicate by the number of the
original prescription the following information:
(1) The name and dosage form of the drug.
(2) The date of each refill.
(3) The quantity dispensed.
(4) The identity of the pharmacist who dispensed the refill.
(5) The total number of refills for that prescription.
(g) This subsection does not apply:
(1) unless a patient requests a prescription drug supply of
more than thirty (30) days;
(2) to the dispensing of a controlled substance (as defined in
IC 35-48-1-9); or
(3) if a prescriber indicates on the prescription that the
quantity of the prescription may not be changed.
A pharmacist may dispense, upon request of the patient, personal
or legal representative of the patient, or guardian of the patient,
not more than a ninety (90) day supply of medication if the patient
has completed an initial thirty (30) day supply of the drug therapy
and the prescription, including any refills, allows a pharmacist to
dispense at least a ninety (90) day supply of the medication.
However, a pharmacist shall notify the prescriber of the change in
the quantity filled and must comply with state and federal laws and
regulations concerning the dispensing limitations concerning a
prescription drug. The pharmacist shall inform the customer
concerning whether the additional supply of the prescription will
be covered under the patient's insurance, if applicable.
(g) (h) A prescription is valid for not more than one (1) year after
the original date of issue.
(h) (i) A pharmacist may not knowingly dispense a prescription after
the demise of the practitioner, unless in the pharmacist's professional
judgment it is in the best interest of the patient's health.
(i) (j) A pharmacist may not knowingly dispense a prescription after
the demise of the patient.
(j) (k) A pharmacist or a pharmacy shall not resell, reuse, or
redistribute a medication that is returned to the pharmacy after being
dispensed unless the medication:
(1) was dispensed to an individual:
(A) residing in an institutional facility (as defined in 856
IAC 1-28.1-1(6));
(B) in a hospice program under IC 16-25; or
(C) in a county jail or department of correction facility;
(2) was properly stored and securely maintained according to
sound pharmacy practices;
(3) is returned unopened and:
(A) was dispensed in the manufacturer's original:
(i) bulk, multiple dose container with an unbroken tamper
resistant seal; or
(ii) unit dose package; or
(B) was packaged by the dispensing pharmacy in a:
(i) multiple dose blister container; or
(ii) unit dose package;
(4) was dispensed by the same pharmacy as the pharmacy
accepting the return;
(5) is not expired; and
(6) is not a controlled substance (as defined in IC 35-48-1-9), unless the pharmacy holds a Type II permit (as described in section 17 of this chapter).
(1) were dispensed to an individual in a county jail or department of correction facility;
(2) are not expired; and
(3) are returned unopened and in the original sealed packaging.
SECTION 7. IC 25-26-19-5 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2012]: Sec. 5. (a) The board shall issue a pharmacy technician certificate to an individual who:
(1) applies to the board in the form and manner prescribed by the board;
(2) is at least eighteen (18) years of age;
(3) has not been convicted of:
(A) a crime that has a direct bearing upon the individual's ability to practice competently; or
(B) a felony involving controlled substances;
(4) is not in violation of this chapter or rules adopted by the board under section 4 of this chapter;
(5) has paid the fee set by the board under section 4 of this chapter; and
(6) has completed a program of education and training approved by the board or has passed a certification examination offered by a nationally recognized certification body approved by the board.
(b) For good cause, the board may waive the age requirement under subsection (a)(2).
SECTION 8. IC 25-26-20-4, AS AMENDED BY P.L.204-2005, SECTION 19, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2012]: Sec. 4. (a) Except as provided in subsections (b) and (c), unadulterated drugs that meet the requirements set forth in
(1) A pharmacist or pharmacy.
(2) A wholesale drug distributor.
(3) A hospital licensed under IC 16-21.
(4) A health care facility (as defined in IC 16-18-2-161).
(5) A hospice.
(6) A practitioner.
(b) An unadulterated drug that:
(1) was returned under IC 25-26-13-25; and
(2) was prescribed for a Medicaid recipient;
may not be donated under this section unless the Medicaid program has been credited for the product cost of the drug as provided in policies under the Medicaid program.
(c) A controlled drug may not be donated under this section.
SECTION 9. IC 25-26-22-4.2 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2012]: Sec. 4.2. (a) A third party payer may cause an onsite audit to occur at a particular pharmacy location not more than one (1) time per calendar year.
(b) A company that conducts an audit for a third party payer may conduct an onsite audit at a particular pharmacy location not more than one (1) time per calendar year for each third party payer. However, if the audit results in a finding of a particular problem at the pharmacy, the auditor may return within the calendar year to determine ongoing compliance.
SECTION 10. IC 25-26-22-5, AS ADDED BY P.L.7-2009, SECTION 1, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2012]: Sec. 5. An auditor conducting an audit shall comply with all of the following:
(1) The contract under which the audit is performed must provide a description of audit procedures that will be followed.
(2) For an onsite audit conducted at a pharmacy's location, the auditor that conducts the audit shall provide written notice to the pharmacy at least two (2) weeks before the initial onsite audit is performed for each audit cycle.
(3) The auditor shall not interfere with the delivery of pharmacist services to a patient and shall use every effort to minimize inconvenience and disruption to pharmacy operations during the audit. This subdivision does not prohibit audits during normal business hours of the pharmacy.
(4) If the audit requires use of clinical or professional judgment, the audit must be conducted by or in consultation with a licensed pharmacist.
(5) The auditor shall allow the use of written or otherwise transmitted hospital, physician, or other health practitioner records to validate a pharmacy record with respect to a prescription for a legend drug.
(6) The auditor shall perform the audit according to the same standards and parameters that the auditor uses to audit all other similarly situated pharmacies on behalf of the third party payer.
(7) The period covered by the audit must not exceed twenty-four (24) months after the date on which the claim that is the subject of the audit was submitted to or adjudicated by the third party payer, and the pharmacy must be permitted to resubmit electronically any claims disputed by the audit. This subdivision does not limit the period for audits under the Medicaid program that are conducted due to a federal requirement.
(8) The audit must not be initiated or scheduled during the first
(9) Payment to the onsite auditor for conducting the audit must not be based on a percentage of any amount recovered as a result of the audit.
(10) Within twenty-four (24) hours of receiving the notice of an audit, a pharmacy may reschedule the audit to a date not more than fourteen (14) days after the date proposed by the auditor. However, if the auditor is unable to reschedule within the fourteen (14) day period, the auditor shall select and reschedule the audit for a date after the fourteen (14) day period.
(11) This subdivision does not apply to an audit conducted by the Medicaid program. If a clerical error is identified by the auditor during the course of an audit, the auditor shall allow the pharmacy to obtain a prescription that corrects the clerical error from the prescribing physician. However, if the clerical error results in an overpayment to the pharmacy, the overpayment may be recouped by the third party payer.
SECTION 11. IC 25-26-22-6, AS ADDED BY P.L.7-2009, SECTION 1, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2012]: Sec. 6. (a) This section does not apply to an audit conducted by the Medicaid, Medicare, or any other federal program.
(b) Following an audit, the auditor shall provide to the pharmacy written audit reports as follows:
(1) The auditor shall deliver a preliminary audit report to the pharmacy not later than ninety (90) days after the audit is concluded.
(2) The auditor shall provide with the preliminary audit report a written appeal procedure for the pharmacy to follow if the pharmacy desires to appeal a finding contained in the preliminary audit report. The written appeal procedure must provide for a period of at least thirty (30) days after the pharmacy receives the preliminary audit report during which the pharmacy may file an appeal of findings contained in the preliminary audit report.
(3) The auditor shall deliver a final audit report to the pharmacy not later than one hundred twenty (120) days after:
(A) the preliminary audit report is received by the pharmacy; or
(B) if an appeal is filed, a final appeal determination is made;
whichever is later.
(4) Each audit report must be signed by the auditor and a pharmacist participating in the audit.
(5) The auditor shall provide a copy of the final audit report to the third party payer.
(c) If requested by the pharmacy, the auditor shall provide the audit report under this section to the pharmacy by a means that allows signature confirmation, including an electronic signature (as defined by IC 25-26-13-2). If the audit report is sent by electronic mail, any other verification system may be used, provided that the receipt is acknowledged by the pharmacy.
SECTION 12. IC 25-26-22-9, AS ADDED BY P.L.7-2009, SECTION 1, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2012]: Sec. 9. (a) This section does not apply to an audit conducted by the Medicaid, Medicare, or any other federal program.
(1) a final audit report must be distributed; and
(2) except when an audit finds that fraud, willful misrepresentation, or alleged serious abuse has occurred, at least thirty (30) days must elapse after the date on which the final audit report is distributed before the recoupment of funds exceeding ten thousand dollars ($10,000).
Interest on funds described in subsection (a) (b) does not accrue during
the audit period.
SECTION 13. [EFFECTIVE JULY 1, 2012] (a) As used in this
SECTION, "commission" refers to the health finance commission
established by IC 2-5-23-3.
(b) During the 2012 legislative interim, the commission shall
study:
(1) retail pharmacies;
(2) community pharmacies; and
(3) mail order or Internet based pharmacies (as defined in
IC 25-26-18-1);
and any limitations that should be placed in statute concerning the
amount of a prescription drug that may be dispensed by the
pharmacies.
(c) The commission shall make findings and recommendations
concerning the following:
(1) The number of individuals covered under a state employee
health plan with a copayment, a coinsurance amount, or other
out-of-pocket costs for prescription drugs that exceed:
(A) two hundred dollars ($200) for a one (1) month supply
of a single prescription drug; or
(B) five hundred dollars ($500) for a one (1) month supply
of more than one (1) prescription drug.
(2) The number of individuals covered under a policy of
accident and sickness insurance with a copayment, a
coinsurance amount, or other out-of-pocket costs for
prescription drugs that exceed:
(A) two hundred dollars ($200) for a one (1) month supply
of a single prescription drug; or
(B) five hundred dollars ($500) for a one (1) month supply
of more than one (1) prescription drug.
(3) The number of individuals covered under a health
maintenance organization contract with a copayment, a
coinsurance amount, or other out-of-pocket costs for
prescription drugs that exceed:
(A) two hundred dollars ($200) for a one (1) month supply
of a single prescription drug; or
(B) five hundred dollars ($500) for a one (1) month supply
of more than one (1) prescription drug.
(4) The number of individuals who may become eligible for
Medicaid as a result of copayments, coinsurance amounts, or
other out-of-pocket costs for prescription drugs as described
in this SECTION.
(d) The state personnel department and the Indiana department
of insurance shall assist the commission in obtaining the
information necessary under subsection (c).
(e) This SECTION expires December 31, 2012.
SEA 407
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