6 Pa. Code § 22.62 - Conditions of provider participation
(a)
Enrollment.
(1) Only providers who have been enrolled in
the PACE Program are qualified to receive payments made under the
program.
(2) A provider seeking
enrollment as a PACE provider may seek to be enrolled as a provider of walk-in
prescription services, as a provider of prescription services by mail or as a
provider of both kinds of services. The Department will assign separate and
distinct provider numbers to be used in identifying claims submitted for
reimbursement as claims for walk-in services or mail -order services and
delivery as required under §
22.11(f)(3)
(relating to general payment principles).
(3) In order to become enrolled in the PACE
Program as a provider of walk-in prescription services, a provider shall:
(i) Meet the conditions of eligibility set
forth in §
22.61 (relating to conditions of
provider eligibility), both at the time of initial application for enrollment
and on an ongoing basis.
(ii)
Satisfactorily complete and submit to the Department the appropriate enrollment
forms.
(iii) Submit a signed
provider agreement with the enrollment forms which sets forth the provisions
and assurances required of all participating providers and makes specific
reference to the instructions in the standard provider manual relating to the
dispensing of walk-in prescription services.
(4) In order to become enrolled as a provider
of PACE prescription services by mail , a provider shall:
(i) Meet the conditions of eligibility set
forth in §
22.61, both at the time of initial application for enrollment
and on an ongoing basis.
(ii)
Satisfactorily complete and submit to the Department the appropriate enrollment
forms which shall include information which establishes the provider's methods
and procedures for carrying out the requirements of subsection (e)(3) and
§
22.63 (relating to other provisions
for providing services by mail ).
(iii) Submit with the enrollment forms a
signed provider agreement which sets forth the standard provisions and
assurance required of participating providers and makes specific reference to
§
22.63 and instructions in the
standard provider manual relating to the dispensing of prescription services by
mail .
(5) Providers who
meet all of the following conditions will not be considered to be providers of
PACE benefits by mail :
(i) Those who do not
have or do not take steps to develop a systematic mail order
operation.
(ii) Those who limit
their use of mail delivery of PACE Program benefits to claimants with whom they
have already established a face-to-face customer relationship and comply with
§
22.63(c)(1).
(iii) Those who
do not dispense to PACE Program claimants more than ten PACE claims by mail in
a given month.
(6) A
provider's enrollment in the PACE Program shall be effective on the date when
the signatures of the Department 's authorized representatives have been affixed
to the provider agreement. Except as provided for in subsection (b), no
services rendered prior to that date shall be eligible for
reimbursement.
(7) A provider's
enrollment shall cease to be effective on the date when the Department suspends
or terminates the provider agreement under §
22.84 (relating to administrative
actions and penalties). Payments or reimbursements will not be made for
prescription drugs dispensed on dates when a provider's enrollment is not
effective.
(b)
Change of ownership. For the purposes of this subsection, a
change of ownership includes a sale, a change in corporate structure or
controlling interest in the pharmacy business, the addition of a partner or
other corporate reorganization. When a change of ownership is to take place in
a pharmacy which has, until that time, been an enrolled provider of the PACE
Program, the following applies to avoid unnecessary interruption in the
participation of the pharmacy and the PACE claimants who use the pharmacy :
(1) As early as possible before the change of
ownership occurs, the prospective provider shall file a PACE enrollment
application and agreement with the Department .
(2) Immediately upon receipt of its pharmacy
permit number, issued by the State Board of Pharmacy , the prospective provider
shall notify the Department of the permit number.
(3) Upon notification of the new owner's
pharmacy permit number, the Department will execute the provider agreement and
enroll the new owner's pharmacy in the PACE Program.
(4) The effective date of the new owner's
provider agreement shall be the date of issuance of the permit number by the
State Board of Pharmacy , unless the Department is reviewing the change of
ownership. If the Department is reviewing the change of ownership, the
Department will determine the effective date of the new owner's provider
agreement. The Department will notify the new owner that a review of the change
in ownership is occurring and that the Department will not pay the provider for
prescriptions filled prior to the date of a valid and fully executed provider
agreement. During the period of review, the provider may service claimants with
the understanding that reimbursement under the PACE Program may subsequently be
disallowed if the Department determines that the provider will not be enrolled
or that disenrollment of the provider is warranted.
(c)
Maintenance of prescriptions.
As required under §
22.11(f)(12), the
Department will not pay for claims for which the following documentation cannot
be presented, and the lack of this documentation may constitute grounds for
terminating a provider agreement:
(1) An
enrolled provider shall retain original hardcopy prescriptions for 4 years at
the principal place of business . An original hardcopy prescription is one of
the following:
(i) The original order as it
was reduced to writing by the prescriber by hand, typewriter, computer or other
mechanical or electronic means.
(ii) The oral order, such as one issued over
the telephone, as it was originally reduced to writing by the pharmacist by
hand, typewriter, computer or other mechanical or electronic
means.
(2) As defined in
paragraph (1), original hardcopy prescriptions which are not handwritten by the
prescriber shall bear the date and the handwritten signature or the handwritten
initials of the dispensing pharmacist.
(3) In addition to the original hardcopy
prescription, the provider shall maintain a daily hardcopy record of filled and
refilled prescriptions. The daily hardcopy record shall identify the prescriber
who ordered the prescription, the patient for whom the prescription is
intended, the strength and dosage of the medication, the number assigned to the
prescription and the date of dispensing . The daily hardcopy record shall bear
the handwritten signature or the handwritten initials of the pharmacist who
filled or refilled the prescription. The data which supports the daily hardcopy
record may be maintained by a manual system or by an electronic data processing
system which meets the requirements in this paragraph.
(i) The provider shall assure that the system
prevents improper access to, and manipulation or alteration of, stored records.
The Department may develop provider instructions for the safeguarding of stored
records. If the Department does develop provider instructions, they will be
distributed to providers as technical assistance to facilitate the provider's
compliance with this subparagraph.
(ii) Arrangements shall be made which assure
completeness and continuity of prescription records if the relationship between
a pharmacy and a supplier of data processing services terminates.
(iii) The system shall provide retrieval of
information regarding the original dispensing and the refilling of
prescriptions.
(iv) A pharmacist,
and a pharmacy intern, if applicable, using a computerized system shall sign or
initial the original hardcopy prescription at the time of the first dispensing
and the initials of the pharmacist shall be entered into the computer record of
the dispensing .
(v) The
introduction of prescription refill records into the system shall meet the
following criteria:
(A) The initials of the
pharmacist who dispensed the refill shall be entered at the time of
dispensing .
(B) One of the
following:
(I) The system shall be capable of
displaying a record of prescriptions refilled each day on a daily hardcopy
printout of prescriptions refilled that day and the dated signature of each
pharmacist whose initials appear on the printout shall be affixed, on a daily
basis, to the daily hardcopy printout to certify that it is a complete and
accurate record.
(II) Documentation
of the required refill information at the time of dispensing shall be reduced
to a hardcopy record of the prescription which contains the information
required by this paragraph. The handwritten signature or the handwritten
initials of the dispensing pharmacist shall be affixed on a daily basis to the
hardcopy record to certify that it is a true, complete and accurate
record.
(III) Documentation of the
required refill information at the time of dispensing shall be reduced to a
pharmacy dispensing log which contains the prescription number which leads
directly to the hardcopy record of information under this paragraph in the
provider's principal place of business ; the signature of the PACE claimant ; and
the date the prescription was refilled. The handwritten signature or the
handwritten initials of the dispensing pharmacist shall be affixed on a daily
basis to the pharmacy dispensing log to certify that it is a true, complete and
accurate record.
(vi) A pharmacy that employs a computerized
system shall have an auxiliary procedure which shall be used for documentation
of all new and refilled pescriptions dispensed during system downtime. The
auxiliary procedure shall provide for the entry into the computer of data
collected during the downtime, and the pharmacist shall insure that the maximum
number of refills authorized on the original prescription has not been
exceeded.
(vii) Only pharmacists,
pharmacy interns or personnel authorized by, and under the direct supervision
of, the dispensing pharmacist may enter prescription data into the computerized
system. A person authorized to enter data into the computerized system shall be
readily identifiable as being accountable for the entering of the specific data
which that person entered.
(4) A change of a prescription order shall be
documented on the original hardcopy prescription. Changes in the nature of a
medication, the brand or manufacturer of a medication, the strength of a
medication, or directions for its use are acceptable only if the consent of the
prescriber was obtained before dispensing . The written explanation of the
pharmacy on the prescription shall state that this was done and give the
reasons for the change.
(5)
Prescription records of PACE claimants shall be readily available for review,
copying or photographing by authorized Commonwealth officials or their
authorized agents. "Readily available" means that the records shall be
maintained in a reasonable and retrievable manner at the provider's principal
place of business .
(d)
Maintenance of other records. Other records necessary to
disclose the full nature and extent of prescription drugs , both covered and not
covered by the PACE Program, which were dispensed by a provider shall be
retained for 4 years and shall be available for review and copying by
authorized Commonwealth officials or their authorized agents within 7 business
days of a request for the records. These records include purchase orders and
invoices, billing records, computer user manuals and computer security
information.
(e)
Access to
records. Enrolled providers shall agree to provide reasonable access
to records necessary to comply with the provisions for program review set forth
in the provider agrement.
(f)
Standards of practice.
(1)
When dispensing prescription drugs to claimants enrolled in the PACE Program,
enrolled providers shall conform to the standards of the State Board of
Pharmacy , 49 Pa. Code §§27.1-27.4 and
27.11-27.18 (relating to general
provisions; and standards), and the State Board of Medicine, 49 Pa. Code
Chapters 16-18 (relating to State Board of Medicine-general provisions; State
Board of Medicine-medical doctors; and State Board of Medicine-practitioners
other than medical doctors), the Controlled Substance, Drug, Device, and
Cosmetic Act (35 P. S. §§ 780-101-780-144), and other Federal and
Commonwealth statutes and regulations applicable to the writing of medical
prescriptions and the dispensing of prescription drugs to the general
public.
(2) It is contrary to
accepted standards of practice for an enrolled provider to differentiate
between PACE Program claimants and the general public in levels or quality of
service.
(3) Enrolled providers are
prohibited from denying services to, or otherwise discriminating against, a
claimant on the basis of race, color, sex, age, religious preference, national
origin or handicap.
(g)
Verification of claimant identity.
(1)
Responsibility. It is
the responsibility of enrolled providers of PACE benefits to establish the
identity and current eligibility status of claimants which they serve under the
PACE Program. Claims for PACE benefits received by persons who are not bona
fide PACE claimants will not be considered valid claims.
(2)
Walk-in services. When
providing walk-in prescription services to PACE claimants, enrolled providers
shall observe a claimant 's signed PACE identification card on each occasion
when a prescription drug is dispensed to a claimant under the PACE Program.
Providers are prohibited from retaining the claimant 's PACE identification card
after dispensing a prescription drug and shall return the card with the
prescription drug to the claimant or the claimant 's designated representative.
Providers may not request PACE claimants to send a PACE identification card
through the mail .
(3)
Services by mail . As a basis for establishing the identity of
PACE claimants as program benefits are provided, an enrolled provider of PACE
Program benefits by mail , shall have, or secure, and maintain on file a
signature reference for each PACE claimant requesting services by mail from
that provider. The signature reference shall bear the original signature of the
claimant or the claimant 's authorized representative and shall form a basis for
signature comparisons carried out under §
22.63(d). The
Department reserves the right to waive this requirement, and the related
requirement of §
22.63(d)(1), for a
provider who can present an alternative system of control which offers
assurance to the Department that verification of claimant identity and claimant
receipt of ordered prescription drugs can and will be effectively accomplished
without signature references.
(h)
Designated
representatives.
(1)
Walk-in
services. As required under §
22.52(c) (relating
to use of the PACE identification card), walk-in prescription services to PACE
claimants may be provided to a designated representative of an incapacitated
PACE claimant . Providers shall see the claimant 's PACE identification card and
obtain the signature and relationship to the claimant of the designated
representative. If a provider has reason to believe that a person presenting a
PACE claimant 's identification card has not been designated by the claimant as
the claimant 's representative, the provider shall refuse to provide the
requested prescription services as a PACE claim .
(2)
Services by mail . As
required under §
22.52(c), a
designated representative requesting PACE benefits by mail shall have legal
authority to represent an incapacitated claimant as evidenced by power of
attorney or other legal document, and shall sign forms requiring the claimant 's
signature. Providers of prescription services by mail shall require designated
representatives to provide documentation of their legal authority to represent
the claimant .
(i)
Authenticity of prescriptions. Prior to the dispensing of
prescription drugs , the provider shall take necessary steps to identify
prescriptions which may not be authentic. These steps shall include the
following:
(1) Prescriptions shall be reviewed
by a pharmacist for obvious irregularities, including noncompliance with
prescription writing standards, dosage errors, technical errors of drug
references and conflicts with claimant medication history .
(2) When an irregularity, as discussed under
paragraph (1), is noted, a provider shall contact the prescriber to determine
the authenticity of the prescription or, as appropriate, establish errors and
make corrections.
(3) Providers
shall refuse to fill prescriptions which they suspect are not authentic. If, in
the professional judgment of the provider, a prescription does not appear to be
authentic, the provider shall contact the indicated prescriber by telephone to
check on its authenticity. Whenever, as a result of a check, the provider is
professionally convinced that the prescription is fraudulent, the provider may
not return the prescription to the claimant , but shall forward it to the
Department accompanied by the name, address and PACE identification card number
of the claimant .
(j)
Payments.
(1) Enrolled
providers shall collect the required copayment and, if applicable, the generic
differential , from each claimant for each prescription filled under the PACE
Program. For the purpose of reimbursement under the program, no provider claim
which relates to services for which the full copayment and an applicable
generic differential have not been collected may be considered an allowable
claim . Failure to comply with this subsection constitutes a false or fraudulent
claim under §
22.82 (relating to false or
fraudulent claims by providers).
(2) Providers shall consider as full payment
for PACE -covered services the claimant copayment , the generic differential
whenever applicable and the Department 's payment for prescription drugs
dispensed. Nothing in this section prevents a provider from appealing an
inappropriate reimbursement under §§
22.101-22.104 (relating to provider
hearings and appeals).
(k)
Claimant health and
safety.
(1)
Walk-in
services. Consistent with 49 Pa. Code §27.18(c) (relating
to standards of practice), enrolled providers of walk-in services are
authorized to take appropriate steps to prevent the inadvertent misutilization
of prescription drugs , with special concern for the potentially dangerous
interaction of two or more prescription drugs from different prescribers. Steps
may include telephone consultation with prescribing physicians and the
maintenance of a medication history on each claimant to whom prescription drugs
are dispensed.
(2)
Services
by mail . Enrolled providers offering mail -ordered or mail -dispensed
prescription service shall have or establish and maintain a medication history
on PACE claimants provided with these services.
(3)
General. When the
Department determines that, in the interest of a claimant 's health and safety,
a prescription should not be filled, the Department may take steps in
accordance with the act and this chapter to prevent the dispensing of the
prescribed drug.
Notes
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