Current through Register Vol. 54, No. 45, November 9, 2024
Section 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.The provisions of this §22.62 adopted June 15, 1984, effective 6/16/1984, 14 Pa.B. 2109; amended March 29, 1985, effective 3/30/1985, 15 Pa.B. 1163; amended December 13, 1985, effective 12/14/1985, 15 Pa.B. 4427; amended December 14, 1990, effective 12/15/1990, 20 Pa.B. 6143. This section cited in 6 Pa. Code § 22.2 (relating to definitions); 6 Pa. Code § 22.11 (relating to general payment principles); and 6 Pa. Code § 22.63 (relating to other provisions for providing services by mail).