Current through September 24, 2024
(1)
Upon filing an initial appeal with a PBM, the pharmacy shall provide the PBM
with a copy of the invoice(s) demonstrating the pharmacy's actual cost as of
the date of the filing of the initial appeal by the pharmacy. If the pharmacy
receives any additional discounts, price concessions, rebates, or other
reductions, excluding cash discounts, during the pendency of an initial appeal,
the pharmacy shall inform the PBM of the additional discount, price concession,
rebate, or other reduction, excluding a cash discount. The PBM may consider the
additional discount, price concession, rebate, or other reduction, excluding a
cash discount, when calculating the pharmacy's actual cost. Additional
discounts, price concessions, rebates, or other reductions received after the
resolution of an initial appeal shall not be grounds for reconsideration of any
initial appeal previously considered and resolved.
(2) A PBM shall request from each pharmacy
filing an initial appeal the name and contact information of the wholesaler or
manufacturer from which it purchased the prescription drug or device at issue.
Failure of a pharmacy to provide this information shall not constitute grounds
to deny an initial appeal; provided, however, if a PBM denies an initial appeal
as otherwise allowed by law or this chapter and the pharmacy fails to provide
this information or the PBM does not already have this information on file
pursuant to Rule
0780-01-95-.03(2)(k),
a PBM may presume the prescription drug or device at issue is available at a
lower cost from the wholesaler or manufacturer from which the pharmacy
purchased the prescription drug or device at issue.
(3) If a pharmacy's initial appeal is
resolved in favor of the appealing pharmacy, the PBM shall comply with the
provisions of T.C.A. § 56-7-3206(c)(3) and, further, provide the pharmacy
the following in writing:
(a) A statement the
initial appeal is granted, along with a summary outlining the basis for its
decision;
(b) Notification the PBM
has adjusted the challenged rate of reimbursement;
(c) Detailed instructions for how to reverse
and rebill the claim upon which the initial appeal is based; and
(d) Written notification the PBM has issued
payment to the pharmacy showing the exact amount of the payment.
(4)
(a) When applying the findings from an
initial appeal that was resolved in favor of a pharmacy to other similarly
situated pharmacies as to the rate of reimbursement and actual cost for the
particular drug or medical product or device that was at issue in the initial
appeal, a PBM shall, within seven business days of resolution of an initial
appeal, apply the findings retroactively as set out in subparagraph (b) of this
paragraph to all similarly situated pharmacies that received the challenged
rate of reimbursement for the particular drug or medical product or device that
was at issue in the initial appeal, including any appeals pending with a PBM
where the challenged rate of reimbursement is the subject of the pending
appeal, by:
1. Notifying all similarly
situated pharmacies of the adjusted rate of reimbursement in writing. The
notice shall contain the applicable national drug code number or the unique
device identifier at issue, as appropriate, and the rate of reimbursement to
which the similarly situated pharmacy is now entitled for the drug or medical
product or device; and
2. Paying
all similarly situated pharmacies the difference in the original rate of
reimbursement the similarly situated pharmacy received and the adjusted rate of
reimbursement that resulted from the initial appeal resolved in favor of a
pharmacy. The PBM shall not charge any fees or require any additional
documentation from similarly situated pharmacies to pay the difference required
under this part.
(b) The
findings from an initial appeal resolved in favor of a pharmacy shall be
applied retroactively under subparagraph (a) of this paragraph by applying the
adjusted rate to all similarly situated pharmacies beginning on the date of
service of the claim that was the subject of the initial appeal and continuing
to apply that rate going forward until the appealing pharmacy and the similarly
situated pharmacy or pharmacies were no longer entitled to the same rate of
reimbursement for the drug or medical product or device at issue.
(c) A PBM shall track initial appeals such
that it can reasonably determine if an adjusted rate of reimbursement
applies.
(5) If a
pharmacy's initial appeal is resolved against the appealing pharmacy, the PBM
shall comply with the provisions of T.C.A. § 56-7-3206(c)(4).
(a)
1. The
PBM shall determine whether the product associated with the national drug code
number or unique device identifier is available at a cost that is less than the
challenged rate of reimbursement from a pharmaceutical wholesaler in this state
as of the date the initial appeal was received from the appealing pharmacy. The
PBM shall make a reasonable effort to identify such information and must
provide to the pharmacy any information complying with, and as set out in,
T.C.A. § 56-7-3206(c)(4)(A).
2. For purposes of this subparagraph (a), the
product associated with the national drug code number or unique device
identifier at issue shall be deemed available if, at the time the initial
appeal was received by the PBM, the product was in stock with a wholesaler
operating in this state.
3. If,
after a reasonable effort to identify the information needed to make the
determination required under part 1. of this subparagraph, the PBM is unable to
make the determination solely because the wholesalers contacted by the PBM
failed to provide the information needed by the PBM within the timeframe within
which the PBM must resolve initial appeals, the PBM shall presume that the
product associated with the national drug code number or unique device
identifier at issue was not available at a cost that is less than the
challenged rate of reimbursement from a pharmaceutical wholesaler in this state
as of the date the initial appeal was received from the appealing
pharmacy.
4. If a PBM fails to
provide the information required under T.C.A. § 56-7-3206(c)(4)(A) within
the required timeframe, it shall be deemed to have determined there is no
pharmaceutical wholesaler operating in this state that offered the product
associated with the national drug code number or unique device identifier at
issue at a cost that is less than the challenged rate of reimbursement as of
the date the initial appeal was received from the appealing pharmacy.
(b)
1. The pharmacy shall provide the PBM with
the name of its majority wholesaler for the purpose of allowing the PBM to
accurately fulfill its obligations under T.C.A. § 56-7-3206(c)(4)(B). The
PBM shall then determine whether the prescription drug or device at issue is
available from the pharmaceutical wholesaler at a cost that is less than the
challenged rate of reimbursement as of the date the initial appeal was received
from the appealing pharmacy. If the pharmacy fails to provide the name of its
majority wholesaler within two business days of a request by the PBM to provide
that name, the PBM may presume the prescription drug or device at issue is
available at a cost that is less than the challenged rate of reimbursement from
the pharmacy's majority wholesaler and take no further action pursuant to
T.C.A. § 56-7-3206(c)(4) or this subparagraph (b).
2. For purposes of this subparagraph (b), the
product associated with the national drug code number or unique device
identifier at issue shall be deemed available if, at the time the initial
appeal was received by the PBM, the product was in stock from the pharmacy's
majority wholesaler.
3. If, after
contacting the pharmacy's majority wholesaler to identify the information
needed to make the determination required under part 1. of this subparagraph,
the PBM is unable to make the determination solely because the wholesaler
failed to provide the information needed by the PBM within the timeframe within
which the PBM must resolve initial appeals, the PBM shall presume that the
product associated with the national drug code number or unique device
identifier at issue was not available at a cost that is less than the
challenged rate of reimbursement from the wholesaler as of the date the initial
appeal was received from the appealing pharmacy.
(c) The pharmacy shall cooperate with the PBM
to assist in its search under subparagraphs (a) and (b) of this paragraph;
provided, however, that, except as provided in part (b)1. of this paragraph,
neither the pharmacy's nor a wholesaler's failure to cooperate or provide the
PBM information shall be grounds for the PBM to fail to meet its obligations
under T.C.A. § 56-7-3206(c)(4) or this paragraph.
(d) Even if the PBM determines it has a basis
to deny an initial appeal for a reason other than that the pharmacy was
reimbursed actual cost, the PBM shall follow the requirements set out in T.C.A.
§ 56-7-3206(c)(4).
(e) If a
pharmacy's initial appeal is resolved against the appealing pharmacy and the
PBM is required to adjust the challenged rate of reimbursement pursuant to
T.C.A. § 56-7-3206(c)(4)(B), the PBM shall, to effectuate adjustment of
the challenged rate, apply the findings from the appeal as to the rate of
reimbursement for the drug or medical product or device at issue to other
similarly situated pharmacies in the same manner as set forth in paragraph (4)
of this rule.
(6) If a
pharmacy's initial appeal is resolved against the appealing pharmacy, the PBM
shall provide the pharmacy the following in writing:
(a) A statement the initial appeal is denied,
along with a summary outlining the basis for its decision;
(b) If applicable, evidence the PBM has
adjusted the challenged rate of reimbursement;
(c) If applicable, detailed instructions for
how to reverse and rebill the claim upon which the initial appeal is
based;
(d) If applicable, written
notification the PBM has issued payment to the pharmacy showing the exact
amount of the payment; and
(e)
Instructions on how to make an external appeal of the PBM's decision to the
Commissioner by:
1. Explaining how to submit
an appeal, including the appropriate phone number or website address for the
Department where appeals are accepted. Each PBM shall be responsible for
ensuring the information provided to pharmacies pursuant to this part 1. is
accurate; and
2. Including the
following statement:
Pursuant to T.C.A. § 56-7-3206(g)(2), you have the right
to appeal this decision to the Commissioner of the Tennessee Department of
Commerce and Insurance.
(7)
(a) If
a PBM is required to pay a pharmacy any additional money upon resolution of an
initial appeal, including a payment to a similarly situated pharmacy under part
(4)(a)2. of this rule, the PBM shall adjust the rate of reimbursement and make
such payment within seven business days after notice of the initial appeal is
received by the PBM. However, subject to subparagraph (b), the timeline for
making the payment(s) shall not begin until the appealing pharmacy has reversed
and rebilled its claim showing the adjusted rate of reimbursement.
(b) If the appealing pharmacy fails to
reverse and rebill its claim pursuant to subparagraph (a), the PBM shall adjust
the rate of reimbursement and make the payment(s) no later than fifteen
business days after the PBM receives notice of the initial appeal.
(8) A PBM shall retain all records
related to an initial appeal pursuant to Rule 0780-01-95-.14. A PBM shall
provide the Department access to all records upon request and comply with
requests for information regardless of whether the request is part of an audit
by the Department.
(9) A PBM shall
not assess any costs to a pharmacy for any services provided by the PBM in
connection with an initial appeal.
(10) An initial appeal shall not result in a
pharmacy, whether the appealing pharmacy or a similarly situated pharmacy,
being required to reimburse or refund a PBM any portion of a payment previously
received by the pharmacy.
(11) This
rule applies only to initial appeals submitted to a PBM under the PBM's initial
appeal process established in accordance with T.C.A. § 56-7-3206(c)(2)(A)
and approved pursuant to Rule
0780-01-95-.03.
Authority: T.C.A. §§
56-7-3101 and
56-7-3206.
