Iowa Admin. Code r. 191-59.8

Current through Regsiter Vol. 46, No. 26, June 12, 2024

Rule 191-59.8 - Complaints

(1)System to record complaints. Each pharmacy benefits manager shall develop an internal system to record and report complaints. This system shall include but not be limited to the following information regarding each complaint:

a. The reason for the complaint and any factual documentation submitted by the complainant to support the complaint;

b. Contact name, address and telephone number of the pharmacy;

c. Prescription number;

d. Prescription reimbursement amount for any disputed claim;

e. Any disputed prescription claim payment date of fill;

f. Third-party payor benefits certificate;

g. The justification for final determination and outcome of the complaint, including but not limited to the section and language of the contract or provider manual that was used in making the determination;

h. The name of any pharmacy services administrative organization, if known by the pharmacy benefits manager, with which the pharmacy or the pharmacy benefits manager has a contract and that is involved in the matter; and

i. For complaints related to the maximum allowable cost or other pricing methodology used to pay a pharmacy, documentation demonstrating compliance with Iowa Code section 510B.8A as appropriate based on the nature of the complaint.

(2)Quarterly complaint summary. A summary of all complaints received by the pharmacy benefits manager each calendar quarter shall be submitted to the commissioner, in a form and manner prescribed by the commissioner, within 30 days after the calendar quarter has ended. The summary shall include the following:

a. Name, address, telephone number and email address for a contact person for the pharmacy benefits manager;

b. Information related to any pharmacy's appeal or request for an independent third-party review of an audit report pursuant to subrules 59.4(4) and 59.4(5);

c. Information related to any pharmacy's comment on or contest or appeal of a maximum allowable cost, maximum allowable cost list or other pricing methodology used to pay a pharmacy;

d. Information related to any request by a pharmacy for and the outcome of an independent third-party review of a termination or suspension decision pursuant to paragraph 59.6(3)"d";

e. A summary of the information listed in paragraph 59.8(1)"a," excluding documentation; and / The information listed in paragraphs 59.8(1)"b," "c," "d," "e, " and "g."

(3)Confidentiality. The quarterly complaint summary shall be confidential pursuant to subrule 59.10(5).

(4)Inquiries and complaints from the commissioner.

a. A pharmacy benefits manager shall comply with Iowa Code section 507B.4A(1) in responding promptly to an inquiry from the commissioner, including a complaint.

b. When responding to an inquiry or complaint from the commissioner, a pharmacy benefits manager shall include the Food and Drug Administration National Drug Code number, the names of the manufacturers of the prescription drugs that are related to the inquiry, and the names of any pharmaceutical wholesalers, if:

(1) The pharmacy benefits managers can determine that information from their records and other knowledge of the subject matter of the inquiry or complaint; or

(2) The commissioner has provided enough information in the inquiry or complaint for the pharmacy benefits manager to identify such facts.

(5)Penalties. A pharmacy benefits manager that fails to timely submit to the commissioner a complete quarterly complaint summary shall pay a late fee of $100. If a pharmacy benefits manager fails to submit a complete quarterly complaint summary within 30 days after the calendar quarter has ended, the pharmacy benefits manager may be subject to penalties as set forth in rule 191-59.12(505,507,507B,510,510B,510C,514L).

Iowa Admin. Code r. 191-59.8

ARC 1466C, IAB 5/28/2014, effective 7/2/2014

Amended by IAB April 27, 2016/Volume XXXVIII, Number 22, effective 6/1/2016

Amended by IAB February 8, 2023/Volume XLV, Number 16, effective 3/15/2023

Amended by IAB June 14, 2023/Volume XLV, Number 25, effective 7/19/2023