Tenn. Comp. R. & Regs. 0780-01-95-.15

Current through June 26, 2024

Section 0780-01-95-.15 - ANNUAL REPORTS

(1) Beginning April 1, 2025, and annually on or before April 1 of each year thereafter, each PBM shall file with the Commissioner a written report that contains the following information for the preceding calendar year on a form and in the manner provided by the Commissioner, along with the review fee required under Rule 0780-01-95-.07(5):

(a) The total number of claims paid by the PBM for prescription drugs or devices;

(b) The total number of claims paid by the PBM to pharmacies physically located in Tennessee, or to mail order pharmacies or specialty pharmacies on behalf of Tennessee residents, for prescription drugs or devices;

(c) Descriptions of all fees assessed by the PBM to pharmacies physically located in Tennessee, mail order pharmacies that serve Tennessee residents, or specialty pharmacies that serve Tennessee residents;

(d) A schedule listing the unique identifier used by the PBM for internal distribution and identification of each MAC list used for pharmacy reimbursement at any point during the year for any pharmacy physically located in Tennessee, any mail order pharmacy that served Tennessee residents, or any specialty pharmacy that served Tennessee residents. For each MAC list, the PBM must specify:

1. Each pharmacy network that utilizes the MAC list as a basis for reimbursement, with each network identified by the unique identifier provided in part (e)1.;

2. The policies, procedures, or criteria used to determine which prescription drugs or devices are placed on the MAC list; and

3. The policies, procedures, or criteria used when updating the MAC list;

(e) A schedule of all the PBM's pharmacy networks that contain pharmacies physically located in Tennessee, mail order pharmacies that serve Tennessee residents, or specialty pharmacies that serve Tennessee residents. For each network, the schedule must include the following information:

1. The unique identifier of the network used by the PBM for internal distribution and identification;

2. A description of the network's purpose;

3. A schedule of all pharmacies physically located in Tennessee, mail order pharmacies that serve Tennessee residents, and specialty pharmacies that serve Tennessee residents that were removed from the network, along with the following information for each pharmacy removed;

(i) Pharmacy name and national provider identifier; and

(ii) The name of the network from which the applicant was removed; and

4. A schedule of denied network applications received from pharmacies physically located in Tennessee, mail order pharmacies that would have served Tennessee residents, or specialty pharmacies that would have served Tennessee residents, along with the following information for each application:

(i) Pharmacy name and national provider identifier; and

(ii) The name of the network into which the applicant was seeking entry;

(f) A schedule of all pharmacies contracted with the PBM that are physically located in Tennessee, mail order pharmacies that served Tennessee residents, or specialty pharmacies that served Tennessee residents. For each pharmacy listed, provide the following information:

1. Name and national provider identifier;

2. Total dollar amount of claims paid by the PBM to the pharmacy;

3. Total number of claims paid by the PBM to the pharmacy;

4. The unique identifier of the PBM's network(s) in which the pharmacy participates;

5. The start and end date(s) of all contracts with the pharmacy, including all amendments, addendums, exhibits, provider manuals, and other documents that contain terms or conditions material to the contractual relationship between the PBM and the pharmacy;

6. Whether the pharmacy is an affiliate of or shares any common ownership through a parent entity with the PBM; and

7. Whether the pharmacy certified as a low-volume pharmacy with the PBM pursuant to Rule 0780-01-95-.10 for any portion of the calendar year;

(g)

1. A complete schedule of pharmacy audits completed during the previous calendar year for pharmacies physically located in Tennessee, mail order pharmacies that served Tennessee residents, or specialty pharmacies that served Tennessee residents, along with the following information on each completed audit:

(i) The name of the pharmacy audited and the pharmacy's national provider identifier;

(ii) The start and completion date of the audit;

(iii) Total number of claims audited;

(iv) Preliminary recoupment amount(s), if any; and

(v) Final recoupment amount(s), if any.

2. For purposes of this subparagraph (g), a PBM's audit of a pharmacy includes, but is not limited to, activities by a PBM that may be described as periodic audits; investigations; prescription validation requests; fraud, waste, and abuse reviews; desktop audits; or other similar processes or reviews intended to allow a PBM to inspect a pharmacy's internal records or processes;

(h) The number of initial appeals filed with the PBM;

(i) The number of initial appeals resolved in favor of pharmacies;

(j) The number of initial appeals resolved against pharmacies;

(k) The total amount of money paid to appealing pharmacies as a result of initial appeals resolved in favor of pharmacies;

(l) The total amount of money paid to similarly situated pharmacies as a result of initial appeals resolved in favor of pharmacies;

(m) The number of initial appeals that were appealed to the Commissioner of which the PBM received notice;

(n) A written statement certifying the PBM meets the requirements of Rule 0780-01-95-.05(1)(c) along with timestamped screenshots of the PBM's website showing the required information is on the PBM's website and is readily accessible by pharmacies; and

(o) Any other documentation or information requested by the Commissioner.

(2) PBMs may exclude information from the report required under paragraph (1) if the information pertains exclusively to plans in T.C.A. § 56-7-3102(1)(B).

(3) On or before August 1, 2024, each PBM shall file with the Commissioner a written report that contains the information required under subparagraphs (h) through (o) of paragraph (1) for calendar year 2023 on a form and in the manner provided by the Commissioner, along with the review fee required under Rule 0780-01-95-.07(5).

(4) The Commissioner may extend a PBM's deadline for filing its annual report for good cause shown.

(5)

(a) A PBM may redact information from its annual report that is confidential or proprietary information or a trade secret as those terms, or substantially similar terms as determined by the Department, are defined in Tennessee or federal law. Upon request from the Commissioner, a PBM shall provide the specific authority and rationale on which it based its determination that redacted information is confidential or proprietary or a trade secret.

(b) A PBM shall not redact information from annual reports pursuant to subparagraph (a) as confidential or proprietary information or trade secrets if such information is confidential under Tennessee or federal law such that the Department determines it is not available for public inspection while in the Department's possession.

Tenn. Comp. R. & Regs. 0780-01-95-.15

New rules filed March 28, 2024; effective 6/26/2024.

Authority: T.C.A. § 56-7-3101.