Chapter 02. Prescription Drug Affordability Fund
Regulation .01 Prescription Drug Affordability Fund.LinkCopy Citation
A.
The Prescription Drug Affordability Fund is a special, non-lapsing fund that is not subject to State Procurement Article, §7–302, Annotated Code of Maryland.
B.
The Prescription Drug Affordability Fund consists of:
(1)
The assessment provided for by Regulation .02 of this chapter;
(2)
Money appropriated by the State budget;
(3)
Interest earnings; and
(4)
Any other money from any other source accepted for the benefit of the Fund.
Regulation .02 Fee Assessment, Exemption, Waiver, and Collection.LinkCopy Citation
A.
Annual Assessment.
(1)
In each State fiscal year, the Board shall issue a fee assessment to each entity identified in Health-General Article, §21-2C-11, Annotated Code of Maryland, and Regulation .03 of this chapter and collect the assessment.
(2)
Unless the entity requests and is granted an exemption from the assessment, the entity shall pay the assessment by October 1.
(3)
An entity may pay the assessment by ACH transfer, wire transfer, or check.
B.
Exemption from Assessment.
(1)
An entity may request an exemption from the annual assessment by submitting a completed exemption form to the Board within 30 days of the Board transmitting the fee assessment.
(2)
The exemption form shall be executed under oath and attest that:
(a)
The entity is not a qualifying entity as defined in COMAR 14.01.01 and Health-General Article, §21-2C-11(b)(1), Annotated Code of Maryland;
(b)
The entity no longer does business in Maryland; or
(c)
The entity is not subject to assessment for another reason with an explanation of that reason.
(3)
The entity bears the burden of demonstrating it qualifies for the claimed exemption and shall submit documentation in support of the exemption request, as follows:
(a)
The entity shall provide an executed certificate of business record (available on the Board’s website) authenticating any business record the entity submits in support of the request for exemption.
(b)
For carriers, supporting documentation may include but is not limited to NAIC “Annual Statement” including the cover page (signature page/jurat), Maryland State page, and Schedule T, acknowledgment from Maryland Insurance Administration of merger/change in subsidiary status, and SEC 10-K (any applicable exhibits).
(c)
For manufacturers, distributors, and PBMs, supporting documentation may include but is not limited to discharge in bankruptcy, documentation of merger/change in corporate structure/subsidiary status (for example, SEC 10-K and any applicable exhibits), acknowledgment from Board of Pharmacy of expiration of license/registration, expired license/registration, documentation that manufacturer/distributor provides only non-covered products (for example, provides gases only, product or inventory lists), and documentation that the entity does not do business in Maryland.
(d)
If the entity is unable to provide any documentation supporting the claimed exemption, the entity shall provide an affidavit (form on Board’s website) from the chief operating officer, chief financial officer, or other authorized official attesting to the factual basis of the claimed exemption.
(4)
While the exemption request is pending, payment of the assessment is deferred.
(5)
The Board shall determine all requests for exemption promptly.
C.
Reconsideration.
(1)
Within 15 days of the notice denying the exemption, an entity may file for reconsideration of the denial of a request for exemption by submitting:
(a)
A request for reconsideration on the form provided; and
(b)
Additional information or documentation in support of the claimed exemption.
(2)
A request for reconsideration that does not include additional information or additional documentation will be denied.
(3)
If the request for exemption is denied after reconsideration, the entity shall pay the assessment within 30 days of the issuance of the notice of denial.
D.
Collection and Penalties.
(1)
Any fee assessment not paid within 30 days of the payment due date may be subject to an interest penalty to be determined and collected by the Board.
(2)
In addition to any penalties the Board may impose on an entity that fails to pay the fee assessed by the Board in a timely manner, the Board may also refer an entity’s delinquent account to the Department of Budget and Management’s Central Collection Unit, pursuant to the procedures in State Finance and Procurement Article, Title 3, Subtitle 3, Annotated Code of Maryland, and COMAR 17.01.01.
E.
Maintenance of Assessment List.
(1)
The Board shall maintain a list of entities that are subject to assessment as identified in Health-General Article, §21-2C-11, Annotated Code of Maryland.
(2)
At any time, Board staff may:
(a)
Review the list, but staff shall review the list on at least an annual basis;
(b)
Add additional entities reported by or obtained from other agencies or identified by staff; and
(c)
Remove entities if the entity:
(i)
Is no longer a going concern; or
(ii)
Has been determined to be exempt from assessment.
Regulation .03 Amount of Assessment.LinkCopy Citation
A.
Entities identified in Health-General Article, §212C11, Annotated Code of Maryland, shall be subject to the following fee schedule:
(1)
Manufacturers engaged in wholesale distribution, as defined in Health Occupations Article, §126C01, Annotated Code of Maryland, shall pay an assessment of $1,000;
(2)
Wholesale distributors, as defined in Health Occupations Article, §126C01, Annotated Code of Maryland, that distribute prescription drugs shall pay an assessment of $1,000;
(3)
Pharmacy benefits managers, as defined in Insurance Article, §151601, Annotated Code of Maryland, shall pay an assessment of $1,000; and
(4)
Carriers that provide health benefit plans, as defined in Health-General Article, §19-132(e), Annotated Code of Maryland, shall pay an assessment of $1,000.
B.
An entity may request to pay the annual assessment in installments by submitting a letter to the Board demonstrating significant financial hardship in paying the assessment in a single payment.
Regulation .04 Use of Funds.LinkCopy Citation
A.
The Fund may only be used to finance the operation of the Board, as permitted in Health-General Article, §21–2C–11(c)(6), Annotated Code of Maryland.
B.
Interest earned from the monies collected through the assessment in Regulation .02 of this chapter shall be retained to the credit of the Fund.
Regulation .05 Surplus Funds.LinkCopy Citation
If the amount of assessed funds collected in a calendar year exceeds the cap identified in Health-General Article, §21–2C–11(B)(4), the Board shall:
A.
Issue a notice of such surplus; and
B.
Remit the surplus funds in a fair and equitable manner across all qualifying entities that have paid the assessment.
Chapter annotations
Authority: Health-General Article, §§21-2C-03(f) and 21-2C-11, Annotated Code of Maryland
History: Effective date: September 6, 2021 (48:18 Md. R. 692)
History: Regulation .02 amended as an emergency provision effective November 16, 2021 (48:26 Md. R. 1107); emergency provision expired May 6, 2022
History: Regulation .02 amended effective August 22, 2022 (49:17 Md. R. 791); October 2, 2023 (50:19 Md. R 854)
History: Regulation .03 amended effective August 19, 2024 (51:16 Md. R. 743)
History: Regulation .03A amended effective October 2, 2023 (50:19 Md. R 854)
History: Regulation .03B amended as an emergency provision effective November 16, 2021 (48:26 Md. R. 1107); emergency provision expired May 6, 2022
History: Regulation .03B amended effective August 22, 2022 (49:17 Md. R. 791)