2712.1 The Department of Health Care Finance (DHCF) shall implement the Pharmacy Lock-In Program established by this section to safeguard against the following types of misuse of medications by beneficiaries enrolled in the District of Columbia Medicaid Fee-for-Service (FFS) program:

(a) Use of drugs in excess of the customary dosage for the proper treatment of the given diagnosis; and

(b) Use of multiple drugs in a manner that can be medically harmful.

2712.2 DHCF shall use the drug utilization guidelines established by the DUR Board in support of the lock-in to a single pharmacy or medical provider, as outlined in further detail in section 2712.3.

2712.3 The Medicaid FFS Pharmacy Benefit Manager (PBM) shall submit a monthly report to DHCF and the DUR Board that identifies Medicaid FFS beneficiaries who, within the prior ninety (90) days, meet one (1) or more of the following criteria:

(a) Three (3) or more controlled substance prescriptions per month;

(b) Three (3) or more prescribers for controlled substance prescriptions per month;

(c) Three (3) or more pharmacies for controlled substance prescriptions per month; or

(d) Ten (10) or more prescriptions per month.

2712.4 If a beneficiary is identified as having met one (1) or more of the criteria listed in subsection 2712.1 or 2712.3, DHCF may impose a lock-in on the beneficiary by doing the following:

(a) Assigning the beneficiary to a single pharmacy provider;

(b) Assigning the beneficiary to a single medical provider; or

(c) Assigning the beneficiary to a single pharmacy provider and a single medical provider.

2712.5 At least thirty (30) days before the effective date of a lock-in, DHCF shall issue to

the beneficiary a notice, consistent with the requirements at 42 CFR § 435.917, that includes the following information:

1. (a) A statement of DHCF's intent to designate the beneficiary as a pharmacy lock-in beneficiary;
2. (b) The reason for the intended lock-in;
3. (c) If DHCF intends to lock in the beneficiary to a single pharmacy provider:
4. (1) A list of three (3) pharmacy providers from which the beneficiary may select their preferred pharmacy for the lock-in, and the deadline by which the beneficiary must make the selection; and
5. (2) An explanation that if the beneficiary does not select a pharmacy provider from the list provided by DHCF within fifteen (15) days of DHCF's notice, DHCF will designate the pharmacy lock-in provider;
6. (d) If DHCF intends to lock in the beneficiary to a single medical provider, the name of the medical provider to which the beneficiary will be locked in (which shall be the beneficiary's primary care provider);
7. (e) The specific laws and regulations, with citations, supporting DHCF's intent to designate the beneficiary as a pharmacy lock-in participant;
8. (f) The beneficiary's right to a hearing if the beneficiary disagrees with the designation, the deadline by which the beneficiary must request a hearing, and the procedures for requesting a hearing;
9. (g) An explanation that DHCF will not implement the lock-in if the beneficiary requests a hearing within thirty (30) days of DHCF's notice.

2712.6 When a lock-in includes assigning a beneficiary to a single pharmacy provider, the beneficiary may select their lock-in pharmacy, from the list provided by DHCF pursuant to section 2712.5(c), within fifteen (15) days of DHCF’s notice under § 2712.5. If the beneficiary does not select a lock-in pharmacy within the fifteen (15) day period, DHCF shall designate a lock-in pharmacy provider.

2712.7 The beneficiary shall have ninety (90) days from the date of the notice described in § 2712.5 to file a request for a hearing with the Office of Administrative Hearings (“OAH”).

2712.8 If the beneficiary requests a hearing within thirty (30) days from the date of the

notice described in § 2712.5, no further action shall be taken by DHCF on the intended lock-in until the request for a hearing is dismissed or a final decision has been rendered by the OAH upholding the lock-in.

2712.9 If the beneficiary does not request a hearing within thirty (30) days from the date of the notice described in § 2712.5, DHCF shall impose the lock-in and send a notice to the beneficiary stating that the lock-in has become effective. The notice shall also identify the lock-in pharmacy assigned to the beneficiary.

2712.10 A lock-in imposed pursuant to § 2712.9 shall remain in effect even if the beneficiary requests a hearing thirty-one (31) to ninety (90) days from the date of the initial notice described in § 2712.5. The lock-in shall be revised or revoked, if necessary, based on the final decision issued by OAH.

2712.11 A pharmacy lock-in may be imposed for a period of time not to exceed twelve (12) months; provided, that the lock-in may be renewed or extended for subsequent periods of time each not to exceed twelve (12) months.

(a) No lock-in shall be imposed without a review by the DUR Board.

(b) Subsequent lock-ins for the beneficiary shall not be imposed until after a review by the DUR Board has concluded.

2712.12 DHCF shall ensure that when a lock-in has been imposed, the beneficiary will continue to have reasonable access to adequate Medicaid services.

2712.13 DHCF shall not apply a lock-in to a situation where the beneficiary uses emergency services.

2712.14 The following beneficiaries shall not be subject to a pharmacy lock-in:

(a) Beneficiaries receiving care in:

(1) Skilled nursing facilities;

(2) Long term care facilities; or

(3) Intermediate care facility for people with developmental disabilities/intellectual disabilities (ICF/IDD);

(b) Beneficiaries with an active cancer diagnosis;

(c) Beneficiaries who are homeless;

(d) Beneficiaries with a recent surgery or hospitalization;

(e) Beneficiaries who are determined to be “self-locked-in” (for the purposes of this provision, when the beneficiary receives approximately 85% of their medications from one (1) pharmacy); and

(f) Other individual beneficiaries designated by the DUR Board, on a case-by-case basis.

2712.15 Each Medicaid MCO, or its designee, shall implement a pharmacy lock-in program as comprehensive as the lock-in program outlined in this section.

2712.16 If a Medicaid FFS beneficiary subject to a pharmacy lock-in subsequently becomes enrolled in a Medicaid MCO, the beneficiary shall be automatically enrolled in the Medicaid MCO’s Pharmacy Lock-In Program. The lock-in shall remain in effect for the length of the lock-in imposed by Medicaid FFS.

2712.17 If a Medicaid MCO beneficiary subject to a pharmacy lock-in subsequently becomes enrolled in Medicaid FFS, the beneficiary shall be automatically enrolled in the Medicaid FFS’s lock-in program. The lock-in shall remain in effect for the length of the lock-in imposed by the MCO.

2712.18 If a Medicaid MCO beneficiary subject to a pharmacy lock-in subsequently becomes enrolled in another Medicaid MCO, that beneficiary shall be automatically enrolled in the new Medicaid MCO’s lock-in program. The lock-in shall remain in effect for the length of the lock-in imposed by the original Medicaid MCO.

SOURCE: Notice of Final Rulemaking published at 59 DCR 2298, 2308 (March 23, 2012); as amended by Final Rulemaking published at 70 DCR 002719 (March 3, 2023).