The Council finds that:
(1) Affordability is critical in providing access to prescription drugs for District of Columbia residents.
(2) AccessRx enables the District to take steps to make prescription drugs more affordable for qualified District residents, thereby increasing the overall health of District residents, promoting healthy communities, and protecting the public health and welfare.
(3) AccessRx can be integrated with any District-wide program for the uninsured.
(4) The intent of AccessRx is not to discourage employers from offering or paying for prescription drug benefits for their employees or to replace employer-sponsored prescription drug benefit plans that provide benefits comparable to those made available to qualified District residents under AccessRx.
(May 18, 2004, D.C. Law 15-164, § 101, 51 DCR 3688.)
HISTORICAL AND STATUTORY NOTES
Legislative History of Laws
Law 15-164, the "Access RX Act of 2004", was introduced in Council and assigned Bill No. 15-569, which was referred to the Committee on Human Services. The Bill was adopted on first and second readings on February 3, 2004, and March 2, 2004, respectively. Signed by the Mayor on March 24, 2004, it was assigned Act No. 15-410 and transmitted to both Houses of Congress for its review. D.C. Law 15-164 became effective on May 18, 2004.
For the purposes of this chapter, the term:
(1) "AccessRx" means the District of Columbia AccessRx program established by § 48-831.03.
(2) "Average wholesale price" means the wholesale price charged for a specific commodity that is assigned by the drug wholesaler and is listed in a nationally recognized drug pricing registry that is updated daily and charged to the retail pharmacy.
(3) "Basic component of AccessRx" includes the provision of drugs and medications for cardiac conditions and high blood pressure, diabetes, arthritis, anticoagulation, hyperlipidemia, osteoporosis, chronic obstructive pulmonary disease and asthma, incontinence, thyroid diseases, glaucoma, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, and other conditions approved by the Department. The term "basic component of AccessRx" shall also include the provision of over-the-counter medications that are prescribed by a health care provider and approved as cost-effective by the Department.
(4)(A) "Covered entity" means:
(i) Any hospital or medical service organization, insurer, health coverage plan, or health maintenance organization licensed in the District that contracts with another entity to provide prescription drug benefits for its customers or clients;
(ii) Any health program administered by the Department or the District in its capacity as provider of health coverage; or
(iii) Any employer, labor union, or other group of persons organized in the District that contracts with another entity to provide prescription drug benefits for its employees or members who are employed or reside in the District of Columbia.
(B) The term "covered entity" does not include a health plan that provides coverage only for accidental injury, specified disease, hospital indemnity, Medicare supplement, disability income, long-term care, or other limited benefit health insurance policies and contracts.
(5) "Covered individual" means a member, participant, enrollee, contract holder, policy holder, or beneficiary of a covered entity who is provided a prescription drug benefit by the covered entity. The term "covered individual" includes a dependent or other person provided a prescription drug benefit through a policy, contract, or plan for a covered individual.
(6) "Department" means the Department of Health.
(7) "Director" means the Director of the Department of Health.
(8) "District" means the District of Columbia.
(9) "Generic drug" means a chemically equivalent copy of a brand-name drug with an expired patent.
(10) "Initial discounted price" for a drug means the price the Department pays D.C. Medicaid participating retail pharmacies for that drug for District of Columbia Medicaid recipients.
(11) "Labeler" means an entity or person that receives prescription drugs from a manufacturer or wholesaler and repackages those drugs for later retail sale and that has a labeler code from the federal Food and Drug Administration under 21 C.F.R.§ 207.20.
(12) "Manufacturer" means a manufacturer of prescription drugs and includes a subsidiary or affiliate of a manufacturer.
(13) "Marketing" means advertising and promotional activities, including, but not limited to, the activities described in § 48-833.03.
(14) "National Drug Code registration number" means the number registered for a drug pursuant to the listing system established by the United States Food and Drug Administration under section 510 of the Federal Food, Drug, and Cosmetic Act, approved October 10, 1962 (76 Stat. 794; 21 U.S.C. § 360).
(15) "Participating retail pharmacy" or "retail pharmacy" means a retail pharmacy located in the District, or another business licensed to dispense prescription drugs in the District, that participates in the program.
(16) "Pharmacy benefits management" means a service provided to covered entities to facilitate the provision of prescription drug benefits to covered individuals for dispensation within the District of Columbia, including negotiating pricing and other terms with drug manufacturers and retails pharmacies. "Pharmacy benefits management" may include any or all of the following:
(A) Claims processing, retail network management, and payment of claims to pharmacies for prescription drugs dispensed to covered individuals for dispensation within the District of Columbia;
(B) Clinical formulary development and management services;
(C) Rebate contracting and administration;
(D) Certain patient compliance, therapeutic intervention, and generic substitution programs; and
(E) Disease management programs.
(17) "Pharmacy benefits manager" means an entity that performs pharmacy benefits management. The term "pharmacy benefits manager" includes a person or entity acting for a pharmacy benefits manager in a contractual or employment relationship in the performance of pharmacy benefits management for a covered entity.
(18) "Qualified resident" means a resident of the District who is eligible for the AccessRx program pursuant to this subchapter.
(19) "Secondary discounted price" means the initial discounted price minus any further discounts paid for out of the AccessRx Fund.
(20) "Supplemental component of AccessRx" includes all prescription drugs and medications provided under the D.C. Medicaid program excluding those provided pursuant to the basic component of AccessRx.
(May 18, 2004, D.C. Law 15-164, § 102, 51 DCR 3688; Mar. 2, 2007, D.C. Law 16-192, § 5062(a), 53 DCR 6899.)
HISTORICAL AND STATUTORY NOTES
Effect of Amendments
D.C. Law 16-192, in par. (4)(A)(iii), substituted "for its employees or members who are employed or reside in the District of Columbia" for "for its employees or members"; and, in par. (16), substituted "to covered individuals for dispensation within the District of Columbia" for "to covered individuals".
Temporary Amendments of Section
For temporary (225 day) amendment of section, see § 2(a) of AccessRx Act Clarification Temporary Amendment of Act of 2006 (D.C. Law 16-154, September 19, 2006, law notification 53 DCR 7926).
Emergency Act Amendments
For temporary (90 day) amendment of section, see § 2(a) of AccessRX Act Clarification Emergency Amendment Act of 2006 (D.C. Act 16-370, May 5, 2006, 53 DCR 4059).
For temporary (90 day) amendment of section, see § 5062(a) of Fiscal Year 2007 Budget Support Emergency Act of 2006 (D.C. Act 16-477, August 8, 2006, 53 DCR 7068).
For temporary (90 day) amendment of section, see § 5062(a) of Fiscal Year 2007 Budget Support Congressional Review Emergency Act of 2006 (D.C. Act 16-499, October 23, 2006, 53 DCR 8845).
For temporary (90 day) amendment of section, see § 5062(a) of Fiscal Year 2007 Budget Support Congressional Review Emergency Act of 2007 (D.C. Act 17-1, January 16, 2007, 54 DCR 1165).
Legislative History of Laws
For Law 15-164, see notes following § 48-831.01.
Law 16-192, the "Fiscal Year Budget Support Act of 2006", was introduced in Council and assigned Bill No. 16-679, which was referred to the Committee of the Whole. The Bill was adopted on first and second readings on May 9, 2006, and June 6, 2006, respectively. Signed by the Mayor on August 8, 2006, it was assigned Act No. 16-476 and transmitted to both Houses of Congress for its review. D.C. Law 16-192 became effective on March 2, 2007.
Miscellaneous Notes
Short title: Section 5061 of D.C. Law 16-192 provided that subtitle F of title V of the act may be cited as the "AccessRx Clarification Amendment Act of 2006".
(a) AccessRx is hereby established. AccessRx shall be administered by the Department, which shall utilize, among other things, manufacturer rebates, pharmacy discounts, and aggregate purchasing to reduce prescription drug prices. In addition, the Department shall investigate the purchase of prescription drugs from outside of the United States.
(b) The Department shall administer AccessRx and other medical and pharmaceutical assistance programs in a manner that is advantageous to the programs and to the enrollees in those programs. In implementing this subchapter, the Department may coordinate the other programs and AccessRx and may take actions to enhance efficiency, reduce the cost of prescription drugs, and maximize the benefits to the programs and enrollees, including providing the benefits of AccessRx to enrollees in other programs.
(May 18, 2004, D.C. Law 15-164, § 103, 51 DCR 3688.)
HISTORICAL AND STATUTORY NOTES
Legislative History of Laws
For Law 15-164, see notes following § 48-831.01.
The Department shall make every effort to reduce and contain the cost of prescription drugs purchased for publicly funded pharmaceutical assistance programs, including D.C. Medicaid, the D.C. Health Care Alliance, and the Department of Mental Health. These efforts shall include manufacturer rebates, pharmacy discounts, and reductions through aggregate purchases, and may include importation of pharmaceuticals from outside of the United States. These savings shall be deposited in the AccessRx Fund established in § 48-831.10
(May 18, 2004, D.C. Law 15-164, § 104, 51 DCR 3688.)
HISTORICAL AND STATUTORY NOTES
Legislative History of Laws
For Law 15-164, see notes following § 48-831.01.
A drug manufacturer or labeler that sells prescription drugs in the District through any publicly funded pharmaceutical assistance program shall enter into a rebate agreement with the Department under AccessRx. The rebate agreement shall require the manufacturer or labeler to make rebate payments to the District for deposit in the AccessRx Fund each calendar quarter or according to a schedule established by the Department.
(May 18, 2004, D.C. Law 15-164, § 105, 51 DCR 3688.)
HISTORICAL AND STATUTORY NOTES
Legislative History of Laws
For Law 15-164, see notes following § 48-831.01.
(a) The Director of the Department shall negotiate the amount of the rebate required from a manufacturer or labeler in accordance with this subchapter.
(b) The Director shall take into consideration the rebate calculated under the Medicaid Rebate Program pursuant to section 1927 of the Social Security Act, approved November 5, 1990 (104 Stat. 1388-143; 42 U.S.C. § 1396r-8), the average wholesale price of prescription drugs, and any other information on prescription drug prices and price discounts.
(c) The Director shall use the Director's best efforts to obtain an initial rebate amount equal to or greater than the rebate calculated under the Medicaid program pursuant to 42 U.S.C. § 1396r-8.
(d) With respect to the rebate that takes effect on October 1, 2005 pursuant to § 48-831.33(d), the Director shall use the Director's best efforts to obtain an amount equal to or greater than the amount of any discount, rebate, or price reduction for prescription drugs provided to the federal government. If the Department is not able to achieve the rebate amount described by this subsection, the Department shall report that fact to the standing committee of the Council having jurisdiction over the Department.
(May 18, 2004, D.C. Law 15-164, § 106, 51 DCR 3688.)
HISTORICAL AND STATUTORY NOTES
Legislative History of Laws
For Law 15-164, see notes following § 48-831.01.
(a) Participating retail pharmacies shall submit claims to the Department to verify the amount charged to qualified residents and to receive reimbursement.
(b) The Department shall not impose transaction charges on participating retail pharmacies that submit claims or receive payments under AccessRx.
(c) On a periodic basis, to be established by the Department, the Department shall reimburse a participating retail pharmacy for:
(1) The discounted price provided to uninsured qualified residents pursuant to § 48-831.33; and
(2) Prescription drugs dispensed to low-income elderly pursuant to § 48- 831.23.
(d) The Department shall conduct ongoing quality assurance activities similar to those used in the D.C. Medicaid program.
(e) The Department shall collect utilization data from participating retail pharmacies submitting claims necessary to calculate the amount of the rebate from the manufacturer or labeler. The Department shall protect the confidentiality of all information subject to confidentiality protection under District or federal law, rule or regulation.
(May 18, 2004, D.C. Law 15-164, § 107, 51 DCR 3688.)
HISTORICAL AND STATUTORY NOTES
Legislative History of Laws
For Law 15-164, see notes following § 48-831.01.
(a)(1) Upon receipt of the data from the Department, the manufacturer or labeler shall calculate the quarterly payment. If a discrepancy is discovered, the Department may, at its expense, hire a mutually agreed-upon independent auditor to verify the manufacturer's calculation. If a discrepancy is still found, the manufacturer or labeler shall justify its calculation or make payments to the Department for any additional amount due. The manufacturer or labeler may, at its expense, hire a mutually agreed-upon independent auditor to verify the accuracy of the utilization data provided by the Department. If a discrepancy is discovered, the Department shall justify its data or refund any excess payment to the manufacturer or labeler.
(2) If the dispute over the rebate amount is not resolved, a request for a hearing with supporting documentation shall be submitted to the Office of Administrative Hearings. Failure to resolve the dispute may be cause for terminating the drug rebate agreement and denying payment to the manufacturer or labeler for any drugs.
(b) All prescription drugs of a manufacturer or labeler that enters into a rebate agreement that appear on the list of approved drugs shall be immediately available and the cost of the drugs shall be reimbursed, except as provided in this section.
(May 18, 2004, D.C. Law 15-164, § 108, 51 DCR 3688.)
HISTORICAL AND STATUTORY NOTES
Legislative History of Laws
For Law 15-164, see notes following § 48-831.01.
(a) The names of manufacturers and labelers who do and do not enter into rebate agreements pursuant to this subchapter are public information. The Department shall release this information to health care providers and the public on a regular basis. The Department also shall publicize participation by manufacturers and labelers that is of particular benefit to the public.
(b) The Department shall impose prior authorization requirements, as permitted by law, in all publicly funded pharmaceutical assistance programs to the extent the Department determines it is appropriate to do so in order to encourage manufacturer and labeler participation in AccessRx, as long as the additional prior authorization requirements remain consistent with the goals of the D.C. Medicaid program and Title 19 of the Social Security Act, approved July 30, 1965 (79 Stat. 343; 42 U.S.C. § 1396 et seq.).
(May 18, 2004, D.C. Law 15-164, § 109, 51 DCR 3688.)
HISTORICAL AND STATUTORY NOTES
Legislative History of Laws
For Law 15-164, see notes following § 48-831.01.
(a) The AccessRx Fund is established as a nonlapsing, dedicated fund, into which shall be deposited revenue from manufacturers and labelers that pay rebates pursuant to this subchapter and any appropriations or allocations designated for the AccessRx Fund, along with accruing interest, to be used for the purposes specified in subsection (b) of this section.
(b) All funds in the AccessRx Fund, including any surplus or interest, shall be used to:
(1) Reimburse retail pharmacies for discounted prices provided to uninsured qualified residents pursuant to § 48-831.33;
(2) Pay benefits described in § 48-831.23; and
(3) Reimburse the Department for contracted services, including pharmacy claims processing fees, administrative and associated computer costs, and other reasonable program costs.
(c) The funds deposited in the AccessRx Fund shall not revert to the General Fund but shall continually be available for the uses designated in subsection (b) of this section, subject to authorization by Congress in an appropriations act.
(May 18, 2004, D.C. Law 15-164, § 110, 51 DCR 3688; Mar. 2, 2007, D.C. Law 16-191, § 88(a), 53 DCR 6794.)
HISTORICAL AND STATUTORY NOTES
Effect of Amendments
D.C. Law 16-191, in subsec. (b)(1), validated a previously made technical correction.
Legislative History of Laws
For Law 15-164, see notes following § 48-831.01.
Law 16-191, the "Technical Amendments Act of 2006", was introduced in Council and assigned Bill No. 16-760, which was referred to the Committee of the whole. The Bill was adopted on first and second readings on June 20, 2006, and July 11, 2006, respectively. Signed by the Mayor on July 31, 2006, it was assigned Act No. 16-475 and transmitted to both Houses of Congress for its review. D.C. Law 16-191 became effective on March 2, 2007.
The Department shall:
(1) Establish simplified procedures for determining eligibility and issuing AccessRx enrollment cards to qualified residents;
(2) Undertake outreach efforts to build public awareness of AccessRx and maximize enrollment of qualified residents; and
(3) Adjust the requirements and terms of AccessRx to accommodate any new federally funded prescription drug program.
(May 18, 2004, D.C. Law 15-164, § 111, 51 DCR 3688.)
HISTORICAL AND STATUTORY NOTES
Legislative History of Laws
For Law 15-164, see notes following § 48-831.01.
The method of prescribing or ordering drugs may include, but is not limited to, the use of standard or larger prescription refill sizes in order to minimize operational costs and maximize economy. Unless the prescribing physician indicates otherwise, the use of the lowest cost generic or chemically equivalent drugs is required; provided, that these drugs are of the same quality and have the same mode of delivery as is provided to the general public, consistent with good pharmaceutical practice.
(May 18, 2004, D.C. Law 15-164, § 112, 51 DCR 3688.)
HISTORICAL AND STATUTORY NOTES
Legislative History of Laws
For Law 15-164, see notes following § 48-831.01.
The Department may contract with one or more third parties to administer any or all components of AccessRx, including outreach, eligibility, claims, administration, and rebate recovery and redistribution.
(May 18, 2004, D.C. Law 15-164, § 113, 51 DCR 3688.)
HISTORICAL AND STATUTORY NOTES
Legislative History of Laws
For Law 15-164, see notes following § 48-831.01.
The Department may seek any waivers of federal law, rule or regulation necessary to implement the provisions of this chapter.
(May 18, 2004, D.C. Law 15-164, § 114, 51 DCR 3688.)
HISTORICAL AND STATUTORY NOTES
Legislative History of Laws
For Law 15-164, see notes following § 48-831.01.
The Department shall submit a written report on the enrollment and financial status of AccessRx to the Council by the 2nd week of January each year.
(May 18, 2004, D.C. Law 15-164, § 115, 51 DCR 3688.)
HISTORICAL AND STATUTORY NOTES
Legislative History of Laws
For Law 15-164, see notes following § 48-831.01.
The District may negotiate and enter into purchasing alliances and regional strategies with the governments of other jurisdictions, and with other public and private entities, for the purpose of reducing prescription drug prices for residents of the District.
(May 18, 2004, D.C. Law 15-164, § 116, 51 DCR 3688.)
HISTORICAL AND STATUTORY NOTES
Legislative History of Laws
For Law 15-164, see notes following § 48-831.01.
The Mayor is authorized to issue any rules necessary to implement the provisions of this subchapter.
(May 18, 2004, D.C. Law 15-164, § 117, 51 DCR 3688.)
HISTORICAL AND STATUTORY NOTES
Legislative History of Laws
For Law 15-164, see notes following § 48-831.01.
