PROPOSAL
Maryland Register
Issue Date: February 1, 2019
Volume 46 • Issue 3 • Page 126-131
Title 10
MARYLAND DEPARTMENT OF HEALTH
Subtitle 18 HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION AND ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS)
Notice of Proposed Action
[19-046-P]
The Secretary of Health proposes to:
(1) Amend Regulations .02, .04, and .05 under COMAR 10.18.01 Maryland AIDS Drug Assistance Program: Temporary Assistance Program;
(2) Amend Regulations .01—.04 and .09 under COMAR 10.18.05 Maryland AIDS Drug Assistance Program: Eligibility;
(3) Amend Regulations .01, .03, .04, .04-1, .05, .09, and .11, and repeal Regulation .04-2, under COMAR 10.18.06 Maryland AIDS Drug Assistance Program: Pharmacy Services;
(4) Amend Regulations .01—.04, .06, .07, and .11 under COMAR 10.18.07 Maryland AIDS Drug Assistance Program: Health Insurance (MADAP-PLUS); and
(5) Amend Regulations .02—.05 under COMAR 10.18.10 Urgent Maryland AIDS Drug Assistance Program.
Statement of Purpose
The purpose of this action is to:
(1) Streamline MADAP application and verification of eligibility procedures for MADAP participants per an assessment finding by the US Health Resources and Services Administration (HRSA);
(2) Revise COMAR to reflect MADAP’s move to an Open Formulary for covered prescription drugs and devices;
(3) Repeal the MADAP Advisory Board; and
(4) Make additional clarifying changes throughout the MADAP COMAR chapters.
Comparison to Federal Standards
There is no corresponding federal standard to this proposed action.
Estimate of Economic Impact
I. Summary of Economic Impact. This proposal will have a fiscal impact on the Department. Switching to an open formulary will increase costs associated with drugs paid for by MADAP due to more drugs being covered. Switching to an open formulary will also have an indeterminable positive impact on MADAP participants because they will be able to access more medications through MADAP. There will be an additional indeterminable positive impact on participants, case managers, and providers due to streamlining the application process for MADAP.
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Revenue (R+/R-) |
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II. Types of Economic Impact. |
Expenditure (E+/E-) |
Magnitude |
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A. On issuing agency: |
(E+) |
$281,512.39 |
|
B. On other State agencies: |
NONE |
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C. On local governments: |
NONE |
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|
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|
|
Benefit (+)
Cost (-) |
Magnitude |
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|
|
|
D. On regulated industries or trade groups: |
NONE |
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E. On other industries or trade groups: |
NONE |
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F. Direct and indirect effects on public: |
(+) |
Indeterminable |
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III. Assumptions. (Identified by Impact Letter and Number from Section II.) |
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A. Switching to an open formulary will result in increased costs to MADAP. MADAP estimates that the cost of this change for State Fiscal Year (SFY) 2020 is $281,512.39. This estimate is based on the number of MADAP participants that utilize the pharmacy benefit, both insured and uninsured, and assumes that participants will, on average, be covered for one additional prescription per year due to adopting an open formulary. For uninsured participants (11.9 percent of total participants), MADAP would pay for the cost of the additional drug (the estimate is based on the average cost for drugs that will no longer be restricted). For insured participants (88.1 percent of total participants), MADAP would pay the associated copay. Further details are in the tables below.
Table 1 is the breakdown of MADAP clients (insured and uninsured) that are pharmacy utilizers for SFY 2019 and 2020. This estimate assumes an approximately 1.8 percent increase in clients per year.
Table 1 — Number of MADAP Pharmacy Utilizers
|
SFY |
Pharmacy Utilizers |
Uninsured MADAP Clients |
Insured MADAP Clients |
Total |
|
2019 — Base Yr (6 months) |
No. Clients (rounded) |
377 |
2,788 |
3,165 |
|
2020 |
No. Clients (rounded) |
384 |
2,846 |
3,230 |
Table 2 is the estimated average drug cost of an additional prescription for uninsured MADAP clients, which assumes a 3 percent increase in prices per year.
Table 2 — Average Annual Rx Cost for Uninsured Clients (Full-Pay)
|
SFY |
Annual Rx Cost Increase Applied |
Estimated Average Cost per Rx |
# Rx (90-day refills) |
Average Cost per Rx |
|
2019 — Base Yr (6 months) |
|
$105.98 |
2.00 |
$211.96 |
|
2020 |
3% |
$109.16 |
4.00 |
$436.65 |
MADAP will benefit from 340B negotiated rebates on prescriptions; however, these estimates do not take the rebates into account. Because it is not possible to forecast what additional prescriptions will be purchased as a result of this change, any rebates cannot be included in this calculation. It is likely that the cost of the additional prescriptions for uninsured participants will be less than what is estimated here due to the availability of a 340B rebate.
Table 3 shows the estimated increase in copayments for insured clients associated with an additional prescription. The copay is estimated to be $10 because the additional drugs covered under the open formulary will likely be generic.
Table 3 — Average Annual Rx Cost for Insured Clients (Co-Pays only)
|
SFY |
Est. Avg. Co-Pay Cost per Rx |
# Rx (90-day refills) |
Avg. Cost per Rx |
|
2019 — Base Yr (6 months) |
$10.00 |
2.00 |
$20.00 |
|
2020 |
$10.00 |
4.00 |
$40.00 |
Table 4 is the estimated total increased costs for SFY 2019—2020. As mentioned above, the estimate takes into account an expected 3 percent increase in drug prices each year and reflects one additional prescription per MADAP participant. If participants were covered for two additional prescriptions, the estimate would double.
Table 4 — Total Increased Costs to MADAP
|
SFY |
Uninsured |
Insured |
Totals |
|
2019 — Base Yr (6 months.) |
$79,910.61 |
$55,760.00 |
$135,670.61 |
|
2020 |
$167,672.39 |
$113,840.00 |
$281,512.39 | |
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F. There will be an indeterminable positive impact on participants in MADAP. The positive impact would result from: (1) participants having access to more medications under MADAP (the number of additional prescriptions and associated covered costs will vary from participant to participant), and (2) streamlining the application process, which will reduce burden on participants and case managers who participate in MADAP. |
Economic Impact on Small Businesses
The proposed action has minimal or no economic impact on small businesses.
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with disabilities.
Opportunity for Public Comment
Comments may be sent to Jake Whitaker, Acting Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to mdh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through March 4, 2019. A public hearing has not been scheduled.
10.18.01 Maryland AIDS Drug Assistance Program: Temporary Assistance Program
Authority: Health-General Article, §§2-104(b), 2-104(j), 2-105(a), and 18-102(a), Annotated Code of Maryland
.02 Definitions.
A. (text unchanged)
B. Terms Defined.
(1)—(6) (text unchanged)
[(7) “Formulary” means a list of prescription drugs and other products covered by the Maryland AIDS Drug Assistance Program as specified in COMAR 10.18.06.04-1.]
[(8)] (7)—[(12)] (11) (text unchanged)
(12) “Open formulary” means all U.S. Food and Drug Administration-approved prescription medications and related devices that are not on the list of excluded drugs and other products maintained by the Department per COMAR 10.18.06.04-1.
(13)—(15) (text unchanged)
.04 Application and Enrollment.
A. (text unchanged)
B. Enrollment.
(1) A recipient shall be approved for coverage beginning the first day of the month in which the:
(a) TAP application was received; or
(b) Recipient will need access to medications through TAP.
(2) (text unchanged)
.05 Covered Services.
A. (text unchanged)
B. [TAP] The Department shall pay for [each] a prescription drug or other product [within the limits established by the Department on] not excluded from the open formulary if the prescription is ordered and signed by a health care practitioner for a recipient.
10.18.05 Maryland AIDS Drug Assistance Program: Eligibility
Authority: Health General Article, §§2-104(b) and (i) [and], 2-105(a) and (b), and 18-102(a), Annotated Code of Maryland
.01 Definitions.
A. (text unchanged)
B. Terms Defined.
(1)—(5) (text unchanged)
[(6) “Enrollment period” means the period of time a recipient may receive Maryland AIDS Drug Assistance Program benefits.
(7) “Formulary” means a list of prescription drugs and other products covered by the Maryland AIDS Drug Assistance Program as specified in COMAR 10.18.06.04-1.]
(6) “Enrolled in MADAP” means that an applicant has been approved to receive Maryland AIDS Drug Assistance Program benefits.
[(8)] (7) “Gross household income” means the income derived from sources provided in [Regulation .02] Regulation .02E of this chapter.
[(9)] (8)—[(12)] (11) (text unchanged)
(12) “Open formulary” means all U.S. Food and Drug Administration-approved prescription medications and related devices that are not on the list of excluded drugs and other products maintained by the Department according to COMAR 10.18.06.04-1.
(13)—(14) (text unchanged)
(15) “Verification of eligibility” means the information a recipient provides to the Department to confirm that the recipient is still eligible to receive MADAP benefits according to Regulation .03B(1)(a) of this chapter.
.02 Eligibility.
A.—C. (text unchanged)
D. Medical Criteria. To meet the medical criteria the individual shall be:
(1) (text unchanged)
(2) Prescribed or will be prescribed, within 3 months from the date the completed application was received by the Department, one or more [of the] antiretroviral drugs [in the formulary] not excluded from the open formulary.
E. Financial Criteria.
(1) To meet the financial criteria the individual shall have a projected gross household income less than or equal to 500 percent of the Federal Poverty Level Guidelines as updated annually in the Federal Register by the U.S. Department of Health and Human Services under authority of 42 U.S.C. §9902(2).
(2) Projected gross household income shall be determined based on what can reasonably be expected to be received during the 12-month period beginning with the month in which the completed application is filed or verification of eligibility is submitted.
(3) Gross household income includes income derived from:
(a)—(b) (text unchanged)
(c) Unemployment [compensation] income;
(d)—(e) (text unchanged)
(f) Retirement [or pension] income;
[(g) Investments, including dividends or interest;]
(g) Pension income;
(h) Investment income;
[(h)] (i)— [(i)] (j) (text unchanged)
(4) Gross household income under this chapter does not include income derived from:
(a)—(f) (text unchanged)
.03 Application and Enrollment.
A. (text unchanged)
B. Enrollment.
(1) A recipient shall:
(a) Attest to continuing eligibility [by completing and submitting the eligibility verification form provided by the Department during the sixth month of the current enrollment period; or] every 6 months:
(i) In writing; or
(ii) By telephone; and
[(b) Lose MADAP benefits, effective at the end of the seventh month of the current enrollment period, if the recipient fails to attest to continued eligibility for MADAP benefits during the sixth month of the current enrollment period;]
(b) If the Department requests it, complete and submit verification of eligibility and supporting documentation on the form provided by the Department.
[(2) A recipient who seeks to continue enrollment shall reapply by submitting a new completed application at least ten business days prior to the end of the current 12-month enrollment period; and]
(2) A recipient shall lose MADAP benefits, effective at the end of the month following the month the verification of eligibility is due, if the recipient fails to attest to continued eligibility for MADAP.
(3) The Department shall:
(a) Enroll an applicant who has been determined eligible [for a 12-month enrollment period] with the stipulation that continued eligibility must be verified by the Department [during the sixth month of the enrollment period] every 6 months;
(b) Establish [the 12-month] enrollment [period] in MADAP beginning on the first day of the month in which the:
(i) Department approves the application; or
(ii) Recipient will need to access medications through MADAP;
(c) (text unchanged)
(d) Send any relevant [application or eligibility] verification of eligibility forms at least 45 calendar days before [the end of the:
(i) First 6 months of the current enrollment period; and
(ii) Current enrollment period.] the forms are due to be submitted to the Department.
.04 Changes in Eligibility and Disenrollment.
A. A recipient shall notify the Department within 10 business days of a change in:
(1) (text unchanged)
(2) Gross household income; or
(3) (text unchanged)
B.—C. (text unchanged)
D. If the recipient is determined to be ineligible before the [end of the current enrollment period] next verification of eligibility is due to be submitted to the Department because of a change in [residency, medical, or financial] eligibility [criteria], the disenrollment shall be the earlier of:
(1) The date on which the recipient’s [current enrollment ends] next verification of eligibility is due to be submitted to the Department; or
(2) (text unchanged)
E. (text unchanged)
.09 Availability of Funding and Program Termination.
A. (text unchanged)
B. If MADAP is terminated the Department shall provide benefits for each current recipient until the earlier of:
(1) The [end of the recipient’s enrollment period] date on which the next verification of eligibility is due to be submitted to the Department; or
(2) (text unchanged)
10.18.06 Maryland AIDS Drug Assistance Program: Pharmacy Services
Authority: Health General Article, §§2-104(b) and (i), 2-105(a) and (b), and 18-102(a), Annotated Code of Maryland
.01 Definitions.
A. (text unchanged)
B. Terms Defined.
(1)—(3) (text unchanged)
[(4) “Enrollment period” means the period of time a recipient may receive Maryland AIDS Drug Assistance Program benefits.
(5) “Formulary” means a list of prescription drugs and other products covered by the Maryland AIDS Drug Assistance Program as specified in Regulation .04-1 of this chapter.]
(4) “Enrolled in MADAP” means that an applicant has been approved to receive Maryland AIDS Drug Assistance Program benefits.
[(6)] (5)—[(9)] (8) (text unchanged)
(9) “Open formulary” means all U.S. Food and Drug Administration-approved prescription medications and related devices that are not on the list of excluded drugs and other products maintained by the Department according to Regulation .04-1 of this chapter.
(10)—(12) (text unchanged)
(13) “Prescription” means a direction, usually written by a health care provider authorized to prescribe drugs and other products and sent to the pharmacist for the preparation, dispensing, and directions for use of a drug or other product [included in the MADAP formulary] not excluded from the open formulary.
(14) (text unchanged)
.03 Conditions for Participation.
A. To participate in MADAP, a pharmacy shall:
(1) Be enrolled in Medical Assistance, be a mail order company that accepts payments from the Department, or submit a request for exception to, and receive approval from, the Department;
(2) Accept payment by [MADAP] the Department as payment in full for the professional services rendered and make no additional charges to the recipient or the recipient’s family;
(3)—(4) (text unchanged)
[(5) Include information required by the Department on all pharmacy invoices;]
[(6)] (5) Provide services without regard to race, color, creed, age, sex, sexual orientation, gender identity, national origin, marital status, or disability; and
[(7) Verify an individual’s eligibility; and]
[(8)] (6) (text unchanged)
B. (text unchanged)
.04 Covered Services.
A. (text unchanged)
B. The Department shall pay for a prescription drug or other product [on] not excluded from the open formulary [within the limits established by the Department] if the prescription is ordered and signed by a health care practitioner for the recipient.
.04-1 Formulary.
The Department shall:
A. Maintain [an updated formulary that is available electronically] a list of drugs and other products excluded from the open formulary; and
B. Make available electronically [copies of] the [formulary; and] list of drugs and other products excluded from the open formulary.
[C. Consider the recommendations of the MADAP Advisory Board in revising the formulary, in accordance with Regulation .04-2G of this chapter.]
.05 Limitations on Covered Services.
A. (text unchanged)
B. The Department may not pay for:
(1) (text unchanged)
(2) Drugs or other products [indicated as restricted on the] excluded from the open formulary, unless the:
(a)—(b) (text unchanged)
.09 Cause for Suspension or Removal and Imposition of Sanctions.
A. If the Department determines that a pharmacy or the pharmacy’s employee, or both, has failed to comply with federal or State laws and regulations, the Department may:
(1) (text unchanged)
(2) Withhold payment to the pharmacy [by MADAP]; or
(3) (text unchanged)
B.—E. (text unchanged)
.11 Confidentiality.
Unless otherwise authorized by law, the Department:
A. (text unchanged)
B. May not disclose personal information kept on [an applicant or] a recipient without written consent of the:
[(1) Applicant;]
[(2)] (1) Recipient; or
[(3) Applicant’s parent or legal guardian; or
(4)] (2) Recipient’s parent or legal guardian;
C.—D. (text unchanged)
10.18.07 Maryland AIDS Drug Assistance Program: Health Insurance (MADAP-PLUS)
Authority: Health-General Article, §§2-104(b) and (i) and 2-105(a) and (b), Annotated Code of Maryland
.01 Definitions.
A. (text unchanged)
B. Terms Defined.
(1)—(4) (text unchanged)
[(5) “Enrollment period” means the period of time a recipient may receive Maryland AIDS Drug Assistance Program—Plus coverage.
(6) “Formulary” means a list of prescription drugs and other products covered by the Maryland AIDS Drug Assistance Program as specified in COMAR 10.18.06.04-1.]
(5) “Enrolled in MADAP” means that an applicant has been approved to receive Maryland AIDS Drug Assistance Program benefits.
[(7)] (6)—[(9)] (8) (text unchanged)
[(10)] (9) “Maryland AIDS Drug Assistance Program—Plus (MADAP-Plus)” means the program administered by the Department to pay insurance premiums, copays, coinsurance, and deductibles for [formulary] drugs and core medical services.
[(11)] (10) (text unchanged)
(11) “Open formulary” means all U.S. Food and Drug Administration-approved prescription medications and related devices that are not on the list of excluded drugs and other products maintained by the Department according to COMAR 10.18.06.04-1.
(12) (text unchanged)
(13) “Verification of eligibility” means the information a recipient provides to the Department to confirm that the recipient is still eligible to receive MADAP benefits according to COMAR 10.18.05.03B(1)(a).
.02 Eligibility.
A. To be eligible for MADAP-Plus coverage, an individual shall be:
[A.] (1)—[B.] (2) (text unchanged)
B. An individual who is eligible for employer-sponsored health insurance with a prescription drug formulary that includes antiretroviral medications may not receive premium assistance unless the individual is:
(1) Enrolled in the employer-sponsored health plan; and
(2) Paying 50 percent or more of the total monthly health insurance premiums.
.03 Application and Enrollment.
A.—B. (text unchanged)
C. The duration of the recipient’s enrollment [period for MADAP-Plus shall be the same as] in MADAP-Plus may not extend beyond the duration of the recipient’s enrollment inMADAP [enrollment period in 10.18.05.03B].
.04 Covered Services.
A. The Department shall pay for health and prescription plan premiums with a prescription drug formulary [comparable to the MADAP formulary] that includes antiretroviral medications.
B. Within the limits established by the Department and in accordance with policy guidance issued by the Health Resources and Services Administration, the Department:
(1) Shall pay for copays, coinsurance, and deductibles for [formulary] drugs; and
(2) May pay for [visits] copays, coinsurance, and deductibles associated with core medical services.
[C. An individual who is eligible for employer sponsored health insurance with a prescription drug formulary comparable to the MADAP formulary may not receive premium assistance unless the individual is:
(1) Enrolled in the employer sponsored health plan; and
(2) Paying 50 percent or more of the total monthly health insurance premiums.]
.06 Reconsideration and Appeal.
A.—E. (text unchanged)
F. If the final decision finds in favor of the Department, the Department shall, upon the date of the decision, cease paying the health insurance costs allowed under this chapter and seek recovery in accordance with [regulation] Regulation .08 of this chapter.
.07 Payment Procedures.
A. (text unchanged)
B. The Department:
(1) [May not] Shall process a payment request [that is not submitted] as required by this chapter;
(2)—(3) (text unchanged)
(4) Shall make subsequent payments:
(a) [On the designated due date or on a later date as] As permitted under a health or prescription drug plan; or
(b) (text unchanged)
.11 Availability of Funding and Program Termination.
A. (text unchanged)
B. If MADAP-Plus is terminated, the Department shall provide coverage for each current recipient until the earlier of:
(1) The [end of the recipient’s enrollment period] date on which the next verification of eligibility is due to be submitted to the Department; or
(2) (text unchanged)
10.18.10 Urgent Maryland AIDS Drug Assistance Program
Authority: Health-General Article, §§2-104(b), 2-104(j), 2-105(a), and 18-102(a), Annotated Code of Maryland
.02 Definitions.
A. (text unchanged)
B. Terms Defined.
(1)—(6) (text unchanged)
[(7) “Formulary” means a list of prescription drugs and other products covered by the Maryland AIDS Drug Assistance Program as specified in COMAR 10.18.06.04-1.]
[(8)] (7)—[(10)] (9) (text unchanged)
(10) “Open formulary” means all U.S. Food and Drug Administration-approved prescription medications and related devices that are not on the list of excluded drugs and other products maintained by the Department according to COMAR 10.18.06.04-1.
(11)—(12) (text unchanged)
.03 Eligibility.
To be eligible for coverage, an individual shall be eligible for MADAP as specified in COMAR 10.18.05.02 and:
A. (text unchanged)
B. Have an acute medical condition needing immediate access to [formulary] medication as attested by the agent; or
C. (text unchanged)
.04 Application and Enrollment.
A. Application.
(1) The agent of the applicant shall:
(a) Submit a complete Urgent MADAP application to the Department on the form designated by the Department; and
(b) [Submit a copy of the complete or incomplete MADAP application; and
(c) Attest to submitting supporting documentation to complete the MADAP application within 30 calendar days after submission of the Urgent MADAP application.] Within 30 business days of submitting the application, submit all supporting documentation required by the Department.
(2)—(3) (text unchanged)
B. Enrollment.
(1) A recipient shall be approved for coverage beginning the first day of the month in which the:
(a) Urgent MADAP application was received; or
(b) Recipient will need access to medications through Urgent MADAP.
(2) (text unchanged)
.05 Covered Services.
A. (text unchanged)
B. [Urgent MADAP] The Department shall pay for [each] a prescription drug or other product [within the limits established by the Department on the] not excluded from the open formulary if the prescription is ordered and signed by a health care practitioner for a recipient.
ROBERT R. NEALL
Secretary of Health
