department of health and social services

Division of Social Services

FINAL

ORDER

Client Cost Sharing for Pharmaceutical Services: Cumulative Maximum

Nature of the Proceedings

Delaware Health and Social Services (“Department”) / Division of Medicaid & Medical Assistance initiated proceedings to amend the Title XIX Medicaid State Plan and the Division of Social Services Manual (DSSM) regarding the Pharmaceutical Services Program. The Department’s proceedings to amend its regulations were initiated pursuant to 29 Delaware Code Section 10114 and its authority as prescribed by 31 Delaware Code Section 512.

The Department published its notice of proposed regulation changes pursuant to 29 Delaware Code Section 10115 in the August 2005 Delaware Register of Regulations, requiring written materials and suggestions from the public concerning the proposed regulations to be produced by August 31, 2005 at which time the Department would receive information, factual evidence and public comment to the said proposed changes to the regulations.

Summary of Provisions

Citation

42 CFR §447.54(d), Maximum Allowable Charges, Cumulative Maximum

Amending the Following Title XIX Medicaid State Plan Pages

Amending the Following Sections of the Division of Social Services Manual

Summary of Amendment Provisions

To ensure that the state delivers an accessible medical assistance prescription drug program, the following describes the proposed change for pharmacy co-payments, effective July 1, 2005:

Once a client has met the individual monthly maximum co-payment for his or her prescriptions, the Point of Sale (POS) System will NOT indicate a co-payment is due. Medicaid will keep track of the cumulative number of prescriptions for a client with co-payments. Any prescriptions dispensed after the cumulative maximum monthly co-payment amount is met are not subject to a co-payment. Reversal of a previously filled prescription with a co-payment will require a refund of the co-payment to the individual, and will cause the next prescription filled for that client to be adjudicated with a co-payment.

By implementing this process, the Department ensures that a cumulative maximum is likely to benefit all eligible Medicaid clients with continued access to prescription medications.

The proposed cumulative maximum pharmacy requirements are subject to approval by the Centers for Medicare and Medicaid Services (CMS).

Summary of Comments Received with Agency Response

The Governor’s Advisory Council for Exceptional Citizens (GACEC); the State Council for Persons with Disabilities (SCPD); the Alliance for the Mentally Ill in Delaware (NAMI of Delaware); and, the Disabilities Law Program, CLASI, Inc. provided observations, comments and suggestions. DMMA considered each one, summarized below, and responds as follows:

Notice of Intent

1. As background, the GACEC and the SCPD consistently recommended that any Medicaid drug co-pay requirement include a cumulative maximum co-pay for high pharmacy users as authorized by 42 CFR §447.54(d). DSS consistently declined to adopt such a cap.

The Councils endorse this latest proposal consistent with our prior recommendations. We recommend a $15.00 cap.

Agency Response: DMMA thanks the Councils for their endorsement.

2. NAMI-DE is grateful that the issue of co-pays for prescription drugs is being considered for revision. We ask that Health and Social Services also add a total exemption from co-pays for very low-income individuals.

Agency Response: The “Notice of Intent” of the proposed amendment published in the June 1, 2005 issue of the Delaware Register of Regulations relates only to Cumulative Maximum on pharmacy services. However, the maximum co-payment chargeable to a Medicaid client and the exemptions from co-payments are set by federal law at 42 CFR §447.54 and 42 CFR §447.53.

Emergency and Proposed Regulations

SCPD

Consistent with prior recommendations, SCPD prefers that no co-pay be imposed, but notes that the $15.00 cap represents a compromise that lessens the financial burden on beneficiaries.

Agency Response: DMMA appreciates the commenter’s input. The implementation of the pharmacy co-pay cumulative maximum preserves the amendment’s intent, yet addresses the commenter’s concern.

Delaware Law Program, CLASI, Inc.

First and foremost, the DLP wholeheartedly applauds the Department’s decision to institute a monthly cumulative maximum co-payment amount of $15.00. Such a maximum amount protects the State’s desire for implementing cost-sharing provisions while yet providing some protection for the health and safety of citizens who rely on Medicaid for vital prescription medications. On behalf of the DLP’s clients, we thank you.

Second, we would like to encourage the Department to take two actions in relation to this proposed amendment:

(1) Widely publicize the cumulative maximum co-payment amount to clients as well as to pharmacy and health care providers.

In the last few months, the DLP has received many calls from clients expressing confusion about the co-payment amounts and any processes related to the co-payments. The DLP respectfully requests that information about the co-payment be mailed out to beneficiaries, providers, and also to interested organizations as soon as possible.

(2) Establish, implement, and publicize a process for clients with concerns about the co-payment maximum and how it is applied to them as a corollary to the amendment. Such a system could also provide a venue for other client concerns about co-payments, and create a structure for the federally-required process concerning the “inability to pay” co-payment provisions required by federal law.

Agency Response: Currently, the Department informs providers of pharmacy benefit changes through various methods, including mailings, website postings and newsletters. Most recently, a new feature was added to the DMAP website. This new tool is called the DMAP E-mail Notification Services (registration required for interested parties). This tool allows the DMAP to communicate important information to all users such as policy changes. Regarding the recommendation to publicize the cumulative maximum co-payment amount to clients as well as to pharmacy and health care providers please, view the following updated “Client Prescription Benefits Tri-fold” brochure mailed to new households currently eligible for Delaware Medical Assistance Program pharmacy benefits and posted on the DMAP website addressing pharmacy benefits:

http://www.dmap.de.us/information/client.pharmacy.tri-fold.072505.pdf

Additionally, informational posters will be sent to participating DMAP pharmacy providers, advocacy organizations, State Service Centers and senior citizen centers to publicize the $15.00 co-payment cap. Also, the Division’s next mass mailings to clients will include an announcement of the co-payment cap.

The Pharmacy Provider is advised via the Point-of-Sale System (POS) regarding the client’s liability for the drug co-payment and the amount of the co-payment. Once a client has met the monthly maximum co-payment amount for his or her prescriptions, the POS will tell the pharmacist that no co-payment is due from the client and exempting the client from a co-payment until the end of the current co-payment year. The POS will track the cumulative number of prescriptions for a client with co-payments.

As previously notified, Medicaid clients may continue to call 1-800-372-2022 Monday through Friday, 8:00am to 4:30pm for questions or concerns about pharmacy benefits.

As previously published in the Delaware Register, the “calculations” for the maximum co-payment chargeable to a Medicaid client is set by federal law at 42 CFR §447.54; and, “exemptions” from co-payments are set at 42 CFR §447.53.

Findings of Fact

The Department finds that the proposed changes as set forth in the August 2005 Register of Regulations should be adopted.

THEREFORE, IT IS ORDERED, that the proposed regulation to amend the Child Care Development Fund State Plan for the period October 1, 2003 through September 30, 2005 is adopted and shall be final effective October 10, 2005.

Vincent P. Meconi, Secretary, DHSS, 9-13-05

DSS FINAL ORDER REGULATION #05-57a

Page 56a

Revision: HCFA-PM-91-4 (BPD) OMB No.: 0938-AUGUST 1991

State/Territory: DELAWARE

Citation 4.18 (b) (3) (Continued)

42 CFR 447.51 (iii) For the categorically needy

and qualified through 447.58

Medicare beneficiaries,

ATTACHMENT 4.18-A

specifies the:

A. Service(s) for which a

charge(s) is applied;

B. Nature of the charge

imposed on each service;

C. Amount(s) of and basis for

determining the charge(s);

D. Method used to collect the

charge(s);

E. Basis for determining

whether an individual is

unable to pay the charge and

the means by which such an

individual is identified to

providers;

F. Procedures for implementing

and enforcing the exclusions

from cost sharing contained

in 42 CFR 447.53 (b); and

G.. Cumulative maximum that

applies to all deductible,

coinsurance or co-payment

charges imposed on a

specified time period.

X Not applicable. There is

no maximum.

 Not applicable. There is

no maximum.

DSS FINAL ORDER REGULATION #05-57b

ATTACHMENT 4.18-A

Page 3

State Plan Under Title XIX of the Social Security Act

State: DELAWARE

E. Cumulative maximums on charges:

 State policy does not provide maximums.

X Cumulative maximum has been established as described below:

$15.00 cumulative monthly maximum co-payment amount aggregated for pharmacy services.

Once a client has met the individual monthly maximum co-payment for his or her prescriptions, the Point of Sale (POS) System will NOT indicate a co-payment is due. Medicaid will keep track of the cumulative number of prescriptions for a client with co-payments. Any prescriptions dispensed after the cumulative maximum monthly co-payment amount is met are not subject to a co-payment. Reversal of a previously filled prescription with a co-payment will require a refund of the co-payment to the individual, and will cause the next prescription filled for that client to be adjudicated with a co-payment.

14960.1 Co-Payment Requirement

Effective January 10, 2005, clients have a nominal co-payment will be imposed for generic and brand name prescription drugs as well as over-the-counter drugs prescribed by a practitioner.

The co-payment is based upon the cost of the drug as follows:

The co-payment is imposed for each drug that is prescribed and dispensed.

149601.1 Cumulative Maximum Monthly Co-payment

Effective July 1, 2005, there is a cumulative maximum monthly co-payment amount equal to $15.00 for each recipient. Any prescriptions dispensed after the cumulative maximum monthly co-payment amount is met are not subject to a co-payment.