department of health and social services
Division of Medicaid and Medical Assistance
PUBLIC NOTICE
proposed
Medicare Part D Prescription Drug Program
In compliance with the State's Administrative Procedures Act (APA - Title 29, Chapter 101 of the Delaware Code) and under the authority of Title 31 of the Delaware Code, Chapter 5, Section 512, Delaware Health and Social Services (DHSS) / Division of Medicaid & Medical Assistance (DMMA) is proposing to amend the Title XIX Medicaid State Plan and the Division of Social Services Manual (DSSM) to implement the Medicare Part D Prescription Drug Program.
Any person who wishes to make written suggestions, compilations of data, testimony, briefs or other written materials concerning the proposed new regulations must submit same to Sharon L. Summers, Policy & Program Development Unit, Division of Medicaid & Medical Assistance, 1901 North DuPont Highway, P.O. Box 906, New Castle, Delaware 19720-0906 by September 30, 2005.
The action concerning the determination of whether to adopt the proposed regulation will be based upon the results of Department and Division staff analysis and the consideration of the comments and written materials filed by other interested persons.
SUMMARY OF PROPOSED CHANGES
Statutory Authority:
New Pre-Print State Plan Pages
Background
The Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) established the Medicare Prescription Drug Program, also known as Medicare Part D, making prescription drug coverage available to individuals who are entitled to receive Medicare benefits under Part A or Part B, beginning on January 1, 2006.
The MMA also established the Low-Income Subsidy (LIS) to assist individuals who have low-income and resources with payment of the premiums, deductibles, and co-payments required under Part D, which began on July 1, 2005.
Effective January 1, 2006, Medicaid beneficiaries who are entitled to receive Medicare benefits under Part A or Part B will no longer receive their pharmacy benefits under the State Medicaid Program, except for excluded drugs. States are required to submit State Plan Amendments that ensure State Medicaid Program pharmacy benefits are consistent with the requirements under Part D.
Given that Medicare is the primary payor with respect to Part D drugs for full-benefit dual eligible individuals, states will continue to receive Federal Financial Participation (FFP) for the payment of the deductible and coinsurance for Medicare Part A and Part B drugs.
Summary of Proposed Changes
State Plan Amendment (SPA)
States must amend their state plans to indicate compliance with the provisions of the MMA. CMS forwarded templates that may be used to amend the State’s Medicaid Plan to reflect the provisions pertaining to LIS and to the screen and enroll requirement and to Medicaid outpatient drug coverage.
Division of Social Services Manual (DSSM)
DSS PROPOSED REGULATIONS #05-45a
NEW STATE PLAN PAGES:
Attachment 2.2-A
Page 27
STATE PLAN UNDER TITLE XIX OF THE SOCIAL SECURITY ACT
STATE: DELAWARE
REQUIREMENTS RELATING TO DETERMINING ELIGIBILITY FOR MEDICARE PRESCRIPTION DRUG LOW-INCOME SUBSIDIES
Agency Citation (s) Groups Covered
1935(a) and 1902(a)(66) The agency provides for
making Medicare
42 CFR 423.774 prescription drug Low
and 423.904 Income Subsidy
determinations under Section
1935(a) of the Social
Security Act.
1. The agency makes
determinations of eligibility
for premium and cost
sharing subsidies under and
in accordance with section
1860D-14 of the Social
Security Act;
2. The agency provides for
informing the Secretary of
such determinations in cases
in which such eligibility is
established or redetermined;
3. The agency provides for
screening of individuals for
Medicare cost-sharing
described in Section
1905(p)(3) of the Act and
offering enrollment to
eligible individuals under the
State plan or under a waiver
of the State plan.
Attachment 3.1.A.1
Page 1
STATE PLAN UNDER TITLE XIX OF THE SOCIAL SECURITY ACT
STATE: DELAWARE
MEDICAID PROGRAM: REQUIREMENTS RELATING TO COVERED OUTPATIENT DRUGS FOR THE CATEGORICALLY NEEDY
Citation (s) Provision (s)
1935(d)(1) Effective January 1, 2006,
the Medicaid agency will not
cover any Part D drug for
full-benefit dual eligible
individuals who are entitled
to receive Medicare benefits
under Part A or Part B.
Attachment 3.1.A.1
Page 2
STATE PLAN UNDER TITLE XIX OF THE SOCIAL SECURITY ACT
STATE: DELAWARE
MEDICAID PROGRAM: REQUIREMENTS RELATING TO PAYMENT FOR COVERED OUTPATIENT DRUGS FOR THE CATEGORICALLY NEEDY
Citation (s) Provision (s)
1927(d)(2) and 1935(d)(2) 1. The Medicaid agency
provides coverage for the
following excluded or
otherwise restricted drugs or
classes of drugs, or their
medical uses to all Medicaid
recipients, including full
benefit dual eligible
beneficiaries under the
Medicare Prescription Drug
Benefit –Part D.
The following excluded
drugs are covered:
(a) agents when used for
anorexia, weight loss,
weight gain (see specific
drug categories below)
(b) agents when used to
promote fertility (see
specific drug categories
below)
(c) agents when used for
cosmetic purposes or hair
growth (see specific drug
categories below)
(d) agents when used for
the symptomatic relief
cough and colds (see specific
drug categories below)
(e) prescription vitamins
and mineral products, except
prenatal vitamins and
fluoride (see specific drug
categories below)
(f) nonprescription drugs
(see specific drug categories
below)
Attachment 3.1.A.1
Page 2a
STATE PLAN UNDER TITLE XIX OF THE SOCIAL SECURITY ACT
STATE: DELAWARE
MEDICAID PROGRAM: REQUIREMENTS RELATING TO PAYMENT FOR COVERED OUTPATIENT DRUGS FOR THE CATEGORICALLY NEEDY
Citation (s) Provision (s)
1927(d)(2) and 1935(d)(2) (g) covered outpatient
drugs which the
manufacturer seeks to
require as a condition of sale
that associated tests or
monitoring services be
purchased exclusively from
the manufacturer or its
designee (see specific drug
categories below)
(h) barbiturates (see
specific drug categories
below)
(i) benzodiazepines (see
specific drug categories
below)
(The Medicaid agency lists
specific category of drugs
below)
(a) Agents when used for
anorexia, weight loss,
weight gain: Megestrol
Acetate, Somatropin, Lipase
Inhibitor. Products in these
categories require prior
authorization.
(d) Agents when used for
the symptomatic relief
cough and colds:
Antihistamines, Antitussive,
Decongestants, and
Expectorants.
(e) Prescription vitamins
and mineral products,
except prenatal vitamins and
fluoride: Single entity
vitamins, Multiple vitamins
w/minerals, Nicotinic acid,
Calcium salts, and Dialysis
replacement products.
(f) Nonprescription drugs:
Analgesic oral and rectal;
Heartburn; Antiflatulents;
Antidiarrheal;
Antinauseants; Cough &
Cold, oral; Cough & Cold,
topical; Contraceptives;
Diabetic supplies;
Hemantinics; Laxatives &
Stool Softeners; Lice Control
Preparations; Magnesium
Supplement, oral; Nasal
Preparations; Nicotine
Cessation Preparations;
Opthalmic Preparations;
Topical Anesthestics;
Topical Antibacterials;
Topical/Vaginal Fungicidals;
Vitamins & Minerals;
Digestive Enzymes; and,
Miscellaneous (Colloidal
Oatmeal Baths).
(h) Barbiturates: the
Division of Medicaid &
Medical Assistance covers
all medications in these
therapeutic categories.
(i) Benzodiazepines: the
Division of Medicaid &
Medical Assistance covers
all medications in
thesetherapeutic categories.
__ No excluded drugs are covered.
DSS PROPOSED REGULATION #05-45b
REVISIONS:
Division of Social Services Manual (DSSM)
14100.4 Disposition Of Applications
The agency must include in each applicant's case record facts to support the agency's decision on his application. The agency must dispose of each application by a finding of eligibility or ineligibility, unless:
a) there is an entry in the case record that the applicant voluntarily withdrew the application, and that the agency sent a notice confirming his decision;
b) there is a supporting entry in the case record that the applicant has died; or
c) there is a supporting entry in the case record that the applicant cannot be located.
d) Certain factors of eligibility must be verified according to specific eligibility groups. If all information requested is not received, DSS cannot determine or redetermine eligibility. This may result in denial of the application or the termination of eligibility. Verifications received and/or provided may reveal a new eligibility issue not previously realized and this may require additional verifications. Failure to provide additional requested verifications may result in denial or termination of eligibility. all verification requested is not received by the due date given to the applicant. If all verification requested is not received by the due date, an eligibility determination cannot be made. This will result in denial of the application. Verification that is received and/or provided may reveal a new eligibility issue not previously realized that requires additional verification. If the additional verification requested is not received by the due date given, this will result in denial of the application.
All applicants will receive a notice of acceptance or denial.
(Break in Continuity of Sections)
14100.6 Redetermination Of Eligibility
Eligibility for continued Medicaid coverage must be redetermined at least annually. A redetermination is a re-evaluation of a recipient's continued eligibility for medical assistance. In a redetermination, all eligibility factors that are subject to change are re-examined to ensure that the recipient continues to meet eligibility requirements. When a redetermination is due, the recipient is required to complete and return a new DSS application form renewal form and provide requested verifications by the due date given. Failure to complete and return a DSS application form renewal form and the requested verifications by the due date given will result in termination of eligibility. A redetermination is complete when all eligibility factors that are subject to change are examined and a decision regarding continued eligibility is reached. Eligibility must be promptly redetermined when information is received about changes in a recipient's circumstances that may affect his eligibility. Some changes in circumstances can be anticipated. A redetermination of eligibility must be made at the appropriate time based on those changes. Examples are: Social Security changes, receipt of child support, return to work, etc.
Medicaid coverage should not terminate without a specific determination of ineligibility. The individual may be eligible under another category of Medicaid. For example, when an individual loses eligibility because of termination from cash assistance, such as SSI, we must make a separate determination of Medicaid eligibility. Medicaid must continue until the individual is found to be ineligible. The individual will be found ineligible when a renewal form and the requested verifications are not returned by the due date given.
Medical assistance will be terminated when DSS or DMMA is notified by the recipient that he or she no longer wants coverage.
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14800 Verifications
Generally, Certain factors of eligibility must be verified according to specific eligibility groups. Verification may be verbal or written and must be obtained from an independent or collateral source. In order for verbal verification to be considered documentation, the DSS case worker must record the information obtained in the case record.
Documentation is the process of collecting written information to substantiate factors required for eligibility. Documentation becomes part of the DSS case record. Documents must be date stamped.
If all information requested is not received, DSS cannot determine or redetermine eligibility. This may result in denial of the application or the termination of eligibility.
Verifications received and/or provided may reveal a new eligibility issue not previously realized. That may require additional verifications.
Failure to provide requested documentation may result in denial or termination of eligibility.
The applicant, recipient, or his or her representative must provide verifications that are essential to the eligibility determination. Failure to provide verifications by the due date given will result in a finding of ineligibility.
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14970 Medicare Prescription Drug Program
The Medicare Prescription Drug, Improvement and Modernization Act of 2003 established the Medicare Prescription Drug Program, also known as Medicare Part D, making prescription drug coverage available to individuals who are entitled to receive Medicare benefits under Part A or Part B, beginning on January 1, 2006. Coverage for the prescription drug benefit will be provided through private prescription drug plans (PDPs), which will offer only prescription drug coverage, or through Medicare Advantage prescription drug plans (MA-PDs), which will offer prescription drug coverage that is integrated with the health care coverage they provide to Medicare beneficiaries under Part C of Medicare.
Effective January 1, 2006, Medicaid beneficiaries who are entitled to receive Medicare benefits under Part A or Part B will no longer receive their pharmacy benefits under the Medicaid Program, except for drugs that are excluded from Part D. Any prescribed drug covered by Medicaid remains subject to the Medicaid co-payment requirement.
(Break in Continuity of Sections)
16310 Termination of Eligibility
Medicaid eligibility may not be terminated until we determine that the individual is not eligible under any other eligibility group. This section discusses termination of eligibility under the poverty level related groups of pregnant women, children, and adults.
(Break in Continuity of Sections)
30000 Delaware Prescription Assistance Program
The 140th General Assembly amended Title 16, Delaware Code, by adding Chapter 30B to enact the Delaware Prescription Drug Payment Assistance Program. The purpose of this act is to provide payment assistance for prescription drugs and certain Medicare Part D costs to low-income seniors and individuals with disabilities who are ineligible for, or do not have, prescription drug benefits or coverage through federal (excluding Medicare Part D coverage), state, or private sources.
The program is administered by the Fiscal Agent under contract with the Delaware Department of Health and Social Services.
The rules in this section set forth the eligibility requirements for coverage under the Delaware Prescription Assistance Program (DPAP). The DPAP is implemented January 1, 2000, with benefits beginning January 14, 2000.
30100 Definitions
Contractor: the agent who is under contract with the State to administer the DPAP.
Department: the Department of Health and Social Services or DHSS
Division: the Division of Social Services or DSS the Division of Medicaid & Medical Assistance or DMMA
Low Income Subsidy (LIS): Assistance provided by the Centers for Medicare and Medicaid Services to pay Medicare Part D costs for individuals with limited income and resources. The LIS will provide payment assistance with the monthly premium, the yearly deductible, and the coverage gap. The LIS will also provide payment assistance for co-payments after an individual with income below 135% of the Federal Poverty Level reaches a total of $5100 in drug expenses.
Medicare Part D: The Medicare Prescription Drug Program established by the Medicare Prescription Drug, Improvement and Modernization Act of 2003.
Medicare Part D costs: monthly premiums, yearly deductible, and drug costs that fall into the Part D coverage gap.
30200 General Application Information
The application for DPAP must be made in writing on the prescribed DSS form. This request for assistance can be made by the applicant, guardian, or other individual acting for the applicant with his knowledge and consent. The application filing date is the date the application is received in either the Contractor's office or a DSS office.
DPAP will consider an application without regard to race, color, age, sex, disability, religion, national origin, or political belief as per Title VI of the Civil Rights Act of 1964.
Filing an application gives the applicant the right to receive a written determination of eligibility and the right to appeal the written determination.
30201 Disposition of Applications
The Contractor must include in each applicant’s case record facts to support the Contractor's decision on his application. The Contractor must dispose of each application by a finding of eligibility or ineligibility, unless:
a) there is an entry in the case record that the applicant voluntarily withdrew the application, and that the Contractor sent a notice confirming his decision;
b) there is a supporting entry in the case record that the applicant has died; or
c) there is a supporting entry in the case record that the applicant cannot be located.
d) Certain factors of eligibility must be verified. If all information requested is not received, the Contractor cannot determine or redetermine eligibility. This may result in denial of the application or the termination of eligibility. Verifications received and/or provided may reveal a new eligibility issue not previously realized and this may require additional verifications. Failure to provide additional requested verifications may result in denial or termination of eligibility. all verification requested is not received by the due date given to the applicant. If all verification requested is not received by the due date, an eligibility determination cannot be made. This will result in denial of the application. Verification that is received and/or provided may reveal a new eligibility issue not previously realized that requires additional verification. If the additional verification requested is not received by the due date given, this will result in denial of the application.
All applicants will receive a notice of acceptance or denial.
(Break in Continuity of Sections)
30305 Requirement to Enroll in Medicare Part D
An individual who is entitled to receive Medicare benefits under Part A or Part B must enroll in Part D in order to be eligible for DPAP. The individual must provide proof of Medicare Part D enrollment.
30306 Requirement to Apply for Low Income Susbsidy (LIS)
An individual must apply for the LIS if potentially eligible. The individual must provide a copy of the LIS denial or approval notice.
30305 30307 No Other Prescription Drug Coverage
The individual must not have or must be ineligible for, prescription drug benefits or coverage through federal (excluding Medicare Part D coverage), state, or private sources regardless of any annual limitations to the benefits.
The individual must not have or must be ineligible for:
(a) Medicaid prescription benefits
(b) prescription drug benefits through a Medicare supplemental policy prescription drug benefits through a third party payer
(c) the Nemours Health Clinic Pharmaceutical benefit as defined on 1/1/99
30305.1 30307.1 Exceptions to No Other Prescription Drug Coverage
Individuals who are eligible for the following drug benefits will not be excluded from eligibility for DPAP:
(a) individuals eligible for Medicaid as Family Planning Only
(b) individuals covered under a specific disease state insurance program, for example a policy that pays only for cancer drugs
(c) individuals who are members of a discount drug program in which the policy does not actually pay for the drugs, for example American Association of Retired Persons (AARP)
(d) individuals eligible for drug coverage through the Division of Vocational Rehabilitation
(e) individuals eligible for drug coverage through the Division of Substance Abuse, and Mental Health.
(f) individuals covered under Medicare Part D
30306 30308 Inmate of a Public Institution
An individual who is an inmate of a public institution is not eligible for DPAP.
An individual is an inmate when serving time for a criminal offense or confined involuntarily in State or Federal prisons, jail, detention facilities, or other penal facilities. An individual awaiting trial in a detention center is considered an inmate of a public institution.
(Break in Continuity of Sections)
30405 Redetermination of Eligibility
A redetermination of eligibility must be completed by June 30 December 31 of each year. If an individual's initial coverage begins in April, May, or June, October, November, or December, a redetermination will not be required until June December of the following year. A redetermination is a re-evaluation of a recipient's continued eligibility for DPAP coverage. In a redetermination, all eligibility factors that are subject to change are re-examined to ensure that the recipient continues to meet eligibility requirements. When a redetermination is due, the recipient is required to complete and return a new DSS application form renewal form and provide requested verifications by the due date given. Failure to complete and return a DSS application form renewal form and provide requested verifications by the due date given will result in termination of eligibility. A redetermination is complete when all eligibility factors that are subject to change are examined and a decision regarding continued eligibility is reached.
DPAP coverage will be terminated when the Contractor or DSS is notified by the recipient that he or she no longer wants coverage.
30500.1 Benefits for Individuals with Medicare Part D Coverage
DPAP will provide payment assistance for Medicare Part D monthly premiums, yearly deductible, those drug costs that fall into the Part D coverage gap, and drugs that are excluded from Medicare Part D.
Medicare Part D coverage will be primary to payment assistance under DPAP.
30501 Limitations on Benefits
Payment assistance to each eligible individual shall not exceed $2,500.00 per State fiscal benefit year. Individuals will receive a notice when 75% of the $2,500.00 cap has been expended.
30502.1 Co-payment Requirement for Individuals with Medicare Part D Coverage
There is a co-payment of $5.00 or 25% of the cost of the prescription (whichever is greater) during the Part D deductible and coverage gap and for drugs that are excluded from Part D. DPAP will not provide payment assistance for Medicare Part D co-payments. When the individual receives a prescription drug that is covered under Medicare Part D, the individual is responsible for the Medicare Part D co-payment.
(Break in Continuity of Sections)
50100 Services Provided by CRDP
Services provided by the CRDP can consist of payment for medications, nutritional supplements, and transportation. Services provided by the CRDP can consist of payment for medications, nutritional supplements, transportation, and payment of Medicare Part D costs. Electronic Data Systems (EDS) is the CRDP's fiscal intermediary. They are responsible for processing all eligible CRDP claims.
50100.1 Medications
The CRDP has the ability to fund prescription medications, over-the-counter medications (OTC's) or both. Services covered include generic and brand name prescription drugs that have been approved as safe and effective by the Federal Food and Drug Administration as well as cost effective over-the-counter drugs prescribed by a practitioner. Prescription drugs covered under CRDP are restricted to products manufactured by pharmaceutical companies that agree to provide manufacturer rebates.
Reimbursement for medications will be made only for clients authorized by the CRDP. A client's eligibility for the medication benefit is based upon the outcome of their medical and financial assessment.
Prescription medications potentially will be funded if prescribed by a physician for eligible clients. Refills may be authorized in compliance with appropriate pharmacy laws.
Reimbursements for OTC products for eligible clients are those, which the physician/practitioner has provided written or verbal authorization to the pharmacist. These products must be for the client's personal use only. There will be no reimbursement for OTC products that are not prescribed by a physician/practitioner. Supplies such as mouthwash, toothpaste, shampoo, etc. will not be reimbursed.
At point of sale, the pharmacist will determine electronically if CRDP will fund the requested product. In order for the pharmacy to receive CRDP payment, they must have a Delaware Medicaid provider number.
Note: All third party resources must be used before CRDP funds are utilized.
(Break in Continuity of Sections)
50100.4 Medicare Part D Costs
The Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) established the Medicare Prescription Drug Program, also known as Medicare Part D, making prescription drug coverage available to individuals who are entitled to receive Medicare benefits under Part A or Part B, beginning on January 1, 2006.
The MMA provides for a Low Income Subsidy (LIS) for individuals with limited income and resources. The LIS is assistance provided by the Centers for Medicare and Medicaid Services to pay Medicare Part D costs for eligible individuals. The LIS will provide payment assistance with the monthly premium, the yearly deductible, and the coverage gap. The LIS will also provide payment assistance for co-payments after an individual with income below 135% of the Federal Poverty Level reaches a total of $5100 in drug expenses.
The CRDP will provide coverage for Medicare Part D costs including monthly premiums, yearly deductible, drug costs that fall into the Part D coverage gap, and co-payments. If an individual is eligible for the LIS, this assistance will be primary to CRDP assistance.
(Break in Continuity of Sections)
50200 Services Not Provided by CRDP
The CRDP will not pay health insurance premiums (except Medicare Part D premiums); nor will the program pay for medical, hospital, or ancillary services, medical supplies, or transportation not directly related to the care of End State Renal Disease (ESRD).
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50500 Technical Eligibility
Only persons who are residents of the State of Delaware shall be eligible for services. Additionally, the individual must be an U.S. citizen or a lawfully admitted alien.
An individual who is entitled to receive Medicare benefits under Part A or Part B must enroll in Part D in order to be eligible for CRDP. The individual must provide proof of Medicare Part D enrollment. Exception: Medicare eligible individuals who have creditable coverage are not required to enroll in Part D as a condition of eligibility. Coverage is creditable if the actuarial value of the coverage equals or exceeds the actuarial value of the standard prescription drug coverage under Part D.
An individual must apply for the LIS if potentially eligible. The individual must provide a copy of the LIS denial or approval notice.
Individuals may be found eligible for CRDP pending their Medicare Part D enrollment and application for LIS for a period of no longer than 90 days from the date of application for CRDP. Current recipients will be notified about the Medicare Part D enrollment requirement and the LIS requirement. They will be given a deadline date by which they must meet this requirement.
