C.M.R. 10, 144, ch. 104, § 144-104-2, subsec. 144-104-2.06
Only those drugs of manufacturers that have both a valid rebate agreement with the federal government pursuant to 42 U.S.C. § 1396r-8 and a DEL Rebate Agreement are covered in the DEL Benefit. A prescription drug of a manufacturer that does not enter into an agreement pursuant to this paragraph is reimbursable only if the Department determines the prescription drug is essential. The Department, at its sole discretion, will determine that a drug is essential based on medical necessity. In addition, drugs may be subject to prior authorization and the step order as set forth in this Section. The Department may refuse coverage for a drug when the prescriber cannot demonstrate medical necessity.
The Basic benefit covers brand-name and generic drugs when administered for the following conditions and illnesses: heart disease, diabetes, high blood pressure, arthritis, chronic lung disease (including emphysema and asthma), anticoagulation, hyperlipidemia (high cholesterol), incontinence, thyroid disease, osteoporosis (bone density loss), Parkinson's disease, glaucoma, and multiple sclerosis/ amyotrophic lateral sclerosis (Lou Gehrig's Disease).
Some over-the-counter drugs are covered in the DEL Benefit when the Department determines that they are both cost-effective and that they have a National Drug
Code (NDC) number. These drugs will be approved only when the prescriber can demonstrate, with appropriate medical justification, that the use of these drugs is medically necessary. The Department may exclude from coverage drugs that are equivalent to drugs that are available over-the-counter.
In the Basic benefit, the participant must pay a co-payment for services requested and rendered from retail pharmacies of 20% of the reimbursement amount as defined in Section 2.11, plus $2 per prescription, not to exceed a 34-day supply for brand-name drugs, and up to and including a 90-day supply for generics.
In the Basic benefit, the participant must pay a co-payment for services requested and rendered from mail order pharmacies of 20% plus $2 of the reimbursement amount as defined in Section 2.11 for up to a 90-day supply of generic drugs or brand-name drugs.
The Supplemental benefit includes all drugs of those manufacturers that have entered a federal rebate agreement and a DEL rebate agreement that are not covered in the Basic benefit, including those used to treat illnesses and conditions not included in the Basic benefit as set forth above.
A prescription drug of a manufacturer that does not enter into an agreement pursuant to this paragraph is reimbursable only if the Department determines the prescription drug is essential. The Department, at its sole discretion, will determine that a drug is essential based on medical necessity.
Under the Supplemental benefit, whether obtained through retail or mail order pharmacies, participants must pay 100% of the MaineCare prescription rate for brand-name drugs, as set forth in Subsection 2.11 of this Section, minus $2 per prescription. For generic drugs, participants must pay the sum of $2 plus 20% of the DEL prescription rate as set forth in Section 2.11.
All drugs covered by either the Basic benefit or the Supplemental benefit are covered in the Catastrophic benefit.
Participants eligible for Medicare Part D are not eligible for catastrophic benefits under this Section.
Participants who are not Medicare Part D eligible are eligible for the Catastrophic benefit once that participant has paid total co-payments in the DEL benefit of at least $1,000 between August 1 and July 31 of any year(s) in which the participant is eligible, provided that:
After the participant has paid a total of $1,000 in co-payments as set forth in 2.06-3(B), the participant may purchase any drugs covered by either the Basic or Supplemental benefit by paying 20% of the reimbursement rate described in Section 2.11 until the next July 31.
The Department may require prior authorization for certain drugs in the DEL benefit as set forth in this sub-section.
In determining when prior authorization will be required, the Department will consider the recommendations of the DUR Committee. The determination to impose prior authorization will be based on the efficacy, safety, and net cost of any given drug and of the other drugs within the therapeutic category. The Department's determination of a drug's efficacy and safety shall be consistent with the standards set forth in (1) the peer-reviewed literature, and (2) the following compendia: the American Hospital Formulary Service Drug Information, the United States Pharmacopoeia-Drug Information, the DRUGDEX Information System, and American Medical Association Drug Evaluations. The Department's determination of a drug's net cost shall consider the pharmacy reimbursement amount as set forth at section 2.10 of this rule, as adjusted by any manufacturer rebates and or supplemental rebates to be paid to the Department for that drug. The Department may not consider net cost when imposing prior authorization unless it determines that the drug to be subject to prior authorization has no significant clinical or safety advantages over one or more alternative drugs, when used for a given purpose. The Department may also consider the indications for which the drug may be prescribed, where appropriate.
The Department may require prior authorization of any generic drug that has a net cost that is greater than the net cost of its brand-name version.
The Department, in consultation with the DUR Committee, may determine that the prior authorization requirement may be waived on a case-by-case basis for patients who are established on a drug that otherwise might be subject to prior authorization.
The Department has the discretion to exempt providers and/or participants from prior authorization requirements. The Department may discontinue these PA compliance exemptions any time with written notice. Exemptions are as described in this Section:
Providers may receive a 3-month exemption from prior authorization requirements for certain categories of drugs when they demonstrate high compliance with the Department's PDL. The Department runs quarterly reports to identify providers who prescribe 95% or more of their prescriptions, within certain categories of drugs, in compliance with the PDL. When providers are thus identified, they may receive a 3-month exemption from PA requirements when prescribing drugs for participants within the identified drug categories. The Department will notify providers in writing which drug categories are included and what dates apply to the exemption.
When providers have met all requirements for the 3-month compliance exemption described above, and have received that exemption for 3 out of 4 quarters of a year, the Department may grant a 1-year exemption for prior authorization requirements when prescribing drugs for participants within certain categories of drugs. The Department will notify providers in writing which drug categories are included and what dates apply to the exemption.
The Department, in consultation with the DUR Committee, and consistent with standards set forth in 2.06-4(A), may waive the prior authorization requirements for specific provider specialists on a drug-by-drug basis.
The Department may waive the prior authorization requirements for participants receiving non-preferred drugs when DEL or MaineCare is the secondary payer.
The Department, in consultation with the DUR Committee, and consistent with standards set forth in 2.06-4(A), may waive the prior authorization requirement for specific drugs or medical conditions, on a drug-by-drug basis for participants who have been established for at least 1 year on a drug that otherwise might be subject to prior authorization.
Participants may receive open-ended PAs for specific drugs after having been established on a non-preferred drug and meeting all other prior authorization requirements for at least 1 year. These open-ended PAs do not need to be renewed on an annual basis. These PAs may be issued after the Department determines that the participant's condition is stable, and will remain unchanged if continued on the specific drug. The Department reserves the right to review the PA status should a new and more efficacious alternative become available.
When the Department requires prior authorization, the participant's physician must complete and submit a written form, including any required attachments, documenting the medical necessity of the prescribed drug. The Department may seek information such as documentation of other measures that have been attempted to correct the risk/condition, the timeframe in which those other measures were attempted, and the reason for failure. The prescriber is also required to submit documentation that other drugs in the same therapeutic category are contraindicated.
The Department will notify prescribers of the drugs that are subject to prior authorization and will provide them with forms for requesting authorization setting forth the information needed to approve a request. The list of drugs requiring PA and forms will be available on a website designated by the Department.
The requesting prescriber must complete the form applicable to the drug for which prior authorization is sought. The prescriber must send the completed form to the Department or its designee, as instructed by the Department, by mail, fax or by hand delivery. During regular business days, the Department or its designee will respond to a completed request for prior authorization by fax, telephone or other telecommunications device within 24 hours of receipt.
In an emergency situation, including weekends, holidays, or any other time that the Department or its designee is not able to respond to a completed prior authorization request within 24 hours of receipt, the pharmacist is authorized to provide a one-time 96-hour supply of any prescribed drug that is a covered drug. The Department or its designee shall respond to a completed request under this subpart on the next regular business day. The provision of a 96-hour supply under this subpart does not relieve the prescriber of the obligation to complete and submit the prior authorization request form.
In the event that a prescriber fails to submit a completed form for a drug requiring prior authorization, the Department or its designee may authorize the pharmacy to dispense a one-time 34-day supply of the prescribed drug. The authorization of a 34-day supply under this provision does not relieve the prescriber of the obligation to complete and submit the prior authorization request form. If the prescriber has still failed to submit a completed prior authorization request by the end of the additional 34-day period, the Department will consider any refills of that prescription on a case-by-case basis.
The Department may require a provider to redo the prior authorization process every 12 months, or sooner if the participant's medical condition or the prior authorization criteria change.
In order to facilitate appropriate utilization, the Department will establish a list of covered drugs, ordered by therapeutic category. Within each therapeutic category, the Department may designate some or all drugs as preferred on the basis of efficacy, safety, and net cost. The Department's determination of a drug's efficacy and safety shall be consistent with the standards set forth in (1) the peer-reviewed literature, and (2) the following compendia: The American Hospital Formulary Service Drug Information, the United States Pharmacopoeia-Drug Information, the DRUGDEX Information System, and American Medical Association Drug Evaluations. The Department's determination of a drug's net cost shall consider the pharmacy reimbursement amount as set forth at Section 2.10 of this rule, as adjusted by any manufacturer rebates and or supplemental rebates to be paid to the Department for that drug. The Department may not consider net cost when imposing prior authorization unless it determines that the drug to be subject to prior authorization has no significant clinical or safety advantages over one or more alternative drugs, when used for a given purpose. This listing will be known as the Preferred Drug List or PDL.
In addition to the preferred/non-preferred designation, the PDL may include information such as generic name, strength/unit, National Drug Code identification number, and brand name.
All covered drugs, whether preferred or non-preferred, are available to any eligible participant for whom those drugs are medically necessary. Some drugs must have their medical necessity confirmed for a given participant through the prior authorization process before the Department will provide reimbursement.
In addition to the preferred/non-preferred designations, the Department may assign some drugs on the PDL a further designation of preference within a therapeutic category. This further designation will be known as step order.
The step order is a means of reducing the need to obtain prior authorization. When a participant has been prescribed all drugs at a higher step(s) within a therapeutic category, the drug at the next lower step will automatically be reimbursed for that participant without requiring prior authorization. Only drugs prescribed to the participant since enrollment and reflected in the Department's automated pharmacy management information Point of Purchase System will be considered in applying the step order.
The Department will post the PDL on the Department's designated web site. The Department will also provide quarterly notification of the drugs selected for placement on the PDL, and any other changes in the PDL. The list will be provided upon request to participants and providers who do not have Internet access.
C.M.R. 10, 144, ch. 104, § 144-104-2, subsec. 144-104-2.06