C.M.R. 10, 144, ch. 101, ch. II, 144-101-II-80, subsec. 144-101-II-80.07
Participant providers may be required by the Department to obtain a generic drug from labelers or manufacturers with which the Department contracts. The Department will notify providers and give instructions for compliance with this provision.
Additionally, drugs that are otherwise covered by MaineCare but are provided from manufacturers/labelers not covered under the rebate agreement may be subject to prior authorization requirements upon thirty days written notice from the OMS. (See 80.07-4 for prior authorization policy.)
Mail order pharmacy providers must be appropriately licensed by the Maine Board of Pharmacy and by the appropriate licensing authority in the state in which they are located. Mail order pharmacy providers must satisfy all MaineCare provider enrollment requirements including, but not limited to, meeting standards for quality of care and prior authorization requirements as established by the Department, accepting Medicare assignment, and operating under contract with the Department. Mail order pharmacy providers must dispense MaineCare prescription medications from within the United States.
The Department may require prior authorization for certain drugs as set forth in this Section. In all instances, MaineCare members will be assured access to all medically necessary outpatient drugs.
In determining when prior authorization will be required, the Department will consider the recommendations of the DUR Committee. The Department will provide notice of DUR meetings in newspapers, through legislative notice procedures, to the MaineCare Advisory Committee, the Maine Medical Association, and the Maine Osteopathic Association.
Those portions of the meetings that do not involve confidential or protected information, including, to the extent possible, the process of decision making, shall be open to the public.
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 Pharmacopeia-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 80.09, 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 will provide prescribers with the list of drugs subject to prior authorization by posting and updating it on the designated website.
The Department will review previous Prior Authorization requests when reviewing a prior authorization for opioids/narcotics. Previous PA requests and medical records, as well as Lock-in or Intensive Benefits Management (IBM) records, may be considered in making decisions for current prior authorization requests.
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 has the discretion to exempt providers and/or members 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 three (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 ninety-five percent (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 three (3) month exemption from PA requirements when prescribing drugs for members 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 three (3) month compliance exemption described above, and have received that exemption for three (3) out of four (4) quarters of a year, the Department may grant a one (1) year exemption for prior authorization requirements when prescribing drugs for members 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 80.07-4(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 members receiving non-preferred drugs when MaineCare is the secondary payer.
The Department, in consultation with the DUR Committee, and consistent with standards set forth in 80.07-4(A), may waive the prior authorization requirement for specific drugs or medical conditions, on a drug-by-drug basis for members who have been established for at least one (1) year on a drug that otherwise might be subject to prior authorization.
The Department may grant members open-ended PAs for some specified drugs listed on the Department's designated website after having been established on a non-preferred drug and meeting all other prior authorization requirements for at least one (1) year, with the exception of any controlled substance drugs. 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 member's condition is stable, and will remain unchanged if continued on the specific drug. The Department reserves the right to review and reconsider the PA status should a new and more efficacious alternative become available.
When the Department requires prior authorization, the member's prescriber must complete a form in writing and submit it and 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 forms will also 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, in compliance with the Health Insurance Portability and Accountability Act (HIPAA) standards.
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 twenty-four (24) hours of receipt.
During weekends, holidays, or any other time that the Department or its designee is not able to respond to a completed prior authorization request within twenty-four (24) hours of receipt, the pharmacy provider is authorized to provide a one-time ninety-six (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 ninety-six (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 provider to dispense a one-time four (4)-day supply of the prescribed drug. The authorization of a one-time 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 four (4)-day period, the Department will consider any refills of that prescription on a case-by-case basis.
Prior authorization is effective for up to twelve (12) months unless otherwise specified by the Department. In instances where coverage is continued pending an approval, the period of PA is calculated from the latter of either the end date of the previous approval or the date of the request for a hearing, unless otherwise specified by the Department.
Drugs that have not been reviewed by the DUR Committee may be subject to temporary prior authorization by the Department under the following circumstances:
Temporary prior authorization requirements imposed pursuant to this subsection shall conform to current DUR Committee prior authorization guidelines described above, and shall be effective immediately. Drugs subject to temporary prior authorization shall be reviewed at the next meeting of the DUR Committee.
In order to facilitate appropriate utilization, the Department will establish a list of covered drugs, ordered by therapeutic category. This listing will be known as the Preferred Drug List or PDL. 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 Pharmacopeia-Drug Information, and the DRUGDEX Information System. The Department's determination of a drug's net cost shall consider the pharmacy reimbursement amount as set forth at Section 80.09, 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 unless it determines that the drug has no significant clinical or safety advantages over one or more alternative drugs, when used for a given purpose.
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 member for whom those drugs are medically necessary.
Some drugs must have their medical necessity confirmed for a given member through the prior authorization process before the Department will provide reimbursement. When medically necessary covered brand-name drugs have an FDA approved A-rated generic equivalent available, the most cost-effective medically necessary version will be approved and reimbursed by MaineCare, since the brand-name and A-rated generic drugs have been determined by the FDA to be chemically and therapeutically equivalent. If an A-rated generic version fails due either to reported inefficacy or side effects, the member should proceed to a chemically different therapy. The Department does not make determinations as to a generic drug's equivalence or clinical efficacy compared to the brand-name version, since this is the role of the FDA.
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 member 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 member without requiring prior authorization. Only drugs prescribed to the member since enrollment and reflected in the Department's automated pharmacy management information Point of Purchase System will be considered in applying the step order.
Once the Department has determined that a member has undertaken a satisfactory trial of a preferred or lower-step drug, the member will not be required to repeat that drug trial in the future unless there is evidence of a change in the member's condition or new or newly acquired research that would warrant a new trial, or newly acquired evidence suggesting that the previous drug trial was inadequate.
The minimum trial periods for each preferred and step-order drug is two weeks unless otherwise stated on the Department's Preferred Drug List, or unless an acceptable clinical explanation is submitted by the attending physician. Trials with less than a two-week duration will be reviewed on a case-by-case basis. A trial will not be considered valid if non-preferred products were readily available (paid by override, individual purchase, cash, or samples, etc.), and certain drug trials may require evidence that the preferred drugs were actually tried (e.g., to confirm trials of preferred narcotics with urine drug screens). Furthermore, adequate trials require documentation of attempts to titrate dose(s) of preferred agents toward the desired clinical response.
The Department shall require substitution for a brand-name drug of a generic and therapeutically equivalent drug as required by Maine Revised Statues, Title 32, Section 13781, absent Prior Authorization from the Department. Prior Authorization requires that the prescriber has indicated that the brand-name drug must be dispensed and that the brand name drug is medically necessary.
The following shall be exempt from the requirements stated above:
The Department may provide drug benefit management to certain high-cost and/or high utilizing members of the MaineCare pharmacy benefit. The Department may identify these members by reviewing any or all of the following factors: drug costs within the top ten percent (10%) of the aggregate prescription drugs costs, utilization within the top ten percent (10%) of specific drug categories, or high costs or utilization within specific drug categories where more cost-effective drug therapies could be utilized while maintaining or improving health outcomes.
The Department may provide drug benefit management intervention for these members and/or prescribers by providing education and case management.
The Department may provide intensive benefits management for members for whom drug benefit management does not result in the implementation of targeted recommendations.
As part of the ongoing drug utilization review process, members whose drug profiles are of sufficient complexity, or who receive prescriptions from multiple prescribers, or whose prescribers have demonstrated frequent disregard for Departmental policies, may be identified for participation in intensive benefits management. Intensive benefits management may require long-term case management for members, enhanced coordination of care among providers, address inappropriate prescribing behavior, and promote cost-effective pharmaceutical care.
Intervention also may require prescriber and/or pharmacy lock-in, prior authorization of all drugs, assignment of prescribers to peer review, and enrollment of members in disease management services or intensive medical management. The Department also may require member participation in the Restriction and Narcotic Prescriber Plans, as described in Chapter IV, Section 1 of the MaineCare Benefits Manual.
The Department will post the PDL and any changes on the Department's designated website. The Department will also provide quarterly notification of the drugs selected for placement on the PDL, and any other changes in the PDL.
Compliance with the following dispensing policies is required:
Also see Section 80.09. Where unit of use packaging prevents the pharmacist from measuring a thirty-four (34)-day supply (e.g., ointments, eye drops, insulin and inhalers) prescriptions shall be dispensed in a size consistent with a thirty-four (34)-day supply.
A pharmacy affiliated through common ownership or control with a hospital, boarding home, ICF-IID, private non-medical institution, assisted living facility and/or nursing home is allowed to dispense covered MaineCare prescription drugs to MaineCare members in that facility. Providers must report these affiliations to the OMS Provider Enrollment Unit and the Pharmacy Director. A registered pharmacist must dispense the drugs according to dispensing regulations. Drugs are to be billed in a manner consistent with the Department's billing guidelines and drug claim processing system (see Section 80.09) without a professional dispensing fee.
Practitioners who have been authorized to dispense drugs for MaineCare members shall not receive a dispensing fee, but will be allowed to charge a three dollar ($3.00) co-payment amount, except for tobacco cessation products (see Section 80.08-4), in addition to the acquisition cost of drugs dispensed. Records of all such dispensing must be available for review and audit.
A pharmacy provider must maintain the original or electronic copy of all prescriptions for which payment from the MaineCare program is requested. The original prescription shall be either a hard copy generated by a computer, written by the prescriber, or reduced to writing when received by the pharmacist by telephone.
Information required by the Maine State Board of Pharmacy shall be recorded on each prescription and must include name of member, name of drug, quantity ordered, directions, name of prescriber, date written and initials of pharmacist filling prescription. A record of each refill must be kept on the prescription or on the profile or be available on a computer.
Except as set forth below, reimbursement for refills will be made only if the following conditions are met:
The Department supports generally accepted professional judgments made by pharmacists, including the right to refuse to dispense any prescription that appears to be improperly executed or unsafe, based on the pharmacist's professional judgment. The Department expects that any pharmacist who suspects that a member may be inappropriately using a drug will report the member to the Pharmacy Unit or Program Integrity Unit, OMS, 1 1 State House Station, Augusta, Maine 04333-0011.
Some members may be enrolled in the Restriction and Narcotic Prescriber Plans. See Chapter IV, Section 1, of MaineCare Benefits Manual for more details.
Program Integrity (formerly Surveillance and Utilization) review requirements are delineated in Chapter I of the MaineCare Benefits Manual.
The Department or its designee may authorize over-rides in certain situations to allow a pharmacy to waive standard conditions or requirements for dispensing a medication. All over-rides enabling a pharmacy to dispense a four (4) day supply or less do not constitute continued benefits under MaineCare. The following is a list of situations where the Department or its designee may authorize an over-ride to dispense medications:
The prescriber has determined that a change in the therapy is required that results in dosage change, i.e., increased dosage or continued treatment after a starter dose.
The co-payment information in the automated eligibility system is not current. This over-ride may be used only when members should be exempt from co-payment, but for whom there is a co-payment indicated, as outlined in Chapter I.
To enable a pharmacy to dispense up to a ninety-six (96) hour supply for situations as defined in Section 80.07-4(C). One-time over-rides enabling a pharmacy to dispense a ninety-six (96)-hour supply or less do not constitute continued benefits under MaineCare, as detailed in Chapter I.
When none of the conditions above apply, yet medical necessity is demonstrated. Providers must call the PA help desk to request these special exceptions, and the Department or its authorized representative will determine approval on a case-by-case basis.
The goal of this section is to offer a balanced approach to pain management that includes recommendations for using opioids when appropriate, such as with acute injuries and flare ups, for postoperative pain management, and during painful procedures; and recommending alternative therapies in general for all chronic pain patients. The section aligns with Maine statutes and the Department of Health and Human Services' Office of Substance Abuse and Mental Health Services Rules Governing the Controlled Substances Prescription Monitoring Program and Prescription of Opioid Medications. (See 14-118, C.M.R. Chapter 11). This section does not address the use of opioids as part of medication-assisted treatment (MAT) for opioid use disorder. MAT is addressed elsewhere in this policy under Section 80.07-13.
Refer to Section 80.05, Covered Services, of this policy for pharmacologic coverage. For nonpharmacological treatment coverage, refer to the corresponding policy chapters of the MaineCare Benefits Manual (MBM) that address the specific treatment or therapy.
Once a member has reached the opioid prescription cumulative maximum of twenty-eight (28) days, the member is considered to have transitioned from treatment of acute pain to treatment of chronic pain for MaineCare purposes of these requirements.
Prescribers must review the Prescription Monitoring Program database as medically indicated and required by 14-118 C.M.R. Chapter 11, Rules Governing the Controlled Substances Prescription Monitoring Program and Prescription of Opioid Medications, to verify that no concomitant narcotic use by the member is occurring, and the reviews must be evidenced in the medical documentation.
Prescribers are required to follow Maine statutes and the prescribing guidelines, limitations, and exemptions as outlined in 14-118 C.M.R. Chapter 11, Rules Governing the Controlled Substances Prescription Monitoring Program and Prescription of Opioids.
Prescribers are required to follow the following prior authorization guidelines when prescribing opioid medications for pain management:
Alternative treatment options include nonpharmacologic treatments, such as physical therapy, occupational therapy, osteopathic manipulation, chiropractic treatment, outpatient counseling, psychological therapies, Eye Movement Desensitization and Reprocessing (EMDR), and nonopioid pharmacologic treatments, such as acetaminophen, NSAIDS, gabapentin, and selected antidepressants. Benzodiazepines will not be considered an alternative treatment option.
Each prescription may be for no more than thirty (30) days. Approved prior authorization will not exceed six (6) months.
The Department may grant prior authorization for an opioid drug when participation in all appropriate alternative treatments is not feasible and opioid treatment is medically necessary.
The prescribing physician shall keep accurate and complete records to include:
Records shall remain current and be maintained in an accessible manner and readily available for review.
MaineCare's coverage of buprenorphine, a Schedule III narcotic, is subject to strict limitations on members qualified to receive the drug, rules regarding prior authorization, and clearly defined maximum daily dosages. MaineCare covers multiple formulations of the drug buprenorphine only for a member who has a diagnosis of Substance Use Disorder (SUD).
All prescriptions for buprenorphine, buprenorphine derivatives, and naltrexone must be reported to the Maine Prescription Monitoring Program (PMP) pursuant to the rules established at 14-118 C.M.R. Chapter 11, Rules Governing the Controlled Substances Prescription Monitoring Program and Prescription of Opioid Medications.
MaineCare covers buprenorphine for a member who has a diagnosis of SUD. The medication must be prescribed by a practitioner who has obtained an XDEA identification number (which denotes buprenorphine prescriber status) from the U.S. Department of Justice, Drug Enforcement Administration, Office of Diversion Control and meets all requirements as set forth in Maine statutes and Maine's Office of Substance Abuse and Mental Health Services, Chapter 11, Rules Governing the Controlled Substances Prescription Monitoring Program and Prescription of Opioid Medications(http://www.maine.gov/sos/cec/rules/10/chaps10.htm). Reimbursement for FDA-approved buprenorphine products for opioid use disorder treatment as listed on the MaineCare Preferred Drug Lists will be made if approved through the prior authorization process. (See Section 80, "Pharmacy Services", § 80.07-4, "Prior Authorization").
For limitation guidelines for prescribing buprenorphine products, please refer to MaineCare's Preferred Drug List at www.mainecarepdl.org for the most current and accurate prescribing criteria.
The prescriber physician shall keep accurate and complete records to include:
Records shall remain current and be maintained in an accessible manner and readily available for review.
C.M.R. 10, 144, ch. 101, ch. II, 144-101-II-80, subsec. 144-101-II-80.07