SOCIAL SERVICES; PHARACEUTICAL ASSISTANCE PROGRAMS;

DRUGS- PHARMACEUTICAL ASSISTANCE PROGRAMS;

You asked for a description of DSS’s PA program for prescription drugs that was implemented on July 16, 2003, including any implementation issues.

SUMMARY

On July 16, 2003, DSS began implementing a prior authorization (PA) program for drugs dispensed under the Medicaid, Connecticut Pharmaceutical Assistance Contract to the Elderly and Disabled (ConnPACE), State-Administered General Assistance (SAGA), and General Assistance pharmacy programs.

PA means that before a patient enrolled in any of these programs can get certain drugs, and before pharmacists can get reimbursed for them, the prescription must be approved by DSS. (DSS has contracted with a company, ACS Healthcare, to run this program. ) PA is now required when DSS clients have prescriptions for:

1. with one exception, brand-name drugs when a chemically equivalent generic is available;

2. early refills; and

3. drugs costing more than $ 500 for a 30-day supply.

Individuals who were already taking atypical antipsychotic drugs on July 16, 2003, and continue to need the drugs can receive these drugs without PA. But patients needing these drugs for the first time after July 16, 2003 will need to get PA.

For brand-name drugs or for early refills of controlled drugs, the prescribing practitioner must request the PA. For all others, the pharmacist requests the PA. Those requesting PA must call ACS’ clinical call center and submit certain forms. Although PA is required for early refills, ConnPACE recipients requesting certain early refills will not be able to get them, even with PA. DSS has said that state regulations prohibit these refills and believes the PA requirement is irrelevant in these cases. DSS commissioner Coker has acknowledged this inconsistency and has said she will consider proposing legislation to fix it.

When PA is denied for a brand name drug, the prescriber can appeal through DSS’ s fair hearing process. Likewise, pharmacists are authorized by law to appeal to DSS when they are denied reimbursement for filling a brand name drug when a generic is available. Patients can also appeal certain PA denials, although they may not always get a generic drug while waiting for a decision on their appeal.

Although the PA programs went into effect on July 16, 2003, the attorney general (AG) and elder law advocates believe that parts of it are illegal. For example, they contend that the portion of the DSS plan and training manual that requires PA every six months for certain brand name non-maintenance drugs violates the law requiring PA for initial prescriptions only. Likewise, when a new generic drug gets federal Food and Drug Administration approval, patients may be required to get PA. The AG and the elder law attorneys are challenging the department’s interpretation of the frequency with which PA must be obtained.

And although the law tries to ensure that patients get their drugs in a reasonable amount of time by deeming requests for PA granted if not denied within two hours, in practice this does not happen. The call centers will apparently not approve those PA requests that are still pending after two hours but will instead dispense a five day supply of drugs (or the full amount of the prescription if the prescription is for less than a 15-day supply). The AG and elder law attorneys are challenging this interpretation as well.

PRIOR AUTHORIZATION (PA)

State Law

In 2000, the legislature directed DSS to adopt a plan for PA of certain prescription drugs dispensed under the Medicaid, ConnPACE, SAGA, and GA programs. Specifically, PA would be required for initial prescriptions for (1) drugs costing more than $ 500 for a 30-day supply, (2) early refills, and (3) brand name drugs for which chemically-equivalent substitutes were available. It required the approval to come from an independent pharmacy consultant acting on DSS’s behalf, under an administrative services only contract.

DSS submitted its plan to the Human Services, Public Health, and Appropriations committees in early 2002. The plan, which the Appropriations and Public Health committees adopted and Human Services rejected, was deemed approved in June 2002.

In 2002, the General Assembly directed DSS to implement the plan. But it also changed the plan to require prior authorization for less than a 15-day supply of maintenance drugs, effectively requiring PA for all maintenance drugs. That law also creates a narrow exception under which PA is not required for atypical antipsychotic drugs that a patient is taking on July 16, 2003, the program’s effective date.

(PA 00-2, June Special Session, codified at CGS §§ 17b-274(d) and 17b-491a; PA 02-7, MSS, § 50).

Implementation Plan

DSS submitted its first PA plan in early 2002. The plan was revised several times to address concerns raised. The plan ultimately adopted establishes three criteria for PA in the pharmacy programs DSS administers. As the law specifies, pharmacists must get prior authorization when DSS clients seek:

1. a brand-name drug when a chemically equivalent generic is available (the plan did not exempt the atypical antipsychotics because it was approved before the legislature added the exemption),

2. an early refill of any prescription, or

3. a prescription costing more than $ 500 for a 30-day supply.

The prescriber must request the PA for the brand-name drugs and for early refills of controlled substances, and the pharmacist must get PA for other early refills and prescriptions above the cost threshold. The plan states that the contract DSS selects to run the program (ACS State Healthcare of Atlanta) must establish a clinical call center that is available 24 hours a day seven days per week. (ACS has been Connecticut’s retrospective drug utilization review contractor since April 2002. )

If patients need to substitute an existing medication to change dosages or strengths of a particular drug or if a prescribed drug is in the same therapeutic class, the plan allows these to be dispensed without PA.

“Brand Medically Necessary” Overrides. The plan and the subsequently published Provider Training Manual set up a process for pharmacists and prescribers to follow when patients come in for their prescriptions. Both the plan and training manual stress that only the prescriber can request PA for brand name drugs when he feels the brand name drug is medically necessary. When a patient has a prescription for a brand name drug and an “A” rated generic (this means the drug has received an “A” rating from the federal Food and Drug Administration because it is bioequivalent to a brand name drug in dosage form, performance, safety, strength, quality, and usage) is available, the prescription must include the prescriber’s basis for prescribing it as brand medically necessary. The prescriber must call the call center to request the drug. The call center informs the prescriber that the generic is available. If the prescriber agrees to the substitution, there is no longer a need for PA and the call is documented as complete. If the prescriber does not agree, he must fax to the call center a Med/Watch form, copy of the prescription, and a PA request form.

Once the prescriber faxes the documentation for the PA request, the call center’s pharmacist opens it in the system and indicates a start time (for purposes of the two-hour window) and reviews the documentation for completeness. If it is complete, the center’s pharmacist approves the request directly in the Electronic Data Systems system (EDS is the claims processor that actually pays the pharmacist for dispensing the drugs). If the documentation is incomplete, ACS calls the prescriber to get additional documentation. If the prescriber cannot be contacted within two hours, the PA request is denied and the precriber must re-submit it. In the latter situation, the pharmacy is authorized to dispense a five-day supply of the drug if it is prescribed for at least a 15-day supply. If the prescription is for less than a fifteen-day supply, the pharmacist can fill the full supply.

Early Refills. When a patient asks a pharmacist to refill a prescription before at least 75% of the previous supply has been used, the pharmacist’s point-of-service system automatically indicates this to the pharmacist. In some cases these refills are necessary, for example when the drugs have been lost or stolen. Sometimes the request is made due to a change in dose. The outcome depends on both the circumstances and the DSS pharmacy program is involved.

When the pharmacist receives an early refill indicator, he must contact the ACS call center to obtain payment for the drug. But when narcotic drugs are lost, stolen, or damaged as a result of property damage, the physician must contact ACS and the patient may be required to present theft or loss reports. This policy will generally apply to drugs prescribed under the Medicaid, SAGA, and General Assistance programs but not ConnPACE.

Although not reflected in the approved plan, DSS has indicated that one of its existing ConnPACE regulations prohibits early refills when the drugs are lost or destroyed (Conn. Agency Regulations, Sec. 17b-262-689). DSS extended this prohibition in the PA training manual to include early refills when the patient is going on vacation. (Even under the other pharmacy programs, PA is not automatic for early refills. The training manual lays out the different scenarios in which PA would be warranted. ) DSS acknowledges that this creates an inconsistency among the pharmacy programs and is considering suggesting a change that would provide consistency on early refills among all of the pharmacy programs.

The process for documenting these requests is similar to those for the brand medically necessary drugs with an important exception. If the two hour window cannot produce the PA, the five day supply can be dispensed only if the drug is identified as an emergency drug that should not be interrupted while the documentation is being gathered. But in no circumstances can controlled drugs be dispensed as an emergency five-day supply.

Drugs Costing More than $ 500 Per Month for 30-Day Supply. When a pharmacist seeks payment for dispensing these types of drugs, he will automatically get a denial message and must call ACS for PA. ACS finds the patient and payment claim in its system and verifies that the billing units and days supply is correctly entered on the claim. If it is correct, ACS enters the approved PA directly into the EDS system, the call is documented, and the call is complete. Then, the pharmacist can re-submit the claim.

Appeals. If a prescriber and the call center cannot reach an agreement that the generic equivalent should be dispensed, the call center will approve a five-day supply, during which time the call center will work with the prescriber to resolve the issue. If after this time it cannot be resolved, the patient receives the balance of his medication in its generic form. The call center then sends a notice to the prescriber notifying him of his right to appeal under the law. The prescriber has 10 days to request in writing, that DSS review the call center’s decision. If this occurs, the call center overrides the generic substitute with the brand name drug pending a decision or other resolution of the dispute. If the department subsequently upholds the call center’s decision, the client is notified of his right to appeal.

Clients can appeal denials when (1) ACS determines that PA is not medically necessary based on documentation the prescriber supplies or (2) it does not have sufficient documentation. But unlike prescriber appeals made within the 10 days, the brand name drug will not be dispensed pending the outcome of the administrative hearing.

The pharmacist is also authorized to appeal when he is denied reimbursement for a brand name drug he dispenses and he has not obtained PA for it.

The lack of notice to clients when PA is denied has caused concern among the advocates and the attorney general. They suggest that this lack of notice is in direct conflict with federal law. Commissioner Coker pointed out in a letter dated July 16, 2003 that DSS was not violating federal law (citing case law) and indicated that clients will be notified of denials once the five-day supply is up if and when ACS and the prescriber cannot agree that the name brand drug is medically necessary or if the precriber fails to submit the needed documentation for ACS to make a PA determination.

DSS’s Pharmacy Prior Authorization Brand Medically Necessary Appeal Procedures document spells out in further detail who can appeal PA denials. Basically, only denials of brand medically necessary requests can be appealed. DSS believes that denials of early refills or drugs costing more than $ 500 do not constitute denials of services.

Areas of Confusion

The AG sent a letter to the Appropriations chairs in June 2002 challenging the legality of certain provisions in the PA plan. More recently, some of these same concerns were raised, as well as some others. These include the duration of PA, whether the lack of approval or denial within the two hours constitute approval, whether all patients will receive a five-day supply of the requested drug, and whether atypical antipsychotics are exempt from PA.

Duration of PA. There has been some question about how frequently patients will need to get PA for brand-name drugs when a generic is available. Although the law says that PA is required for initial prescriptions only, the plan applies a more narrow interpretation.

For maintenance drugs, the PA lasts for the lifetime of the therapy unless another chemically equivalent generic is subsequently approved by the Food and Drug Administration (In the event this happen, the Medical Prior Authorization Advisory Panel and the Drug Utilization Review Board review and advise DSS on the appropriateness of additional PA in this situation. ) For non-maintenance drugs, PA is required every six months. But prescriptions for a less than 15-day supply of nonmaintenance drugs are never subject to PA.

If PA is approved for drugs costing more than $ 500 for up to and including a 30-day supply, the PA lasts for the duration of the prescription for up to six months.

The attorney general and New Haven Legal Assistance have challenged the legality of PA’s two-tier durational policy.

Two-Hour Window and PA Deemed Approved. The law specifies that if PA is not granted or denied within two hours, it is deemed granted. The PA plan allows for a five-day supply when a PA request is incomplete or the prescriber cannot be contacted.

The attorney general and New Haven Legal Assistance are also challenging this interpretation, which appears to be more restrictive than what the law requires.

Five-Day Supply. Commissioner Coker in her letter reiterated her department’s intention to provide a five-day supply of a brand name drug if there is no decision made after the two-hour window expires. Some believe this means that anyone will get this supply after the two hours is up. However, patients for whom no PA is requested (i. e. , the pharmacist fails to call the prescriber or the prescriber fails to call ACS to request PA) will apparently not get this supply.

Treatment of Atypical Antipsychotic Medications. The law exempts from PA atypical antipsychotic medications that the patient is already taking when he goes to the pharmacy to fill a prescription. This exception was carved out after the plan was approved and is therefore not reflected in that document. The training manual is likewise silent on this exception, leading to some concern by the advocates. Commissioner Coker in her July 16 letter offers assurances that these drugs are not subject to PA. Only new prescriptions for these drugs will require PA and then only for the initial prescription (they are considered maintenance drugs).

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