AUTO-FILL Regulations Part D Plans

I would advise pharmacy providers to read their contracts carefully, because this is a contractual issue between them and the Part D sponsors. However, if you read the high-lighted section, it should answer most of your questions.

SUBJECT: Clarifications to the 2014 Policy on Automatic Delivery of Prescriptions

The Centers for Medicare & Medicaid Services (CMS) announced in the 2014 Call Letter that starting January 1, 2014, Part D sponsors should require their network pharmacies offering automatic shipments or home delivery of prescriptions to obtain beneficiary or authorized representative consent prior to delivery. CMS is offering additional guidance on the implementation of this policy for both new and refill prescriptions.

Refill Prescriptions
For any Part D plans offering mail order or home delivery, CMS would like to reiterate that pharmacies only need to obtain beneficiary or authorized representative consent prior to shipping for refills that the beneficiary or authorized representative did not initiate (e.g. refills prompted by auto-fill systems). A pharmacy would not need to obtain consent to deliver a refill that was prompted by the beneficiary (e.g. refills requested by phone, fax, or online).

Auto-Ship Refill Programs in Part D

To improve adherence, pharmacies often employ refill reminders to notify patients that a medication is soon due to be filled, or that a medication has already been filled and is ready for pickup. Consistent with fraud, waste, and abuse requirements in retail settings, medications that are not picked up by the patient must be returned to stock, and the claim must be reversed. However, some retail and mail-service pharmacies also employ “automatic refill” services that automatically trigger delivery of medications to the patient. While these pharmacies obtain an initial beneficiary consent to provide the automatic refill service, the pharmacies do not invariably verify that the beneficiary still needs the medication before each refill is delivered. In a related issue, CMS has received complaints indicating that some mail-service pharmacies automatically deliver new prescriptions that were phoned in or e-prescribed from the physician’s office without confirming that the patient wants the prescription filled and delivered.

As a result of the automatic delivery practices described above, CMS has received complaints that beneficiaries have had medications delivered that had been previously discontinued or were otherwise unwanted and unnecessary at the time of delivery. Once the prescription is delivered, pharmacies are unable to return the medication to stock and generally do not reverse the claim if the patient does not want the prescription. Consequently, automatic delivery practices are potentially generating significant waste and unnecessary additional costs for beneficiaries and the Part D program overall. While proponents of these programs tout improved adherence, it remains unclear to us that they can provide evidence of actual improvement in adherence, or that permitting such programs to continue without reorder confirmation is cost-effective.

Therefore, to help control fraud, waste, and abuse as required by 42 CFR §423.504, and ensure that Medicare beneficiaries only receive new prescriptions and refills that are requested, for coverage year 2014, Part D sponsors should require their network retail and mail pharmacies to obtain patient consent to deliver a prescription, new or refill, prior to each delivery. We believe unintended waste and costs could be avoided if pharmacies confirmed with the patient that a refill, or new prescription received directly from the physician, should be delivered. Such confirmation is unnecessary when the beneficiary personally initiates the refill or new prescription request. This policy does not affect retail refill reminder programs that require the patient to pick-up the prescription and does not apply to long-term care pharmacy dispensing and deliveries.

While we expect this policy to be implemented no later than January 1, 2014, we strongly encourage sponsors to make this a requirement of their network pharmacies that offer such automatic refill programs for the rest of 2013 as well.

We received some comments citing concerns that requiring beneficiary confirmation prior to each delivery will negatively affect beneficiary adherence based upon the current adherence measures. On the contrary, we believe this policy will make the adherence measure more meaningful by at least ensuring the beneficiary confirms a need for the medication. Although auto-ship programs undoubtedly improve adherence measure scores by simply ensuring more refills are processed on a schedule, such automatic refills may diminish the accuracy of the adherence measure by including unwanted and unnecessary refills that do not reflect actual adherence. Shipment of unwanted medications is not only wasteful, but also a source of significant beneficiary aggravation and a financial imposition that can negatively affect enrollee satisfaction with the plan. Supporting this idea, we received a number of comments that indicate beneficiaries return large quantities of unneeded medications to community pharmacies for take-back programs because they were unable to stop auto-ship refill programs. Commenters were divided as to whether the policy should apply to all fills, refills, or only first-fills. The policy will apply to all fills, and CMS will re-evaluate its efficacy at a future time.

We invited commenters to propose alternative interventions that would be effective in addressing this problem. Several plans shared their current systems for obtaining enrollee consent in automatic refill services. Although some sponsors have existing systems, those systems should be improved, such that, at the initial enrollment, it is impressed upon enrollees that if they wish to use the service, they must provide a reliable means of communication that will enable effective confirmation outreach. If the beneficiary is unable or unwilling to do so, then mail-order or pharmacy delivery services may not be the appropriate way for that individual to access this benefit. We maintain that shipments should be predicated on a beneficiary’s confirmation that he or she still wants the medication.

Some commenters stated that this policy undermines the goals of e-prescribing. E-prescribing provides a more efficient way of transmitting information between prescribers and dispensers, thereby decreasing errors and costs. However, prescribing and dispensing remain distinct operations. Providers sometimes prescribe in anticipation of a condition becoming worse.

Moreover, a beneficiary has the right to put filling a prescription on hold or even to refuse a treatment. Therefore, it is counter-intuitive and contrary to its goals to use e-prescribing as a rationale for automatically delivering prescriptions that the beneficiary may not need or want.

Finally, we are concerned that the practice of plans offering powerful incentives such as $0 or other very low cost sharing for 30-day supplies at mail-service, without offering the same cost sharing at their retail network, is driving purchasing behavior for beneficiaries for whom mail-service may not be a good option. This would include beneficiaries that have limited means of communication, some LIS beneficiaries, and beneficiaries filling non-maintenance medications who may need them immediately. Significant mail-service incentives make it difficult for any of these beneficiaries to choose to obtain 30-day supplies of their medications at retail even if it otherwise is in their best interest. Moreover, mail-service historically has been designed for extended-day supplies of maintenance medications, which allow for appropriate reorder and delivery timeframes. Generally, we do not believe that mail-service order processes and delivery timeframes are conducive to ensuring beneficiaries receive their 30-day prescriptions timely. We have already seen high complaint rates and numerous access problems around this issue in 2013. Furthermore, we received comments from community pharmacies indicating that their staff spends a lot of time helping their customers resolve problems with switching to mail-order service. Consequently, we are reconsidering the appropriateness of such 30-day mail-service benefit designs for the Part D program and Part D sponsors should anticipate that CMS may not approve 2014 benefit designs with extremely attractive mail-service cost sharing incentives for 30-day supplies if such cost sharing is not also available throughout their retail network.