Part D Trial-Size Prescriptions Will Be Voluntary For Plans In 2011

CMS will not require Medicare Part D plan sponsors to allow beneficiaries to obtain seven- to 14-day trial supplies of medicines that are new to enrollees, the agency says in its final "call letter" to contractors for the 2011 benefit year.

The agency floated the concept in its draft 2011 call letter, suggesting that the partial fill at a reduced or prorated co-payment would allow an enrollee to gauge tolerance to a new drug. CMS also posited that trial fills would help to curb the waste of unused drugs (¹ (Also see "CMS Proposes "Trial Sizes" Of Prescriptions To Curb Waste Of Unused Drugs In Part D" - Pink Sheet, 23 Feb, 2010.)). CMS released the final letter, which provides guidance for Part D plan sponsors for the next year, on April 5.

While it stops short of mandating the practice, CMS is encouraging plan sponsors to make smaller quantities available to enrollees, with the decision to prescribe a smaller amount to be made at the provider level.

CMS noted in the call letter that commenters claimed that any savings that might result from the smaller initial prescriptions "would be offset by additional dispensing fees, administrative (programming) costs or costs of a fill that would otherwise be made available via a free prescription sample."

The agency responded by saying that it believes "further outreach and discussion with prescribers, pharmacists and Part D sponsors are warranted to explore these assertions." CMS said it would expect plans and pharmacies to negotiate appropriate dispensing fees related to trial fills.

CMS also suggested there could be safety issues related to relying on free samples over trial fills.

"We believe the use of samples sometimes results in additional costs to the program in the long run and may even increase the risk of adverse medication events as long as plan sponsor drug utilization review systems do not reflect the drug therapies initiated through sample use."

CMS acknowledged that implementation would create some administrative challenges and added that the agency "will also contemplate the need for additional guidance around how a trial fill would impact Part D benefit rules, specifically application of the Part D low-income subsidy cost share at the pharmacy and our current transition policy."

The agency said it is committed to exploring this proposal in the coming months and in the meantime, "we continue to encourage our Part D sponsors to consider the implications of implementing such a program, as well as any other waste reduction strategies, with their network pharmacy contacts and with CMS."

No LIS "Chooser" Reassignment

The other key proposal in the draft call letter was to automatically reassign low-income subsidy enrollees who chose their Part D plans if their premium liability would be $10 or more in the following year.

"Slightly more than half of commenters supported the proposal to reassign some choosers in principle, although there was no consensus on the $10 threshold," CMS noted in the final call letter, adding that supporters suggested additional criteria such as whether the plan had a premium over the LIS benchmark when the individual originally selected it.

Opponents of the auto-reassignment of choosers said enrollee choice needed to be respected and added concerns about drug disruption and "CMS' inability to discern which choosers wanted to stay in their current plan."

In response to the mixed comments, "the lack of any evidence that this population is failing to pay its premiums, and concerns over the possibility of unintended negative consequences for affected enrollees, we have decided not to expand our reassignment process for 2011 to include this population," CMS said. "However, we will continue to explore the merits of this approach for future years."

CMS added that it is continuing to explore intelligent reassignment based on an enrollee's drug utilization, a notion that received support from a majority of commenters, with some concern about whether it could be done effectively.

One proposal that met with substantial opposition from contractors was related to the public release of Parts C and D payment data after risk adjustment and Part D payment reconciliation were completed. Nevertheless, CMS said in the near future, "we intend to publish a proposed regulation which would propose to authorize the release of Part C and D data."

Protected Classes, Cost-Sharing Limits

In a separate final rule released April 6, CMS addresses Part D formulary policies including the so-called "protected classes," as well as beneficiary protections, such as limits on cost sharing.

The agency announced that formulary requirements for the six protected classes will be maintained through 2011 and until the agency establishes otherwise through rulemaking (² 'The Pink Sheet' DAILY, April 8, 2010).

The final rule suspends the plan, set out in a proposed rule released in October, to develop a regulation formally establishing the protected classes. The current policy is governed by sub-regulatory guidance. CMS has decided to postpone the rulemaking while it digests the changes to the Part D program brought about by the new health care reform law.

However, the final rule does formalize other aspects of the proposed rule that relate to improved beneficiary access to drugs and are of concern to the biopharmaceutical industry. The new requirements will be applicable for the 2011 benefit year.

CMS will set annual limits on tiered cost sharing requirements by Part D sponsors - copayments or coinsurance - for "non-defined" standard benefit plan designs.

To do so, the agency will review Medicare plan bids from the prior year to develop an estimate of what the average cost sharing should be and then limit cost sharing that exceeds those averages to a degree that could be considered discriminatory.

The final rule also requires that insurers' pharmacy and therapeutics committees review and approve formulary utilization management controls - prior authorization, step therapy and quantity limits - before they can be implemented. CMS has heightened its oversight of plans' usage of utilization management, most recently citing Aetna for violations.

CMS previously required only that P&T committees review for "clinical appropriateness" the Part D sponsor policies that guide utilization management processes.

- Gregory Twachtman ( ³ [email protected]) and Cathy Kelly ( ⁴ [email protected] )