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AMCP Releases Summary Of Proposed Medicare Part D Rule

Main Category: Medicare / Medicaid / SCHIP

Article Date: 10 Nov 2009

In the Oct. 22 Federal Register, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule calling for a significant number of policy and technical changes to Medicare Advantage and stand-alone Part D prescription drug plans. A summary of key items of interest to Academy members is provided below.

The complete text of the Federal Register notice can be found here. Comments on the proposed rule must be submitted to CMS by Dec. 8, 2009. AMCP will submit comments. Members who are interested in providing input should contact Marissa Schlaifer, AMCP's Director of Pharmacy Affairs, at mschlaifer@amcp.org or (703) 683-8416 x 603 by Nov. 13.

CMS Proposed Rule - Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program

Some areas of suggested change include:

-- Changes to strengthen CMS' ability to make certain that all current and potential MA-PDs and PDPs understand and can anticipate how CMS measures sponsor performance, determines non-compliance, and decides when enforcement actions are warranted.

- CMS will only provide three opportunities to submit an approvable contract application. CMS will require applicants to demonstrate that they meet all (not a substantial number) of the program requirements. CMS will exercise its authority to consider an organization's past performance in determining opportunities for additional contracts. CMS has strengthened requirements for plans on the notice on intent to apply, for determining whether applicants are qualified for a contract, and has allowed for denial of contract applications based on past performance and the use of data to evaluate for continued participation in the program.

- CMS has proposed to stress the importance of a plan's compliance program by clarifying what will constitute an "effective" compliance program.

- CMS has proposed a change to its requirement that sponsoring organizations must include training and education for first tier downstream entities. CMS has become aware that the requirement for organizations' first tier downstream entities has created a potential problem where a pharmacy may contract with dozens of plans each of which is required to provide training. CMS seeks comments on how to best rephrase its language to clarify this point to ensure that its objective is met, while eliminating unnecessary duplication.

- CMS has proposed to clarify which regulatory requirements are "deemable" for prescription drug plan sponsors.

-- Changes to strengthen beneficiary protections, including eligibility and enrollment policy, transition period requirements, coordination of benefits policy, retroactive claims adjustment, reimbursement and recoveries, and use of standardized technology.

- CMS has proposed greater standardization of plan marketing materials, requiring that plan sponsors use standardized marketing material language and format, in every instance where CMS provides standardized language.

- CMS has proposed changing the length of time for which individuals are determined to be eligible for low income subsidy (LIS) after each annual review.

- Current regulations require Part D plans to provide for an appropriate transition process for new enrollees prescribed Part D drugs that are not on the plan's formulary. Current CMS guidance documents require plans to provide a one-time, temporary supply of non-formulary drugs (including drugs that are on formulary but require step therapy or prior authorization). CMS now plans to codify in regulation that:

- A plan must provide for a transition for new enrollees and current enrollees who are affected by formulary changes from one contract year to the next.

- The transition process is applicable to both Part D drugs not on formulary and Part D drugs that are on formulary but require prior authorization (PA) or step therapy.

- The transition process applies during the first 90 days of coverage under a new plan.

- The one-time, temporary supply must be for at least 30 days of mediation, unless the prescription is for less than 30 days. For long-term care, the temporary supply must be for 31 days, and refills must be honored up to the first 90 days.

- A plan must send a written notice to each enrollee that receives a transition fill within three business days of the temporary fill.

- Plans must make a reasonable effort to notify prescribers that the prescription cannot be refilled. (This provision is not in the current guidance).

- CMS requests input to determine how to best handle retroactive claims adjustments whenever the adjustment cannot be resolved between the sponsor and the pharmacy (for example, multiple payors).

- In response to issues related to $4 generics, CMS has proposed to require Part D sponsors to contractually mandate that their network pharmacies submit claims electronically to the plan on behalf of their beneficiary whenever feasible unless the enrollee expressly requests that a particular claim not be submitted. CMS does acknowledge that an enrollee may need to pay out of pocket and submit for reimbursement if the pharmacy's lower price is not its usual and customary (U&C) price but is instead only available to patients enrolled in a special program.

-- Changes to provide plan offerings with meaningful differences.

- CMS has proposed that MA-PD and PDP sponsors must ensure that they submit bids for multiple plans only if those plans have significant differences from each other in terms of key benefit or plan characteristics (premiums, cost-sharing, formulary structure, benefits)

- CMS has proposed to provide as a ground for nonrenewal that a MA-PD or PDP has failed to attract more than a small number of enrollee over a sustained period of time (with exceptions for certain SNPs and employer retiree plans).

-- Changes to improve data collection for oversight and quality assessment.

- CMS has proposed that Part D sponsors pay for data collection costs of the Consumer Assessment of Healthcare Providers and System (CAHPS) annual survey.

- CMS has proposed that each Part D sponsor be subject to an independent yearly audit of Part D measures to determine their reliability, validity, and completeness.

- CMS proposed that the regulation adopted for the use of prescription drug event (PDE) data for nonpayment related purposes be expanded to all data elements. Data elements added since the regulation was adopted includes: "estimated rebate amount applied to the point-of-sale price," "vaccine administration fee," and "prescription origin code." CMS has proposed permitting disclosure of unencrypted plan identifiers to Department of Health and Human Services grantees when certain requirements are met.

-- Changes to the regulatory requirements affecting the inclusion of protected drug categories and classes on Part D formularies.

Under current CMS regulations adopted in January 2009, CMS indicated its plans to determine which categories and classes of drugs meet two statutory requirements: (1) restricted access to the drugs in the category or class would have major or life threatening clinical consequence for individuals who have a disease or disorder treated by drugs in such category or class; and (2) there is a significant need for such individuals to have access to multiple drugs within a category or class due to unique chemical actions and pharmacological effects of the drugs within a category or class.

CMS has indicated that these requirements should be read in the context of other Part D program protections, including the transition process and exceptions process, in order to avoid establishing unnecessary duplicative protections. Therefore, CMS has proposed to closely define the scope of the protections and to propose several definitions. CMS has defined the first of the two provisions as applying to "those circumstances wherein a short time delay that results from the application of existing procedures will result in the exacerbation of the enrollee's underlying disease to an extent that it would cause persistent or permanent damage." "Major or life threatening clinical consequences" have been defined by CMS to mean "serious clinical events that arise as a result of not taking a drug that leads to patient hospitalization, or a persistent or significant disability or incapacity, or that result in death." CMS has defined the second of the two provisions as instances in which there is a "need for simultaneous use of multiple drugs within a drug grouping because such drugs work in combination with each other" or there is a "strong likelihood of sequential use of drugs within a class or category within a short period of time due to a significant likelihood of failure of a specific drug in a class leading to the substitution of another drug or drugs in the same class."

In the January 2009 regulations, CMS introduced a three-part process to review drug classes:

-- Contract with an organization to complete a data-driven analysis to identify possible protected classes and exceptions;

-- Arrange for a secondary review by a validation panel that would develop a consensus-driven set of recommendations;

-- Complete a notice-and-comment rulemaking to both identify the protected categories or classes and to establish exceptions.

In this proposed rule, CMS has offered some clarification of its plans, which include, arranging for the secondary review by a group of government clinicians to validate the findings of the initial analysis. CMS believes that a panel of government physicians and pharmacists will obviate any problems surrounding independence of clinical judgment and potential conflicts of interest.

CMS is seeking input on whether the public comment process should best be addressed through: (1) an announcement of protected classes through subregulatory guidance (the Call Letter) that provides a notice and comment process but does not entail full notice and comment rulemaking, or (2) an announcement through formal notice and comment rulemaking.

-- Changes to the regulatory requirements for medication therapy management (MTM) programs.

CMS has proposed to codify the policies introduced in the 2010 Call Letter, indicating that Part D sponsors shall:

- use only an opt-out method for enrollment;

- target beneficiaries for enrollment at least quarterly;

- offer a minimum level of services that includes interventions for beneficiaries and providers, comprehensive medication reviews, and quarterly targeted mediation reviews;

- use a minimum number of chronic diseases for eligibility of no more than three chronic diseases; and

- use a minimum number of multiple Part D drugs for eligibility of no more than eight.

-- Changes to requirements for pharmacy and therapeutics (P&T) committee input on formulary changes.

In the original Part D regulations, CMS required that P&T committees must be involved in determining which drugs are placed on a formulary but did not require P&T committee determination in the application of utilization management tools that are applied to the drugs placed on the formulary. Specifically, the regulations said that P&T recommendations on tools such as PA, step therapy and quantity limits were advisory only and not binding. Now CMS has proposed to require that Part D P&T committee review and approve all clinical PA criteria, step therapy protocols, and quantity limit restrictions applied to each covered Part D drug.

-- Changes to standard timeframe and notice requirements for coverage determinations and for expediting coverage determinations.

CMS has proposed revising the timeframe for Part D plan sponsors to notify an enrollee of a payment determination, which is currently no later than 72 hours after the receipt of the request. CMS proposed changing the requirement to allow plan sponsors to process requests for payment no later than 14 calendar days after the receipt of the request. In addition, CMS will now allow plans to notify enrollees orally so long as a written follow-up notice is sent within 3 calendar days.

CMS also proposed requiring plan sponsors to send written notice of fully favorable expedited decisions to enrollees and allowing plans the option of providing the initial notice orally so long as a written notice is sent within three calendar days. CMS has developed a form for adverse coverage determinations and has proposed requiring that plan sponsors use that form for adverse expedited determinations. The form is already used for adverse standard coverage determinations.

-- CMS has also proposed minor clarifications to the generic equivalent price difference requirements and to the Part D pharmacy network requirements.

Source
Academy of Managed Care Pharmacy

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AMCP Releases Summary Of Proposed Medicare Part D Rule

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