Part D Protected Classes: Manufacturers, Payers Agree On Need For Specifics

Both levels of review for determining protected classes under Medicare Part D could stand to have more specific guidelines on the selection of participants and on what drug information is to be considered, manufacturers and payers told CMS in comments.

A number of manufacturers and payers - and the associations that represent them - as well as patient advocacy groups, submitted comments on CMS' interim final rule on protected classes by the March 17 deadline. Most comments express an interest in having more details on the review process the agency outlined in the rule and offered suggestions on how the process could be made more thorough and more transparent.

The interim final rule, published in January, lays out the multi-level process for determining which classes should be protected under Part D, ensuring that all drugs in those classes are covered by Medicare prescription drug plans (¹ (Also see "CMS Opens Way To Add, Or Subtract, Protected Classes In Part D Formularies" - Pink Sheet, 19 Jan, 2009.), p. 14).

CMS proposed having a contractor create an initial list of classes on a review of "widely used treatment guidelines." An "expert panel of physicians and pharmacists" would conduct a second review, forming the basis for CMS to propose protected classes through a public rule-making process.

Clarifying The First Level Of Review

The rule does not say much on how the contractor will be selected, other than it will be familiar with the Part D formulary process, nor does it say anything other than it will use "widely used treatment guidelines" and Part D prescription data to develop its list. As comments from the Academy of Managed Care Pharmacy note, "the rule is vague on the actual selection of the contractor."

The Pharmaceutical Research and Manufacturers of America's comments recommend identifying specific criteria for a selecting a contractor "that are directly related to the issues involved in designating protected classes," such as clinical and pharmacologic expertise related to treatments for the elderly and the disabled and a thorough knowledge of the scientific literature on chronic conditions prevalent in those populations.

The group also recommends choosing more than one contractor to conduct the review "and obtain different types of expert recommendations."

The BlueCross BlueShield Association recommends choosing a government agency as the contractor: the Agency for Healthcare Research and Quality. It notes that AHRQ "has a well-respected track record on working on evidence-based practices." BCBSA also says the first level of review should look at clinical effectiveness and appropriateness of medications within the Medicare population, as widely accepted within the medical community.

Some commenters question how useful treatment guidelines would be on their own in narrowing the contractor's choices. Comments note that treatment guidelines are developed for a different purpose than the one CMS is proposing to use them for, and are not always up to date. For some conditions, there may be hundreds of guidelines available, while for rare conditions, they may not exist at all.

The Biotechnology Industry Organization says that, first of all, CMS needs to clarify how the review of treatment guidelines would be conducted and how it will determine which guidelines are "widely used."

The group recommends that CMS should rely on guidelines with "desirable characteristics," such as: quickly incorporating new evidence in updated guidelines; having a transparent process for evaluating guidelines; public identification of the members of review committees, with broad representation to mitigate perceived conflicts of interest; and a description of evidence reviewed for each recommendation.

BIO also asks for greater detail on how prescription drug event data will be used, noting that claims data have limitations, since they may not reflect the medical necessity of therapies used in subpopulations or may overlook drugs new to the market.

The Pharmaceutical Research and Manufacturers of America's comment recommend that "widely used treatment guidelines" be defined as "those that are developed by U.S.-based organizations that are committed to maintaining the guidelines by updating them on a regular basis, and that use an expert group of clinicians practicing in the given therapeutic area."

To complement what may be lacking in treatment guidelines, comments recommend that the contractor turn to other sources.

CMS should "rely on compendia and medical journal articles to address instances where treatment guidelines do not exist or are not adequate, such as where there are new treatments that have yet to be incorporated into the guidelines," BIO says.

PhRMA adds that the contractor should seek input from "stakeholders, including specialty societies, clinicians practicing in a particular therapeutic area, and organizations representing patients."

Payer groups note the large amount of expertise in plan pharmacy and therapeutics committees. The PBM trade group Pharmaceutical Care Management Association recommends "CMS utilize the government multi-level expert panel process ... to review the work conducted by P&T committees as opposed to being the first line of review in determining if a class is automatically protected."

Will Expert Panel Be Public?

For the second level of review by an "expert panel," the interim final rule provided no information on the composition of the panel, how members would be chosen, their procedures for making decisions, or what if any of their proceedings would be open to the public.

BCBSA notes that "ironically, CMS' process for imposing a broad coverage mandate for classes of Part D drugs has fewer requirements and standards than those imposed by CMS on plans and the P&T committees in establishing and modifying Part D formularies."

The Blues association recommends that CMS accept nominations from the public for panel members. It says that in addition to having the qualities required for Part D P&T committees, members should reflect the perspectives of stakeholders, including patient groups and plan sponsors.

PhRMA's comments on this issue are similar. They argue that the panel should consist "predominantly" of physicians and pharmacists - consistent with Part D P&T requirements. The group also asks for inclusion of one or more "industry representatives," as FDA advisory committees do, as well as stakeholder groups representing patient advocates and disease state organizations. PhRMA also would like the ability to comment on candidates for the panel.

However, AMCP warns that CMS should guard against allowing disease specialists to have "undue influence" on the panel. "Specialists must not be allowed to let their concentrations on given disease states lead to inappropriate classifications of drug classes as protected."

AMCP urges CMS to require that panelists have expertise in formulary decision making, since many physicians and pharmacists "are not aware of the detailed review of clinical evidence that is part of the formulary development process used by Part D plans." The group cites the experience of CMS contracting with the U.S. Pharmacopeia to create its Part D formulary guidelines, whose expert panel AMCP claims had little understanding of the formulary-making process.

BCBSA urges CMS to adopt specific parameters on the information and data the panel will consider in its recommendations, as it does for P&T committees. "Such evaluations and recommendations should be based, at a minimum, on clinical data, clinical practice guidelines, scientific evidence, standards of practice as well as clinical appropriateness and effectiveness," the comments say.

And in order for the public to make meaningful comments, BCBSA recommends that CMS open to the public all expert panel meetings, meeting minutes and documentation and data supporting the panel's recommendations.

PhRMA agrees that the panel's proceedings should be fully open to the public, recommending that CMS confirm that the panel will be subject to the Federal Advisory Committee Act.

Finally, PhRMA notes that "it would be helpful if CMS specified how it plans to use the input from the expert panel in drafting the proposed rule on protected classes and exceptions and confirmed that while the panel's recommendations will be important, the proposed rule will include significant input from CMS."

- Scott Steinke ([email protected])