MAPRx Comments on Draft 2013 Medicare Call Letter

March 2, 2012

Marilyn Tavenner
Acting Administrator Centers for Medicare and Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Dear Ms. Tavenner:

MAPRx brings together beneficiary, patient advocacy, family caregiver and health professional organizations committed to improving access to prescription medications and safeguarding the well-being of beneficiaries with chronic diseases and disabilities under the Medicare prescription drug benefit (Part D). On behalf of millions of Medicare beneficiaries with chronic conditions who rely on Part D for essential medications, the MAPRx Coalition appreciates this opportunity to submit comments in response to the Draft 2013 Medicare Call Letter regarding proposed actions related to the Part D program.

Specifically, MAPRx would like to address the following issues raised in the Draft Call Letter:

- Improved beneficiary protections;
- Specialty Tier guidance;
- Co-pay thresholds;
- Tier labeling and hierarchy;
- Proposed plan rating criteria;
- Medicare Therapy Management (MTM) Programs

Drug Utilization Review Controls in Part D

In addition, MAPRx would like to address two issues vital to the communities we represent that were not specifically raised in the Draft Call Letter. First, we urge CMS to maintain and strengthen the six protected classes (antineoplastics, immune suppressants, anti-retrovirals, anti-convulsants, antidepressants, and antipsychotics) as the Secretary develops and issues new criteria as directed under the Affordable Care Act. It is critical that beneficiaries continue to have access to the full range of therapies within these six classes in order to pursue the optimal management of their conditions. Furthermore, medication utilization management requirements, such as a “fail first” policy requiring beneficiaries to try less expensive drugs before obtaining a prescribed drug, prior authorization, or dosage restrictions, for drugs within the six protectedclasses are being used with increasing frequency by Part D plans. MAPRx urges CMS to undertake vigilant oversight of such policies to strictly limit their burdensome impact on beneficiaries. These utilization management tools directly impede the patient-doctor relationship by denying the beneficiary access to their physician’s recommended course of treatment. This may ultimately have the effect of worsening health outcomes by delaying access to needed medication, which has major cost implications for the beneficiary and Medicare due to avoidable hospitalizations and emergency room or doctor’s visits. MAPRx strongly condemns practices that negatively affect beneficiaries by hindering their access to the most appropriate therapies for their condition(s) and asks CMS to strictly monitor use of such techniques.

Second, MAPRx remains concerned about the issue of increasingly burdensome cost- sharing amounts for beneficiaries. While the issue of cost-sharing for medications on the specialty tiers has received a great deal of attention, this is a problem facing all beneficiaries for treatments on all plan formulary tiers. As noted above, CMS will again accept formularies with six tiers for Calendar Year (CY) 2013; meaning plans may have additional high-cost tiers in addition to the specialty tier. The increasingly common mix of copayments and coinsurance is particularly noteworthy in this respect as coinsurance places more of the cost on consumers. We urge CMS to conduct vigilant plan oversight on this issue to alleviate the financial burden placed on Part D beneficiaries, many of whom are on limited incomes and can least afford expensive drug treatments.

Improved Beneficiary Protections

MAPRx appreciates the steps CMS has taken and continues to take to improve the Part D program for beneficiaries. Specifically, we are pleased to see that CMS continues efforts to ensure that plans have meaningful differences and eliminate duplicative plans that can easily confuse Part D enrollees. Ongoing enforcement of this requirement will help ensure that beneficiaries have an easier time selecting a plan that best meets their needs. Additional steps to oversee plans are also appreciated. We applaud CMS’ proposals to disable the MPF online enrollment function for low performing plans and to scrutinize marketing materials for misuse of 5 star ratings.

We recognize your efforts to enhance the Medicare Plan Finder (MPF) and support requiring plans to provide mechanisms to submit and display additional pricing information. Especially if plans use clear and understandable language, these enhancements can provide important information to beneficiaries that will assist in comparing Part D plans.

MAPRx also applauds your proposal to address beneficiary confusion over cost-sharing at preferred and non-preferred network pharmacies. We support changing the Plan Finder to require beneficiaries to select a pharmacy for purposes of providing cost estimates that reflect the selected pharmacy’s status within the network as preferred or non-preferred. This will be an important tool for beneficiaries to make an informed choice and protect against potentially unnecessary out of pocket costs. In addition to

your stated goal of transparency, we urge CMS to also ensure that plans make these arrangements clear and understandable for beneficiaries.

Specialty Tier Guidance

The Draft Call Letter notes that the threshold drug price for inclusion on a specialty tier will remain at $600 for CY 2013. MAPRx remains very concerned about this policy. This will be the sixth year in which the threshold remains at $600 despite significant increases in drug prices over the same period. Even if accounting only for inflation, as opposed to specific pharmaceutical price increases, one would expect some rise in the threshold for inclusion on the specialty tier. It is particularly surprising that CMS would opt to retain the $600 minimum after the release of the GAO study “Medicare Part D: Spending, Beneficiary Cost-sharing and Cost-Containment Efforts for High Cost Drugs Eligible for a Specialty Tier” (GAO-10-242) in January 2010 that found the median price of drugs included in specialty tiers, based on 2007 data, was $1100 per month. This alone suggests the need to increase the threshold to reflect the higher price point for drugs in general and for high cost drugs and biologics in particular.

CMS, in the draft Call Letter, notes the possibility of discriminatory cost-sharing by plans yet ignores this issue in relation to the specialty tier, where it would likely be most prevalent due to the high costs of included medications. This is yet another reason for CMS to reevaluate the low threshold for inclusion on this plan formulary tier. In addition, MAPRx asks that the final call letter clearly address the methodology used to determine the cost threshold for the specialty tier in order for plans and beneficiaries to have a better understanding of exactly how this amount is determined.

With biologics likely to become an ever-increasing share of the medication market, it is imperative that CMS establish a realistic threshold for inclusion on the specialty tier. Otherwise, a growing number of medications will become eligible for this tier and its higher cost-sharing requirements due to the combined factors of drug price increases and newly available biologics. This would have the effect of placing further financial burdens on Part D beneficiaries, many of whom are on fixed income and simply cannot afford dramatic increases in out-of- pocket expenses. It would be a tragedy if more and more seniors and people with disabilities were unable to afford their medications and suffered worse health outcomes due to something as simple as an unrealistically low specialty tier threshold.

Finally, MAPRx continues to urge CMS to establish an appeals/exception process for drugs included on the specialty tier. Though not addressed in the draft Call Letter, this issue remains exceptionally important for beneficiaries with conditions that have limited treatment options, all of which are included on the specialty tier. For all other plan formulary tiers, beneficiaries may file an appeal for a drug to be placed on a lower costsharing tier if the medication is the only therapy available to them. Specialty tier drugs are the sole exception to this, despite these drugs often having the most

burdensome costsharing requirements simply because they ARE on the specialty tier. There is no justification for the lack of an appeals process in these cases. MAPRx respectfully asks CMS to reconsider this policy and implement an appeals/exception process immediately.

Co-pay Threshold

CMS fails to provide specific dollar amount thresholds regardless of the costsharing mechanism for tiers 4-6 despite stating in the draft Call Letter that it will accept six-tier plan formularies. The absence of thresholds for each of these tiers is alarming to MAPRx since these tend to be the high cost-sharing tiers and the tiers plans would likely utilize to engage in discriminatory practices. Without an established threshold for each accepted tier, it will be impossible to determine with certainty whether a plan is engaging in such practices. It will also be difficult for CMS to take corrective action against any plan that does use tiers 4-6 in a discriminatory manner since plans will be able to legitimately claim that they lacked any guidance from CMS on acceptable thresholds.

Therefore, MAPRx asks that CMS provide plans with guidelines on the acceptable costsharing threshold amounts for ALL tiers that a plan may seek to include on its formulary in order to provide clarity to the plan and beneficiaries.

Tier Labeling and Hierarchy

The CY 2013 Call Letter states that no changes have occurred in how CMS establishes Part D benefit thresholds and benefit parameters. MAPRx urges CMS to continue efforts to carefully review and scrutinize plan offerings with a large number of drug tiers. We acknowledge and understand that CMS’ policy affords plan sponsors who offer multiple benefits flexibility to create unique, distinguishing formularies. We are concerned, however, that plan sponsors who offer only one drug plan are using this policy to their advantage and unnecessarily creating multiple drug tiers. This leads to beneficiary confusion when attempting to understand whether the formulary covers their drugs and the applicable cost-sharing amounts. MAPRx requests that CMS amend this policy by making it applicable to plan sponsors who intend to offer multiple drug benefits.

In addition, MAPRx asks that CMS provide further guidance on exactly what products/services are subject to inclusion on the sixth tier. As noted previously, MAPRx is extremely concerned with the dramatic increases in cost-sharing that subject Part D beneficiaries to ever-increasing out- of- pocket expenses that few of them can afford. Therefore, we are alarmed at that possibility that some plan sponsors may use CMS’ acceptance of six-tier formularies to institute yet another high cost-sharing tier in addition to the specialty tier and/or multiple non-preferred brand or non-preferred generic tiers. Such an abuse of this policy would cause not only greater confusion due to the proliferation of multiple tiers and varying cost-sharing requirements – making plan-to-plan comparisons nearly impossible for beneficiaries – but could become an

additional financial hardship and barrier to effective, necessary treatment. MAPRx urges CMS to engage in strict oversight of any and all plans that submit five- or six-tier formularies to ensure that this structure does not become a way to push costs on to beneficiaries or to discriminate against those beneficiaries with serious chronic conditions.

Proposed Plan Rating Criteria

MAPRx strongly supports CMS’ efforts to align the Plan Ratings strategy with CMS’ Three-Part Aim (better care, healthier people/communities, and lower costs through improvements.) As criteria are added to the Plan Rating evaluations, it will be essential to present this information to beneficiaries in clear, concise language that enables them to better identify plans scoring highest on these critical points and, in conjunction with other key factors such as formulary design and cost-sharing requirements, are therefore deserving of consideration for enrollment.

Medicare Therapy Management (MTM) Programs

MAPRx appreciates CMS’ commitment to increase beneficiary awareness about MTM programs. In addition, we support auto-enrollment of targeted beneficiaries, as long as beneficiaries understand their option to opt out of this voluntary program. We also support CMS’ designation of 2 additional core chronic conditions, Alzheimer’s disease and ESRD (requiring dialysis), as targeted conditions for 2013.

Drug Utilization Review Controls in Part D

MAPRx recognizes CMS’ concerns with respect to fraudulent, overutilization of opiods. As CMS implements and oversees these new policies, the agency must maintain a balanced approach that ensures beneficiaries have access to prescription drugs in accordance with their need. While heightened scrutiny of drug use may be warranted with respect to overutilizers of drugs, CMS should avoid drastic measures that severely restrict access to needed prescription drugs; general “rules of thumb” should not be used to restrict utilization. For example, we are concerned about a situation where a beneficiary who has side effects from one medication may be restricted from obtaining a medically appropriate alternative due to plan restrictions.

Dispensing Fee in Donut Hole

Beginning in 2013, plans will cover a small percentage of both brand and generic drugs during the coverage gap stage (as required by the ACA). MAPRx supports the CMS policy to define plan sponsor liability to include dispensing fees for coverage gap claims, as it does during the other stages (and straddle claims) of the benefit.

MAPRx appreciates the opportunity to comment on the Draft 2012 Call Letter. Thank you for consideration of our input. For questions related to MAPRx or the above comments, please contact Bonnie Hogue Duffy, Convener, MAPRx Coalition, at (202) 457-1110 or Bonnie@maprxinfo.org.

Sincerely,
MAPRx Members