Ms. Marilyn Tavenner
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244
Re: Draft 2014 Call Letter for the Medicare Advantage (MA) and Prescription Drug Programs
Dear Acting Administrator Tavenner:
On behalf of millions of Medicare beneficiaries with chronic diseases and conditions who rely on Medicare Part D for essential medications, MAPRx appreciates the opportunity to submit comments in response to the Draft 2014 Call Letter regarding proposed actions related to the Medicare Part D program. The Medicare Access for Patients Rx (MAPRx) brings together more than 45 national 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 conditions under the Medicare prescription drug benefit.
MAPRx comments on the Calendar Year (CY) 2014 Draft Call Letter specifically address the following:
- Improved beneficiary protections;
- Medicare Therapy Management (MTM) Programs;
- Drug utilization review controls in Part D; and,
- Specialty tier guidance.Improved Beneficiary ProtectionsMAPRx appreciates the steps the Centers for Medicare and Medicaid Services (CMS) has taken to improve the Part D program for beneficiaries. Specifically, MAPRx supports and applauds CMS’ efforts to:
- Ensure plans have meaningful differences and eliminate duplicative or low-enrollment plans that can easily confuse Part D enrollees. Ongoing oversight of this area 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.
- Address beneficiary confusion over cost-sharing at preferred and non-preferred network pharmacies. CMS must work to ensure that sponsors use clear and unambiguous language in their communications to beneficiaries. These complex arrangements must be clear and understandable for beneficiaries.
- Address the inappropriate use of prior authorization forms. MAPRx supports efforts to identify and halt these practices.
- Ensure real-time direct access to systems for claims adjudication. MAPRx urges CMS to be vigilant in this and all areas of claims adjudication, appeals, and grievances processing.
- Address patient consent with regards to auto-ship refill. Current plans that allow this practice should be required to notify beneficiaries of the change. In addition, CMS should consider if there are situations where beneficiaries should be allowed to have the choice to opt-in for an auto-ship refill.Medicare Therapy Management (MTM) ProgramsMAPRx applauds CMS for recognizing the Million Hearts partnership and encouraging plans to support the initiative.
Drug Utilization Review Controls in Part D
CMS’ concerns with fraudulent and overutilization of opioids is to be commended. However as CMS implements its policies, the agency must maintain a balanced approach that ensures beneficiaries have access to medications in accordance with their needs. While heightened scrutiny of drug use may be warranted with respect to those who overutilize 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, a beneficiary who has side effects from one medication may be restricted from obtaining a medically appropriate alternative due to plan restrictions. As CMS considers expanding current policy to additional categories, MAPRx urges CMS to study the experience with opioids and proceed with caution.
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 2014. MAPRx remains very concerned about this policy. CY 2014 marks the seventh 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 $1100per month. The data alone supports the need to increase the threshold to reflect the higher price point for drugs and biologics in particular.
In the Draft Call Letter, CMS notes the possibility of discriminatory cost-sharing by plans yet ignores this issue in relation to the specialty tier, where discrimination would most likely be prevalent due to the high costs of specialty tier medications. This is yet another reason for CMS to reevaluate the low threshold for inclusion on this plan formulary tier. MAPRx urges CMS to address and disclose the methodology used in determining the cost threshold for the specialty tier for reasons of transparency and to better understand how the threshold amount is determined.
MAPRx continues to urge CMS to establish an exceptions and appeals process for drugs included on the specialty tier. Though not addressed in the Draft Call Letter, the 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 exception for a drug to be placed on a lower cost-sharing tier, if that medication is the only therapy available. Specialty tier drugs are the sole exception to this, despite these drugs often having the most burdensome cost-sharing 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 exceptions and appeals process immediately.
MAPRx remains concerned about increasingly burdensome cost-sharing for beneficiaries. While cost- sharing for medications on the specialty tiers receives attention, it is a problem facing all beneficiaries for treatments on all plan formulary tiers. In CY 2014, CMS will again accept formularies with six tiers; 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 with coinsurance placing a larger cost burden on the beneficiaries. MAPRx urge CMS to conduct vigilant plan oversight to help alleviate the financial burden placed on Part D beneficiaries, many of whom are on limited incomes and can least afford expensive drug treatments.
MAPRx appreciates the opportunity to comment on the 2014 Draft Call Letter, and thank you in advance for your consideration. 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.