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August 12, 2019

SUBMITTED ELECTRONICALLY VIA www.regulations.gov

Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

Re:       CMS-6082-NC; Request for Information: Reducing Administrative Burden to Put Patients over Paperwork

Dear Administrator Verma:

The Center for Medicare Advocacy (“Center”) appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services’ (“CMS”) request for information (“RFI”) regarding reducing administrative burden through the Patients over Paperwork initiative.

The Center, founded in 1986, is a national, non-partisan education and advocacy organization that works to ensure fair access to Medicare and to quality healthcare. At the Center, we educate older people and people with disabilities to help secure fair access to necessary health care services. We draw upon our direct experience with thousands of individuals to educate policy makers about how their decisions affect the lives of real people. Additionally, we provide legal representation to ensure that people receive the health care benefits to which they are legally entitled, and to the quality health care they need. Based on these experiences, we offer the below recommendations:

Federal-State Data Exchanges

Determining and maintaining eligibility for programs affecting dual eligibles requires regular and accurate data exchange among state Medicaid agencies, CMS, and the Social Security Administration (SSA).  Delays or errors in data exchange can result in delays in receiving benefits and also lead to dropping people from programs for which they qualify.  In June 2019, the Center submitted comments in response to a CMS proposal to require all states to participate in “MMA” data exchanges on a daily basis. We strongly support this proposal, as it will help speed auto-enrollment of full-benefit dually eligible beneficiaries into Medicare prescription drug plans and deeming full- and partial-benefit dually eligible beneficiaries automatically eligible for the Medicare Part D Low Income Subsidy. However, we urge CMS to take action now, before those regulations would take effect in 2021.

This is particularly important because many beneficiaries who experience delays in deemed eligibility for the Extra Help subsidy will be unable to afford their prescriptions. This will impact medication adherence for beneficiaries.

Daily submissions, and the ability for states to receive daily response files from CMS, spread state staff workload more evenly across the month, permit errors to be corrected more quickly, and connect new beneficiaries more quickly to Medicare benefits. We urge CMS to work with states now to voluntarily move more quickly toward daily transmittals.

Eliminate the Asset Test for MSPs

Many Medicare beneficiaries with limited incomes are not eligible or not enrolled in Medicare Savings Programs (MSPs) because of the stringent eligibility thresholds that limit not only income, but also the assets a beneficiary can have. The asset test unfairly penalizes low-income beneficiaries for putting aside modest savings for retirement and emergency expenses, forcing them to spend down their assets.

Asset tests also discourage beneficiaries from attempting to enroll.  Even those who would qualify find that collecting information on assets is a challenge and many give up simply because of the paperwork burden, which can be especially challenging for beneficiaries who are ill or have disabling conditions.  As a result, many beneficiaries with minimal income remain ineligible for this crucial cost-sharing assistance. Eliminating the asset test would also simplify the application’s processing burdens, reducing administrative costs.  States would no longer need to confirm asset values, and the application would be considerably shortened.

Access to Durable Medical Equipment (DME) for Duals

We appreciate CMS efforts in addressing the misalignment of payment procedures in Medicare and Medicaid that results in denials, delays, and higher than appropriate health care costs for essential Durable Medical Equipment (DME) among dually eligible beneficiaries. Particularly, we support the CMS bulletins that have encouraged states to adopt strategies to improve dual eligible beneficiaries’ access to DME, such as prior authorization. However, we urge CMS to go beyond this and require state Medicaid programs to prior authorize DME for dually eligible beneficiaries whenever it does so for those who receive only Medicaid. For example, the state of Connecticut has such a requirement, see Conn. Gen. Stat. § 17b-281a, and it has dramatically simplified the process of obtaining DME for beneficiaries, and ensured payment for providers, while still complying with the requirement that Medicaid always be the payer of last resort.

Under the long-standing Connecticut statute and process, Connecticut providers know that if Medicare payment is not forthcoming, the existing Medicaid prior authorization means that Medicaid payment will eventually be forthcoming, so they are willing to provide, and then bill Medicare for, equipment that has already been found by the state to be covered under Medicaid and medically necessary for such dually eligible individuals. This process fully complies with the requirement that Medicaid be the payer of last resort because actual Medicaid payment will only be made after Medicare payment is denied. This simple solution reduces burdens on beneficiaries and providers alike. We have outlined these proposals in letters to CMS over the years.

Change in Overpayment Recovery Rate for LIS-eligible beneficiaries

We support a recommendation by Justice in Aging regarding the Overpayment Recovery Rate for LIS-eligible beneficiaries, and hereby incorporate their comments on this issue, urging that CMS work with SSA to eliminate the current unnecessary requirements and change procedures so that anyone with 100% LIS subject to an overpayment automatically is provided overpayment rate relief and is told of this relief in the original letter informing the beneficiary of the overpayment.

Part D Exceptions and Appeals

The multi-level, protracted Part D exceptions and appeals process is onerous and time-consuming for Medicare beneficiaries, pharmacists, and prescribing physicians and often significantly delays access to necessary medications. Many Part D enrollees are unaware of both their right to appeal and how to go about initiating the appeals process. Further, Part D enrollees are not provided individually-tailored information when refused a medication at the pharmacy counter, and such refusal does not trigger an appeal.  This set up results in considerable time and effort on the part of the beneficiary and his/her physician trying to obtain enough information to affirmatively file an appeal, while many individuals who are denied at the pharmacy counter simply give up. We recommend the following improvements to the Part D exceptions and appeals process.

Individually-Tailored Notice at Pharmacy Counter

When a medication is denied, require that Part D plans provide beneficiaries with an individually-tailored notice that explains the reason behind the drug denial, as is required in the Medicaid program. We believe that access to information about the reason for a plan denial—provided at the pharmacy counter—will both eliminate significant beneficiary confusion and limit delays in accessing needed medications. Armed with information about why a prescription drug was refused at the pharmacy counter, Part D enrollees and their providers will be better equipped to determine the best course of action for the beneficiary’s health.

Denial at Pharmacy Should Trigger Appeal

Along these same lines, we strongly support allowing the pharmacy counter refusal to serve as the coverage determination by the Part D (or Medicare Advantage-Prescription Drug) plan. This proposal serves the dual purpose of removing a burdensome step for beneficiaries and their prescribers, first, by explicitly stating why the drug is not covered and, second, by expediting the appeals process for those who need it.

Allow Tiering Exceptions for Specialty Tier Drugs

Tiering exceptions are currently not allowed for medications on the specialty tier—despite the fact these are among the highest cost medications, making them unaffordable for many beneficiaries with fixed incomes and limited resources. We strongly support the establishment of a cost-sharing exception and appeal process for drugs included on the specialty tier, both as a matter of fairness and to promote affordable access to high-cost medications.

Use Part B Standards for Part D Off-Label Usage

In order to be covered under Part D, drugs must be prescribed for a “medically accepted indication,” meaning their use for a particular disease must be approved by the FDA, or supported by one of three largely inaccessible Compendia, identified at Section 1927(g)(1)(B)(i) of the Social Security Act.  (The Act was subsequently modified to allow coverage of anti-cancer drugs if their use is supported in peer review journals.)  Under Part B, however, all drugs, not just those used in an anti-cancer regimen, may be supported by peer reviewed literature.

This inconsistency with standard practice of many other insurers (including private insurance and state Medicaid programs) has created serious barriers to access to effective and sometimes life-saving prescription drugs and has been a source of frustration to providers and beneficiaries alike.  We recommend that the Part D program align with current standards of “medically accepted indication” currently applicable to Part B.

Conclusion

We appreciate the opportunity to submit these comments. For additional information, please contact Kata Kertesz, Policy Attorney, kkertesz@MedicareAdvocacy.org, or at 202-293-5760.

Kata Kertesz
Policy Attorney
Licensed in DC and MD

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