See also comments on Chapter 4…
Department of Health and Human Services
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850
Submitted Via Email:
RE: Ch. 18 of the Medicare Prescription Drug Benefit Manual
To whom it may concern:
The undersigned organizations appreciate the opportunity to comment on the draft Ch. 18 of the Medicare Prescription Drug Benefit Manual.
We are pleased to see a number of important improvements included in Ch. 18 and appreciate the Center for Medicare and Medicaid Services (CMS’s) continuing efforts to consider consumer needs in drafting guidance. However, there are still a number of concerns we would like communicate.
Please see our detailed comments below. Again, we appreciate the opportunity to comment on the draft Ch. 18 of the Medicare Prescription Drug Benefit Manual. We look forward to working with you on this and other matters in the future. Should you have any questions or require additional information please contact Ilene Stein of the Medicare Rights Center at 202-637-0961 ext. 5 or .
Sincerely,
California Health Advocates
Center for Medicare Advocacy
Health Assistance Partnership
Medicare Rights Center
National Council on Aging
National Senior Citizens Law Center
Comments: Chapter 18 of the Medicare Prescription Drug Benefit Manual
10.2 – Responsibilities of the Part D Plan Sponsor, p. 8
Description of Issue: Part D sponsors must provide information on the “Appeal procedure, including the right to expedited review at initial enrollment, upon notification of an adverse coverage determination denial, and annually thereafter.” Also, if an enrollee is affected by changes in a formulary or cost-sharing, the plan must notify the enrollee of grievance and appeal procedures.
Comment: Plans should be required to provide appeals information upon an enrollee’s request. It is important that enrollees are able to access key information about the appeals process and their rights at all times.
20.2 – Distinguishing Between Grievances and Coverage Determinations, p. 16
Description of Issue: The guidance states that the facts surrounding a complaint will determine whether the grievance or coverage determination process should be initiated.
Comment: Please include language that encourages plans to initiate the coverage determination process over the grievance process. The agency should demonstrate its preference for the coverage determination process because it is more responsive to consumer needs and allows beneficiaries to seek specific remedies.
20.2.2 – Co-Payment Complaints, p. 19
Description of Issue: The language in the note is too ambiguous and the process available to resolve disagreements about TrOOP calculations that results from a dispute over Low Income subsidy eligibility is unclear. For example, the note states, “a dispute must be resolved with the agency responsible for the determination.” It is unclear to what agency this statement refers.
Comment: CMS should more clearly articulate the appeals process or mechanism for resolving these issues in this chapter. Also, if this information is included in guidance located elsewhere, please include a link or information on where that guidance can be found. It is imperative that those with low incomes have an articulated process, with independent review, for remedying TrOOP miscalculations. Any appeals process must be clearly expressed for this reason.
30.1 – Prior Authorization or Other Utilization Management Requirements, p. 29
Description of Issue: Prior Authorization is not defined by statute, regulations, or guidance and is confusing to providers, advocates, and beneficiaries. The term is often used in different contexts and given a variety of meanings. For example, it is unclear if prior authorization refers to all utilization management tools or is a utilization management tool in itself.
Comment: CMS should include a clear definition of Prior Authorization. Please be sure that this term and all terms are used in a consistent manner throughout guidance and model forms.
Description of Issue: This section describes what should be counted as a coverage determination.
Comment: A denial of access to a drug at the pharmacy counter or any other point of sale should be considered a coverage determination and enrollees should be able to ask a plan for a redetermination based on this denial. Not doing so further delays an enrollee’s access to medically necessary drugs and in practice adds an additional step to the appeals process.
30.2 – Exceptions, p. 33-34
Description of Issue: Notice is sent 60 days prior to expiration of an exception unless the end date for the exception was clearly stated in a previous appeals related notice. (p.33) In addition, there is no standard CMS notice. The guidance does include information that plans are required to include in a notice but the information is not adequate. (p.34)
Comment: We commend CMS for emphasizing the importance of providing proper notice to enrollees. However, we believe plans should be required to send notices to all enrollees 60 days prior to losing access to a drug even if the date of expiration was stated in a prior notice that was sent as the result of a successful appeal. Many enrollees will have lost or forgotten the original notice and not realize that the exception has expired until they seek a prescription refill, most likely after their enrollment rights under the AEP have passed. Due to important health implications it is imperative that enrollees are made aware of potential barriers to access as frequently as possible.
In addition, plans should be required to provide information in the notice that explains an enrollee’s right to apply for a new exception once the current exception expires and provide instructions on how to do so.
Furthermore, it would be beneficial if CMS created a model notice for plans to use that included information about all exceptions processes available to the enrollee, including those for formulary exceptions, and tiering exceptions. We are particularly concerned that beneficiaries seeking a formulary exception to override a utilization management requirement for an on-formulary drug will not understand that they may also have the right to seek a tiering exception.
Description of Issue: An enrollee may not be able to access medically necessary drugs between the time of the expiration of his or her exception and the time her or she obtains a new exception from the plan.
Comment: Please allow enrollees to access transition fills of medications after the expiration of their exception. If an enrollee does not receive a new exception from the plan immediately after the expiration of his or her former exception, or if they must seek a new drug, it is important that his or her treatment not be interrupted due to the adverse health implications an interruption will cause.
Description of Issue: The definition of exceptions is unclear and confusing.
Comment: Exceptions is a broad term that applies to non-formulary drugs, tiering, dosage limits, and utilization management tools. For example, an enrollee must apply for an exception to avoid the imposition of a utilization management tool. Please clarify the term “exception” in this section and use the term in a consistent manner through out all guidance and notices.
§30.2.1- Tiering Exceptions, pgs 38-40
Description of Issue: Examples conflict with statute and regulation. Examples 2, 3, 4, and 5 in this subsection indicate that an enrollee may only ask for a tiering exception if there is a brand drug (Ex.2, 4, 5) or generic drug (Ex. 3, 4, 5) approved to treat the same condition on the lower tier. The statement that there must be a drug approved to treat the same condition on the lower tier is more restrictive than both the statute and the regulations and should be eliminated.
Comment: The statute, 42 USC § 1395w-104(g)(2), says, “Under such an exception, a nonpreferred drug could be covered under the terms applicable for preferred drugs if the prescribing physician determines that the preferred drug for treatment of the same condition either would not be as effective for the individual or would have adverse effects for the individual or both.” The term “could” is not a limiting statutory term and the above language only provides an example of a possible exception. However, the language as a whole gives CMS the discretion to draft regulations that define this process. Therefore, it does not require that the preferred drug be approved to treat the same condition. In addition, the statute does not make a distinction between generic and brand-name preferred drugs.
This is confirmed by the regulations. Under the regulation, 42 CFR 423.578(a)(2)(ii), (iii), a plan may consider as part of its tiering exception criteria whether the drug for which an exception is sought is the therapeutic equivalent of another drug on the plan’s formulary, as well as the number of formulary drugs with the same class and category as the drug under consideration. However, the regulation does not require that there be a non-preferred drug in the same class or category in order to request or grant an exception. Indeed, the regulations specifically prohibit only tiering requests to have a non-preferred drug placed on a separate tier for generic drugs and requests for tiering exceptions for specialty tier drugs. 42 CFR 423.578(a) (6), (7). Under the language in the draft examples, if a plan had a 3-tiered formulary, with Tier 1 for generic drugs, Tier 2 for preferred brand name drugs, and Tier 3 for non-preferred brand name drugs, a beneficiary who is prescribed a brand name drug on Tier 3 could not ask for a tiering exception to Tier 2 if the only other formulary drug prescribed for that condition was a generic drug on Tier 1. That result conflicts with the purpose and intent of 42 USC § 1395w-104(g)(2).
30.2.2 – Formulary Exceptions, p.40-44
Description of the Issue: CMS allows plans to decide the co-payment tier in which to place non-formulary drugs that have been approved through the exceptions process.
Comment: We ask CMS to monitor tier placement decisions by plans for approved non-formulary drugs in order to ensure that achieving a favorable coverage determination results in genuine and substantial benefit for the enrollee.
30.3 - Requests for Reimbursement, p. 45-46
Description of the Issue: This section addresses requests for reimbursements and plans responsibilities in issuing reimbursements.
Comment: We commend CMS for detailing a process for reimbursement that requires plans to provide notice to enrollees, makes the plans responsible for gathering necessary information, and properly enforces the regulations. We urge CMS to monitor plan performance, in meeting deadlines and otherwise responding appropriately to reimbursement requests.
40.2 – Standard Time Frames for Coverage Determinations, p. 50
Description of Issue: The example includes a typo; the dates are incompatible.
Comment: The date 3/4/05 should be changed to 9/4/05.
40.3.1 – Notification by Network Pharmacies, p. 50
Description of Issue: Network pharmacies can either post or distribute notices about plan benefits and rules. However, in our experience posting notices in pharmacies is inadequate. Posted notices, which appear among a clutter of other notices and advertisements, do not effectively communicate to enrollees. Moreover, advocates have observed that in a large number of pharmacies, notices cannot be found anywhere.
Comment: CMS should require pharmacies to distribute individual notices to beneficiaries rather then posting notices.
40.3.2 – Oral Notification by Part D plan Sponsors, p. 51 - 52
Description of Issue: Plans are allowed to make initial notifications orally. If notice is provided orally, plans are not required to provide written notice about favorable decisions, or, in the case of providers and pharmacists, on adverse decisions. (p. 51)
Comment: Please allow for enrollees, providers, and pharmacists to request a written notice of both adverse and favorable decisions if the plan provides notice orally.
Description of Issue: The note instructs plans what to do when “good faith efforts” to provide oral notice of a decision to an enrollee fails and that they must send written notice “immediately” if they are not able to inform the enrollee orally. (p. 52)
Comment: The term, “immediately” is too vague. Please require plans to send written notice the same day “good faith efforts” to provide oral notice are unsuccessful. It is important, especially in light of potential health risks, that enrollees are notified of plan determinations without delay.
40.3.3 – Written Notification by Part D Plan Sponsors, p. 52 -54
Description of Issue: The guidance does not instruct plans if they should consider partially unfavorable decisions to be an initial coverage determination subject to appeal.
Comment: If an enrollee applies for more than one exception, meaning formulary exception, tiering exception, or exception to a utilization management tool, in the same request and the decision is partially favorable, the aspects of the decision that are unfavorable should be considered an initial coverage determination and subject to redetermination and appeal. The plan notice to the beneficiary in cases such as example 4 should state clearly that the beneficiary has appeal rights with respect to the portion of the decision that is unfavorable. Moreover, in situations such as example 4, CMS should instruct plans that they must notify the provider of all information that is needed to determine whether to approve the prescription as written. Thus, in example 4, if the provider has presented justification with respect to step therapy requirements but not for the dosage, the plan has an obligation to tell the provider in a timely manner what other information would be necessary to make a decision with respect to dosage.
40.4 – Effect of Failure to Provide Timely Notice, p. 54; 70.10 – Forwarding Untimely Redeterminations to the Independent Review Entity, p. 71-73
Description of Issue: These sections instruct plans to escalate cases to the next level of appeal if they fail to issue a timely decision.
Comment: While 42 C.F.R. 423.590 requires plans to escalate appeals automatically, some plans fail to do so. We ask that the guidance specify that while plans are always required to forward the information, beneficiaries may also send a request for review to the IRE if they have not received a decision within the regulatory timeframe. In addition, we ask that CMS monitor plans to examine if plans are escalating cases appropriately, and if they do not escalate cases as a result of the failure to meet regulatory timeframes, that plans are subject to sanctions.
70.9.2 – Adverse Expedited Redeterminations, p. 72
Description of Issue: The note states, “If plans make a completely favorable decision soon after the adjudication timeframe expires, (ie. within 24 hours) and notifies the enrollee of the decision, the plan sponsor should not forward the case file to the IRE.” This could be problematic if it becomes a regular practice of the plan.
Comment: CMS should specify that plans should use this exception sparingly. Also, please state that if a plan does not regularly meet the adjudication timeframe and CMS finds that a plan uses this exception frequently, CMS may consider the plan in violation of its Medicare contract and subject to sanctions.
70.30 – Preparing the Case File for the Independent Review Entity, p. 73-75
Description of Issue: This section instructs plans to forward case files to the IRE and specifies what information to include in the case files.
Comment: Under the current regulations, in order to obtain coverage for an off-label use, the drug’s use must be favorably listed in specific compendia, or in the case of cancer drugs, in peer reviewed medical literature. However, subscriptions to these compendia and other materials are very expensive and the public and the IRE do not have ready access to these listings. For this reason, we ask that CMS require plans to include literature or compendia entries used in coverage determinations as part of the case file so it is available to both the IRE and the enrollee.
Also, please include language that reminds plans that an enrollee is entitled to a copy of his or her complete case file upon request. Further, we ask that CMS add guidance telling plans that they should automatically waive any copying charges for files requested by LIS-eligible beneficiaries.
80.7.1.1 – Summary of the LEP Reconsideration Process (p. 79-81)
Description of Issue: A beneficiary only has 60 days to file an appeal of a Late Enrollment Penalty (LEP). If a beneficiary does not meet the 60 day timeframe, the beneficiary will need to pay an LEP for life, even if they had creditable coverage. Currently, a beneficiary is able to file an appeal later than 60 days only if they demonstrate good cause for missing the deadline.
Comment: We recognize that it may be appropriate to impose a time limit for retroactive relief from the LEP but see no reason why a beneficiary should be time-barred from requesting prospective relief from the LEP. Not allowing an individual to challenge an LEP at any time if it is improperly assessed is overly burdensome; an LEP is an extra payment a beneficiary owes for life. It is true that the draft guidance allows a beneficiary to demonstrate good cause for an extension, but plans have little incentive to find good cause because they directly benefit monetarily from the imposition of an LEP. In order to balance the policy interests involved, we recommend that a beneficiary be allowed to challenge the prospective application of an LEP at any time without the need for a good cause showing. Moreover, in light of the time likely needed to collect documentation to support a request for relief from the LEP, we also think that the time limit for retrospective relief should be longer than 60 days.
130 – Effectuating Favorable Decisions, p. 95-96
Description of the Issue: The dates provided in the first example are incorrect and incompatible. The example states, “On 6/1/07, the enrollee submits a request for reimbursement fir the 9/1/07 purchase . . . .” (p. 95)
Comment: Please correct the dates so that they are compatible.
Description of Issue: The distinction made in the guidance and the example concerning UM requirements that are or are not exceptions is confusing and conflates the issue. Under the examples and guidance, coverage determinations based on fulfilling UM requirements can be applied retroactively but not prospectively. (p. 96)
Comment: While we commend CMS for explicitly requiring plans to reimburse enrollees retroactively, please clarify the examples provided. The distinction between utilization management requirements that are and are not exceptions is erroneous. For example, if a plan requires step therapy, requiring an individual to submit documentation each month that they tried alternative medications that failed and met the UM requirement is burdensome. In practice, if utilization management requirements are met, coverage should be continued for the entire year as it does with all exceptions. Accordingly, we ask that the guidance clearly defines terms, such as exceptions and prior authorization, and use them consistently throughout the guidance.
Appendix 4 – (Model) Notice of Redetermination
Comment: Please include the SHIP number on the “Important information about your appeal rights” document. The SHIP number would be of greater use to beneficiaries than the Elder Care Locator number currently included. We also suggest simplifying the wording of the opening statement in the notice. Telling a beneficiary that the plan has “affirmed” a determination “denying” coverage can lead to confusion. Plain English usage with simpler non-contradictory terms would be clearer.
Appendix 15 – Late Enrollment Penalty Reconsideration Request Form
Description of Issue: See comment concerning 80.7.1.1 above.
Comment: If CMS chooses to incorporate our suggestion regarding the change to the LEP reconsideration deadline, please change the model form to be consistent with those changes.
General Comment – Appendices
Description of Issue: The draft guidance includes no requirement for translating the consumer correspondence and forms in the appendices into other languages and does not even require tag lines offering oral translations.
Comment: Because correspondence and forms related to exceptions and appeals are vital documents affecting the rights of beneficiaries to access their prescription drug benefit, they are the kind of documents for which Title VI protections should apply. We urge CMS to either itself translate the model documents into multiple languages or require plans to do so. If these steps cannot be undertaken immediately, then CMS should at least add tag lines, in English and in other key languages, telling enrollees that if they need help in other languages, they can call their plan and interpreters will assist them.
General Comment – Use of the term “appointed representative,” p. 8, 12, 15, 48, 51, 52, 55, 56, 59, 61-66, 69, 70, 72, Appendix 4, Appendix 13
Description of Issue: We applaud CMS for eliminating the word “appointed” when referring to an enrollee’s representative. See 10.1. However, the term “appointed representative” still appears throughout the chapter and in the notices included in the appendices as well.
Comment: We ask that CMS remove the word “appointed” when referring to an enrollee’s representative in those instances where it has not already done so.
General Comment – Submitting request for coverage and redetermiantions
Description of Issue: Some plans do not allow requests for coverage determinations or redeterminations to be submitted via fax.
Comment: Because of the immediate need of coverage determinations and redeterminations, especially in the case of requests for expedited review, we ask that CMS require plans to allow submission of requests for coverage and redeterminations by fax. It is expensive for beneficiaries to be required to overnight parcel these requests and it also slows down emergency requests.
General Comment – Consumer friendly guidance
Comment: We commend CMS for its consumer friendly approach to this Chapter. We appreciate CMS’s emphasis on notice requirements to enrollees and providing more detailed instructions to plans on properly effectuating coverage decisions and reimbursements.