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Back to index of statements Centers for Medicare and Medicaid Services Re: CMS File Code – 4068-P: October 4, 2004 Dear Sir or Madam: The Alzheimer's Association appreciates the opportunity to comment on the proposed regulations for the Medicare Prescription Drug Benefit of the Medicare Prescription, Drug, Improvement and Modernization Act of 2003 (MMA), published in the Federal Register on August 3, 2004. The Alzheimer's Association is the premier source of information and support for the 4.5 million Americans with Alzheimer's disease. Through its national network of chapters, it offers a broad range of programs and services for people with the disease, their families, and caregivers and represents their interests on Alzheimer-related issues before federal, state, and local government and with health and long term care providers. The largest private funder of Alzheimer research, the Association has committed nearly $150 million toward research into the causes, treatment, prevention, and cure of Alzheimer's disease. General Comment Our comments and concerns reflect our objective to ensure access to medications that treat Alzheimer’s beneficiaries. Access to effective medical treatment must be paramount to CMS during the revision process. We encourage CMS to consider the impact of these regulations on the most vulnerable Medicare beneficiaries, including the chronically ill, the dual eligibles and the residents in nursing facilities. Specific Comments Subpart B: Eligibility and Enrollment On January 1, 2006, more than 6.4 million dual eligible individuals will lose their Medicaid drug benefit and transfer their drug coverage to Medicare Part D. As provided in the proposed regulation, dual eligibles who do not enroll in a plan will be automatically enrolled in a low income plan on May 15, more than five months after the termination of their Medicaid drug coverage. Therefore, these individuals must be enrolled in a Medicare Part D plan prior to the end of 2005. CMS plans to permit dual eligible individuals to choose a Prescription Drug Plan (PDP) or Medicare Advantage (MA) plan within their region beginning on November 15, 2005. Individuals who do not choose a plan voluntarily will be automatically enrolled through random assignment to a plan in their region. Dual eligible individuals will only be able to enroll in plans that are at or below the benchmark cost within their region. Thus, all dual eligibles, the sickest and poorest Medicare beneficiaries, will be enrolled in only the lowest-cost plan(s) in the region. If CMS begins auto-enrollment prior to December 31, as is necessary, the auto-enrollment would occur in early December, providing only a two-week window for dual eligibles to evaluate and enroll in a specific plan before being randomly assigned. Choosing from among multiple PDPs will be a complicated decision for these individuals. Critical factors to be evaluated include:
In regions where more than one plan is available to duals, the complexity of evaluating all the critical factors and selecting a plan will likely mean that few individuals will choose a plan during the brief time permitted. This is especially true for the dual eligible population, which has a high prevalence of Alzheimer’s disease, mental illness, chronic conditions and other barriers to decision-making. Those individuals will be randomly assigned to an available plan. The likely result of random assignment is that many individuals will no longer be able to get prescriptions filled at their customary pharmacy, forcing them to seek assistance in locating a participating pharmacy near their home. They are also likely to discover that one or more of their medications will no longer be covered by their drug program, as it was under Medicaid. Individuals will be forced to contact their physicians to obtain a prescription for a different medication, or seek assistance in applying for permission to continue their current medication. When this scenario is multiplied by millions of individuals, it is clear that physicians will be overwhelmed by millions of requests for assistance with medication changes or appeals to continue existing medications. If all of these changes are expected to occur in the space of a few weeks, as currently proposed by CMS, then the expectation is unrealistic. The Alzheimer’s Association is particularly concerned about the automatic enrollment of dual eligible individuals who reside in nursing facilities. Most, if not all, nursing facility residents require multiple medications. On January 1, 2006, their medications may need to be changed to comply with the plan formulary. In addition, if the pharmacy serving the long-term care facility is enrolled in only one of the available PDPs, all of the dual eligible individuals in that facility should be enrolled in the plan for which the long-term care pharmacy is included in that network. It would not make sense to auto-enroll dual eligibles into plans for which the long-term care pharmacy is not included in the network. We recommend that the transition of dual eligible individuals from Medicaid to Medicare Part D be substantially lengthened for at least six months. In addition, CMS should require that PDPs and MA-PDs offer an open formulary for all dual eligible individuals for a minimum of six months, through June 30, 2006, to ensure adequate time for physicians and patients to navigate administrative barriers and change medications to comply with formularies. This will permit dual eligible individuals to continue their existing medications while adequate time is permitted for a transition to the new drug benefit. Special Enrollment Periods (§423.36(c)): CMS should allow a special enrollment period when a beneficiary moves into a nursing facility. A special enrollment period comparable to the discount card program would increase choices for Medicare beneficiaries seeking the best plan for their needs, and allow the beneficiary (or CMS, in the case of full benefit dual eligibles,) to avoid additional costs until the next open enrollment period. Therefore, we recommend that admission into a nursing facility should qualify as a beneficiary for special enrollment into a different PDP plan. Disenrollment by the PDP (§423.44(d)(2)): CMS should eliminate the provisions allowing for involuntary disenrollment of beneficiaries for “disruptive or threatening” behavior. The proposed rule would permit plans to involuntarily disenroll beneficiaries due to disruptive, unruly, abusive, uncooperative or threatening behavior. The Alzheimer’s Association strongly believes that this provision could result in the inappropriate disenrollment of beneficiaries with Alzheimer’s disease or other dementias. This is of particular concern given the prevalence of neuropsychiatric symptoms in Alzheimer’s individuals. In a recent study, Prevalence of Neuropsychiatric Symptoms in Dementia and Mild Cognitive Impairment; Results form the Cardiovascular Study, JAMA, September 25, 2002-Vol 288, No. 12, 1475, researchers found a high prevalence (60-80%) of neuropsychiatric symptoms in participants with dementia. These symptoms include agitation, depression, apathy, anxiety, delusions, hallucinations, paranoia and sleep impairment and have serious adverse consequences on the patients. Appropriate treatment of these symptoms provides substantial benefits to these individuals, such as the improvement of function and the reduction of disruptive behavior. However, if an Alzheimer’s beneficiary is not stable, possibly because the unsuccessful attempts to find the proper medication for the individual or due to a plan’s “step therapy” requirement, there may be incidents that are perceived as “disruptive” behavior. Alzheimer’s disease is not a “one size fits all” condition. Each individual has different manifestations of particular symptoms. Providing symptom relief for an individual requires an understanding of the specific symptoms of the individual and creativity in devising the treatment plan. Treatment must be dynamic and flexible. Treatment plans are often developed by trial and error to acquire the correct combination of medications. Some medications take several weeks to show any therapeutic impact. Although we acknowledge CMS’ desire to have parallel provisions for the PDPs and the MA-PDPs, it is difficult to understand when the disenrollment of a beneficiary for disruptive behavior in a PDP would ever be appropriate. A beneficiary should never have in-person contact with PDP employees. Should there be a problematic encounter with pharmacy personnel, then the pharmacy could take appropriate protective measures as the situation warrants. Should plans be allowed to disenroll beneficiaries for disruptive behaviors, these provisions will create severe hardships and barriers to access to all medications. Those who are disenrolled will not be allowed to enroll in another drug plan until the next annual enrollment period, and as a result they could also be subject to a late enrollment penalty increasing their premiums. For some Alzheimer’s beneficiaries, especially those who are also on Medicaid, they will be forced to forgo medications that may stabilize them because they cannot afford to pay out of pocket for them. In addition, as noted in the preamble, if a beneficiary is disenrolled from the sole PDP in the region, the beneficiary will be denied any access to the Medicare drug benefit. Plans must be required to re-enroll a beneficiary who has been disenrolled if there is no other drug plan in the area. Unlike the Medicare Advantage program, there is no alternative program, such as Original Medicare, to provide coverage to the individual. Disenrolled beneficiaries should be provided a special enrollment period during which time they can enroll in an alternative plan or re-enroll in the plan if there is only one PDP in the area. Congress intended for all Medicare beneficiaries to have access to the drug benefit. If CMS decides to maintain this troubling disenrollment provision in the final regulations, CMS must require plans to develop mechanisms for accommodating the special needs of these individuals, and ensure that this vulnerable population does not lose access to drug coverage. Late Enrollment Penalty (§423.46): CMS should allow an initial grace period and provide for appeals before imposition of the late enrollment penalty. Implementation of the late enrollment penalties should be delayed for one year while beneficiaries are informed about this complex, new program. We believe that individuals most at risk of not applying for the Part D benefit are the most vulnerable beneficiaries, such as those with Alzheimer’s disease. Community studies indicate that 20 to 25% of people with dementia live alone. About half of these people have a relative or friend who functions as a caregiver, and the other half have no one to assist them. It is doubtful that they will have the ability to understand and navigate the application process without assistance and to impose the significant penalty of an additional 1% for each month of late enrollment would be inequitable. In addition, CMS should incorporate an enrollment “grace period” for individuals with disabilities, including Alzheimer’s disease. In the preamble, CMS explains the rationale for requiring “creditable coverage” with a gap of no more than 63 days is to encourage healthier individuals to maintain coverage and thus to minimize adverse selection for Part D. This rationale does not apply to beneficiaries with Alzheimer’s disease, and these beneficiaries might well require additional time to make a selection and complete the enrollment process. Therefore, CMS should incorporate a late enrollment “grace period” for the disabled, vulnerable population. Approval of Marketing Materials and Enrollment Forms (§423.50): CMS should require that marketing materials, notices relating to formulary changes and all other communications to plan enrollees regarding plan benefits and formularies be written in accordance with the principles of clear health communications so that beneficiaries, their families and their caregivers have the ability to obtain, process and understand available health information. Literacy skills are a stronger predictor of an individual’s health status than age, income, employment status, education level, race or ethnicity. When health literacy (that is, the ability to read, understand and effectively use basic medical instructions and information) is low, individuals are less likely to comply with prescribed treatments and self-care regimens and often fail to seek preventive care. These individuals are at higher risk for hospitalization, they remain in the hospital longer, and they generally require additional care that results in higher annual health care costs. To ensure that Medicare beneficiaries have the ability to obtain, process and understand instructions and information related to the Part D benefit, CMS should require that all enrollee communications be written in accordance with principles of clear health communications. Specifically, all documents should be appropriate for Medicare beneficiaries and family members with low health literacy. In addition, for beneficiaries who are cognitively impaired, it is imperative that their caregivers or personal representatives also receive copies of all pertinent notices and information. CMS should prohibit plans sponsors from marketing other services to Medicare beneficiaries. In the preamble, CMS asked for comments on whether it would be advisable to permit prescription drug plan sponsors to market and provide additional products (such as financial services, long term care insurance, credit cards) in conjunction with Medicare prescription drug plan services. CMS should not allow plans to market other services, nor should it seek to encourage other entities, such as financial institutions, to participate as PDPs. Allowing plans to offer additional service would blur the line between a government program and private services. It would create a great deal of confusion among beneficiaries. Beneficiaries might believe that CMS had approved the additional services being offered in conjunction with the “Medicare approved card.” For beneficiaries who are cognitively impaired, there is the additional potential of financial abuse or exploitation. This section specifically prohibits marketing activities that could “mislead or confuse.” Permitting plan sponsors to market additional services will create situations that confuse and mislead beneficiaries and should be forbidden. Subpart C: Benefits and Beneficiary Protections Access to Covered Part D Drugs (§423.120, §423.124): We urge CMS to explore administrative or legislative remedies to ensure coverage of benzodiazepines in 2006. The Alzheimer’s Association is extremely concerned that benzodiazepines are specifically excluded from coverage by statute as passed by Congress. This exclusion will result in a loss of coverage for dual eligibles since benzodiazepines are currently covered by nearly every state. Benzodiazepines are a group of medications commonly prescribed to Alzheimer’s beneficiaries for the treatment of insomnia and anxiety. It is estimated that benzodiazepines are prescribed to 1 in 5 Medicare recipients and approximately 10% of nursing home residents. Without benzodiazepines, acute anxiety and agitation will have to be managed with alternative medications that are either more toxic, more expensive, or both. For example, Meprobamate is an old antianxiety agent that is highly addictive and sedating. It is on the “Beers list” of medications considered to be generally inappropriate for use in the elderly. Antipsychotic medications can be used but can produce significantly more long term side effects, many of which are irreversible. The atypical antipsychotics are also much more expensive than generic benzodiazepine medications. An estimated one million dual eligible individuals take benzodiazepines. When coverage of benzodiazepines is terminated on January 1, 2006, the likely result will be a flooding of emergency rooms and thousands of hospitalizations resulting from withdrawal symptoms of benzodiazepine cessation, and exacerbations of acute anxiety. We fear that among those most adversely affected by this exclusion will be beneficiaries with Alzheimer’s disease. Balancing convenient access with appropriate payment for long-term care pharmacies. In the preamble, CMS requested comments on how to balance the need for convenient access to LTC pharmacies with appropriate payment to them. Government figures from the required Minimum Data Set (MDS) assessment show that in 2001, 46% of nursing home residents had moderate to severe cognitive impairment, and 26% had mild cognitive impairment. Over 80% of nursing home beds are in facilities that require the resident to use a long-term care pharmacy. The Alzheimer’s Association believes plan enrollees residing in LTC facilities should have access to the in-network pharmacy in the facility where they reside or should be exempted from differential cost-sharing requirements for accessing an out-of-network pharmacy. We could support one of two approaches for achieving an appropriate balance of convenient access with appropriate payment:
Further, we believe that there are overlapping responsibilities for the delivery of services between LTC facilities and prescription drug plans. To the extent that prescription drug plans are responsible for coordination and medication management, the final rule should encourage plans to contract with LTC pharmacies to provide these services to the plan’s enrollees in long-term care facilities. Formulary Requirements (§423.120): CMS should ensure that the full range of prescription drugs commonly used in clinical practice for treating chronically ill and disabled populations is available to all Medicare beneficiaries. Although the MMA directed CMS to request that the U.S. Pharmacopeia (USP) develop a list of categories and classes of drugs that may be used by plans, CMS retains significant discretion under the statute with respect to formulary development. The new Medicare Part D benefit should provide a comprehensive range of medications to Medicare beneficiaries. The scope of prescription drugs covered under plan formularies will dramatically affect beneficiary access to care. As a result, the Alzheimer’s Association urges CMS to use its authority and work aggressively to ensure that the full spectrum of necessary medications is available. The final Medicare Model Guidelines should reflect a broad range of categories and classes to ensure that Medicare beneficiaries, especially the chronically ill and disabled, have sufficient access to critical prescription drug therapies. In some instances, the USP’s draft Model Medicare Guidelines are too narrow to encompass drugs needed by Medicare beneficiaries and could create barriers to access. Therefore, we urge CMS and USP to expand the list of categories and classes to prevent impediments to beneficiary access caused by overly restrictive formularies. At a minimum, the Alzheimer’s Association believes that the USP’s final Medicare Model Guidelines should have as many categories and classes as Medicare’s Prescription Drug Discount Card and the VA health system. In addition, the MMA requires that the Medicare Model Guidelines be revised “from time to time” to reflect the changes in therapeutic uses of Part D drugs and to cover new FDA-approved drugs. There is nothing in the draft Medicare Model Guidelines that reflect a plan that provides for this review procedure. Given the recent increase in research and development of drugs for Alzheimer’s disease that would benefit the Medicare population, this process should be expedited and require automatic inclusion of these drugs within 30 days of FDA approval. We are including a copy of our specific comments to USP for your consideration. The Alzheimer’s Association urges CMS to revise its proposal to require coverage of more than two drugs for each formulary category or class. This provision is much too restrictive and will cause a problem for many beneficiaries, as well as their physicians. In many instances, especially among the chronically ill and disabled Medicare populations, two drugs per category or class will not provide sufficient access to prescription drug therapies. The drug-to-drug interactions and adverse drug reactions make prescribing a challenging task and sometimes physicians need to shift among several drugs in a class to find the one that works best for the specific patient. For example, the inclusion of the three FDA approved cholinesterase inhibitors should be considered. Research confirms that patient’s responses to the individual agents vary widely. Therefore, clinicians require access to the full selection of these drugs in order to prescribe the best agent for the particular patient. Forcing a change in medications could cause adverse health outcomes among this vulnerable population. CMS should revise its requirements relating to P&T committee procedures. CMS should institute procedural requirements for P&T committees to ensure access to medically necessary medications. These requirements should include the following:
Without implementation of these procedural safeguards, beneficiaries may encounter barriers, such as potentially long and unnecessary delays that hinder their access to medication therapies. CMS should create standards for off-label use of prescription drugs as well as combination therapies. CMS states in the proposed rule that physicians and other health care professionals may prescribe drugs for off-label indications, although CMS strongly encourages physicians to clearly document and justify the off-label use in patients’ clinical records. Plan sponsors also may assign an FDA-approved drug to a category or class based on an off-label use so long as the FDA has not determined that such use is unsafe. The Alzheimer’s Association does not believe that the language in the proposed rule is sufficient to protect beneficiaries’ access to appropriate off-label use of medications. Atypical antipsychotics are FDA-approved for the treatment of schizophrenia. In the Late-Stages of Alzheimer’s disease, behavioral problems are significant issues for patients, families and other caregivers. The treatment of hallucinations, psychosis, and paranoia are off-label uses of these drugs. They work well, are used in over 25% of nursing home patients and have a permanent place in the successful treatment of Late-Stage disease. The Alzheimer’s Association strongly recommends that CMS preserve the flexibility for drugs to be prescribed for “off-label” uses. CMS should ensure that the USP’s Medicare Model Guidelines are constructed to include sufficient categories and classes of drugs that will include the drugs most often used for their off-label uses. In addition, coverage for off-label uses of formulary drugs, including cost-sharing requirements equivalent to the formulary’s most favorable terms, should be provided regardless of whether the drug is classified under the formulary for treating the enrollee’s specific condition. CMS should recognize beneficiaries with Alzheimer’s disease as a vulnerable population for purposes of the Part D benefit. Additional protections and restrictions on plan sponsors should be incorporated to protect this vulnerable patient population. We are concerned that the cost containment strategies employed by some of the plans may encourage the use of older or less effective drugs that often result in increased side effects and adverse reactions in older, frailer beneficiaries, such as those with Alzheimer’s disease. With impaired memory and judgment, individuals with Alzheimer’s disease may not be able to recognize, understand or report early signs of adverse reactions until it results in an acute episode. Due to the increased age, lower metabolism and co-existing conditions of this population, physicians require a wider range and greater flexibility of therapeutic agents when treating their patients. Ninety-five percent of Medicare beneficiaries with dementia have one or more other chronic conditions, including congestive heart failure (28%), diabetes (21%), chronic obstructive pulmonary disease (17%) and coronary heart disease (30%). As previously noted, 60-80% of Alzheimer’s individuals suffer from neuropsychiatric symptoms including agitation, depression, apathy, anxiety, delusions, hallucinations, paranoia and sleep impairment. These patients are taking a combination of medications to appropriately manage these conditions. It is a delicate balance that requires access to specific medications to enhance the care to the beneficiaries. In the proposed rule, CMS expressed concern regarding the potential impact of plans’ cost-saving strategies on vulnerable populations. For example, CMS highlighted that Medicare beneficiaries enrolled in long-term care facilities tend to be more sensitive to and less tolerant of many medications. This dynamic has resulted in many long-term care facilities permitting physicians to prescribe a wide variety of medications in different dosages and forms. CMS suggested that these institutionalized patients could suffer as a result of formulary restrictions or cost-sharing requirements that hinder access to necessary medications. The Alzheimer’s Association shares CMS’ concern for vulnerable patient populations and urges CMS to recognize patients with Alzheimer’s disease as a vulnerable population for purposes of the Part D benefit. Many formulary restrictions and cost-sharing requirements could have significant and disproportionate adverse impacts on patients Alzheimer’s disease. Given the high prevalence of neuropsychiatric symptoms and co-existing conditions, these beneficiaries often rely heavily on multiple medications to treat their conditions and are likely to be more sensitive to and less tolerant of many medications. To ensure appropriate access to necessary prescription drugs, CMS should provide meaningful beneficiary safeguards for vulnerable populations, including those with Alzheimer’s disease. CMS must enhance the notification requirements for enrollees directly affected by a formulary change. The proposed rule requires that plan sponsors provide only 30 days notice of an intended formulary change, such as removal of a drug or a change in the drug’s preferred or tiered cost-sharing status. The Alzheimer’s Association believes that 30 days does not provide beneficiaries and their providers sufficient time to respond to a formulary change. We are particularly concerned about the most frail and vulnerable individuals, which includes those who have the greatest difficulty with drug compliance, both intentional and unintentional. These individuals, their visiting nurses, case managers and families, need as much lead time as possible for smooth transitions in therapy to avoid drug misadventures resulting in hospitalizations or other adverse events. Accordingly, we strongly recommend that CMS require plan sponsors to provide enrollees with at least 90 days written notice of a formulary change, which should include information about the exceptions and appeals process. The 90-day time period would permit beneficiaries to consult with their physicians regarding alternative medication therapies or request an exception to the coverage determination. In addition, CMS should include a provision to require plans to allow vulnerable enrollees to continue the course of the “removed” medication regimen (grandfather) if the enrollee has been stabilized on it. CMS should impose limitations on mid-year formulary changes. The Alzheimer’s Association recommends that the final rule place strict limitations on mid-year formulary changes, requiring plans to justify a decision to remove drugs from a formulary. Permitted reasons for discontinuing coverage would include the availability of new clinical evidence indicating that a particular covered Part D drug is unsafe or contraindicated for a specific use or when all manufacturers discontinue supplying a particular covered Part D drug in the United States. As previously noted in our comments to Subpart B, many Alzheimer’s beneficiaries have had trials and errors on multiple medications and have achieved therapeutic benefits on a medication that may then be removed from the formulary. At the minimum, CMS must assure that the exceptions and appeals procedures and beneficiary protections are sufficiently strong to assure that the beneficiaries, who have worked hard with their physicians to find the correct therapeutic combination, can be maintained on those medications. Should the final regulation fail to effect such a restriction, we strongly recommend that plans be required to continue dispensing all discontinued drugs until the end of the plan year for all persons currently taking a discontinued drug as part of an ongoing treatment regimen. In addition, CMS should restrict the frequency of mid-year formulary changes to once during the contract year. Subpart D: Cost Control and Quality Improvement Requirements for Prescription Drub Benefit Plans Medication Therapy Management Programs (§423.153(d)): CMS should require a wide range of services and stress quality outcomes of patents overall health. The Alzheimer’s Association believes that the medication therapy management programs (MTMP) could provide a special opportunity to enhance health outcomes and reduce adverse effects for chronically ill beneficiaries, such as those with Alzheimer’s disease. A characteristic feature of Medication Therapy Management (MTM) services is a focus on the total patient. Whereas some drug utilization programs focus on use of a particular drug or on a single disease, MTM services should focus on all the drugs and diseases related to a specific patient. This comprehensive approach is the best strategy to optimize therapeutic outcomes in the frail elderly population, which is characterized by multiple chronic conditions, high use of medications, and high drug costs. We believe that individuals with Alzheimer’s disease should be identified as “targeted beneficiaries” who should be eligible to receive these services. As previously noted, of all Medicare beneficiaries with Alzheimer’s disease and dementia:
This vulnerable population takes many medications, some of which may result in adverse drug reaction or drug interaction. They have higher use of Medicare hospital and physician services, higher Medicare costs for hospital, skilled nursing facility services and home health services, and higher total Medicare costs compared with all other Medicare beneficiaries. The type and intensity of MTM services provided to an individual beneficiary should be determined by the needs of that individual. We support the CMS approach of ensuring that PDPs offer a range of MTM services to assure that needs of diverse Medicare beneficiaries are met. As noted by CMS, “One beneficiary may require only a fifteen-minute phone consultation, while another would be better served by a one-hour in-person visit with the pharmacist.” CMS should require that PDPs provide a wide range of MTM services, rather than limiting these services to exclusively telephone provision, for example. A telephone consultation will not work with a person with cognitive impairments. In addition, it would be imperative to include the individual’s caregiver as a participant to any MTM services for an Alzheimer’s enrollee. We urge that the financial incentives in MTMPs encourage quality outcomes and not solely reduced costs. Payment for reducing costs without regard to quality could impede access to certain drugs. The preamble says that CMS “may provide a mechanism for plans to demonstrate” the value of their MTMPs to the public. We urge CMS to develop such a mechanism to ensure quality outcomes. Given that PDPs are not financially responsible for poor health outcomes of Original Medicare beneficiaries, we are concerned that they may not have sufficient incentives to devote significant resources and attention to developing MTMPs that would improve overall health. Subpart F: Submission of Bids and Monthly Beneficiary Premiums: Plan Approval Nondiscrimination provision (§423.272): CMS must ensure that the design of all plans and their respective benefits (including any formulary and tiered-formulary structure) do not discourage enrollment of people with chronic diseases and/or disabilities. The MMA’s nondiscrimination clause prohibits plans from substantially discouraging enrollment by high-risk Part D eligible enrollees. The statute gives CMS the authority to utilize significant tools to protect beneficiaries from inappropriate use of case management tools. Although we applaud the regulatory provision that provides that a plan would not be approved if its design were likely to substantially discourage enrollment, it is merely a recital of the law. The preamble language interprets discriminatory to mean discouraging enrollment “on the basis of health status, including medical condition (related to mental as well as physical illness), claims experience, receipt of health care, medical history, genetic information, evidence of insurability and disability.” The preamble goes on to say that CMS would review plans for features that have “differential impacts for beneficiaries with particular medical conditions.” This preamble language should be included in the final regulations and strictly enforced by CMS. In 1999, after an extensive analysis of carrier and intermediary local medical review policies, the Alzheimer’s Association presented then-HCFA with evidence that its contractors were systematically discriminating against Medicare beneficiaries with Alzheimer’s disease. These beneficiaries were automatically denied payment of claims for medically necessary services solely because of their Alzheimer’s diagnosis. CMS issued several Program Memorandums and Transmittals to prohibit these barriers to payment of claims. But for the research, analysis and advocacy of the Alzheimer’s Association, and ultimately cooperation by CMS, these discriminatory practices would still be operational. CMS must be vigorous in its review and monitoring of all plans for anti-discrimination behavior that may impact beneficiaries’ access to prescription drugs. The statute also provides that plans implementing formularies modeled after the USP’s Medicare Model Guidelines cannot be determined on the basis of their therapeutic categories and classes alone to violate this statutory provision. As stated in the proposed rule, plans that adopt the Medicare Model Guidelines may still be found to discriminate against groups of Medicare beneficiaries based on factors other than their formulary structure. For example, a plan that covers only certain drugs or assigns select drugs to a particular tier in the cost-sharing structure, thereby imposing higher cost-sharing requirements on the beneficiary, may be found to discourage enrollment by individuals requiring those medications. Similarly, a cost-sharing tier will have a different impact if the beneficiary pays 50% of the cost of the drug if the prescription costs $10 or $200. Other case management tools, such as prior authorizations and step therapy, must also be reviewed for discriminatory impact. Again, there is some important language and examples provided in the preamble and the issue paper that were not included in the proposed regulations. We strongly encourage the preamble language, as well as other strong nondiscrimination provisions, to be incorporated into the final regulation. Enforcement of the nondiscrimination standard will be a significant but important challenge for CMS. CMS must develop a timely process to review and monitor all plans for anti-discrimination behavior that may impact beneficiaries’ access to prescription drugs. In addition, CMS must devote adequate staff and financial resources to ensure that the nondiscrimination provision of the law is enforced. Subpart M: Grievances, Coverage Determinations and Appeals CMS proposed regulations in this area are highly complicated and fail to provide needed protections for Medicare beneficiaries. The appeals process as described in Subpart M does not accord dual eligible and other Part D enrollees with adequate notice of the reasons for the denial and their appeal rights, with an adequate opportunity to a face-to-face hearing with an impartial trier of fact, with an adequate opportunity to have access to care pending resolution of the appeal, or with a timely process for resolving disputes. As a general comment, this entire subpart needs to be made much simpler. To have two tracks, depending on (1) whether one personally pays for a drug and files an appeal or (2) does not obtain the drug and files an appeal, is far too complicated. The timeframes, the paperwork, and the processes should be simplified into one course of action that beneficiaries may hope to understand. All coverage determinations and appeals concerning drugs, including those in which the enrollee has paid for the drug, should be treated as requests for expedited review. An enrollee would suffer adverse consequences if required to wait for the longer time periods; many people will simply go without prescribed medications pending the outcome of the review. Doubling the time frames and disallowing expedited review in cases when enrollees pay for their drugs out-of-pocket could adversely affect the health of those who forego other necessities like food and heat in order to pay for their medicine. Exceptions Process (§423.578): CMS should ensure that there is sufficient consistency in the exceptions processes among all plans in a given region so that providers can assist beneficiaries in an efficient and effective manner. The proposed rule requires that plan sponsors establish and maintain a process through which enrollees (including their authorized representative or their physician) can seek exceptions to the application of a plan’s tiered cost-sharing structure as well as exceptions to a plan sponsor’s decision not to include a drug in its formulary. Although the proposed rule provides some guidelines for plan sponsors to follow when establishing exceptions processes, plan sponsors nonetheless retain significant discretion to develop their own procedures for determining coverage of non-formulary drugs. The potential variation in plans’ exceptions processes could create substantial challenges for Medicare providers who seek to assist beneficiaries in requesting exceptions across a number of plans. To ensure that beneficiaries and their providers can access necessary prescription drugs through the exceptions process, we strongly recommend that CMS develop a standardized, quick process to minimize the burden on providers and patients. CMS should not allow plans to require an enrollee to try the preferred drug and suffer adverse consequences when there has been a change in the sponsor’s formulary The statement in the preamble that plans could require an enrollee to first try the preferred drug, i.e., a fail first requirement, conflicts with the statutory language of the standard that the doctor only has to certify the preferred drug would not be as effective or cause adverse effects. The statute does not support allowing ‘fail first.’ For many enrollees, a fail first requirement per se would cause adverse effects. Such requirements would be dangerous for the medically vulnerable populations of frail elderly, dual eligible, and long-term care individuals. CMS should require plans to make determinations regarding exceptions requests and notify the enrollee of these determinations in 24 hours as required under Medicaid for determinations regarding prior authorization requests We are deeply concerned that the timeframes for exceptions determinations are far too long. It is extremely unfair to require longer time frames if a beneficiary has paid out of pocket for a needed medication when their alternative would be to wait two weeks to a month for a determination or an emergency one-month supply of the needed drug. Beneficiaries’ health and safety may well be at risk if they are forced to forego other necessities because of the added, and most likely very significant, expense of paying out of pocket for their medicines. Although the proposed regulations include some provisions for an emergency supply of medications while a plan is considering an exceptions request, it is unreasonable and bad health policy to make beneficiaries wait two to four weeks before the drug plan must provide an emergency supply. In addition, plans should be required to demonstrate that an extension of the standard time frame for exceptions determinations is in the best interest of the enrollee and the final rule must charge independent review entities with exercising oversight over these extensions. At a minimum, all requests for exceptions should be automatically given expedited consideration. Where someone seeks expedited review of a request to continue a drug that is no longer on the formulary, the plan should be required to process the request in 24 hours under the provision that requires an expedited review to be completed as fast as the beneficiary’s condition requires. The enrollee should be given a 72-hour supply of the medicine, which is renewable if the plan decides to take longer than 72 hours. CMS should adopt its proposal that enrollees be permitted to obtain refills of medications at the same cost-sharing level without requesting additional approvals once a plan extends an initial approval. Under the proposed rule, a plan sponsor must continue to cover a drug approved under an exception request, including refills, so long as the drug continues to be prescribed for the enrollee and is considered safe for treating the enrollee’s condition. Plan sponsors also are prohibited from imposing a special formulary tier, co-payment or other cost-sharing requirement that applies only to drugs that have been approved under the exceptions process. The Alzheimer’s Association strongly supports these requirements and urges CMS to adopt them in the final regulations. Such requirements would ensure that beneficiaries for whom certain drugs have been determined to be necessary will have uninterrupted access to these important medication therapies. Subpart P: Premiums and Cost Sharing for Low-Income Individuals Definition of Personal Representatives (§423.772): CMS should clarify who is permitted to act as an individual’s personal representative. The Alzheimer’s Association supports the definition of personal representative which will broaden the range of individuals who can act in that capacity. Many individuals with Alzheimer’s disease rely on family, friends, neighbors and others to assist with a variety of tasks, including handling health insurance matters. We would recommend a revision to be incorporated into the definition to prohibit any employee of a plan or plan sponsor from acting as the personal representative, unless the employee is a family member. This would alleviate concerns about a conflict of interest of the personal representative. Definition of Institutionalized Individual (§423.772): CMS should include nursing home eligible beneficiaries who are receiving waiver services in the definition of institutionalized individual for purposes of cost-sharing subsidies. The definition should include those individuals eligible for home and community based services under a Medicaid waiver (see, e.g., definition of “institutionalized spouse” at 42 U.S.C. § 1396r-5(h)(1)(A)), since those individuals must meet the acuity standards for Medicaid coverage in a nursing facility. Many states have increased the use of home and community based waiver programs (e.g. 1915c) to allow nursing home eligible individuals to remain in the community or in alternative settings, such as assisted living or board and care homes. Many individuals with Alzheimer’s disease opt to participate in home and community based services waiver program rather than reside in a nursing facility. Under proposed regulation §423.782(2)(ii), “institutionalized individuals” are exempt from prescription drug cost-sharing for covered Part D drugs. If states use waiver programs to encourage nursing home eligible individuals to remain in the community, the beneficiaries would be required to pay the co-payments. Including these individuals in the definition of institutionalized individuals removes the perverse financial incentive to admit these individuals into nursing homes. It should be noted that low-income nursing home eligible Medicare beneficiaries who live in alternative settings, such as assisted living, often are provided with only a minimal cash allowance (e.g. $20 per month) to pay for haircuts and incidentals. For these individuals, prescription drug co-payments could serve as a significant deterrent to living in these alternative settings, forcing them into the more expensive nursing home facility. Conclusion The Alzheimer’s Association appreciates the enormous effort of CMS to implement these provisions of the Medicare Modernization Act. We recognize the challenges that this entails, including the difficulty of balancing the interests of the various stakeholders with the need for protection of vulnerable Medicare beneficiaries. We hope that our comments will assist CMS in achieving the proper balance. Given the breadth of these regulations, the numerous agency requests for comments on substantive issues and the importance of these regulations to implementation of the Part D program, we urge CMS to provide another second comment period before promulgation of final regulations. We appreciate the opportunity to comment on these proposed regulations. Over the years, we have had successful collaborations with CMS to ensure that the needs of individuals with Alzheimer’s disease are met. The Alzheimer’s Association is ready to work with you, and to assist in identifying appropriate clinical experts, to assure access to medically necessary drugs for beneficiaries with dementia. Please feel free to contact Leslie B. Fried, Director of the Association’s Medicare Advocacy Project, (202) 662-8684, to further discuss these matters. Sincerely, Bonnie Hogue Leslie B. Fried Download as PDF (INSERT PDF) 
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