Center Comments on Medicare Advantage and Part D “Transformation Ideas”

April 24, 2017

VIA ELECTRONIC SUBMISSION
PartCDcomments@cms.hhs.gov

Seema Verma, Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Baltimore, MD 21244

Re:                  2017 Transformation Ideas – Response to Request for Information re: Medicare Advantage and Part D

Dear Administrator Verma:

The Center for Medicare Advocacy (Center) is pleased to provide the Centers for Medicare & Medicaid Services (CMS) comments on its Request for Information concerning Medicare Advantage and Part D.  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.

Overarching comment: while we recognize CMS’ stated intention to maintain benefit flexibility and efficiency throughout the MA and Part D programs, we stress that CMS’ focus should not be on rolling back regulations, reducing oversight or minimizing plan sponsor burdens.  We anticipate that many plan sponsors will vigorously push for reduction in regulations and oversight – we think granting such requests would be a dangerous path to tread.  Rather, we urge CMS to focus squarely on ensuring Part C and D enrollees (and the broader Medicare population) have access to and receive timely, quality health care.  CMS needs to ensure that MA and Part D plans provide what taxpayers are paying for; ultimately, both beneficiaries and taxpayer dollars must be safeguarded.

We divide our comments into the following broad sections:

1. Beneficiary Support and Education
2. Medicare Advantage
3. Part D

​I. Beneficiary Support and Education

Medicare is a complex program, often requiring assistance in navigating the myriad choices regarding coverage options, rules regarding coverage, and resolving problems, including informally and through the administrative appeals process.  People with Medicare, their families and caregivers require adequate, actionable information about each decision point they face.  A combination of written (print, online), telephonic, and individualized, in-person assistance is required to achieve this end. We join other consumer advocacy organizations in strongly urging CMS to strengthen educational tools and beneficiary supports, including the following:

Support State Health Insurance and Assistance Programs (SHIPs)

State Health Insurance and Assistance Programs (SHIPs) are at the forefront of providing accurate, timely and unbiased information to people with Medicare.  The scope of SHIP counseling encompasses a broad range of areas, including coverage options, fraud and abuse issues, billing problems, appeal rights, and enrollment in low-income assistance programs. As such, SHIPs offer increasingly critical services that cannot be supplied by 1-800 MEDICARE or through web-based and written materials. A high volume of partner referrals to SHIPs – approximately one-third – originate from MA and Part D plans, local and state agencies, CMS, the Social Security Administration (SSA), and members of Congress and their staff. In addition, these partners include SHIP contact information in their websites, publications, and correspondence as a leading source of assistance when people need help with Medicare.

SHIP counselors are essential to helping people with Medicare make informed, individualized choices about how to receive coverage and care.  Accordingly, we strongly encourage CMS to actively support the SHIPs, and we urge this Administration to revisit a FY2017 funding proposal to eliminate SHIP funding.  Rather than cut funding for the SHIP network, we urge greater investment in this vital, cost-effective program.

Improve Notices

Written notices regarding enrollment, plan changes, coverage decisions, appeals, and costs are the most frequent method of communication between Medicare, MA plans, Part D plans, and beneficiaries.  Such notices are also often a source of considerable confusion for Medicare beneficiaries and those assisting them.  Thus, we encourage CMS to continue to develop model notices in consultation with numerous stakeholders, including consumer advocates.  Where CMS does not require MA and Part D plans to use model notices, plans should be encouraged to test notices and to report on such testing to CMS.

Additionally, we ask CMS to improve communications with individuals with limited proficiency in English.  Such improvements would serve the goals of transparency, supporting the doctor-patient relationship in care delivery and facilitating individual preferences, all identified in the RFI.  Improvements would also address the agency’s goal of reducing health disparities.  Accordingly, we incorporate here, by reference, the comments of our colleagues at Justice in Aging, who encourage, among other things, to expand the categories of documents subject to the translation requirements, and add numerical thresholds to the percentage thresholds for translation.   

Promote Active and Informed Plan Choice

CMS’ Request for Information (RFI) places appropriate emphasis on “facilitating individual preferences” and ensuring that people with Medicare have “options that fit their individual health needs.”  In furtherance of this goal, we believe CMS should advance policies that encourage people with Medicare to make active and informed choices about the coverage option(s) that are right for them, selecting among Traditional Medicare, Medicare Advantage plans (including integrated Medicare-Medicaid options), supplemental Medigap policies, and stand-alone Part D prescription drug plans. We support, and incorporate by reference here, the comments of our colleagues at the Medicare Rights Center, including the following recommendations:

Personalize the Annual Notice of Change (ANOC)

The ANOC is one of the most important documents for improving beneficiaries’ ability to make wise choices.  We continue to advocate for an individualized MA and Part D ANOC to better serve beneficiary needs, specifically one that details which specific providers or pharmacists are leaving a plan network, which specific prescription drugs are no longer on the plan formulary, and where utilization management tools will be newly applied. Ideally, these customizations should reflect an individual’s actual providers, pharmacists, services, and prescription drugs.

Revitalize the Plan Finder

The Medicare Plan Finder is the premier online tool available to help people with Medicare, family caregivers, and professionals evaluate and compare the MA and Part D plan options available in a given region. While this tool has significantly improved since the inception of the Part D benefit, more can and should be done to enhance the usability of the Plan Finder.

We encourage CMS to establish a long-term goal to incorporate a searchable MA provider directory in Plan Finder that includes both individual practitioners and hospitals. To date, provider network information is not fully integrated in Plan Finder, significantly diminishing its utility for those seeking to compare and contrast MA plan options. Clearer information on cost-sharing and coverage for MA supplemental benefits, like dental and vision care, is also needed. Further, we believe CMS should add information on Medigap options to Plan Finder to allow beneficiaries to full assess the coverage choices available to them. This content should include information on states that allow a guaranteed issue right to Medigap beyond a beneficiary’s initial eligibility.

At a minimum, we urge CMS to engage in a transparent, multi-stakeholder process to solicit input on needed Plan Finder improvements and how best to redesign this important consumer tool. Now more than ten years following the establishment of Medicare Part D, we believe Plan Finder is overdue for a comprehensive update. With 10,000 people becoming eligible for Medicare each day and MA enrollment on the rise, we encourage CMS to redesign Plan Finder to better meet the needs of a growing population of MA and Part D enrollees.

Standardize MA Benefit Packages

As reflected in numerous studies as well as our experience assisting individuals, many people struggle to select among several MA plans and multiple, complex plan variables. A recent Health Affairs study attributes some degree of beneficiary inertia with having too many plans from which to choose. The authors write, “Our study suggests that the Medicare Advantage program presents an overabundance of choices for elderly beneficiaries, posing a level of complexity far beyond that experienced by the nonelderly.” The findings also show that difficulty selecting among MA plans and Original Medicare is more pronounced among older adults with low cognitive function, such as those in the early stages of dementia.[1]

To encourage efficient plan selection, distinctions among plans must be made more meaningful. We strongly support CMS’ ongoing efforts to eliminate plans too alike to other plans offered by the same insurer, and we encourage the agency to continue in this manner. At the same time, CMS should consider standardizing MA benefit packages, like the rubric required for supplemental Medigap plans (i.e., Plan A, Plan B, Plan C), to encourage “apples-to-apples” comparisons among plan options.[2]  Confusion surrounding Medigap policies – both concerning benefits offered and value for premiums paid – significantly diminished when Medigap plans were standardized.   Medicare beneficiaries shopping for and comparing MA plans would similarly benefit from being able to compare standardized MA benefit packages between and among plan sponsors.

II. Medicare Advantage (MA)

While the MA program serves some enrollees well, our experience shows that many enrollees face problems accessing care in MA plans, including problems they would not encounter were they in traditional Medicare.  As discussed below, research has shown that not everyone is well-served by MA plans.  For these reasons, our overarching comment with respect to Medicare Advantage is that CMS should not erode essential protections for beneficiaries.  Instead, CMS should both further improve consumer protections, and maintain and expand current oversight of plans.  Finally, CMS should ensure that MA enrollees specifically, and taxpayers more generally, get what we are paying for.  At a time when some plan sponsors push for changes in funding mechanisms and formulas that would yield higher payment, some sponsors inappropriately “upcode” and receive more payment than what is owed to them.  It’s unfair to ask beneficiaries in traditional Medicare and taxpayers to shoulder extra payments to private Medicare plans.  We address these issues, in turn, below.

Our Experience Assisting MA Plan Enrollees

While we recognize that MA plans can be a viable option for some enrollees, as a beneficiary advocacy organization, we are rarely contacted by individuals who are happy with their plans.[3]  Instead, we regularly hear from individuals and their families who are having trouble accessing services through their MA plans.  For many of these individuals, their MA plans worked fine while they were relatively healthy, but once they required more intensive medical services, or needed to see a particular provider, their MA plan became a barrier to care. 

One of the most frequent issues we encounter concerning MA coverage relates to post-acute care. In the skilled-nursing facility setting, beneficiaries are denied coverage, even when they are receiving daily services that are defined as “per se skilled care” in federal regulations – and thus should trigger Medicare coverage.[4]  For example, the Center has periodically fielded complaints from across the country about MA plans that deny coverage for skilled nursing facility (SNF) care, including for individuals receiving their nutrition through a feeding tube.  Similarly, we regularly hear from MA enrollees who are denied home health coverage to which they are entitled.[5]

The Center also hears from providers when MA plans don’t follow Medicare coverage guidelines.  For example, at trainings the Center has conducted for home health agencies, there is often general agreement among those present that it is more difficult to obtain Medicare coverage for necessary home health care from MA plans than from traditional Medicare.

Our experience is echoed elsewhere.  For example, in late 2013, Minnesota’s Attorney General (AG) asked CMS to investigate plans offered by one MA carrier and presented numerous affidavits of beneficiary complaints, including allegations that the insurer “denied reimbursement for services that it is required to cover for all Medicare beneficiaries—including diagnostic ultrasounds, mammograms and care in a skilled-nursing facility for a stroke patient”; in addition, the AG alleged that the plan “created confusion by not adequately disclosing which providers were in-network and does not comply with required appeals processes.” [6]

Access to Quality Care for All Enrollees

Too many plans fail to provide adequate coverage and access to care when enrollees are seriously ill or injured.  While beneficiaries who are relatively healthy may fare well in MA plans, and while some studies show that MA plans perform better than traditional Medicare in certain areas (such as provision of certain preventive benefits), that is often not true for sicker enrollees. 

There is a growing body of evidence that Medicare Advantage plans might not serve poorer and sicker beneficiaries as well as healthier people. Beneficiaries who are poorer and sicker tend to disenroll from MA plans at disproportionately higher rates than other enrollees.[7]  Further, beneficiaries tend to rate traditional Medicare more favorably than MA plans for quality and access with this differential in rating even more pronounced for those who are sicker.[8]  In addition, CMS’ own recent research has highlighted health disparities among certain populations enrolled in MA plans.[9]

Thus, it is based on both our experience and the research surrounding MA enrollees’ experience that shows that consumer protections for plan enrollees and oversight of such plans must be strengthened, not weakened.

Preserve and Strengthen Essential Consumer Protections

We anticipate that many MA plan sponsors will urge CMS to loosen current rules and restrictions on plans in the name of innovation or easing administrative burden.  We urge CMS to proceed very cautiously when considering such requests.  Based upon our experience assisting MA enrollees, and the research showing people who are sicker tend to disproportionately disenroll from MA plans, we do not support waiving existing anti-discrimination rules that prevent MA plans from denying, limiting or conditioning coverage or provision of benefits based on any health status-related factors.[10] Correspondingly, rules should not be changed to allow MA plans to design covered benefits in such a way that is likely to discourage enrollment by certain individuals.  

We remain concerned that too much flexibility risks allowing some MA plans to devise discriminatory plan designs, intentionally or otherwise.   Any flexibility given to MA plans must be subject to transparent, well-developed criteria established by CMS in consultation with other stakeholders, including clinicians, researchers and consumer advocates. When assessing whether to give plans any flexibility in benefit design or cost-sharing, we commend CMS for the approach taken in the MA Value Based Insurance Design (VBID) model, in which consumer protections remained paramount.[11]

Any lessons learned and potential successes from demonstrations or trials relating to flexibility in MA plan benefits and structure should, to the extent possible, be applicable to all Medicare beneficiaries, regardless of how they choose to access their benefits. Lowering or eliminating cost-sharing in traditional Medicare, as well as offering some of the other positive incentives outlined in the MA-VBID proposal, could also benefit the majority of beneficiaries who choose to remain in Traditional Medicare.

Should the MA-VBID model and others like it result in positive health outcomes for MA enrollees, we hope that CMS will both make lessons learned from this model publically available and, as appropriate, integrate promising practices into the Traditional Medicare program and beyond. Thus, we encourage CMS to evaluate this demonstration program—through design, implementation, and monitoring—in light of how positive results might be expanded beyond the MA program. 

We offer the following suggestions to strengthen existing consumer protections.[12]

Seamless Conversion Enrollments

The Medicare statute and implementing regulations allow insurance plan sponsors to petition CMS to auto-enroll an individual currently in one of their commercial or Medicaid products into an MA plan when that person becomes Medicare-eligible, a process known as “seamless conversion enrollment.”  In 2016, the Center began to hear from beneficiaries who were seamlessly enrolled into MA plans without their knowledge or consent.[13]

Out of concern that existing consumer protections were not adequate to prevent such enrollments without informed consent, the Center worked with partner organizations and CMS to address these concerns.[14]  In October 2016, CMS issued a temporary moratorium on its acceptance of any new seamless conversion proposals and released previously unavailable data concerning plan sponsors’ use of this process.[15]

As CMS is reviewing the current seamless conversion enrollment policy, we urge CMS to add stronger consumer protections and transparency to the process before lifting the moratorium. We direct CMS to the Joint Advocates letter, linked below, for specific consumer protections, including: write-in confirmation, a Special Enrollment Period (SEP), 1-800-MEDICARE scripts, tailored notifications and outreach for commercial insurance vs. Medicaid managed care plans, and continued and enhanced transparency.  Further, we ask CMS to provide the opportunity for public comment on any proposed or revised seamless conversion policies.

            Access to Providers

One of the most important health care considerations for an individual is the ability to choose one’s doctor(s) and other health care providers.  This is the choice that people really care about. By design, however, MA plans contract with a limited network of providers to care for their enrollees.  Networks are supposedly designed to coordinate care and control costs; whether they do so or not, they do limit the choice of doctors and health care providers.  MA networks can also cause problems for enrollees who seek health care outside their geographic area – and even for some close to home.

Access to providers includes issues surrounding network adequacy, provider directories, and provider termination, discussed below.  

MA Network Adequacy

As CMS is aware, in 2015 the General Accounting Office (GAO) released a report entitled “Medicare Advantage: Actions Needed to Enhance CMS Oversight of Provider Network Adequacy”.[16]  GAO examined several factors relating to CMS’ oversight of MA organization (MAO) network adequacy, and made corresponding findings.

As a result of this review and these findings, GAO recommended that “[t]he Administrator of CMS should augment oversight of MA networks to address provider availability, verify provider information submitted by MAOs, conduct more periodic reviews of MAO network information, and set minimum information requirements for MAO enrollee notification letters.”  

While we recognize that CMS has made efforts to address some of the deficiencies highlighted by GAO, so far such efforts appear to be primarily directed at provider directories alone.  CMS noted in the draft 2016 Call Letter that “[t]he data collected through our monitoring activities could drive additional reviews of network adequacy, as well as future monitoring and/or audit-based activities” [emphasis added].  We urge CMS to more broadly expand its oversight and definition of network adequacy, as suggested by GAO.

MA Provider Directories

We appreciate and encourage CMS’ ongoing effort to make sure Medicare Advantage provider directories are accurate for Medicare beneficiaries and those that assist them who rely on such directories to make informed decisions about their coverage and provider options.  Recent CMS findings from a review of 54 MA organizations, showing widespread inaccuracies in MA provider directories, underscore the need for further work in this area.[17] In response to these findings, CMS issued additional guidance reiterating the rules MA organizations must follow for provider directories.  

We urge CMS to continue to strengthen required data elements in future regulatory updates.  In addition, as mentioned in previous comments (and above), we continue to believe that provider directory integration in Plan Finder would greatly enhance beneficiaries’ ability to choose among MA plans based upon the criteria most important to them. Incorporating accurate provider directories in a searchable and integrated way would significantly improve the utility of Plan Finder for MA searches and ease plan selection for people with Medicare. As such, we strongly encourage CMS to incorporate this goal in the agency’s planning as it develops future policy on this issue.

            Provider Network Terminations

Sometimes Medicare Advantage enrollees face barriers to care even within the plan’s service area, including due to provider network changes and limitations.  When MA plans change their provider networks, as they often do each year, it can be highly disruptive to plan enrollees.  For example, for 2014, Medicare beneficiaries enrolled in the largest MA plan in the state of Connecticut experienced major disruptions in access to care.  In late 2013 United Healthcare jettisoned approximately 2,250 providers and healthcare facilities from its Connecticut Medicare Advantage network, including Yale New Haven Hospital.[18]  In a small state like Connecticut, that’s a very large number – about one physician or hospital or nursing home, or other healthcare provider lost, for every 260 Connecticut Medicare beneficiaries.  Neither physicians nor Medicare patients were given adequate notice of this extraordinary decision by United. In fact, it was only as the 2013 Medicare enrollment period came to a close, that people enrolled in the United Healthcare MA plan learned that their doctors and/or hospital would not be available to them in United’s reduced Medicare Advantage network in 2014.  Many others did not learn until after the new year, when they sought medical care during 2014, only to find their doctor or other healthcare provider was no longer in their Medicare plan. 

More recently, in March 2017 in Connecticut, United Healthcare (UHC) set off a panic among its Medicare Advantage (MA) enrollees by sending out letters indicating that they would no longer be affiliated with Hartford HealthCare HHC), one of Connecticut’s largest provider networks.[19]  We also learned that UHC may have engaged in similar behavior in the Tucson, Arizona area.

These Connecticut MA enrollees often received multiple letters – one for each of their HHC providers. One older person with multiple conditions called the Center for Medicare Advocacy greatly alarmed, having received 14 letters telling her that care from her providers would no longer be covered.  The letters indicated that patients would need to find new primary care physicians, specialists, home health agencies, and hospitals.  Some patients who contacted the Center had surgeries scheduled that week.

The Center contacted UHC and was told that negotiations were actually ongoing, and the letter that was sent should have indicated that. We were told that a corrected letter would be sent, but that the process could take a long time.  In mid-April, negotiations between UHC and HHC finally concluded successfully.  HHC patients and providers will now be sent letters from UHC indicating that a new 2-year agreement has been reached.  Some patients, however, likely already experienced disruptions, as they scrambled to find new providers based on the earlier letter. 

CMS must ensure that contract negotiations between MA plan sponsors and providers not entangle, confuse and/or affect the continuity of care of MA enrollees. We urge CMS to take further action to strengthen consumer protections surrounding MAO mid-year provider network terminations, including:

• Prohibit mid-year provider terminations: The most effective way to protect consumers from being trapped in their plans after their own doctors are involuntarily terminated is to prohibit MAOs from terminating network providers mid-year without cause.  CMS signaled that it was exploring this option in the draft 2015 Call Letter, but has not adopted this proposal.  
• At least 60-days advance notice to affected beneficiaries: CMS also proposed, but did not finalize, an effort to extend the current 30-day advance notice to affected beneficiaries, as also suggested in the 2015’s Draft Call Letter.  We urge CMS to require Medicare Advantage plans to provide notice at least 60 days before the Annual Enrollment Period when more than a certain percentage of their provider network is to be cut. And, regardless of the overall percentage, provide notice to each enrollee whose physicians or closest hospitals and nursing homes will no longer be in the network.
• Expand SEP related to network terminations: further, CMS has failed to strengthen or otherwise expand the limited special enrollment period (SEP) right available only to beneficiaries affected by “significant” network terminations.  In addition, the availability of this limited SEP right is not adequately expressed in beneficiary-oriented materials, including those issued by plan sponsors (e.g. the Annual Notice of Change) or by CMS (e.g. Medicare & You and the www.medicare.gov website). 

Increase Plan Sponsor Oversight

We strongly believe that robust consumer-oriented regulations, ongoing monitoring and evaluation, and a reliance on transparent processes to guide any proposed changes to administrative policies are integral to the ongoing participation of private plans in the administration of the Medicare Advantage and Part D programs.  

We urge CMS to continue and increase its oversight and management of the MA and Part D markets through multiple means, including the Star Ratings program, audit and enforcement procedures, and open and ongoing dialogue with stakeholders who represent diverse interests. Each of these tools plays a critical role in ensuring not only that MA and Part D plans are optimally serving their enrollees but also that taxpayer dollars are well spent. Towards this end, we encourage CMS to consider the following:

Enhance Audit Capacity and Increase Transparency on Enforcement Actions

We urge CMS to revisit the agency’s prior proposal to increase audit and inspection authority. In a 2015 proposed rule, CMS details the criteria by which it determines which MA and Part D plan sponsors are audited each year and acknowledges that limited resources allow the agency to perform annual audits on only 10% of plan sponsors—30 of 300. CMS previously proposed, but chose not to finalize, a rule requiring plan sponsors to hire independent auditors. Given persistently poor plan audit results, namely involving appeals and grievances, we ask CMS to revisit this proposal.[20]

Further, we greatly appreciate the ongoing dialogue with CMS and other consumer advocates on how to make enforcement actions, including intermediate sanctions and civil money penalties, more transparent. We are grateful for CMS’ commitment to enhancing content on plan websites to reflect intermediate sanctions and for the additional information on common plan deficiencies recently incorporated in the agency’s public report on audit findings.

Further align Star Ratings and enforcement actions

We continue to support CMS’ evaluation of how audits, civil money penalties, and sanctions impact Star Ratings.  Any disconnect between audit scores and the Star Ratings system can be a source of confusion for people seeking to evaluate and compare plan quality.

We continue to strongly urge CMS to ensure that the Star Rating system does not camouflage or minimize plan behaviors that put Medicare enrollees at risk. When CMS determines that a plan’s conduct poses a serious threat to the health and safety of beneficiaries, CMS should accurately signal this assessment through Star Ratings, providing beneficiaries with a clear tool that helps them fully evaluate and compare health plans. Of particular concern is the repeated finding of the same serious deficiencies in audit scores while Star Ratings continue to rise. To address this imbalance, it is critically important that Star Ratings incorporate audit measures and reflect audit results in meaningful ways, while CMS continues to impose significant sanctions and penalties when serious deficiencies are identified.[21]

Medicare Advantage Payment Rates

We urge CMS to direct more attention to protecting public funds by ensuring that payment to Medicare Advantage plans is accurate.  MA “upcoding” – when an MA plan inappropriately reports an enrollee as being more sick than they actually are in order to obtain a higher risk-adjusted payment from the Medicare program – remains an ongoing  problem that policymakers must address. 

Various studies have attempted to document the scale of inappropriate MA coding intensity, or upcoding, and the resultant overcharges by MA plans.  An investigation by the Center for Public Integrity, for example, found that Medicare paid MA plans nearly $70 billion in “improper” payments, mostly from upcoding, from 2008 through 2013 alone.[22]  More recently, a study published in Health Affairs found that coding intensity practices could result in overpayments to MA plans totaling $200 billion over the next decade.[23]

 In April 2016, the General Accounting Office (GAO) issued a report entitled “Medicare Advantage: Fundamental Improvements Needed in CMS’s Effort to Recover Substantial Amounts of Improper Payments.”[24]  The report states that CMS estimates that about 9.5% of its annual payments to Medicare Advantage (MA) organizations were improper – totaling $14.1 billion in 2013 alone – “primarily stemming from unsupported diagnoses submitted by MA organizations.”  The report also highlights the significant flaws in CMS’ current efforts to address and recoup such payments, including execution of the Risk Adjustment Data Validation (RADV) audit process.

As CMS is aware, Senator Grassley has recently sent a letter to CMS about upcoding.[25]  As Senator Grassley noted in his letter, “[b]y all accounts, risk score gaming is not going to go away.  Therefore, CMS must aggressively use the tools at its disposal to ensure that it is efficiently identifying fraud and subsequently implementing timely and fair remedies.  The use of these tools is all the more important as Medicare Advantage adds more patients and billions of dollars of taxpayer money is at stake.”  We applaud the Senator for seeking answers to several questions, including the following raised in this letter:

1.  What steps will CMS take, or is currently taking, to ensure that insurance companies are not fraudulently altering risk scores?  Please explain.
4.  In the past two years, how many Medicare Advantage audits have been performed?  How many audits are currently ongoing?”

The Center is deeply concerned by these ongoing improper payments to MA plans and CMS’ lack of progress in recouping previous payments and deterring future misconduct.  In order to ensure that the traditional Medicare program is not further disadvantaged by inappropriate overpayments to MA plans, CMS must employ more rigorous oversight of MA payment.

With respect to other payment issues we refer you to our comments to the Draft 2018 Call Letter[26], wherein we touch on a number of issues, including the following:

• In order to ensure greater payment equity between Medicare Advantage Employer Group Waiver Plans (EGWPs) and non-EGWP MA plans, we urge CMS to not delay in fully implementing the alternative payment policy for MA EGWPs;
• We recommend CMS increase the coding intensity adjustment for 2018 above the proposed level of 5.91 percent — the statutory minimum;
• We support CMS’ transition to the use of encounter data in calculating MA risk scores so that risk adjustment can be gauged by actual care provided by MA plans.  However, we do not support applying a uniform industry-wide adjustment to the encounter data-based portion of the blended risk score under the Part C and ESRD models.  The purpose of collecting and using encounter data is to improve the accuracy of the MA risk adjustment system, which may have the effect of lowering risk scores and hence reducing payments to MA plans.  Applying an industry-wide adjustment, though, would seriously undermine the benefits of using encounter data; and 
• We urge CMS to enhance oversight of MA plan sponsors’ in-home risk assessments to ensure that the services provided to beneficiaries through these visits are meaningful and effective, not simply a means for collecting risk adjustment diagnoses without ensuring that meaningful follow-up care is delivered.  We urge CMS to adopt its initial proposal in its draft 2015 Call Letter to exclude, for payment purposes, diagnoses from in-home risk assessments that were not confirmed by a subsequent clinical encounter (a policy change also supported by MedPAC). We are concerned that voluntary best practices – a proposal from the 2016 Call Letter – will not achieve CMS’ goal of linking heightened risk scores to care that addresses beneficiaries health needs. Use of such best practices should be only an interim step while CMS works to develop a strong evidence-based in-home assessment tool. We again urge CMS to exclude, for payment purposes, diagnoses identified during a home visit that are not confirmed by a subsequent clinical encounter. Simply enhancing a risk profile without benefiting enrollees serves no useful purpose to the Medicare program or its beneficiaries.

III. Part D

With respect to the Part D program, we reiterate our support of preserving and enhancing consumer protections, and strengthening oversight of plan sponsors.  In addition, we offer the following recommendations.

Streamline Part D Appeals Process

The appeals process is an essential safety valve, allowing access to prescription medications that are not on the plan’s formulary, or are subject to high cost sharing, when formulary or lower cost alternatives are not appropriate for a beneficiary’s unique medical needs. To ensure that Part D enrollees can successfully navigate the appeals process, we endorse the comments of our colleagues at the Medicare Rights Center and strongly encourage CMS to improve information at the point of sale and to streamline the appeals process.

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. Along these same lines, we strongly support allowing the pharmacy counter refusal to serve as the coverage determination. 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.

These recommendations represent long-term solutions, as pursuing either of these proposals will require the National Council for Prescription Drug Programs (NCPDP) to update electronic transaction standards under the Health Insurance Portability and Accountability Act (HIPPA). Nevertheless, we encourage CMS to recognize these options as viable and worthwhile pursuits.

At the same time, we continue to support efforts CMS has undertaken to explore opportunities to help beneficiaries secure access to needed medications absent coverage determination requests and appeals. We also remain strongly supportive of commitments made by CMS in 2016 to strengthen beneficiary denial notices and to establish a data tracking system to monitor each stage of the Part D appeals process. We encourage this administration to continue to move forward with these initiatives.

Remove Restrictions on Part D Tiering Exceptions

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 urge CMS to allow tiering exceptions for prescription drugs placed on a Part D plan’s specialty tier, both as a matter of fairness and to promote affordable access to high-cost medications. Alternatively, we recommend that CMS consider limited cases where these exceptions would benefit a notable share of beneficiaries or establish another mechanism for cost-sharing relief among Part D enrollees unable to afford specialty tier medications, namely those ineligible for LIS/Extra Help.

Further, we urge CMS to move swiftly to complete the agency’s analysis announced in the Final 2017 Rate Notice and Call Letter on the effects of allowing tiering exceptions for specialty tier medications.[27] We continue to believe further study is needed to determine whether the longstanding prohibition on tiering exceptions for specialty tier medications is warranted. Particularly if any such analysis were to reveal that allowing tiering exceptions would have a minimal effect on plan costs, then we would hope this policy would be revisited.

Protect Nursing Home Residents from the Inappropriate Prescribing of Antipsychotic Drugs 

While the Center supports the current rules surrounding protected categories of drugs under Medicare Part D, we have ongoing significant concerns about the inappropriate prescribing of antipsychotic drugs in the long-term care setting, and urge CMS to impose stronger requirements on Part D plans to protect such individuals.[28]  With respect to 2018 CMS Display Measures and Chronic Use of Atypical Antipsychotics by Elder Beneficiaries in Nursing Homes (Part D), see the Center’s comments to the Draft 2018 Call Letter.[29]  

Whether or not antipsychotic drugs remain a protected class for Medicare beneficiaries who have a medical need for such drugs is a separate issue from the need to protect nursing home residents from the inappropriate prescribing of antipsychotic drugs.  Establishing long overdue protections for residents does not depend on changing the rules for antipsychotic drugs for people for whom they are medically necessary, as CMS implies in the proposed rules.

There is no question that antipsychotic drugs are medically inappropriate for the vast majority of nursing home residents who receive them.  The Inspector General conclusively documented in 2011 that hundreds of thousands of residents received antipsychotic drugs and that 83% of the claims were for off-label conditions, including 88% for conditions specified in the black-box warning given to antipsychotic drugs by the Food and Drug Administration (FDA).[30]  The American Geriatric Society’s Beers List of drugs that are inappropriate for older people includes antipsychotic drugs.[31]  The Senate Special Committee on Aging held a hearing in 2011 on the misuse of antipsychotic drugs in nursing homes, Overprescribed: The Human and Taxpayers’ Costs of Antipsychotics in Nursing Homes (Nov. 30, 2011).[32]  

CMS’s effort to reduce the inappropriate use of antipsychotic drugs – the Partnership to Improve Dementia Care in Nursing Homes – has led to only small reductions in the use of these drugs.  As the evidence mounts about the dangers of antipsychotic drugs for residents who have dementia, hundreds of thousands residents continue to take them.

CMS abandoned an earlier effort to address the problem of antipsychotic drugs through revisions to consultant pharmacist rules.  The Nursing Home Reform Law’s requirement that nursing homes engage consultant pharmacists to review residents’ drug regimens each month (and to make recommendations to the prescribing physician(s)), 42 C.F.R. §483.60(c), has been undermined by drug companies’ using consultant pharmacists as part of their marketing teams.  CMS proposed making consultant pharmacists independent, 76 Fed. Reg. 63017, 63038-63041 (Oct. 11, 2011), but decided not to make the proposed rule final, 77 Fed. Reg. 22071, 2211-22107 (Apr. 12, 2012), despite receiving overwhelming evidence that conflict-of-interest problems are pervasive and serious.

The current regulatory system has also failed to protect residents from inappropriate use of antipsychotic drugs.  The Center for Medicare Advocacy and Dean Lerner Consulting completed a study of antipsychotic drug deficiencies cited by seven states in 2011 and 2012.  The study found that 95% of the deficiencies were cited at a no-harm level, regardless of how many residents were harmed or how serious the harm.  As a consequence of labeling deficiencies as no-harm, however, CMS was unlikely to impose any penalties against the facilities.[33] 

CMS is aware of the problem of the pervasive misuse of antipsychotic drugs in nursing homes and already has the tools to address it.  CMS expressed concern in a 2014 proposed rule, which was never made final, that the use of antipsychotic drugs for nursing home residents “is, in many cases, unwarranted and in others, possibly dangerous.”[34]  CMS also recognized in the proposed rule that “Coverage under Part D is not available for drugs that are not used for a medically-accepted indication” and that “Prior authorization requirements to determine medically-accepted indications should be limited to those drugs for which it is reasonably foreseeable that use for non-medically-accepted indications are likely to occur.”[35] CMS must apply its knowledge and these principles to protect residents.

We urge that Part D rules be amended to

• Require plans to implement prior authorization rules for antipsychotic drugs for nursing home residents.  Plans know which plan participants are in nursing homes.
• Require plans to implement medication therapy management for all nursing home residents who receive antipsychotic drugs.

Conclusion

We appreciate the opportunity to submit these comments. For additional information, please contact David Lipschutz, Senior Policy Attorney, dlipschutz@medicareadvocacy.org, and Kata Kertesz, Policy Attorney, kkertesz@medicareadvocacy.org, both at 202-293-5760.

David A. Lipschutz                                                    Kata Kertesz
Senior Policy Attorney                                               Policy Attorney