Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs
2009-12-15 2009-12-15 2009-12-15 2009-12-15 2009-12-15 2009-12-15
CMS-2009-0088-0046 CMS-2009-0088-0062 CMS-2009-0088-0026 CMS-2009-0088-0076 CMS-2009-0088-0094 CMS-2009-0088-0063
05:00:00 05:00:00 05:00:00 05:00:00 05:00:00 05:00:00
https://api.regulations.gov/v4/comments/CMS-2009-0088-0046 https://api.regulations.gov/v4/comments/CMS-2009-0088-0062 https://api.regulations.gov/v4/comments/CMS-2009-0088-0026 https://api.regulations.gov/v4/comments/CMS-2009-0088-0076 https://api.regulations.gov/v4/comments/CMS-2009-0088-0094 https://api.regulations.gov/v4/comments/CMS-2009-0088-0063
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Please see the attachment. Takeda Pharmaceuticals North America, Inc. (Takeda) appreciates the opportunity to comment on the proposed rule published by the Centers for Medicare and Medicaid Services (CMS) concerning changes to the Medicare Advantage and Medicare Part D programs.   Takeda is one of the nations leading pharmaceutical companies and is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.  We currently market oral diabetes, insomnia, gastroenterology, and hyperuricemia treatments.  We also seek to bring innovative products to patients through a robust pipeline that includes two new unique compounds in late-stage development for the treatment of Major Depressive Disorder.  Takeda is encouraged by several provisions that CMS is proposing to refine and implement the Medicare Part D program especially in the areas of medication therapy management programs and maximum allowable cost sharing amountsto name a few.  Because of our current research and development activities that have the promise to enrich the lives of Medicare beneficiaries, our comments focus on the provisions in the proposed rule concerning Part D protected classes.   Takeda commends CMS for focusing on these critical issues regarding protected drug classes on Part D formularies.  However, we are concerned that the new interpretations CMS proposes of the Medicare Improvements for Patients and Providers Act (MIPPA)  176 provisions could erode essential beneficiary protections and contravene Congress intent in enacting this provision.  An unduly restrictive policy on MIPPA protected classes could have very serious consequences for Medicare beneficiaries, and strong beneficiary protections have been key to the success of the Part D benefit. Takeda therefore supports an approach that preserves and builds on the beneficiary protections in CMS current classes of clinical concern policy, and we encourage CMS reconsider its new proposed interpretations of the MIPPA  176 provisions.  Specifically, we request that CMS not finalize its proposals interpreting the terms restricted access, major or life-threatening clinical consequences, and significant need for access to multiple drugs.  Instead, we ask that CMS consider alternatives that we describe below, which better reflect the text and intent of MIPPAs protected classes provisions.  Consistent with that approach, Takeda also urges CMS to recognize antidepressants (an existing class of clinical concern) as a MIPPA protected class and that the agency use notice and comment rulemaking to establish the protected categories or classes of drugs and any exceptions to the protected classes. Please review document - CMS-4085-P Dear Ms. Frizzera: WellPoint, Inc. (WellPoint) appreciates this opportunity to comment on the Centers for Medicare  Medicaid Services (CMS) proposed Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs, published on October 22, 2009.  We commend the efforts of CMS to ensure the delivery of quality services to beneficiaries enrolled in Medicare Advantage and Medicare Part D plans.  As a committed participant in the Medicare Advantage and Part D programs, WellPoint looks forward to working with CMS to ensure beneficiary access to robust medical and prescription drug coverage under the Medicare program.WellPoint appreciates this opportunity to offer our suggestions for ways in which CMS might strengthen beneficiary protections, increase program transparency, and ensure participation by strong, qualified plans.  We look forward to working with CMS to uphold these objectives.  Should you have any questions or wish to discuss our comments further, please contact Jennifer Boyer at 202-628-7831 or Jennifer.Boyer@WellPoint.com. Sincerely, Elizabeth P. HallVice President, Public Policy Subpart C 422.100 Maximum OOP costs amount for Medicare Parts A/B servicesComparing local MA plans to Regional PPO (RPPO) as the reason for all local MA plans to include an annual out-of-pocket cap on members total cost-sharing liability (for Part A and Part B services) did not take into consideration the substantial difference in network or medical management between these product types.  Maintaining an optional out-of-pocket for local MA plans will provide beneficiaries richer benefits above Traditional Medicare and maintain affordable premiums for the beneficiary.  By requiring out-of-pocket maximums, it is not only reducing choice for beneficiaries and increasing premium prices, it will impact utilization and medical trend that ultimately impacts Traditional Medicare.  As has been experienced with Commercial Health Insurance, more benefit requirements increases utilization and premiums, and more beneficiaries will default to Traditional Medicare due to cost.  Member materials and the plan compare tools developed by CMS and MAOs assist beneficiaries in making informed choices.  Additionally, by requiring plan offerings with meaningful differences and the non-renewing of low-enrollment plans, the concern about too many complex choices and beneficiaries not being able to confidently compare health plans and make meaningful choices has already being addressed.  Special Needs Plans, particularly D-SNPs, should be excluded from the requirement to add a maximum out-of-pocket requirement.  States often cover cost sharing for dual eligible members who qualify for cost sharing protection, which would negate the necessity for an OOP limit.  Additionally, D-SNPs already must provide Part D at the benchmark and offer plans without a Part C premium.  Requiring an out-of-pocket cap, in addition to absorbing these costs, would be an undue financial burden on the MAO.Subpart C 422.100 and 423.104 Maximum allowable cost sharing amount for Medicare Parts A/B services and prescription drugsClarity is required on how CMS will review  cost-sharing levels and whether these levels are discriminatory.  In previous call letters, the specific benefits (such as DME, home health, and renal dialysis) were listed.  These areas of concern should already be known and should not change on an annual basis.  The broad statement in determining acceptable cost-sharing levels does not take into account actuarial equivalency and the ability to design plans that provide choice for additional or richer benefits in other areas important to beneficiaries.  For example, maximum Part D brand cost-sharing levels will impact the ability to offer Part D generic $0 copay (supported by a robust generic formulary with equal alternatives to brand drugs); therefore, ultimately inhibiting the greater affordability and access to Part D drugs to these beneficiaries and premiums.  This will ultimately impact CMS benchmarks.Subpart C 422.112 Network Adequacy for MA PlansTiers for plan membership size (or development of provider/member ratio) should also be included in the determination of minimums to take into account plan/membership size and access need.  Additionally, certain minimums should be adjusted based on the unique needs of SNP membership (Dual and Chronic). We recommend that CMS continue to afford an opportunity for the plans to provide narrative descriptions of how access will be accommodated or alternatives offered in the event the plan cannot meet a particular CMS-established access parameter in a specific geography.  Additionally, we recommend that CMS make allowance for market-specific access pattern alternatives, particularly in markets that have experienced consolidation of physician and hospital systems.Subpart C 423.120(b)(2)(v) Clarify the MIPPA 176 Protected Classes formulary provisionCMS should state whether this will be set forth in sub-regulatory guidance or regulations.Plans would prefer formal guidance allowing them the opportunity to give comments to CMS.  If changes are made to the protected classes, CMS must give ample notice to plans well in advance of the bidding cycle. Full transparency of the process (three stages) should be the standard.  Plans should have the opportunity to review the data and recommendations of new classes as CMS is going through each of the three stages. Subpart C 423.120(b)(3)Transition ProcessWhile we appreciate CMS efforts it is unclear what constitutes a reasonable effort. It is highly unlikely the plan would have sufficient information to reach the out of network provider. We would encourage CMS to dialogue with the industry  to review operational challenges. Subpart C Generic equivalent disclosure 423.132  We would support CMSs original decision to require disclosure of generic equivalent pricing.  Many plans already have programming in place to support this practice and removing it would require substantial process changes for Long Term Care only.  Additionally, while we agree with CMS that enrollees could not make a change at the time of purchase, they would have the opportunity to change at a later date (the next time a prescription is filled) and should be informed of generic pricing differences.  Furthermore, it is vitally important that this information be included on EOBs, as EOBs are used to identify Fraud, Waste and Abuse.  Subpart D 423.505 Allow collection of all PDE data elements to be collected for non-payment purposes  CMS should state specifically who the grantees are and that limits will be made as to who has access to this data listing limits such as research companies or drug manufacturers.  Subpart G Risk Adjustment Data Validation Appeals  We support CMS allowing organizations the opportunity to 1) submit signed provider attestations for physician and other outpatient medical records with missing or illegible signature and/or credentials that could result in payment error, and 2) to dispute certain types of medical record review-related errors through the use of a documentation dispute process, and 3) appeal CMS RADV payment error calculation.We would recommend CMS allow the attestation process for inpatient records as well.  While we recognize the logic CMS uses to determine inpatient record attestations would be unnecessary, we would respectfully submit there are circumstances, just as with outpatient medical records, when a provider will fail/neglect to sign the record.We would recommend adding an appeal process to the attestation review and determination process and urge CMS to reconsider.  While we recognize CMS authority in this matter, there could be and likely will be legitimate circumstances in which final negative decisions should be reviewed and reconsidered. We understand CMS desire to streamline processing and limit organizations ability to dispute medical record documentation reviews to operational errors (those associated with the collection and processing of medical records for audit).  However, legitimate disputes over interpretation of specific issues and processes can arise.  We would urge more flexibility in determining what disputes can be reconsidered, including issues that arise when an organization feels there are interpretation issues with one or more reviewers/levels of review.Subpart J 423.466 Time limits for COBCMS proposes a three-year timeframe for plans to adjudicate COB claims.  We would recommend that the timeframe for adjudication be limited to 18 months to align it to PDE submissions.Subpart K 422.502 and 423.502 Compliance Measures/AnalysisWe would urge transparency and CMS consideration with regard to SNP plans and what measures will be used to determine outliers.  Consideration in determining outliers for SNPs seems warranted since measures for SNPs may be skewed in terms of clinical performance based on the population the SNP serves.  If CMS is considering using star ratings as evidence of poor performance and denial/non-renewal actions, we would respectfully ask that CMS be very transparent in what data will be collected, and ask to be provided with updates on data collection changes or additions as early in the process as possible.  Additionally, we would ask for transparency on how plans will be compared to each other, and whether like plans are being compared to each other in determining outlier status.  We would ask for thoughtful consideration of how, when a SNP may be part of an overall CCP contract, it would be rated and compared to other SNPs. We would respectfully request such methodology of any and all denial and non-renewal actions be shared with all plans. Subpart M Standard 423.568 Timeframe for coverage requirements   As these are paper claims and manual processes must exist in order to process payment, we would recommend CMS consider allowing plans to make determinations and affect payment within 30 days to allow for the manual payment processing.  Requiring plans to make determinations and payments within 14 days would require significant process changes that would be overly burdensome to plans, particularly considering the enrollee has already received medication.  In lieu of allowing plans to process payment within 30 days, CMS should consider postponing the requirement to process payment within 14 days until 2011 to allow for systems/process upgrades. In addition, PBM check runs are on a cycle and this change would be it difficult to meet the 14 day timeframe.  Subpart M 422.622 and 422.626 Generic Notice Requirements  If delivery of the notice is no longer the responsibility of the MAO, we would like to suggest adding that the development of the notice is no longer the MAOs responsibility in order to clarify.  Subpart O 422.750 and 423.750 Deny Contract Qualification Applications Based on Past Contract PerformanceWith the consideration of a SNP plan we would urge transparency and CMS consideration with regard to what measures will be used to determine outliers.  Consideration in determining outliers for SNPs seems warranted since  measures for SNPs may be skewed in terms of clinical performance based on the population the SNP serves.  If CMS is considering using star ratings as evidence of poor performance and denial/non-renewal actions, we would respectfully ask that CMS be very transparent in what data will be collected, and early updates on data collection changes or additions.  Additionally, we would ask for transparency on how plans will be compared to each other, and whether like plans are being compared to each other in determining outlier status.  We would ask for thoughtful consideration of how, when a SNP may be part of an overall CCP contract, it would be rated and compared to other SNPs. We would respectfully request such methodology of any and all denial and non-renewal actions be shared with all plans. We would ask that CMS take into consideration the needs of the state(s) a SNP would support and allow for expansion if the SNP is current in fulfilling contractual obligations to CMS. Subpart P 422.773(c)(2)  Requirements for LIS eligibility: expand the deeming period for LIS eligible beneficiaries to cover at least 13 monthsTable 2, page 88, indicates that this provision is going to expand the deeming period for LIS eligible beneficiaries to cover at least 13 months. However, the text in section 8, pages 107-109 and in the Regulation 423.773(c.) (2), page 425 indicates that the deeming period is remaining the same as it is today.  Deeming period is for full calendar year depending on receipt of deeming/redeeming status. A member, under the current policy and that being codified on page 425, could be eligible for LIS for as little as 7 months or as many as 18 depending on when the member was deemed.Subpart V 422.2262 and 423.2262 Required Use of Standardized Model Materials under Parts C/DWhen developing standardized materials, we would urge CMS to be more flexible with SNP materials in order to allow plans the opportunity to describe benefits and services. It is vitally important SNPs have ample free text to develop a piece of member material that delivers clear, concise information.  As in the past, it may be necessary to grant integrated SNPs or D-SNPs with state contracts exceptions to using certain standardized materials as well as the specific timeframes that may be associated with those standardized materials. The educational requirement does not take into consideration those companies or locations that have existing compliance programs that include specific training on fraud waste and abuse. This training is provided during orientation and annually.  Furthermore, Codes or Standards of Conduct discuss reporting of any FWA related concerns.  As required by the DRA of 2005, providers who have at least $5 million in annual Medicaid revenues are required to provide training on false claims and whistleblower protection.   In short,  all of the components now required of MAOs by CMS are already in place and have been for some time in our respective organizations.  It appears that there are a number of MAOs who have been willing to accept a providers current training as meeting their requirements. However,  there are others that are insisting on presenting their version of the training, much of it totally irrelevant to our employees, e.g., prescibing drugs is not meaningful to a certified nursing assistent.  Other MAOs have been reported as completely nonresponsive to inquiries. I am aware that compliance programm are currently voluntary but I personally am not familiar with any LTC provider which has not implemented such a program. Thanks you for considering my comment.