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May 30, 2019

Via Electronic Submission to DPC@cms.hhs.gov   

Adam Boehler
Director, Center for Medicare and Medicaid Innovation
Centers for Medicare & Medicaid Services
200 Independence Ave, SW
Washington, DC 20201

Re: Request for Information on Direct Contracting—Geographic Population-Based Payment Model Option

Dear Director Boehler:

The Center for Medicare Advocacy (Center) is pleased to provide the Centers for Medicare & Medicaid Services (CMS) comments on the Center for Medicare and Medicaid Innovation (CMMI) Request for Information (RFI) on Direct Contracting—Geographic Population-Based Payment Model Option.

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.

General Comments

In comments the Center submitted to the previous direct contracting RFI[1], we stated the following:

“While CMS articulates some of its goals for the DPC models in the RFI, and solicits feedback on many issues relating to such models, the current proposal is so ambiguous that it is difficult to provide meaningful feedback and specific recommendations without more substance offered.  From a consumer perspective, specific details about enrollment, access, cost-sharing and other issues trigger other, specific issues and questions about which consumer advocates can provide thoughtful comments and help troubleshoot.  The Center has significant reservations about this proposal, but should CMS move forward, at the very least, it must provide other, more fleshed out iterations on which to comment before proceeding further.”

Overall, we reiterate our previous concerns about the lack of detail, and the posing of very specific questions in the RFI, about a concept that still remains largely abstract.  The lack of details of this proposal make it difficult to provide thoughtful comments and adequately troubleshoot problems Medicare beneficiaries might face.  In the absence of a more clearly formed proposal, we offer the following general and specific comments.

On the one hand, we are encouraged that CMMI is exploring ways to address social determinants of health (SDOH) outside of the Medicare Advantage setting, and urge CMMI, and CMS more broadly, to continue this exploration beyond the direct contracting models.  We also appreciate that the current RFI notes that traditional Medicare beneficiaries aligned to DCEs participating in the Geographic PBP model option “would retain all of their Original Medicare benefits, including freedom of choice of any Medicare provider or supplier, even if the provider or supplier does not have an arrangement with the DCE.”

On the other hand, any model that relies on capitation must have rigorous oversight and a heavy focus on beneficiary-reported outcomes and satisfaction to ensure beneficiaries are receiving the care they need.  Given our current concerns about oversight of the Medicare Advantage program, we are uneasy about how this proposed model seems to invite even less regulatory oversight.  Stinting on care would remain a constant threat for beneficiaries with chronic or complex conditions.  It is unclear how DCE incentives would work, how DCEs would achieve savings, and what authority DCEs would have to control costs (e.g., would they employ utilization management?).  More broadly, it is unclear, exactly, what current problems or issues within the Medicare program the Geographic PBP is attempting to resolve.  In other words, there are significant details missing that would certainly inform our, and other consumer advocates’, input.

Questions Related to Selection of Target Regions

  1. What are the benefits and/or risks to access, quality, or cost associated with the implementation of the Geographic PBP model option in a target region that includes a rural area? What safeguards might CMS consider to preserve access and quality for beneficiaries in rural areas in a Geographic PBP target region? How would rural market forces (for example, out-migration, hospital closures, and mergers/acquisitions) affect the DCE’s ability to lower cost and improve quality under the payment model option?

By contracting directly with DCEs to account for total costs of care, CMS may spur more rapid consolidation of providers. This is especially problematic in rural areas where the effect of holding down wages may cause permanent economic instability to the area and where a lack of provider choices can cause access issues.  More broadly, consolidation is also a dangerous trend for the health system as a whole. While hospital systems, for example, may gain efficiencies through consolidation and may be able to hold down administrative costs or even costs of care, this does not necessarily result in a reduction in prices or higher quality. Approaches that increase the attractiveness of rural target areas may simply exacerbate this trend and create new or worsening issues for the communities within the region.

Questions Related to DCE Eligibility

  1. What are the benefits and/or disadvantages of the DCE selection criteria under consideration for the Geographic PBP model option, described above? What other selection criteria and core competencies should CMS consider requiring applicants to address? Please describe the benefits of including such additional selection criteria. What criteria are of the greatest importance and therefore should receive the greatest weight in our selection decisions?

CMMI materials, including the RFI, make continued reference to health plans as potential DCEs.  Such references beg questions about how administering the Geographic PBP model would differ from administering a Medicare Advantage plan, and whether MA plan sponsors that participate in this model would be able to circumvent current MA guidelines, reporting and consumer protections.  Given current challenges CMS has with regulating MA plans, and mixed outcomes for MA enrollees despite inflated payment to plans[2], we are concerned about health plans administering or overseeing a Geographic PBP model with presumably even less oversight than they receive now.

More broadly, in addition to the list of criteria given, the DCEs must be free from conflicts of interest and from any significant history of sanction, penalty, or termination from Medicare, Medicaid, the Veterans’ Administration, professional licensing, or similar authorities, obligations, rules, or laws. The DCEs should both be financially sound enough both to withstand two-sided risk and to be free of extreme incentive to inappropriately skew enrollment, reporting, or care. In addition, they must exhibit demonstrated capabilities in care coordination for older adults or people with disabilities and have mechanisms for meaningful beneficiary engagement, capacity to provide culturally- and linguistically-competent communication, and privacy protocols to effectively protect beneficiary information as a condition of their participation.

Questions Related to Beneficiary Alignment

  1. Are there transparency/notification requirements, in addition to or in lieu of the requirements described above, that CMS should consider to protect beneficiary freedom of choice of any Medicare provider or supplier for beneficiaries aligned to a DCE participating in the Geographic PBP model option?

CMS should provide consumer-tested written notices clearly informing individuals that they retain their freedom of choice of provider both within and outside of their target region in order to avoid potential confusion or steering.

  1. How might DCEs inform beneficiaries of the payment model option and engage them in their care? What barriers would DCEs face in engaging with beneficiaries in their target region?

Beneficiaries may become confused about how the Geographic PBP scenarios interact with their Medicare coverage, as well as their Medigap, Part D, employer or any other additional coverage. In addition to developing clear rules concerning how different benefits coordinate, CMS should develop and test timely, accurate education and outreach materials to mitigate this confusion, even if the interaction would otherwise be completely invisible to the beneficiary.

Questions Related to Program Integrity and Beneficiary Protections

  1. What monitoring methods can CMS employ to ensure beneficiary access to care is not compromised and that beneficiaries are receiving the appropriate level of care? What data or methods would be needed to support these efforts?

As noted above, absent more detail about how beneficiary care is to be overseen/administered, it is difficult to provide meaningful feedback.  Generally, though, CMS must update its existing tools and resources to reflect new models. This includes developing customized, model-specific scripts for 1-800-MEDICARE, so that callers can get the answers and information they need in a timely manner. As one of the most visible resources for Medicare beneficiaries, 1-800-MEDICARE is well positioned to play a vital role in keeping enrollees and potential enrollees informed of the model’s purpose and of any potential changes they may see. In addition to informational purposes, this resource can serve as an oversight tool. CMS could establish a process for auditing calls to 1-800-MEDICARE for complaints about the model and develop a standardized process for following up on any such complaints, similar to the Complaint Tracking Module (CTM) for Medicare Advantage and Part D plans.

Similarly, State Health Insurance Assistance Programs (SHIPs) should receive training and information on any new model. SHIPs are perfectly placed to help with model enrollment or other issues but must first understand the model themselves. Importantly, SHIP programs must be sufficiently resourced to meet these new, specific counseling needs, which would come in addition to the local, one-on-one assistance they are already providing to help beneficiaries navigate their Medicare coverage options and understand their rights.

The trainings and scripts that CMMI develops for 1-800-MEDICARE and SHIP counselors should also be available to providers to help them explain the model to enrollees in language that is easily understood, consistent with other CMS resources, and culturally and linguistically competent.

As noted in our General Comments above, any model that relies on capitation must have a heavy focus on beneficiary-reported outcomes and satisfaction to ensure beneficiaries are receiving the care they need. Stinting on care is a constant threat for beneficiaries with chronic or complex conditions. A new model must grapple with such risks up front and must be carefully designed with both beneficiary and expert feedback to ensure that care is based on clinical evidence (that can include value) and beneficiary needs and desires.

A strong, easily navigated grievance and appeals process must be included in any model. Beneficiary and advocate input should help assess the ease of navigability in the real world. Such a process should provide protections that are at least as robust as the existing Medicare processes, and notice of appeal rights should be included in all communications with beneficiaries.

A robust set of quality measures that are patient centered and patient reported are absolutely vital, including patient reported outcome measures, patient satisfaction measures, and grievance and appeals measures. The model should include a quality threshold that providers must meet before they are given any bonuses or other incentives and provide a clear notice of any conflict of interest between providers and other entities. Data on quality measures must be easily understood and readily available to beneficiaries and also to their families, caregivers, and advocates.

  1. What regulatory flexibilities or operational activities would be needed to promote DCE success and how might such flexibilities affect program integrity of the Medicare program?

We object to any incentivizing of participation through a relaxation of current regulations that protect Medicare beneficiaries’ health and financial interests. Such safeguards are foundational to the Medicare program, and must not be waived or otherwise diluted.

  1. Providing incentives to beneficiaries to positively influence their behavior and healthcare decision-making could implicate the fraud and abuse laws and potentially raise quality of care, program cost, or competition concerns, particularly if the incentives would cause beneficiaries to be aligned to one DCE over another entity participating in DC or another CMS initiative. What safeguards should CMS put in place to ensure that any beneficiary incentives provided do not negatively impact quality of care, program costs, or competition?

In our comments to the original RFI, we noted, with respect to questions related to program integrity and beneficiary protections, CMS appropriately raised concerns about stinting on needed care. We appreciate this sentiment, but it does not necessarily mesh with a guiding principle of “reducing regulatory burden.”  Often, what providers view as burdens, including notice, reporting and other requirements, serve as important oversight tools for the regulator and protections for consumers.  This or other models should not start from a premise of erasing existing rules in an effort to ensure maximum provider flexibility, then seek ways to potentially back-fill vital consumer protections by guessing about what safeguards should be put in place in an undefined model.

Many existing safeguards in Medicare are designed specifically for the type of coverage (e.g., MA v. traditional Medicare), care setting, service, item, etc.  As noted above, the lack of details of this proposal make it difficult to provide thoughtful comments and adequately troubleshoot problems Medicare beneficiaries might face.  For example, what would be the recourse for a beneficiary who is denied a requested service from a provider or practice – would it constitute an organization determination similar to a Medicare Advantage decision?  Would Advance Beneficiary Notices (ABNs) be required as they are in traditional Medicare in certain scenarios?  If the DPC models were, as contemplated, integrated with Medicaid and/or MA plans, how would the scope of services be determined, and what notice and appeal rights would apply in which situation?  In addition to questions about coordination with other insurance, would providers be bound by such consumer protections as QMB balance billing, or the limiting charge applicable to current participating Medicare providers?  These, and other questions that would be triggered by more details about a proposed model, would need to be addressed before proceeding any further with this proposal.

Questions Related to Payment

  1. If DCEs were to enter into their own downstream payment arrangement with healthcare providers, how should cost sharing amounts be determined and collected from beneficiaries?

For any model under which beneficiaries would pay something other than standard Medicare cost sharing to the practice, we reiterate our insistence that it must not increase out-of-pocket costs. Beneficiaries must not be subject to unexpected billing, either before or after they receive care.

As we noted in comments to the original RFI, as CMS is aware, most people with traditional Medicare have some form of supplemental insurance that covers at least some of their cost-sharing, such as employer-sponsored coverage, Medicaid or Medicare Supplemental Insurance (Medigap).  Cost-sharing for individuals in MA plans must be actuarially equivalent to costs in traditional Medicare.  In the original RFI, CMS appropriately raised the issue of how the DPC model would coordinate with supplemental coverage, given it would appear to be based on a capitated payment to a medical practice, similar to managed care.  We assert that any DPC model should not minimize, diminish or negate any supplemental coverage a beneficiary has, both with respect to cost-sharing and access to additional services.

On the one hand, any model must be affordable and accessible.  Low-income individuals should not be priced out of any demonstration due to inability to afford cost-sharing. Dual eligibles must retain coverage of cost-sharing and additional services, as well as important protections such as the prohibition of balance billing Qualified Medicare Beneficiaries (QMBs).  Allowing such balance billing could be a back door means to excluding dual eligibles from participation.

On the other hand, the DPC model should not be a means to merely expand options for more wealthy beneficiaries – e.g. establish boutique medicine practices, or provide a means to allow coordination with Health Savings Accounts (HSAs).  This or any other model should not serve as a subsidy to higher income beneficiaries or an expansion of the current private contracting provisions in Medicare.

  1. How should CMS address utilization of services and costs for beneficiaries aligned to a DCE that occur outside of the DCE’s target region?

Regardless of how a DCE is paid, beneficiaries should remain unrestricted in their ability to engage in free choice of providers both within and outside of their target region, and should not face any additional costs, similar to services received by providers within the DCE target region that do not have an arrangement with the DCE.

Conclusion

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

David A. Lipschutz
Associate Director/Senior Policy Attorney

Licensed in CA and CT

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[1] Center for Medicare Advocacy comments on Request for Information on Direct Provider Contracting Models (May 25, 2018), available at: https://www.medicareadvocacy.org/cma-comments-on-request-for-information-on-direct-provider-contracting-models/.
[2]See, e.g., Center for Medicare Advocacy Weekly Alert “Important Health Policy Article Published In New England Journal of Medicine: “Medicare Advantage Checkup” (November 2018), available at: https://www.medicareadvocacy.org/important-health-policy-article-published-in-new-england-journal-of-medicine-medicare-advantage-checkup/, and “Report Highlights Overpayments to Medicare Advantage Plans and Raises Important Policy Considerations” (May 2019), available at: https://www.medicareadvocacy.org/report-highlights-overpayments-to-medicare-advantage-plans-and-raises-important-policy-considerations/.

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