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Proposed Rule Change Would Make U.S. Healthcare System Even More Complicated and Potentially More Costly

November 01, 2023
1:27 pm

The last thing the U.S. healthcare system needs is more paperwork. Unfortunately, the federal Centers for Medicare & Medicaid Services (CMS) is proposing a policy change that would assign more “busy work” to key players across the health sector.

The proposal specifically targets Medicaid, the government program that provides health care for millions of low-income Americans and people with disabilities.

Back in 1990, Congress passed legislation requiring drug makers to pay rebates to Medicaid in exchange for their medicines being covered by the program. For brand drugs, these rebates are set at either 23.1% of a drug’s average manufacturer price (AMP), or the difference between the AMP and the “best price” available to any public or private entity purchasing the drug.The best price requirement has worked well for over three decades, saving taxpayers money while preserving access for patients in need. Manufacturers, clinics, insurers, pharmacies, and others have grown to rely on it.

Yet, CMS’s proposal would completely upend this system. The agency seeks to redefine a drug’s best price as the net price of the combined total of rebates associated with that drug across the entire pharmaceutical supply chain.

Imagine for a given drug, the manufacturer offers a 30% rebate to private insurers, a 10% rebate to pharmacies, and a 10% rebate to community clinics. Under existing rules, the manufacturer would have to offer the highest discount of the three — 30% — to Medicaid. But under the proposed formula, all of the rebates are added together — resulting in a 50% rebate.

This practice of rebate “stacking” is problematic for a few reasons.

First, it’s impractical. The modern U.S. healthcare system is incredibly complex. To comply with the new rule, entities across the drug supply chain — including wholesalers, distributors, pharmacies, hospitals, clinics, and insurers — would have to create complicated new databases and coordinate with each other to meticulously track drug transactions down to the last cent. This would divert finite resources away from where the focus should be: treating patients.

Second, rebate stacking could indirectly lead to higher costs. If the proposal is finalized, any rebate a manufacturer offers to a public or private entity would factor into Medicaid’s best price calculations. Such a system would encourage drug makers to dole out discounts more sparingly than they currently do.

We all share the goal of reducing costs and improving quality across the healthcare system. But CMS’s proposed overhaul of the best-price requirement would be a step in the opposite direction.

Is Mandatory Participation in Medicare Demonstrations Necessary?

May 25, 2022
10:31 am

Recently, Health Affairs Forefront, published a post by Dan L. Crippen, former director of the Congressional Budget Office and currently a Healthcare Leaddership Council consultant, that should be a catalyst for discussion on a critical element of the Center for Medicare and Medicaid Innovation’s future direction.

In his post, Dr. Crippen enters the debate over whether models being tested by CMMI should have mandatory or voluntary participation on the part of healthcare providers.  Some have argued that demonstration projects have floundered under voluntary participation because providers have brought in cohorts of comparatively healthy patients not reflective of the Medicare beneficiary population at large. He points to several examples, though, to make the case that voluntary participation did not result in adverse selection and that a more weighty problem plaguing CMMI demonstration projects has been the lack of timely data flowing to model participants.

The Crippen post is below and at the link above, which will take readers to the Health Affairs Forefront site.

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The tenth anniversary of the Center for Medicare and Medicaid Innovation (the Innovation Center) was in 2020. This anniversary was accompanied by several retrospectives of the results of the Innovation Center’s first decade of operation. Unfortunately, most of the analysts, including those from the Centers for Medicare and Medicaid Services (CMS), reached similar conclusions: that the demonstrations deployed by the Innovation Center neither saved much money nor greatly improved quality, the two primary objectives set out for the Innovation Center in the Affordable Care Act.

Past and present Innovation Center directors concluded that the primary reason for the demonstrations’ failure to achieve the objectives was selection bias by the providers who had volunteered to participate in the various models. The claim is that the providers brought with them a cohort of healthier-than-average patients, making it easy to show savings relative to the benchmark. Relative to providers with sicker patient populations, these providers were more motivated to participate in the demonstrations due to the potential opportunity to earn a bonus from the Innovation Center if they spent less than the Innovations Center’s benchmarks.

Some of the demonstrations included an alignment algorithm for assigning patients to providers within an accountable care organization (ACO), at least one of which assigned patients depending upon their previous use of participating providers in the ACO. In some demonstrations, there was considerable turnover in both the beneficiaries and providers, which theoretically allowed ACOs the opportunity to alter their risk pool by selecting or changing providers (or other aspects of the model) to create a patient population with certain characteristics or health care needs. The former and current directors concluded that only mandatory participation by providers would overcome this perceived selection bias.

However, before seeking a solution to this problem, the question of whether selection by voluntary providers contributed to the disappointing results of the demonstrations should be explored. This article summarizes a multitude of analyses surrounding the reasons the demonstrations show little savings or quality improvement. The analyses indicate that the failure was not due to voluntary, as opposed to mandatory, participation by providers. The article then suggests several ways that any future selection challenges could be addressed, should they occur, without requiring mandatory participation.

 

The Evidence On Selection Related To Voluntary Participation

As described below, outside observers, papers published by think tanks, academic research, contractors hired by the Innovation Center to provide an independent evaluation of the demonstrations, as well as reports by the Innovation Center itself neither found the existence of selection bias nor recommended mandatory participation. These experts offered many suggestions on how the Innovation Center could achieve its stated objectives, but mandatory participation was not among them.

The ACO model is one of the Innovation Center’s longest running demonstrations, albeit in different forms over time, which attempts to measure cost-effectiveness and quality of treatment. It is the early experience of this model that most proponents of mandatory participation cite as proof of selection bias, primarily because so many providers dropped out at the beginning of the demonstration. Only 123 (36 percent) of the 339 ACOs entering the program between 2012 and 2014 were still participating in 2020.

There were several reasons for the attrition, much of which occurred early in the program. Many of the provider groups were small and ill-equipped to provide the complex reporting and data required by the Innovation Center. The participants did not understand the convoluted requirements before they enrolled, and only thereafter realized they were very unlikely to achieve savings, and therefore the bonuses offered by the Innovation Center. Moreover, participants did not have the processes, experience, or capital to ultimately assume the downside risk required later in the demonstration. In accordance with the rules of the program, they were allowed to drop out and did so.

An outside evaluator concluded: “Pioneer ACO stakeholders also noted that the relationship between the ACOs’ activities and their financial results were not well understood or articulated and that they struggled to firmly understand the Pioneer model rules such as the beneficiary alignment algorithm and financial benchmark calculations…[which] raises the question of whether the alignment algorithm may de-align or not align beneficiaries who are less healthy.”

Other credible sources determined that voluntary participation did not result in adverse selection. For example:

  • One analysis concluded: “We also find no evidence that ACOs systematically manipulated provider composition or billing to earn bonuses…. Robustness checks revealed no evidence of residual risk selection…. Careful examination of selection issues revealed that these findings were not driven by nonrandom participation.”
  • A study published by the Brookings Schaffer Center concluded: “Evidence suggests that there was minimal systematic patient-level risk selection by ACOs in the first three years of the Medicare Shared Savings Program (MSSP).”  
  • An internal CMS evaluation noted: “It does not appear that participants are selecting healthier patients.”
  • The Innovation Center engaged outside experts to evaluate the operation of each demonstration, several of whom included explicit conclusions about selection bias. One expert concluded: “This finding suggests that AIM [AIM Investment Model] ACO participant changes over time did not result in selection of certain types of beneficiaries, on average.”

No evaluator of the many demonstrations suggested that that mandatory participation was necessary to produce better results. In one demonstration, the third-party reviewer concluded that the results of the mandatory model were no better than voluntary models. One study directly compared results for mandatory verses voluntary participation and concluded: “spending changes did not differ between the voluntary and mandatory hospitals. This result does not support the concept that organizations perform better when self-selecting into programs.”

If Not Selection, Then What?

While adverse selection did not distort model results, studies did show that there was a myriad of other factors that plagued the initial demonstrations and persisted throughout much of the first decade. A common complaint by providers was a lack of timely data from the Department of Health and Human Services on demonstration operation and performance. One CMS internal evaluator lamented that the inability of CMS technology systems to perform basic tasks for value-based care, including providing performance data to participants, was a key contributor to the reasons providers dropped out.

Additionally, in a 2020 Medicare Payment Advisory Commission meeting, commissioners expressed the view that the multiplicity and overlap of demonstrations made it difficult for participants to sort out the effects of one demonstration from the other. This burden of sorting through the complex requirements for providing data and reports, and inconsistent reporting specifications between the demonstrations, caused many smaller participants to quickly drop out of the demonstrations.

The benchmark calculations, which were intended to measure providers’ effects on costs, were too narrowly drawn and created disincentives that increased over time. The use of historical performance for providers could lock in original calculations of savings/costs. Savings by providers with high-cost patients resulted in lower future benchmarks, which made it more difficult to continue to achieve savings, reducing the incentive to do so.

Many of the shortcomings of previous demonstrations were recognized by the Innovation Center in its assessment of the first decade. The review included a number of suggestions, including health equity a centerpiece of every model; reducing the number, complexity, and redundancy of the many models; re-evaluating how the Innovation Center designs financial incentives to ensure meaningful provider participation (presumably including mandatory participation given the director’s previous comments); better enabling participants to handle down-side risk by providing the tools to participate; reducing the complexity of establishing benchmarks; and expanding the definition of success to include lasting transformation and a broad array of quality investments, rather than focusing on each model’s cost and quality.

Looking Ahead

Despite evidence to the contrary, the Innovation Center has not publicly dropped its position that adverse selection is a problem and that the solution is to require mandatory participation by providers.

Even if selection remains a concern for the Innovation Center, there are ways to detect and correct for selection. One alternative is the expanded use of risk adjusters to assess each participant’s risk before, during, and after the demonstration. Risk adjustment, which is typically used to establish initial payment rates, can also be used to evaluate the risk pools of participants at the end of demonstrations, with payments and shared savings adjusted accordingly.

If benchmarks remain the comparator, risk adjustment will become more important, especially as applied to high- and low-cost beneficiaries as benchmarks converge over time. Risk adjustment is and will continue to be an imperfect process but can be improved by better data, improved statistical techniques, and perhaps, artificial intelligence.

Evidence from many different sources shows that adverse selection has not heretofore been an issue and is not a cause of the failures of past Innovation Center demonstrations in meeting the objectives of savings and quality. Other factors in the operation of the demonstrations are much more likely to explain the results. If selection should ever become an issue, there are ways to adjust models other than forcing providers to participate.

 

Quantifying the Medicare Advantage advantage

July 25, 2018
2:51 pm

In the 15 years since its inception, the increase in popularity of Medicare Advantage (MA) – health coverage provided by private plans in contrast to traditional fee-for-service (FFS) Medicare – has been undeniable.  Roughly half of all Medicare-eligible seniors are enrolled in Medicare Advantage plan and that proportion keeps rising.

Now there is a new addition to the growing body of evidence that MA plans are not only serving their enrollees well, but is bringing greater overall value to the Medicare program than that generated by the FFS approach.

A newly-released study by Avalere Health, Medicare Advantage Achieves Better Health Outcomes and Lower Costs for Beneficiaries with Chronic Conditions Compared to Fee-for-Service Medicare, finds that Medicare Advantage is outperforming traditional FFS Medicare with higher rates of preventive screenings, fewer avoidable hospitalizations, and fewer emergency room visits.  In other words, healthier patients and significant dollar savings.

Overall, the Avalere study found that MA beneficiaries had 23 percent fewer emergency stays and 33 percent fewer emergency room visits than their peers in FFS coverage.  This wasn’t the result of MA plans enrolling healthier individuals at the outset.  Rather, the study found that a greater percentage of MA beneficiaries were in clinical and social risk categories that traditionally drive up costs in FFS Medicare.

Avalere found that MA outperformed FFS on a range of cost, utilization, and outcome metrics in caring for individuals with one or more chronic health conditions.  Among patients with diabetes, for example, those enrolled in MA experienced 73 percent fewer serious clinical complications than FFS beneficiaries.  And patients dually eligible for Medicare and Medicaid – who generally have more complicated and serious health conditions – had 49 percent fewer hospital visits and a 17 percent lower average-cost-per-beneficiary in MA plans.

Former Congresswoman Allyson Schwartz, president and CEO of the Better Medicare Alliance (of which the Healthcare Leadership Council is a member) said “this study adds to the growing body of evidence showing the ability of Medicare Advantage to align incentives to better manage the care for a high-need population with multiple chronic conditions.”  These patients, of course, account for the most significant portion of our country’s healthcare spending.

This study adds fuel to the argument that we can enhance healthcare quality and better contain spending through improved patient health when healthcare entities compete on the basis of value.

The Power in Planning Ahead

April 17, 2017
4:53 pm

Now that most of us have filed our taxes for 2016, this is an opportune time to review our health planning with the same level of attention.  There is a nationwide effort to make the day after Tax Day “National Healthcare Decisions Day” – a day in which we think about our long-term healthcare needs and make a plan for how we would like to be cared for in our final days.  At one point or another, all families face challenges with advanced illness and must make decisions about end-of-life care, but too few of us have given thought to issues like designating power of attorney or creating advance directives and living wills.  Advanced illnesses cause many challenges for families.  One of the most difficult is when family members become the primary caregiver for their loved ones and are placed in decision-making roles that they never expected.  Advanced care planning is a useful tool that can assist individuals in preparing for end-of-life care, and keeping family members and healthcare providers updated on their wishes.

For individuals faced with end-of-life care decisions, it is important to have conversations with their physicians about their treatment options and their wishes regarding advanced illness care.  Studies indicate that patients and their families are interested in discussing their end-of-life options with their physicians.  However, there is concern that physicians may lack the training or resources to engage in long-term conversations with their patients on end-of-life healthcare decisions.   For instance, a recent survey of 736 physicians, link above, found that less than one-third reported any formal training on discussing end-of-life care with their patients and their families.

The Coalition to Transform Advanced Care (CTAC), a non-partisan organization, is collaborating with the AHIP Foundation on “The Advanced Care Project,” which offers suggestions for how healthcare professionals can help patients make their decisions about their end-of-life care needs.  A combination of education and collaboration on advanced care allows for patients and family caregivers to develop their own care plan that is specifically designed to fit their needs.

Healthcare plans and providers are embarking on their own initiatives to assist and ensure that patients are able to make their own decisions about their healthcare.  For instance, Aetna offers support to its members through its Compassionate Care Programs, in which individuals experiencing end-of-life care are assisted by nurse care managers who are available to provide resources to patients and their family members, as well as assist physicians in managing the care of the patient.   The Franciscan Missionaries of Our Lady Health System in Louisiana is collaborating with the Louisiana Health Care Quality Forum in the Louisiana Physician Orders for Scope of Treatment (LaPOST) initiative on how a patient’s desires and goals into their treatment plan can be medically translated and applied to multiple healthcare settings.

SCAN Health Plan has constructed a new system to make it possible for patients and their families to understand the full array of care options available to them and to receive treatment that best fits their values, goals, and cultural preferences.  This system is called the Program for Advanced Illness (PAI). A palliative-trained nurse case manager serves as the member’s personal advocate.  The nurse will help members and their caregivers navigate care options that reflect patient’s goals and wishes, encouraging articulation and documentation of end-of-life requests while identifying healthcare proxies and making referrals to hospice.  Additionally, the nurse will communicate with all medical staff and other parties to ensure everyone understands the critical decisions being made as well as following up with the family to offer bereavement services.  More program details are available in the Viable Solutions compendium recently released by the Healthcare Leadership Council.

On National Healthcare Decisions Day, let us continue to have the conversation about how healthcare providers can best assist individuals in making their own decisions about their health care needs.  Create an advance directive and talk to your family and friends about the importance of care planning.  Visit www.nhdd.org for more information.

Walden Discussed Repeal and Replace Strategies at HLC Meeting

January 26, 2017
3:06 pm

On January 24 at a dinner hosted by the Healthcare Leadership Council for its members, U.S. Representative Greg Walden (R-OR), the new chairman of the influential House Energy and Commerce Committee, spoke of his panel’s goals for the upcoming healthcare overhaul.  CQ Roll Call published the following article based upon his prepared remarks.


CQ: Walden Outlines Obamacare Strategy to Health Care Executives By Joe Williams, CQ Roll Call

Energy and Commerce Chairman Greg Walden was poised Tuesday night to outline to health care industry executives his panel’s strategy for repealing and replacing the 2010 health care law, including insights on his plans to overhaul Medicaid.

The Oregon Republican planned to use his closed-door meeting with the Healthcare Leadership Council to discuss several measures his panel would consider in the coming weeks, according to prepared remarks obtained by CQ Roll Call.

A pair of hearings to be scheduled for late next week will center on stabilizing the health insurance marketplaces and on Medicaid. Walden is working with Senate Finance Chairman Orrin G. Hatch of Utah on changes to Medicaid, which provides health insurance to more than 73 million Americans.

Walden planned to confirm during his speech Tuesday night that Republicans will model their legislation largely on a repeal bill President Barack Obama vetoed last year.

“We will use our 2015 reconciliation bill as a starting point in order to repeal major portions of Obamacare, such as the individual and employer mandates, and address the Obamacare Medicaid expansion and the failing exchanges,” Walden’s prepared remarks say. They also say a “stability period” would be included in the legislation.

Walden also is expected to say that Republicans will “maintain protections for those with pre-existing conditions” and permit children to stay on their parents’ insurance plan until age 26, two provisions in the current law (PL 111-148, PL 111-152) that President Donald Trump has voiced support for keeping in a replacement plan.

In his prepared remarks, Walden calls on the Healthcare Leadership Council to engage publicly in the health care debate. The group includes executives from hospitals, insurers, pharmaceutical companies, medical device manufactures and other industries.

“We can’t do this alone. But by working together . . . we can reach our mutual goal of helping people live healthier lives and giving every American a new opportunity to get affordable health care coverage,” Walden will say, according to the prepared remarks.

Changes to Medicaid

Walden’s remarks don’t detail how the GOP would address the 2010 law’s Medicaid expansion, but he confirmed to CQ Roll Call earlier in the day he has had several meetings with Hatch to discuss their legislation on changes to the program.

Earlier this month, Walden organized a meeting between Republican lawmakers on his panel and GOP governors to discuss potential changes to Medicaid. He also attended a separate but similar meeting organized by Senate Finance.

A top aide to Trump said earlier this week the president would propose turning Medicaid into a block grant system. Some GOP governors at the meetings last week, however, suggested a per capita approach that would explicitly require the federal government to incorporate enrollment changes when determining reimbursement rates.

J. Mario Molina, president of Molina Healthcare, told CQ Roll Call both Republican and Democratic governors are likely to push for a per capita approach because it would account for potential increases in each state’s Medicaid population.

“This is going to be a debate between the states and the federal government as to how best to continue this entitlement program while trying to rein in costs,” he said in a recent interview.

Others Republican governors, including Gov. John R. Kasich of Ohio, proposed lowering the Medicaid coverage threshold to 100 percent of the poverty level and allowing people with income above that amount to get exchange coverage. The law’s expansion provides Medicaid coverage for individuals up to 138 percent of the poverty level.