Tag Archives: Medicaid

Will Federal Courts Uphold Trump Administration Medicaid Waiver Approvals?

Posted on by • Posted in Uncategorized • Tagged , , , , , , , , , , , , , , , , • Leave a comment

https://www.healthaffairs.org/do/10.1377/hblog20180213.18720/full/

Court decisions are likely to have an enormous impact on the future of the Medicaid program. On January 12, the Centers for Medicare and Medicaid Services (CMS) announced approval of a Medicaid demonstration waiver in Kentucky incorporating unprecedented restrictions on Medicaid eligibility for adults. These restrictions have been summarized by Sara Rosenbaum on Health Affairs Blog in the context of a powerful review of Medicaid demonstration law and policy. Kentucky’s new waiver includes not only a highly publicized “work/community engagement” requirement, but additional elements new to Medicaid including lockouts for beneficiaries who do not complete the annual renewal process or who fail to report changes in income.

Twelve days after the CMS approval announcement, the Kentucky Equal Justice Center, the Southern Poverty Law Center, and the National Health Law Program filed suit to stop the waiver in U.S. District Court for the District of Columbia, representing 15 Medicaid beneficiaries in Kentucky. Similar lawsuits are virtually certain as Medicaid waivers imposing new coverage and benefits restrictions on adults are approved in Indiana and likely other states.

Why The Current Round Of 1115 Waivers Are Different

As noted by Sara Rosenbaum, Nicholas Bagley, and others, there is a limited history of federal lawsuits challenging Medicaid section 1115 demonstrations. But it is important to note the reason there have been few of these legal challenges: until 2018, over its 50-plus year history, Medicaid waiver authority was almost exclusively used to expand Medicaid eligibility and benefits rather than to restrict them, or to try a different approach to delivering existing benefits. When I oversaw Medicaid 1115 waiver review from 2013 to early 2017, the Obama administration agreed to try a variety of conservative ideas under Medicaid waiver authority for the Affordable Care Act (ACA) adult expansion population. But each of these ideas was tied into a good faith hypothesis about potential improved access or benefits within the Medicaid program. Premiums were to be tested as an alternative to cost-sharing in some states or in combined premium/cost-sharing approaches that sought to encourage and incentivize healthy behaviors; private marketplace plan networks were to be tested and evaluated as an alternative to traditional Medicaid providers; the impact of the Non-Emergency Medical Transportation benefit on unmet need would be measured closely to see if eliminating the benefit helped or hurt self-reported access to care.

The approvals in Kentucky and Indiana, and possible pending approvals in other states, base their legal claim to be promoting the objectives of the Medicaid program on a far more brazen and cynical premise. The waiver approvals assert that taking away Medicaid from statutorily eligible individuals can act as an incentive that ultimately improves health: either by forcing the beneficiary to get a job to stay insured in the case of work requirements, or by “educating beneficiaries on enrollment requirements” in the case of lockouts from eligibility for beneficiaries who fail to complete an annual renewal or inform the state of income changes.

Because the hypothesized Medicaid objectives are so dubious, a lot more than these specific waiver requests rests on the plaintiffs’ case in these states. At risk are not only specific Medicaid eligibility principles, but the entire statutory enterprise of congressional legislation of mandatory Medicaid eligibility or benefits of any kind. Consider what it would mean for Medicaid law were the justifications upheld: if waivers can overturn congressional Medicaid eligibility guarantees and claim to promote Medicaid objectives because Medicaid itself is a barrier to health, or because cutting off eligibility is a way to teach people about private insurance or enforce compliance with new extra-statutory eligibility requirements, then there is no meaningful legal limit on state waivers of federal Medicaid eligibility law. Congress’s ability—in place since 1965 and upheld in hundreds of federal court decisions—to mandate that state Medicaid agencies cover specific categories of individuals for specific periods of time and with specific benefits will be subject to an extra-statutory waiver process in toto.

Will courts allow it anyway? After all, section 1115(a) defining the scope of the demonstration authority specifically references “the judgment of the Secretary”, suggesting executive branch latitude.

Will Courts Overturn Work Requirements?

But there are a number of important legal and contextual factors that point to court action to overturn these waiver approvals. First, the work requirement component of these waivers is a particularly blatant attempt to achieve under waiver authority what could not be achieved via statutory change. Both the House and primary Senate version of “repeal and replace” 2017 included state options to impose work requirements in Medicaid. These efforts—in a rather high-profile manner—failed to pass Congress. Courts will be considering the tactic of the executive branch trying to change the Medicaid program via demonstration waivers when it failed to change the law.

Second, the primary federal court precedent for judicial review of Medicaid section 1115 demonstrations sets a high bar for legal scrutiny. Although (as summarized by Nicholas Bagley) the courts historically authorized some restrictive state section 1115 waivers with regard to Aid to Families with Dependent Children (AFDC) cash welfare in the name of supporting transitions to independence, these decisions were tied to a statutory framework for the AFDC program that itself supported transitions to work as an explicit goal beginning in the 1960s. This is not true when it comes to Medicaid: Medicaid’s statutory framework is as an ongoing health insurance program, and it now covers 70 million people, many times the enrollment level in AFDC/Temporary Assistance for Needy Families (TANF) over its history. And the limited court challenges to Medicaid section 1115 waivers have had a high success rate, with courts insisting that not only meet the “promote Medicaid objectives” standard but that they meet an additional level of scrutiny regarding research or experimental value relative to the health policy literature. Strikingly, the court in Newton-Nations v. Betlach—the primary precedent for Medicaid waiver judicial review—approvingly cited expert testimony on the health policy literature as evidence for why further research on cost-sharing was not needed. If judges are citing literature reviews to question whether waiver hypotheses involve groundbreaking experiments, that does not indicate a high degree of judicial deference.

Third, we have had strong indications in the last year that federal courts are not working with an assumption of good faith in stated agency rationales, particularly when significant published information from Trump administration leaders contradicts those ostensible public rationales. Judicial skepticism has extended from presidential tweets cited as evidence of discriminatory intent in immigration cases, to asserting “invidious partisan intent” in drawing of voting districts. And the Trump administration has made abundantly clear that its reasons for supporting restrictions on adult Medicaid enrollment have nothing to do with health: CMS Administrator Seema Verma has repeatedly stated her broad opposition to Medicaid coverage of low-income non-disabled adults as such, and the Trump administration worked vigorously to undo the Medicaid expansion during the ACA repeal effort in Congress.

Fourth, the fact that states are pairing work requirement waivers with other extra-statutory restrictions on Medicaid eligibility undermines whatever health claims they are making regarding the work requirement. With the exception of Mississippi—a state with Medicaid income eligibility levels for adults that are so low virtually no employed adults qualify—every state that has proposed a work requirement has also proposed to waive Medicaid law in other ways to take away coverage. Kentucky’s and Indiana’s new “lockout” provisions that will bar people from Medicaid for six months if they fail to report a change in income or if they fail to submit an annual redetermination of eligibility will likely lead to dramatic reductions in Medicaid coverage, given the high rates of enrollment churn associated with Medicaid’s unique annual redetermination requirements. States that are trying to cut Medicaid coverage for adults in multiple ways and a federal Administration that opposes Medicaid coverage of non-disabled adults would appear to be attacking Medicaid coverage of adults any way they can. They will not make for persuasive exponents of the health benefits of work requirements.

The pending litigation will be the first time the courts have thoroughly defined the scope of executive branch section 1115 waiver authority in Medicaid. As a matter of law and policy, one way or another this important part of the Medicaid program and the American health system will likely be changed by the time the federal courts have completed their adjudication. Many thousands of lives will be at stake. But with multiple judicial imperatives at stake as well, there is good reason to expect that the courts will step in.

 

KHN’s ‘What The Health?’ What Do The Budget, Idaho And FDA Chief Scott Gottlieb Have In Common?

Posted on by • Posted in Uncategorized • Tagged , , , , , , , , , , • Leave a comment

https://khn.org/news/podcast-khns-what-the-health-what-do-the-budget-idaho-and-fda-chief-scott-gottlieb-have-in-common/?utm_campaign=KFF-2018-The-Latest&utm_source=hs_email&utm_medium=email&utm_content=60750320&_hsenc=p2ANqtz-_fH8PLw8MQcK5-6PQpM5hnAT-lUReNyxbqcVv3CQftN_JErkzwdKT74g8pG-zb0KDTi4MLTSaD8zofdRUaejz_MhZWpw&_hsmi=60750320

Image result for kaiser what the health

 

President Donald Trump released his first full budget proposal this week, with many recommended cuts and some major changes to health programs. But Congress has already agreed on most spending levels for next year, so this budget is even more likely to be ignored than a typical presidential budget plan.

Meanwhile, states are trying to cope with last year’s changes to the Affordable Care Act in very different ways. Several states, mostly led by Democrats, are considering whether to set penalties for people who don’t have insurance — a provision of the ACA that Congress repealed in December. Idaho, meanwhile, is offering to let insurers sell plans that don’t cover the ACA’s required set of benefits and discriminate against people with preexisting health conditions.

Plus, Scott Gottlieb, commissioner of the Food and Drug Administration, talks about getting generic drugs to market faster and how the agency is working with Congress on ways to help patients with terminal illnesses get easier access to experimental treatments.

This week’s panelists for KHN’s “What the Health?” are Julie Rovner of Kaiser Health News, Stephanie Armour of The Wall Street Journal, Paige Winfield Cunningham of The Washington Post and Margot Sanger-Katz of The New York Times.

Among the takeaways from this week’s podcast:

  • Even though few of the proposals in Trump’s budget are likely to be enacted, it does lay down some important markers for the administration. Those include backing sweeping changes to Medicaid and eliminating many of the ACA’s coverage requirements.
  •  Blue states considering stepping into the void left by Congress’ repeal of the individual insurance mandate penalties have limited time to act. Insurers start making decisions about whether to participate in the individual market in the spring.
  • The FDA’s Gottlieb tells Rovner and KHN’s Sarah Jane Tribble he expects there will be a compromise on Capitol Hill on “right-to-try” legislation that would make it easier for patients with terminal illnesses to gain access to experimental therapies.
  • Idaho is moving forward on its plan to allow insurers to offer policies that do not comply with the requirements of the Affordable Care Act. On Capitol Hill this week, Health and Human Services Secretary Alex Azar would not say whether the federal government will step up to stop them.

Trump’s Budget Would Cut HHS Funding 21%; Azar Approves

Posted on by • Posted in Uncategorized • Tagged , , , , , , , , , • Leave a comment

http://www.healthleadersmedia.com/leadership/trumps-budget-would-cut-hhs-funding-21-azar-approves?utm_source=edit&utm_medium=ENL&utm_campaign=HLM-Daily-SilverPop_02142018&spMailingID=12931448&spUserID=MTY3ODg4NTg1MzQ4S0&spJobID=1341286596&spReportId=MTM0MTI4NjU5NgS2#

Image result for health policy

The White House calls for an increase in funding for veterans healthcare services, while proposing cuts to HHS and a repeal of the Affordable Care Act.

President Donald Trump released his budget proposalMonday for fiscal year 2019. It includes overall reductions in nondefense spending while also increasing funding for veterans healthcare services.

The White House’s $4.4 trillion budget request to Congress comes days after a two-year, $300 billion bipartisan budget deal was signed into law following the second government shutdown in as many months.

Though Congress is unlikely to vote on a singular budget, the various provisions listed in the executive proposal outline the legislative agenda the Trump administration would like to pursue in 2018.

“I applaud President Trump for laying out his vision for the country in today’s budget request and welcome his partnership as the Energy and Commerce Committee works to tackle several shared priorities,” said Rep. Greg Walden, R-Ore., chairman of the House Committee on Energy and Commerce in a statement. “Many of the administration’s other proposals to lower health care costs complement our continued commitment to addressing the cost drivers across every facet of our nation’s health care system.”

Below is a breakdown of the proposals affecting the healthcare world, including cuts to the Department of Health and Human Services (HHS), Medicare, a repeal-and-replace plan for the Affordable Care Act (ACA), and more money for veterans healthcare.

Major cuts to HHS

The proposal features a $68.4 billion budgetary line for HHS, a 21% reduction in funding compared to FY 2017. The budget also proposes a $451 million cut to training programs for health professionals, arguing the initiatives “lack evidence that they significantly improve the nation’s health workforce.”

If adopted, the policies would extend Medicare’s solvency by eight years, according to the budget proposal. Current projections estimate Medicare will become insolvent by 2029. The Trump administration also proposed a limit on Medicaid reimbursements to federal providers at no more than the cost of providing services to beneficiaries.

“The President’s budget makes investments and reforms that are vital to making our health and human services programs work for Americans and to sustaining them for future generations,” said HHS Secretary Alex Azar in a statement. “In particular, it supports our four priorities here at HHS: addressing the opioid crisis, bringing down the high price of prescription drugs, increasing the affordability and accessibility of health insurance, and improving Medicare in ways that push our health system toward paying for value rather than volume.”

Bundled payments for community-based medication-assisted treatment would see an opportunity to expand through the budget proposal, with the White House highlighting a new Medicare reimbursement for methadone treatment.

Medicare beneficiaries would also be able to save for out-of-pocket costs by allowing tax deductible contributions to health savings accounts associated with high deductible health plans offered by employers or Medicare Advantage.

The budget proposes a ‘$5 returned for every $1 spent’ policy for the Medicare Health Care Fraud and Abuse Control, a $45 million increase compared to FY 2017 which totals $770 million,. The White House believes the additional funding will bolster the program’s efforts to “identify and prevent fraudulent or improper payments from being paid in the first place.”

Two-part ACA repeal

Arguing that “national healthcare spending trends are unsustainable,” the budget offers a solution in the form a two-part repeal of the Affordable Care Act.

Modeled on the Graham-Cassidy proposal, the first step would focus on providing block grants to states for healthcare spending plans.

The Market-Based Health Care Grant Program, the new block grant program, would offer states and consumers with options outside of the ACA’s “insurance rules and pricing restrictions.” The administration believes this will address high premium costs and rising deductibles.

The second part of the plan focuses on Medicaid reform, specifically the repeal of Medicaid expansion spurred on by the ACA, as well as reducing “state gimmicks” like provider taxes. This move would shift federal authority over healthcare access to states, which could in turn design individualized plans.

Major increase for veterans healthcare

Continuing with a campaign promise to address issues facing veterans, Trump’s budget proposal includes an increase in spending for veterans healthcare programs over the next three fiscal years.

For FY 2019, the Veterans Health Administration would receive $70.7 billion, a 9.6% increase compared to FY 2017. By 2020, that number rises to $75.6 billion in advance appropriations for VA medical care program costs.

This covers 9.3 million enrollees in the Veterans Affairs health system.

Additionally, the budget provides $8.6 billion for veterans mental health and suicide prevention programs, and $11.9 billion would be used to enhance and expand veterans’ access to high-quality community care.

The administration proposes the consolidation of the Veterans Choice Program and other community care programs into a new, unified program: the Veteran Coordinated Access & Rewarding Experiences program.

 

Budget, White Paper Provide Insight Into Trump Administration’s Strategy On Drug Pricing

Posted on by • Posted in Uncategorized • Tagged , , , , , , , , , , , , , , , • Leave a comment

https://www.healthaffairs.org/do/10.1377/hblog20180212.852840/full/

During his first year in office, President Donald Trump spoke often about the problem of high drug prices but took no action on the subject. President Trump’s new budget proposal and a newly released white paper from the White House Council of Economic Advisors (CEA) aim to change that by laying out a strategy for action moving forward. These documents are, of course, aspirational, but they do provide a window into the administration’s priorities, and they should be evaluated to consider whether the administration has a possibility of achieving its stated goals.

In this post, I review several of the key elements of those proposals, considering their impact on a range of relevant dimensions. I discuss what’s included in the proposals, and, as importantly, what’s left out.

Medicare Reforms

The bulk of the proposed reforms would act on the Medicare and Medicaid programs. For Medicare, the Trump administration’s proposals are largely targeted at 1) assisting beneficiaries with high out-of-pocket costs and 2) realigning incentives to alter prescribing and reimbursement practices.

First, the administration is advancing a set of proposals to assist Medicare Part D beneficiaries with high out-of-pocket costs. Both the white paper and budget proposal argue that plans should be required to share with beneficiaries at the point-of-sale some amount of the rebates the plan negotiates with drug manufacturers. In November, the Centers for Medicare and Medicaid Services (CMS) already requested public comments on the implementation of this proposal, and it seems as if the budget document’s inclusion of the proposal is evidence that the administration is hoping to move it forward.

However, like many of the other reforms in the budget proposal and white paper, there are few details proposed. In CMS’s November proposal, the agency modeled a set of scenarios in which insurers pass through 33 percent, 66 percent, 90 percent, or 100 percent of their negotiated rebates. Each scenario comes with a set of advantages for beneficiaries, but also costs for the federal government. That is, CMS anticipated that reducing cost-sharing for particular high-cost beneficiaries would increase premiums for all beneficiaries, and therefore increase CMS’ overall spending through premium subsidies. How much the proposal would increase overall spending depends on the amount of rebates being passed through.

The budget proposal simply says that sponsors must pass through “at least one-third” of total rebates, so it does not provide further clarity on this proposal. However, it states that this proposal will cost the government $42.2 billion over 10 years. That estimate lies between CMS’s November estimates for 33 percent ($27.3 billion in spending) and 66 percent ($55.1 billion in spending), so it is possible that the administration has in mind a pass-through provision at 50 percent or so.

Another proposal aimed at out-of-pocket costs would establish an out-of-pocket maximum for patients who enter the Medicare Part D catastrophic phase. Currently, patients who reach the catastrophic phase of the Part D benefit are responsible for 5 percent of the costs of their prescription drugs, with no upper limit. The budget proposal would reduce their payments to 0 percent, although it is light on the details as to how this would be accomplished. The Henry J. Kaiser Family Foundation estimated that just over one million Part D enrollees have out-of-pocket costs above this threshold, and those patients would likely be the primary beneficiaries of this proposal. At the same time, however, the budget proposes to exclude manufacturer discounts from patient out-of-pocket cost calculations, which would likely slow the rate at which patients move into the catastrophic phase.

Second, the Trump administration proposes a number of changes to drug classification and reimbursement that would both enable plan sponsors to negotiate more effectively and alter prescribing behavior. The budget proposal would change current Part D plan formulary rules, requiring sponsors to cover just one drug per class, rather than two. The proposal also mentions increased use of utilization management tools for the six protected classes of drugs, suggesting that the general coverage requirement for those classes would remain as-is. This proposal is projected to save $5.5 billion over ten years.

More interestingly, both the budget proposal and CEA white paper suggest the possibility of moving a set of Part B drugs (those administered in an outpatient setting) into Part D coverage. Medicare Part B does not presently have a number of the tools that enable Part D plan sponsors to negotiate discounts with drug manufacturers, and Secretary Alex Azar spoke during his confirmation hearing about the need to “take the learnings from Part D and apply them to Part B.” This proposal would accomplish that goal, just through the reverse mechanism: by shifting drugs from Part B into Part D. The budget proposal envisions giving the authority to do this to the Secretary, noting that “[t]he Secretary will exercise this authority when there are savings to be gained from price competition.” As such, it does not provide any particular budgetary impact.

The budget proposes two other changes to Part B reimbursement. At present, when a physician is reimbursed for providing a drug under Part B, she is reimbursed based on the Average Sales Price (ASP) of the drug plus 6 percent. There is widespread concern that this reimbursement system encourages physicians to prescribe and administer more expensive drugs than may be medically necessary. The Obama administration proposed a demonstration project that would have moved from the current ASP+6 percent system to a system of ASP+2.5 percent+a flat fee for prescribing the product. After extensive criticism from a range of stakeholders, the administration shelved the initiative. Now, the administration is proposing to reduce payment rates for new drugs (for which the ASP information is not yet available, and so for which the only price available is the Wholesale Acquisition Cost (WAC)). Instead of paying 106 percent for these new products, the administration would pay 103 percent of the WAC during the period before ASP information has yet to be provided. This proposal is quite narrow in its scope, applying only to new drugs and only during the brief period before ASP information is available; it is therefore unlikely to save much money.

The Trump administration is also proposing to establish an inflation limit for the reimbursement of Part B drugs more generally. Instead of continually updating the ASP+6 percent figure if the ASP increases, this proposal would limit the growth of the reimbursement to the Consumer Price Index for all Urban Consumers. CMS would therefore pay “pay the lesser of (1) the actual ASP +6 percent or (2) the inflation-adjusted ASP +6 percent.” At present, Medicaid is protected from price increases when the Average Manufacturer Price (AMP) for a drug increases faster than inflation. The Department of Health and Human Services Office of Inspector General has proposed that CMS and Congress consider extending this provision to Medicare Part D, but as yet Congress has not moved to do so. This budget proposal can be thought of as proposing a similar constraint on Part B pricing.

Medicaid Reforms

The Medicaid portion of the budget proposal puts forth an idea which is potentially ground-breaking, but which is also potentially a sign of the administration’s recalcitrance to move on drug pricing (depending on the details). Specifically, the administration is proposing “new statutory demonstration authority to allow up to five states more flexibility in negotiating prices with manufacturers, rather than participate in the Medicaid Drug Rebate Program, and to make drug coverage decisions that meet state needs.” The idea is something like this: at present, state Medicaid programs must cover essentially all drugs approved by the U.S. Food and Drug Administration (FDA), which limits their ability to extract discounts. To be sure, Medicaid programs are already entitled by statute to large discounts off of the AMP, and to the inflation clawback as noted above. But many state Medicaid programs are worried that pharmaceutical spending has become an unsustainable part of their budget and are seeking ways to control their costs in this area. This proposal might empower them to do so.

Here’s the thing: Massachusetts has already submitted an 1115 waiver to CMS along these lines. Massachusetts is seeking 1) to pay for a single drug in each therapeutic class (as noted above, this is a reform the administration is proposing to make to Medicare Part D), and 2) to exclude entirely from coverage drugs “with limited or inadequate evidence of clinical efficacy,” likely to be those approved through the FDA’s accelerated approval process. This budget proposal may be a sign that the administration is interested in approving Massachusetts’ waiver. However, the fact that the budget explicitly calls for new statutory authority to do so suggests that the administration may not think it has the legal authority to approve Massachusetts’ waiver, as is. And given Congress’ inability to act thus far on drug pricing, the administration may be seeking to hide behind Congress’ inaction here.

Yet the call for new statutory authority is puzzling. At present, pharmaceutical coverage is an optional benefit under the Medicaid program. States do not have to cover drugs and therefore are not required to participate in the Medicaid Drug Rebate Program, although all have chosen to do so, and choosing to do so comes with a set of requirements. But it is not clear to me why CMS could not conduct this demonstration at present, under the Center for Medicare and Medicaid Innovation’s (CMMI) existing authority.

A potential clue may lie in the administration’s statement that the demonstration would “exempt prices negotiated under the demonstration from best price reporting.” Having written recently on the topic of the Medicaid best-price rule and innovative contracting for pharmaceuticals, it is not clear to me exactly why this is a sticking point. The Medicaid best price rule entitles Medicaid to the “best price” available for a particular drug for a particular set of providers. The statute contains large carve-outs—for instance, discounts provided to the Department of Veterans Affairs or to Medicare Part D are exempt from the best-price calculation. But it is strange to talk about needing to exempt Medicaid programs from the best-price rule when the best-price rule was intended to benefit Medicaid itself. I imagine that the administration sees the 340B program as a potential concern here, but again it is not obvious why CMMI could not waive the best-price rule as part of its existing authority.

FDA Activities

As I have written here previously, FDA Commissioner Scott Gottlieb has been at the forefront of the Trump administration’s efforts on drug pricing. He has taken a number of actions to promote generic competition, and although it will take some time to observe their benefits, the FDA’s existing legal authority to address drug pricing issues is quite narrowly circumscribed. The CEA white paper and budget proposal largely acknowledge this point, with the white paper lauding the actions the FDA has taken thus far on expediting review of generic drug applications, providing guidance on the development of complex generics, and other similar activities.

President Trump’s budget proposal calls for Congress to give the FDA more power to promote generic competition, by “ensur[ing] that first-to-file generic applicants who have been awarded a 180-day exclusivity period do not unreasonably and indefinitely block subsequent generics from entering the market beyond the exclusivity period.” More specifically, the concern is that first-to-file generic applicants—perhaps those whose initial applications may be rejected—can unduly delay generic entry while they remedy the deficiencies in their application. The administration projects that this reform will save the government $1.8 billion in Medicare savings over 10 years.

Other pieces of legislation have called for reform of the 180-day exclusivity period in different ways. Last year, Democrats in both the House and Senate introduced the Improving Access to Affordable Prescription Drugs Act, which included provisions preventing generic entrants from receiving the statutory 180-day exclusivity benefit if they had engaged in pay-for-delay conduct (Sections 402 and 403). But the idea in the president’s budget proposal may dovetail nicely with the FDA’s efforts to improve first-cycle approval rates for abbreviated new drug application products, as well.

What’s Missing

Perhaps what’s most notable about the budget proposal and the CEA white paper is not what’s included, but rather what is missing. Gone are some of President Trump’s older arguments that Medicare should negotiate drug prices, or that drug importation should be permitted more widely. Some of the more significant cost-saving provisions from President Obama’s budget, like a reform that would have put low-income patients back on Medicaid prices, are also absent.

A key set of missing proposals are those which would directly assist privately insured patients. The budget’s focus on Medicare and Medicaid may well have a positive impact on the more than 100 million Americans enrolled in those programs. But for the roughly half of Americans (closer to 160 million) with employer-sponsored insurance, these reforms will provide no assistance. Growing numbers of Americans with employer-sponsored insurance are enrolled in high-deductible plans, and many of them may face the same affordability concerns that Medicare beneficiaries are facing.

You could imagine proposals that would address the drug pricing problem more broadly, rather than just within the publicly-insured population. The above-mentioned Improving Access to Affordable Prescription Drugs Act would have addressed the problem of drug pricing for a broader segment of the population. As I’ve explained here, the Act would have taxed companies which engage in large, year-over-year list price increases. It would also have capped patient out-of-pocket costs in Affordable Care Act-regulated plans, at $250 per month for an individual or $500 per month for a family.

More generally, even these proposals which would affect drug companies directly would have a minimal impact on their bottom lines. This set of proposals is largely very friendly to the pharmaceutical industry and is primarily aimed at curtailing patients’ financial burdens and tweaking incentives for stakeholders at the margin.

In this blog post, I have covered just a handful of the many different drug pricing-related proposals included in the new budget proposal and in the CEA white paper. As usual, observers should stay tuned to the actions CMS and the FDA take on this front, as they will show whether the administration is serious about these proposals or is merely posturing.

 

Trump budget seeks savings through ObamaCare repeal

Posted on by • Posted in Uncategorized • Tagged , , , , , , , , • Leave a comment

Trump budget seeks savings through ObamaCare repeal

Trump budget seeks savings through ObamaCare repeal

The White House budget for fiscal 2019 seeks major savings by repealing ObamaCare and endorsed a Senate GOP bill as the best way to do so.

“The Budget supports a two-part approach to repealing and replacing Obamacare, starting with enactment of legislation modeled closely after the Graham-Cassidy-Heller-Johnson (GCHJ) bill as soon as possible,” the White House said in its budget request.

The legislation from Sens. Lindsey Graham (R-S.C.), Bill Cassidy (R-La.), Ron Johnson (R-Wis.) and Dean Heller (R-Nev.) would replace ObamaCare with a series of block grants to states.

The budget proposes over $90 billion in savings over 10 years if the policies in the Graham-Cassidy bill were enacted. Combined with other provisions like Medicaid changes, the White House projects there would be nearly $675 billion in savings over a decade tied to repealing ObamaCare.

Advocacy groups were quick to denounce the proposal, which is unlikely to gain traction in Congress.

“By asking Congress to revive the deeply unpopular Graham-Cassidy repeal bill that ended protections for Americans with pre-existing conditions, gutted Medicaid, ripped away coverage from millions, and raised costs for millions more, while also proposing drastic cuts to Medicare, Trump has chosen to ignore the American public’s overwhelming preference for a bipartisan path forward on health care,” said Protect Our Care campaign director Brad Woodhouse.

Republican leaders have signaled that they are not interested in diving back into the contentious ObamaCare repeal fight this year. The Senate last year failed to pass a repeal bill, and there is no indication that the votes have shifted since then.

A number of Republicans have even discussed taking bipartisan actions to stabilize ObamaCare markets and try to bring down premiums through actions such as funding known as reinsurance.

Graham has said he will continue fighting for his bill and is not completely alone. Sen. Ted Cruz (R-Texas) is also calling for Congress to not give up on repeal this year.

 

The Medicaid Agency of the Future: What capabilities and leadership will it need?

Posted on by • Posted in Uncategorized • Tagged , , , , , , , , , , • Leave a comment

https://www.mckinsey.com/industries/healthcare-systems-and-services/our-insights/the-medicaid-agency-of-the-future–what-capabilities-and-leadership-will-it-need?cid=other-eml-alt-mip-mck-oth-1802&hlkid=f3e96b6a484442438bbdc44b7744e1e9&hctky=9502524&hdpid=c2f3cd34-a3e9-46d4-bc69-f4a9cc3b0ac9

Image result for The Medicaid Agency of the Future: What capabilities and leadership will it need?

Medicaid’s scale and complexity are unprecedented. State Medicaid leaders will need to innovate if they are to develop the capabilities that will enable them to steer their agencies into the future.

Since its inception in 1965, Medicaid has grown to have an expanded role in state governance—it is usually the first- or second-largest state program. Nationwide, Medicaid agencies manage about $574 billion in annual spending.1In an average-sized state, Medicaid directors are the single largest purchaser in the health sector, overseeing about $10 billion each year in payments to providers (roughly 17% of the state’s economy).2The agencies typically serve nearly one-quarter of their state’s population3and, in our experience, procure the largest IT infrastructure projects in state government.

Recently, demands on state Medicaid agencies have grown. Increasingly, Medicaid agencies are playing a multi-part role, fulfilling their traditional responsibilities (i.e., payer-purchaser, operator) and taking on new ones (i.e., market shaper and innovator). And while they are doing this, the agencies must address an array of competing priorities, as well as uncertainty about future funding levels. To perform well in these new roles, the agencies must develop new, next-generation capabilities so they can address the needs of their state’s citizens—even those not enrolled in Medicaid.

We believe the roles played by state Medicaid agencies will continue to evolve, but the agencies—in conjunction with the state government leaders they work with—can choose their strategic path forward (primarily, the extent to which they want to be market shapers). Those that pursue this path aggressively will be the first of their peers to evolve into a Medicaid Agency of the Future.

As we discuss below, all state Medicaid agencies will need to strengthen their capabilities if they are to meet the demands of the future—an issue that has important implications not only for the agencies themselves but also for state government leaders, managed care organizations (MCOs), local providers, and others. However, agencies focused on becoming market shapers will need to double down on capability building if they want to succeed on their chosen path.4

Trends shaping Medicaid

A number of trends are shaping what Medicaid agencies need to do to prioritize the direction of their efforts.

Spending growth is putting pressure on state budgets. Medicaid is putting continued cost pressure on state budgets. Program spending (including federal and state funding) increased from 20.5% of state budgets in 2008 to 29.0% in 2016.5The continued increase in Medicaid spending could have funding implications for other state programs, such as elementary and higher education, public assistance, and transportation. The cost pressures resulting from Medicaid spending are expected to continue regardless of what, if any, changes are made at the federal level.

Medicaid programs can lead to payment inno­vation. As program costs have risen, Medicaid directors have increasingly tried to slow the medical cost trend. One lever available to them is transitioning from fee-for-service reimbursement to payment innovations that include meaningful levels of provider risk-sharing. New payment models that reward providers for delivering high-quality care at lower cost have been shown to improve care quality and reduce costs by 5% to 10% when rolled out across the full spending base.6In several states, Medicaid programs have led multi-payer efforts to achieve payment inno­vation across the state.7

Medicaid plays an important role as both a payer and a convener. In the aggregate, Medicaid is the country’s largest payer in terms of covered lives and, in many states, is the largest purchaser of healthcare ser­vices.8Thus, Medicaid agencies are uniquely positioned to facilitate change. In addition, the agencies can often bring together multiple stakeholders to help align on improvements that would affect not only Medicaid but also the entire healthcare market.

Recognition of Medicaid members as consumers is increasing. Some Medicaid agencies are beginning to approach Medicaid members as consumers. For example, they are offering members technological tools, such as apps and patient portals, that empower greater decision making (e.g., about choice of provider, care setting, or treatment). If well utilized, these tools can improve member experience and encourage higher-value care.

Awareness of social determinants is rising. Increasingly, states are turning their attention to non-health factors, such as housing, education, and transportation, that influence Medicaid members’ ability to maintain their health and adhere to treatment. Some programs are beginning to address these determinants head on (e.g., by providing housing or transportation vouchers). Experimentation in special needs care is underway. Integrated models typically deliver better quality and cost outcomes. For example, integrated behavioral and physical healthcare approaches for high-needs patients have been shown to reduce emergency department and inpatient visit spending by 10% to 25%.9The successes to date are paving the way for further innovation in other special needs areas.

Analytics is playing an increasing role. Advanced analytics and big data can help Medicaid and other public health officials better understand state needs, design programs, and target interventions to maximize the impact of limited funds. The emergence of new national data-sets, such as the Transformed Medicaid Statistical Information System (T-MSIS, which includes states’ comprehensive claims and enrollment data) and CMS’ online database of state waivers and state plan amendments, may enable states to draw on experiences elsewhere when designing new programs.10

In short, state Medicaid agencies are facing an increasingly complex and difficult set of challenges at a time when the expectations of multiple stakeholders—members, families, and advocates; providers and MCOs; the federal government, state leaders, and other state agencies—are rising. If Medicaid agencies are to address these challenges successfully, the role they play must evolve.

Introducing the Medicaid Agency of the Future

In the future, some state Medicaid agencies may opt to follow the path set by previous state leaders. In other cases, they may want to respond to the trends just discussed by taking the lead in transforming healthcare delivery in their programs and their states. These Agencies of the Future will have to be able to chart a strong strategic direction and execute the activities that follow both efficiently and effectively. To accomplish those goals, they will need to use a data-driven approach to program management, build new capabilities, and improve their organizational health (Exhibit 1).

Agencies that opt to follow a more traditional path would also benefit from strengthening their operational performance and organi­zational health, but the level of improvement needed is lower for them than for the Agencies of the Future. Both sets of agencies, however, will want to prioritize their strategic investments once they have chosen their path forward.

 

Hospital Impact—Medicaid on the chopping block in 2018

Posted on by • Posted in Uncategorized • Tagged , , , , , , , • Leave a comment

https://www.fiercehealthcare.com/hospitals/hospital-impact-medicaid-chopping-block-2018?mkt_tok=eyJpIjoiTnpReE1EaGhZamt5TVRsbSIsInQiOiJ0UHBtVE1DclpRckhmUjVyMUF2ZWF1ZStSRE93QmtRYWM0ckdYXC9lalRYbERcL1E0R2o5S3g4blhTN2VZU1NsVkNndjRWZ1RRMnhJVXJHdmp6Z1liRWNXS2JyWHlrTyt6Y3hEeVVHZ0xxRWFUYmdjU2RsZWVhYzZmWWZxTCtBUjlcLyJ9&mrkid=959610

Filling out job application

Medicare and Medicaid have always been a “work in progress,” as they’ve evolved from entitlement programs for the elderly and the poor in the 1960s to the largest health insurers—public or private—in the nation.

Medicaid is the more controversial program of the two, as its original intent was to provide temporary, safety-net health coverage for the poor and not as a permanent entitlement. This issue has been politicized by both parties as of late with little attention paid to the impact that nonclinical determinants—such as genetics, socioeconomics, environment and lifestyle choices—have on healthcare outcomes and life expectancy.

Democrats support expanding Medicaid under the Affordable Care Act to every state for everyone within 138% of the federal poverty level. Republicans favor increasing beneficiary responsibilities to take greater control and responsibility over their own healthcare and are encouraging states to pursue waivers to experiment with different Medicaid models designed to optimize quality, drive down costs and enable beneficiaries to move toward greater economic self-sufficiency.

President Donald Trump’s proposed budget last May recommended $800 billion in Medicaid cuts as well as cuts in nutritional assistance ($192 billion) and welfare programs ($272 billion). With the passage of the Tax Cuts and Jobs Act adding $1 trillion to the federal deficit, Republicans are making cuts to Medicaid a priority for 2018.

The rise of work requirements

Last month, the Trump administration announced that it would grant states the right to impose work requirements for able-bodied Medicaid recipients. Pregnant women, full-time students, primary caretakers of children under 19, disabled adult dependents and frail elderly individuals would be exempt from these requirements.

There are many complex issues that arise from this proposal, including:

  • The likelihood that it will be challenged in federal court (as is already the case in Kentucky)
  • The impact that denial of coverage would have on healthcare costs with elimination of preventive healthcare services, treatment for opioid addiction and job restrictions for those with chronic addictions
  • The requirement that states would bear the burden of job training, child care, transportation to work sites and other administrative costs with limited resources.

Democrats responded that this proposal violates the Medicaid statute as well as the original intent of the state waiver program. They also pointed out that the majority of Medicaid beneficiaries who can work do work, and often carry more than one low-paying service job that does not permit them to afford commercial health insurance coverage.

Many Republican governors support the proposal, as they would like to see a greater number of Medicaid beneficiaries receive health insurance through an employer rather than through the state. Earlier this month, Kentucky became the first state to receive approval to impose job requirements as a part of its Medicaid program, followed in short order by Indiana.

Cost-sharing considerations

Another approach to reducing Medicaid costs is cost-sharing, which is already permitted under federal law. Like the job-requirement proposal, children, pregnant women and others are partially waived from this requirement with lower premiums and cost-sharing limits.

In addition, states may impose higher premiums and cost-sharing limits for the option to purchase brand as opposed to generic prescription drugs and the nonemergency use of emergency departments as determined by a medical screening exam under the Emergency Medical Treatment and Labor Act.

All about the execution

There is no question that the United States cannot sustain the current unfunded liabilities that include Medicaid, Medicare and Social Security. In addition, cuts to the Medicaid program are supported by a significant number of Americans. However, doing this successfully will be complicated by the fact that those receiving this coverage deeply appreciate its benefits and that many studies support the positive economic value of Medicaid expansion.

Imposing work requirements and cost-sharing on Medicaid beneficiaries will only work if the jobs available to them are not minimum-wage service jobs and provide employer-based insurance. Thus, the main question is: Can states invest in the infrastructure necessary to help get their most vulnerable populations on their feet in an economically meaningful way? Or is the intent to merely withhold healthcare services to compensate for federal and state budgets that have spiraled out of control?

 

Senate poised to approve budget redistributing state Medicaid funding

Posted on by • Posted in Uncategorized • Tagged , , , , , , • Leave a comment

http://www.tampabay.com/florida-politics/buzz/2018/02/07/senate-poised-to-approve-budget-redistributing-state-medicaid-funding/

 

The Senate proposal, which would funnel away higher state Medicaid payments to hospitals with a large fraction of Medicaid patients, would need to be reconciled with the House’s budget preserving the current policy.

Safety net hospitals in Florida could see their state Medicaid payments decrease by $170 million under a proposal in the budget the state Senate is poised to approve Thursday. The proposal, which would target about $318 million in payments that currently go to 28 hospitals with a higher percentage of Medicaid patients, would funnel those funds into the base rates paid to all hospitals instead.
The reshuffling in the Senate budget would largely affect safety net hospitals, which include public and teaching hospitals, while for-profit hospitals could gain more than $63 million, according to the Safety Net Hospital Alliance of Florida.
Miami’s Jackson Memorial Hospital would lose $59 million, Broward Health would lose about $17 million and Tampa General would lose $14 million, according to Safety Net’s analysis. Nicklaus Children’s Hospital in Miami and Johns Hopkins All Children’s, which each see about 70 percent of patients covered by Medicaid, would lose $10.5 million and $5 million respectively. In contrast, for-profit chain HCA could see its reimbursements rise more than $40 million.
Senate Health and Human Services Appropriations Chairwoman Anitere Flores, R-Miami, said the new system would more fairly distribute funds to all hospitals, which she said also provide charity care like the 28 hospitals that currently meet the 25 percent threshold of Medicaid patients to receive automatic rate enhancements.
“We’re making sure that the dollars actually follow the patient that is being served,” she said.
Flores contended that the new proposal corrects an “arbitrary” formula that set the higher payment rates in past years, and that the hospitals that had been reimbursed at a higher rate would be able to recoup their losses through federal Low Income Pool funding, which reimburses hospitals for charity care serving the uninsured.
But Lindy Kennedy, vice president of the Safety Net Alliance, told the Senate Democratic Caucus that the policy is needed because Medicaid rates do not cover the cost of care. Those 28 hospitals, which largely comprise public or not-for-profit private institutions in the state, lose proportionately more money because a larger slice of their patients are covered by Medicaid, she said.
“If Medicaid would pay these costs and if didn’t go into the red for every Medicaid patient we had, we wouldn’t need this policy,” she said. “This puts us back to status quo.”
“These hospitals cannot afford this type of cut,” she added.

Lidia Amoretti, a spokeswoman for Jackson Health System, called the Senate’s plan “alarming,” though she added “it is still early in the process.”

“We trust that the Miami-Dade delegation will fight fiercely – as it always does – to protect the people who rely upon Jackson for world-class care,” she said in a statement. 
Sen. Jose Javier Rodriguez, D-Miami, proposed an amendment that would revert the Senate proposal to match the House’s version this year, though it was rejected on the floor.
Tony Carvalho, president of the Safety Net Hospital Alliance, said that the Senate plan would also cut $94 million from three of the four largest teaching hospitals — UF’s Shands in Gainesville, Jackson Memorial and Tampa General.
“All hospitals lose money, and I appreciate that, but the average annual margin for the three largest teaching hospitals is $57 million over the last five years…for the operation of in-patient out-patient services in hospitals,” he said. “The Senate bill would cut them $95 million — that’s $30 million more than their operating margin in the last five years.”
By contrast, he said, HCA makes an operating margin, on average over the last five years, of $868 million per year.
Carvalho said one of the biggest cuts to hospitals are employees and this would be “damaging some of your premier medical institutions.”
“Their slogan is the money follows the patient,” he said. “That would be pertinent if all hospitals were paid their cost of care or all hospitals did the same percentage of Medicaid. That’s not the case. If you are going to pay hospitals way below the cost of care, our position is — and it has been the legislative position for years — is that you make a special adjustment when one of four of their patients are in the Medicaid pool.”
The Senate is expected to pass its budget tomorrow, setting up a clash with the House, whose version of the budget preserves the higher reimbursement system. The Senate’s plan also includes $130 million in nursing home funding, which differs from the House plan.

U.S. Pays Billions for ‘Assisted Living,’ but What Does It Get?

Posted on by • Posted in Uncategorized • Tagged , , , , , , , , , • Leave a comment

Image result for U.S. Pays Billions for ‘Assisted Living,’ but What Does It Get?

WASHINGTON — Federal investigators say they have found huge gaps in the regulation of assisted living facilities, a shortfall that they say has potentially jeopardized the care of hundreds of thousands of people served by the booming industry.

The federal government lacks even basic information about the quality of assisted living services provided to low-income people on Medicaid, the Government Accountability Office, a nonpartisan investigative arm of Congress, says in a report to be issued on Sunday.

Billions of dollars in government spending is flowing to the industry even as it operates under a patchwork of vague standards and limited supervision by federal and state authorities. States reported spending more than $10 billion a year in federal and state funds for assisted living services for more than 330,000 Medicaid beneficiaries, an average of more than $30,000 a person, the Government Accountability Office found in a survey of states.

States are supposed to keep track of cases involving the abuse, neglect, exploitation or unexplained death of Medicaid beneficiaries in assisted living facilities. But, the report said, more than half of the states were unable to provide information on the number or nature of such cases.

Just 22 states were able to provide data on “critical incidents — cases of potential or actual harm.” In one year, those states reported a total of more than 22,900 incidents, including the physical, emotional or sexual abuse of residents.

Many of those people are “particularly vulnerable,” the report said, like older adults and people with physical or intellectual disabilities. More than a third of residents are believed to have Alzheimer’s or other forms of dementia.

The report provides the most detailed look to date at the role of assisted living in Medicaid, one of the nation’s largest health care programs. Titled “Improved Federal Oversight of Beneficiary Health and Welfare Is Needed,” it grew out of a two-year study requested by a bipartisan group of four senators.

Assisted living communities are intended to be a bridge between living at home and living in a nursing home. Residents can live in apartments or houses, with a high degree of independence, but can still receive help managing their medications and performing daily activities like bathing, dressing and eating.

Nothing in the report disputes the fact that some assisted living facilities provide high-quality, compassionate care.

The National Center for Assisted Living, a trade group for providers, said states already had “a robust oversight system” to ensure proper care for residents. In the last two years, it said, several states, including California, Oregon, Rhode Island and Virginia, have adopted laws to enhance licensing requirements and penalties for poor performance.

But the new report casts a harsh light on federal oversight, concluding that the Centers for Medicare and Medicaid Services has provided “unclear guidance” to states and done little to monitor their use of federal money for assisted living.

As a result, it said, the federal health care agency “cannot ensure states are meeting their commitments to protect the health and welfare of Medicaid beneficiaries receiving assisted living services, potentially jeopardizing their care.”

Congress has not established standards for assisted living facilities comparable to those for nursing homes. In 1987, Congress adopted a law that strengthened the protection of nursing home residents’ rights, imposed dozens of new requirements on homes and specified the services they must provide.

But assisted living facilities have largely escaped such scrutiny even though the Government Accountability Office says the demand for their services is likely to increase because of the aging of the population and increased life expectancy.

That potential has attracted investors. “Don’t miss out on the largest market growth in a generation!” says the website of an Arizona company, which adds that “residential assisted living is the explosive investment opportunity for the next 25 years.”

Carolyn Matthews, a spokeswoman for the company, the Residential Assisted Living Academy, said: “Unfortunately, there has been elderly abuse in this business. We are trying to change the industry so the elderly have better quality care and we are not warehousing them.”

The government report was requested by Senator Susan Collins of Maine, a Republican who is the chairwoman of the Special Committee on Aging; Senator Orrin G. Hatch of Utah, a Republican who is the chairman of the Finance Committee; and two Democratic senators, Claire McCaskill of Missouri and Elizabeth Warren of Massachusetts.

The Trump administration agreed with the auditors’ recommendation that federal officials should clarify the requirement for states to report on the abuse or neglect of people in assisted living facilities. The administration said it was studying whether additional reporting requirements might be needed.

“Although the federal government has comprehensive information on nursing homes providing Medicaid services, not much is known about Medicaid beneficiaries in assisted living facilities,” the report said.

Assisted living was not part of the original Medicaid program, but many states now cover it under waivers intended to encourage “home and community-based services” as an alternative to nursing homes and other institutions.

The report said that assisted living could potentially save money for Medicaid because it generally cost less than nursing home care. Under the most common type of waiver, Medicaid covers assisted living only for people who would be eligible for “an institutional level of care,” in a nursing home or hospital.

 

 

No Car, No Care? Medicaid Transportation At Risk

Posted on by • Posted in Uncategorized • Tagged , , , • Leave a comment

No Car, No Care? Medicaid Transportation At Risk

Image result for No Car, No Care? Medicaid Transportation At Risk

For over 50 years, the program for the poor and sick has been required to ferry certain clients to and from medical appointments. Though California is not among the states out to cut this service, it could feel the pinch if the feds slash Medicaid funding overall.

This  special series examines the reach and the role of Medicaid, the federal-state program that began as a medical program for the poor but now provides a wide variety of services for a large swath of America.

EVERETT, Wash. — Unable to walk or talk, barely able to see or hear, 5-year-old Maddie Holt waits in her wheelchair for a ride to the hospital.

The 27-pound girl is dressed in polka-dot pants and a flowered shirt for the trip, plus a red headband with a sparkly bow, two wispy blond ponytails poking out on top.

Her parents can’t drive her. They both have disabling vision problems; and, besides, they can’t afford a car. When Maddie was born in 2012 with the rare and usually fatal genetic condition called Zellweger syndrome, Meagan and Brandon Holt, then in their early 20s, were plunged into a world of overwhelming need — and profound poverty.

“We lost everything when Maddie got sick,” said Meagan Holt, now 27.

Multiple times each month, Maddie sees a team of specialists at Seattle Children’s Hospital who treat her for the condition that has left her nearly blind and deaf, with frequent seizures and life-threatening liver problems.

The only way Maddie can make the trip, more than an hour each way, is through a service provided by Medicaid, the nation’s health insurance program started more than 50 years ago as a safety net for the poor.

Called non-emergency medical transportation, or NEMT, the benefit is as old as Medicaid itself. From its inception, in 1966, Medicaid has been required to transport people to and from such medical services as mental health counseling sessions, substance abuse treatment, dialysis, physical therapy, adult day care and, in Maddie’s case, visits to specialists.

“This is so important,” said Holt. “Now that she’s older and more disabled, it’s crucial.”

More than 1 in 5 Americans, about 74 million people, now rely on Medicaid to pay for their health care. In California, one-third of the population — about 13.5 million people — are enrolled in the state’s Medicaid program, called Medi-Cal.

Nationally, the numbers have grown dramatically since the program expanded in California and 31 other states, plus the District of Columbia, to cover prescription drugs, health screening for children, breast and cervical cancer treatment and nursing home care.

With a Republican administration vowing to trim Medicaid, Kaiser Health News is examining how the U.S. has evolved into a “Medicaid Nation,” where millions of Americans rely on the program, directly and indirectly, often unknowingly.Medicaid’s role in transportation is a telling example. Included in the NEMT coverage are nearly 104 million trips each year at a cost of nearly $3 billion, according to a 2013 estimate, the most recent, by Texas researchers.

Citing runaway costs and a focus on patients taking responsibility for their health, Republicans have vowed to roll back the benefits, cut federal funding and give states more power to eliminate services they consider unaffordable.

Already, states have wide leeway in how to provide and pay for the transportation.

In California, Medi-Cal members in managed care get transportation through their health plans, while fee-for-service enrollees can arrange for the service through their counties, said Amber Christ, a Los Angeles-based staff attorney for Justice in Aging, a legal advocacy group.

Medi-Cal transportation is a “lifeline” for the low-income seniors she works with, she said.

“Most of them cannot afford a car, or if they have a car they can’t afford to keep gas in that car, or they can’t use public transportation,” she said. “Medicaid transportation is the only way they are going to their doctor appointments.”

California has not proposed cutting this service, but should the federal government slash Medicaid funding overall, “you could see where states would feel the pressure to make cuts, and this might be one of the first places to do that,” Christ said.

Proponents of limiting NEMT say the strategy will cut escalating costs and more closely mirror private insurance benefits, which typically don’t include transportation.

They also contend that changes will help curb what government investigators in 2016 warned is “a high risk for fraud and abuse” in the program. In recent years, the Centers for Medicare & Medicaid Services (CMS) reported that a Massachusetts NEMT provider was jailed and fined more than $475,000 for billing for rides attributed to dead people.

Last year, a public interest law office in Los Angeles sued a company contracted to provide transportation to Medicaid enrollees in California and other states for allegedly failing to provide “safe, reliable and timely transportation” to fragile patients — some with brain injuries and amputations. That caused them to miss appointments, the suit alleges.

Two ambulance programs in Connecticut paid almost $600,000 to settle claims that they provided transportation for dialysis patients who didn’t have medical needs for ambulance transportation. And the mother of a Medicaid patient who was authorized to transport her child for treatment billed Medicaid for trips that didn’t take place. She was sentenced to 30 days in jail and ordered to pay $21,500.

Last March, Rep. Susan Brooks, an Indiana Republican, introduced a resolutionthat would have revoked the federal requirement to provide NEMT in an effort to provide states with “flexibility.” That effort stalled.

Another Republican proposal in 2017 would have reversed the Affordable Care Act’s Medicaid expansion and reduced federal funding for the NEMT program. It failed, but other efforts by individual states still stand.

Former Health and Human Services Secretary Tom Price and CMS Administrator Seema Verma encouraged the nation’s governors to consider NEMT waivers, among other actions, in a March letter to them.

“We wish to empower all states to advance the next wave of innovative solutions to Medicaid challenges,” they wrote. The Trump administration has used state waivers to bypass or unravel a number of the Obama administration’s more expansive health policies, and has granted some states’ requests.

At least three states, Iowa, Indiana and Kentucky, have received federal waivers — and extensions —allowing them to cut Medicaid transportation services. Massachusetts has a waiver pending.

Critics of the cuts worry the trend will accelerate, leaving poor and sick patients with no way to get to medical appointments.

“I wouldn’t be surprised to see more of these waivers in the pipeline,” said Joan Alker, executive director of the Georgetown University Center for Children and Families.

Because medical transportation isn’t typically covered by the commercial insurance plans most Americans use, it’s unfamiliar to many people and could be seen as unnecessary, said Eliot Fishman, senior director of health policy for Families USA, a nonprofit, nonpartisan consumer health advocacy group.

Formerly a Medicaid official in the federal government, Fishman called the transportation program “vital” not only for children with severe disabilities, but also for non-elderly, low-income adults.

CMS released results of a 2014 survey of Medicaid users, which found that lack of transportation was the third-greatest barrier to care for adults with disabilities, with 12.2 percent of those patients reporting they couldn’t get a ride to a doctor’s office.

“This is not something to be trifled with lightly,” Fishman said. “We’re talking about a lifesaving aspect of the Medicaid program.”

About 3.6 million Americans miss or delay non-emergency medical care each year because of transportation problems, according to a 2005 study published by the National Academy of Sciences.

That same study analyzed costs for providing NEMT to patients facing 12 common medical conditions and found that providing additional transportation is cost-effective. For four of those conditions — prenatal care, asthma, heart disease and diabetes — medical transportation saved money when the total costs for both transportation and health care were tallied.

Medicaid is required to provide NEMT services using the most appropriate and least costly form of transportation, whether that’s taxis, vans or public transit.

Most states rely on NEMT brokers or managed-care organizations to administer the transportation services. Other states run the service directly, paying providers on a per-ride basis, while some use local ride services and pay independent taxi firms to shuttle patients.

Proponents of revamping NEMT note that disabled children like Maddie and other people with serious disabilities are in little danger of losing services. In Iowa and Indiana, Medicaid transportation remains available to several groups of patients, including those classified as “medically frail,” though the definition of who qualifies can vary widely.

In addition, one managed-care provider, Anthem, continues to transport Indiana Medicaid patients, despite the waiver that was first enacted in 2007.

Still, Medicaid clients like Fallon Kunz, 29, of Mishawaka, Ind., are often stuck. Kunz, who has cerebral palsy, migraine headaches and chronic pain, uses a power wheelchair. When she was a child, she qualified for door-to-door service to medical appointments, she said.

Today, she lives with her father, whose home is outside the route of a Medicaid transit van. Getting to and from medical appointments for her chronic condition is a constant struggle, she said. Taxis are too expensive: $35 each way for a wheelchair-enabled cab.

“The only way I can get rides to and from my doctor’s appointment is to ride the 2 miles in my wheelchair, despite all kinds of weather, from my home, across the bridge, to the grocery store,” she said. “Right outside the grocery store is the bus stop. I can catch the regular bus there.”

Sometimes, she’s in too much pain or the Indiana weather — warm and humid in the summer, frigid and windy in the winter — is too much to battle and she skips the appointment.

“Today I didn’t go because it was too cold and my legs hurt too much,” she said on a December Tuesday. “I didn’t feel like getting blown off the sidewalk.”

In Maddie Holt’s case, she was shuttled to Seattle Children’s on a rainy Tuesday morning in a medical van driven by Donavan Dunn, a 47-year-old former big-rig trucker. He works for Northwest Transport, one of several regional brokers that manage NEMT services for Washington state.

Dunn said he received special training to transport patients like Maddie, who is loaded onto a motorized platform, wheelchair and all, into the van and then carefully strapped in.

“I have to drive different,” said Dunn. “I have to watch my corners, watch my starts, watch my stops. It’s always in the back of my mind that I have somebody on board that’s fragile.”

We’re talking about a lifesaving aspect of the Medicaid program.

Eliot Fishman, senior director of health policy for Families USA

The transportation service can be used only for medical visits to the specialists who treat Maddie’s condition, which is caused by mutations in any one of at least 12 genes. If Meagan Holt needs to pick up prescriptions or get groceries, she leaves Maddie and a second daughter, Olivia, 3, at home with their dad and takes the bus or walks to her destinations.

Caring for a severely disabled child is not the life she expected, Meagan Holt said, but she cherishes time with Maddie, who has learned to communicate through tactile sign language spelled into her hand.

“She knows about 100 words. She knows the alphabet,” Meagan said. “She likes Disney princesses. She loves ‘Frozen.’”

Maddie is one of hundreds of NEMT-eligible children transported to Seattle Children’s each month. Last September, for instance, more than 1,300 clients made more than 3,600 trips at a cost of more than $203,000, according to the Washington Health Care Authority, which oversees the state’s Medicaid program called Apple Health.

The need is so great, in fact, that the hospital created a transportation will-call desk to help organize the comings and goings.

“When we realized how much transportation is a barrier to getting to your appointment, we decided to do something about it,” said Julie Povick, manager of international exchanges and guest services at Seattle Children’s.

“The majority of our patients are in survival mode,” Povick added. “You need a lot of handholding.”

But Verma, the architect of Indiana’s Medicaid overhaul plan, has suggested that too much handholding might be “counterproductive” for patients — and bad for the country.

In a 2016 Health Affairs essay, Verma noted that early analysis of the effects of curtailing NEMT in Indiana showed that more Medicaid patients with access to the program said transportation was a primary reason for missed appointments than did members without access.

“Moreover, 90 percent of [Healthy Indiana Plan] members report having their own transportation or the ability to rely on family and friends for transportation to health care appointments,” she wrote.

But Marsha Simon, a Washington, D.C., health policy consultant who has tracked NEMT for years, said Medicaid is the option of last resort. People who are able to get rides on their own already do.

“If 90 percent can and 10 percent can’t, what about the 10 percent?” Simon said.

It’s a question that haunts Kunz every day.

“I’m a college student, I have a cat,” said Kunz, who is studying psychology online at Southern New Hampshire University. “I’m just a regular human trying to do things, and the inaccessibility in this area is ridiculous.”