“Later this year, the federal government is supposed to start a serious attempt to rein in drug prices: For the first time, Medicare will negotiate with pharmaceutical companies over the prices it’s willing to pay for a short list of drugs. It’s a long-awaited change that is supposed to save the government and patients billions of dollars over time.
But the drug industry is now launching a legal fight aimed at stopping Medicare’s negotiations over prescription drug prices before they begin. The stakes are higher than just a drug price reform: The case could set an important precedent for the government’s authority to try to constrain health care prices.”
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“The Merck lawsuit focuses on the Constitution’s takings (or compensation) clause in the Fifth Amendment, which protects private owners from having property taken without “just compensation” by the government. It also raises First Amendment claims centered on the law’s requirements that drugmakers not disclose information they receive from the government as part of the negotiations. The Chamber of Commerce’s case rests on a constitutional right to due process, arguing that, because the Medicare negotiations are exempt from review by the courts under the IRA, drugmakers are being denied due process.
Taken together, the lawsuits give any judges predisposed to side with private industry over the federal government a few options for a legal foundation upon which to base a decision in pharma’s favor.
A number of legal experts say they are skeptical of these arguments. Merck’s takings clause case turns on defining a patent — an issuance from the government — as private property subject to the just compensation clause, said Robin Feldman, a law professor at UCSF, a difficult assertion. She also said the premise present in both cases — that the federal government as a health care purchaser through Medicare can’t say no to the companies it purchases drugs from and can’t dictate prices as the consumer — is “problematic.”
“It can’t be that the government as a buyer has to pay whatever a seller wants to charge,” she said. “That the government could be forced to spend itself into bankruptcy.”
Regarding the chamber’s due process claim, several legal experts have pointed out that Medicare’s various contracts with health care providers are already often generally exempted from judicial review. It is understood that this is necessary to allow the program to function; the government, as the administrator of the program, needs that authority without each of its decisions being subject to litigation.”
“Pharmacy benefit managers are companies that, behind the scenes, determine what patients have to pay for medications. They manage insurance benefits for prescription drugs, dictating which drugs are covered by insurers and what costs patients will face when they fill their prescriptions.
To do that, they negotiate discounts, or rebates, with drug manufacturers and afford privileged status to the companies that give them the best deals.
And over the past few decades, as the prescription drug market has evolved and become more lucrative, so have PBMs. They run their own mail-order and specialty pharmacies. More recently, they have begun merging with health insurers, creating behemoth companies with the power to determine where and how billions of dollars are spent within the US health system.
Pharmacy benefit managers have become known as the mysterious middlemen of the pharma trade — and as a useful scapegoat for drug companies seeking to deflect blame from their own pricing practices.
Now the Senate, as part of forthcoming prescription drug legislation, appears poised to impose new rules on them. The committee overseeing health care debated last week a slew of measures requiring PBMs to be more transparent about their business and cracking down on some of their moneymaking practices.”
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“Experts generally agree that these companies play a role in driving up drug costs for some US patients, even as they negotiate discounts with drugmakers that benefit others, and that the amount of secrecy about their financial arrangements warrants scrutiny.
But reforms to the PBM industry aren’t a cure-all for making drugs more affordable: Sanders said the PBM measures being considered in the Senate would not meaningfully lower the cost of medicine for most people, even if they would bring more accountability and transparency to the sector.”
“Hundreds of thousands of Americans lost their Medicaid benefits in April, as emergency pandemic provisions that kept people enrolled over the past few years began to end. The coverage losses are going to only grow.
In Florida, nearly 250,000 people lost Medicaid coverage in April, as states began a process to check whether everyone currently enrolled in Medicaid still meets the eligibility criteria. About 73,000 people were also deemed ineligible in Arkansas. Another 53,000 had their coverage terminated in Indiana and 40,000 were removed from Medicaid in Arizona.
Policy experts and advocates warned before the eligibility checks began that people who are still eligible for Medicaid could lose their insurance due to administrative problems, such as not receiving mail from the state or not returning documentation to confirm they are still eligible. Now the early evidence suggests that’s exactly what is happening.”
“Almost half of people on Medicare, 31 million Americans, are now enrolled in a Medicare Advantage plan, nearly double the share of 10 years ago. It is widely assumed that Medicare Advantage will cover a majority of the program’s beneficiaries within the next few years.”
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“Medicare Advantage allows private insurers to offer their own plans that provide Medicare benefits as well as some additional perks not available in the original program. The secret to the program’s success is simplicity. Traditional Medicare is a fragmented program; Part A covers hospital care and Part B covers outpatient services. Patients must enroll in a separate Part D plan for prescription drug coverage that is administered by private insurers. Most people also purchase supplemental coverage, extra insurance that helps reduce their out-of-pocket costs.
Medicare Advantage, also known as Part C, combines those benefits into one insurance plan that also includes an annual limit on out-of-pocket costs, something that does not technically exists in regular Medicare.
But the benefits to patients seem to come at a cost to taxpayers. Though the health insurance industry disputes these findings, MedPAC, the independent committee tasked with overseeing Medicare on Congress’s behalf, found Medicare Advantage plans cost the federal government more money per patient than the original program would have if those same people had stuck with the traditional benefits.
Private companies are also making healthy margins on their Medicare business.”
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“Medicare Advantage enrollees are more likely to report trouble affording health care than people on traditional Medicare. Some of the behavior by Medicare Advantage plans, such as using AI to decide when to stop covering services for their enrollees, may be becoming more common in the private sector but is still unheard of for public programs.
The trade-off the United States seems to be making is accepting more administrative bloat and more stringent provision of benefits in exchange for a more navigable Medicare plan. The trade-off is one other countries have made as they designed universal health care programs. (A similar trend is underway in Medicaid.)
But as concern grows about Medicare facing a potential financial cliff, and evidence mounts about the costs of Medicare Advantage, the risks of the trade-off are becoming clearer. Medicare is no longer what it used to be: Once the epitome of government-run health insurance, its benefits are on the verge of being primarily funneled through private companies. Any attempts to change the program will have to wrestle with that reality.”
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“In traditional Medicare, for example, patients can go to any doctor or hospital that accepts Medicare; Medicare Advantage has more limited provider networks, and patients can be on the hook for higher costs if they are treated at an out-of-network doctor or hospital.
The federal government pays Medicare Advantage plans a flat rate for the expected cost of covering their particular customers and the insurers are required to adhere to certain rules about benefits and costs. But companies still have flexibility about how to run their plans and have a financial incentive to limit expenses. The less money they spend, the more they get to keep for themselves.
Still, customers will vote with their feet and, after slower-than-expected initial uptake, Medicare Advantage is now growing so quickly that it will soon be the dominant form of Medicare.”
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“The premiums people pay for a Medicare Advantage plan can be significantly lower than the combined cost of supplemental coverage and a Part D plan — less than $50 compared to more than $200 on average, per Terry and Muhlestein — with the added benefit of having only a single insurance card. According to a 2022 Commonwealth Fund survey, the additional benefits offered by Medicare Advantage plans (such as dental or vision) and the limits on out-of-pocket costs were the most common reasons seniors gave for choosing the alternative over the original program.”
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“Medicare Advantage patients are less likely to receive medical care at the highest-rated facilities for their particular needs, compared to people with traditional Medicare, a reflection of more restrictive provider networks.”
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“A report from federal investigators published in April 2022 found that tens of thousands of Medicare Advantage customers were denied coverage for services they should have been entitled to. A significant number of prior authorization denials (13 percent) and payment denials (19 percent) reviewed by the investigators were for services that should have been covered by the program but were not.”
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“According to MedPac, since 2004, Medicare has always paid more to Medicare Advantage plans for the cost of covering their customers than the program would have spent if the same beneficiaries had instead been enrolled in traditional Medicare. Some years, the private plans were receiving a nearly 20 percent markup compared to the original benefit structure.”
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“The growth of Medicare Advantage is contributing to the financial crunch. Those plans receive funding based on the type of service provided to their customer, which means money for hospital care comes from Part A. Annual Part A payments to Medicare Advantage plans are expected to increase from about $176 billion in 2022 to $336 billion by 2030.
With revived concerns over Medicare’s solvency and evidence of excess spending in Medicare Advantage, policymakers are starting to look at making changes to the program. But that won’t be easy.”
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“States have outsourced much of the administration of Medicaid to managed care plans. Countries like the Netherlands have set up health systems that use private insurers, operating under strict government oversight, to provide insurance benefits to their citizens. Giving people more choice and a more streamlined experience can have its benefits, as evidenced by the popularity of Medicare Advantage in the US.
But asking private actors, with profit motivations, to administer government benefits to which people are supposed to be entitled brings risks. People are more likely to have trouble affording health care and their claims are more likely to be denied; that is true in places like the Netherlands, compared to other countries with more direct government administration, and that is true of Medicare Advantage when compared to the traditional Medicare program.”
“Perhaps the greatest success of the American health care system these last few benighted years is this surprising fact: The uninsured rate has reached a historic low of about 8 percent.
That’s thanks in part to the pandemic — or, more precisely, the slew of emergency provisions that the government enacted in response to the Covid crisis.
One policy was likely the single largest factor. Over the past three years, under an emergency pandemic measure, states have stopped double-checking if people who are enrolled in Medicaid are still eligible for its coverage. If you were enrolled in Medicaid in March 2020, or if you became eligible at any point during the pandemic, you have remained eligible the entire time no matter what, even if your income later went up.
But in April, that will end — states will be re-checking every Medicaid enrollee’s eligibility, an enormous administrative undertaking that will put health insurance coverage for millions of Americans at risk.
The Biden administration estimates upward of 15 million people — one-sixth of the roughly 90 million Americans currently receiving Medicaid benefits — could lose coverage, a finding that independent analysts pretty much agree with. Those are coverage losses tantamount to a major economic downturn: By comparison, from 2007 to 2009, amid the worst economic downturn of most Americans’ lifetimes, an estimated 9 million Americans lost their insurance.”
“Health care policy researchers Erin C. Fuse Brown and Elizabeth McCuskey tracked the number of unique single-payer bills introduced in state legislatures across the country from 2010 to 2019, finding a sharp uptick in bills introduced since 2017. During each of those three years, at least 10 single-payer proposals were introduced, according to Brown and McCuskey’s research, for the first time since 2013. In total, state legislators proposed more single-payer bills from 2017 to 2019 than in the previous seven years combined. And for 2021, we’ve identified 10 single-payer bills that legislators introduced across the country, from liberal states like California and Massachusetts to more conservative ones including Iowa and Ohio.1
What do all these proposals have in common? They’ve all universally failed. In fact, Vermont, the only state that managed to pass single-payer health care in 2011, ended up shelving its plan three years later.”
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“passing single-payer health care at the state level is next to impossible, as states are particularly limited in how they can allocate federal and private health care funds. There is, however, evidence that Americans may have an appetite for a public option, or government-run health insurance that people can opt into at the state level. Three states (Colorado, Nevada and Washington) have already passed a public option. It’s not single-payer health care reform, but it’s possible that we might see more states adopt their own public-option reforms.
One big reason single-payer proposals haven’t caught on at the state level is because finding a reliable way to pay for such a program is challenging. Single-payer advocates originally envisioned a federal proposal that would cover all Americans under a more generous version of a preexisting program — that is, Medicare, but now for all. Doing this state-by-state would require each state to apply for waivers to divert federal funds used for Medicare, Medicaid and Affordable Care Act exchanges to be used for their own single-payer plans. And that’s tricky because the Department of Health and Human Services has wide discretion to approve or deny states’ requests, which makes any proposal highly dependent on the national political climate.”
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“Employer-sponsored health insurance plans, which cover 54 percent of Americans, are another hurdle for states trying to pass single-payer health care. Federal law largely prevents states from regulating employer-provided health insurance, so states can’t just stop employers from offering their own health care benefits. The exact scope of this law has been litigated for decades, but suffice it to say that it’s successfully put the kibosh on many statewide health care reforms. Single-payer health insurance is particularly tricky as there’s no way to get everyone onto the plan without first changing how private insurance works. States have tried to address this through measures like increasing payroll taxes or restricting providers’ ability to accept reimbursement from private insurance plans. But the more elaborate these mechanisms get, the more complicated it becomes to implement — and the more people that could slip through the cracks.
Finally, another big financial barrier is that state governments have far less leeway than the federal government to increase budgetary spending. That means tax increases, which come with their own political challenges, are often necessary for states to secure the funding they need.”
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“All of this creates a daunting picture for statewide single-payer health care.”
“The United States health system, more than any other in the developed world, forces patients to manage their health care on their own. They pay a lot of their own money for medical care. They have to make sure their specific doctor is covered by their specific insurer. And even if their doctor believes they need a certain treatment, patients must follow rules set by their health insurer, or risk delays in treatment or ultimately having their insurance claims denied.
Patients run into these obstacles all the time — with serious consequences for their well-being. A recurring finding in health care research is that when patients run into any friction, whether high cost-sharing, limited access to providers, or something else, they tend to receive less timely and appropriate care. Over time, that will make people more likely to develop serious health conditions and, ultimately, die younger than they would with proper care.
It starts with the sheer cost of health care to US patients. Out-of-pocket spending per person is higher in the US than in any other wealthy country save Switzerland, and roughly twice as much as in countries like the UK, the Netherlands, and Japan. Recent research has found that even small cost obligations, as little as $10 for a prescription, can discourage patients from taking their medicine as prescribed. A third of Americans have reported in public opinion surveys that they skip medications or other necessary medical care because of the cost.
But the US health system puts up other, subtler hurdles. Insurers don’t cover care at every doctor’s practice or hospital; they instead contract with certain providers to create provider networks, within which their patients must seek care for their treatment to be covered. These networks put the onus on patients to figure out where they can go for care, at the risk of incurring huge medical bills if they get it wrong. That problem came to the forefront in the recent debate over surprise billing: Many people were going to the hospital for an emergency, only to find out after the fact that either the hospital or a doctor who treated them was not covered by their insurer.
That has been a common experience for American patients: About one in four heart attacks lead to the patient being charged for out-of-network care in the emergency department or if they are admitted.
Networks also make shopping for health insurance more difficult. Patients have to try to figure out in advance whether their existing primary care doctor or specialists, or the local hospital, will be covered by their new plan.”
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“Patients can run into the same kind of problem with drug formularies, a list of approved drugs that health plans use to prioritize coverage for certain medications. If a drug is not on a plan’s formulary, customers must pay more of their money than they would for approved drugs. Sorting out which drugs are covered or preferred under a health plan’s formulary can be a headache, and research has shown that such restrictions lead to patients using fewer medications.”
“About 4.6 million people signed up for Obamacare through the fifth week of open enrollment, with roughly 923,000 people newly enrolled, according to the Centers for Medicare and Medicaid Services.
Enrollment is up 20 percent in Texas and 9 percent in Florida compared to this time last year, administration officials told reporters…crediting increased subsidies from the American Rescue Plan.”
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“These two states also have some of the highest uninsured rates in the country. Texas leads the nation with 17.5 percent of its population uninsured, according to the Kaiser Family Foundation. Florida ranks fifth, with 12.3 percent of its population uninsured.”
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“Overall, states that have not expanded Medicaid — which includes Florida and Texas — saw a 9 percent uptick in enrollment, officials said.”
“I document a large and mounting body of empirical research that shows that key market-based policies in health care have failed. Even if well intended, these policies have often not helped people make meaningful choices of medical care or insurance plans. And neither have they controlled spending, as experts promised.
In fact, they are doing exactly the opposite. They are setting people up to make poor choices and are scaffolding a massive, ineffective market bureaucracy.
One-third of people said they would rather file their taxes than read the terms of a health plan. And reams of studies summarized in my article affirm that people do not choose well among health insurance plan options, and these errors are hard to remedy with anything short of a strong default plan—in which case, one must ask whether “choice” even matters.
Likewise, even when people have to pay a large share of their own medical care and have easy access to price information, they still do not compare prices or choose the lowest-price options, even for services with little variation in quality. One partial explanation is that health care patients look to doctors—not price lists—to steer their care. Patients lack the desire, time, knowledge, and skills to navigate medical decisions as “consumers.”
The focus of the last several decades of health regulation has been to try to fix broken markets and flawed consumers through constant regulatory, technocratic tinkering—either to spur competition or to nudge consumers toward better choices. This tinkering has fallen short, and it has produced a massive market-based bureaucracy.
Thick layers of government regulations and regulators attempt to scaffold failing market-based policies. Plus, this scaffolding has deeply embedded private health care enterprises—with high profits and salaries—into the bureaucracy. As one example, the 2018 salary for the CEO of Blue Cross and Blue Shield of Michigan was recently reported to be $19 million, which is not an unusual sum among health care executives.
Because markets do not meaningfully enhance choice, do not avoid bureaucracy, and have certainly not solved cost problems, it is time to stop tinkering and to seek a better foundation for the next era of health policy and regulation.”
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“It is time to give up the false hope that health care markets and individual purchase decisions will produce a health care system that Americans want and, in the process, drive down spending. Policymakers have spent a half-century avoiding the hard questions about what values, objectives, and tradeoffs should guide health policy, by hoping that markets would magically answer these questions.
The reality is that the only way to build effective health policy—and, in turn, health regulation—is by engaging deeply in these hard questions and the challenging political battles they necessarily provoke.”