Stephanie Armour
Mon, 01 Jul 2024 15:30:00 +0000

A landmark Supreme Court decision that reins in federal agencies' authority is expected to hold dramatic consequences for the nation's health care system, calling into question government rules on anything from consumer protections for patients to drug safety to nursing home care.

The June 28 decision overturns a 1984 precedent that said courts should give deference to federal agencies in legal challenges over their regulatory or scientific decisions. Instead of giving priority to agencies, courts will now exercise their own independent judgment about what Congress intended when drafting a particular law.

The ruling will likely have seismic ramifications for health policy. A flood of litigation — with plaintiffs like small businesses, drugmakers, and hospitals challenging regulations they say aren't specified in the law — could leave the country with a patchwork of disparate health regulations varying by location.

Agencies such as the FDA are likely to be far more cautious in drafting regulations, Congress is expected to take more time fleshing out legislation to avoid legal challenges, and judges will be more apt to overrule current and future regulations.

Health policy leaders say patients, providers, and health systems should brace for more uncertainty and less stability in the health care system. Even routine government functions such as deciding the rate to pay doctors for treating Medicare beneficiaries could become embroiled in long legal battles that disrupt patient care or strain providers to adapt.

Groups that oppose a regulation could search for and secure partisan judges to roll back agency decision-making, said Andrew Twinamatsiko, director of the Health Policy and the Law Initiative at Georgetown University's O'Neill Institute. One example could be challenges to the FDA's approval of a medication used in abortions, which survived a Supreme Court challenge this term on a technicality.

“Judges will be more emboldened to second-guess agencies,” he said. “It's going to open agencies up to attacks.”

Regulations are effectively the technical instructions for laws written by Congress. Federal agency staffers with knowledge related to a law — say, in drugs that treat rare diseases or health care for seniors — decide how to translate Congress' words into action with input from industry, advocates, and the public.

Up until now, when agencies issued a regulation, a single rule typically applied nationwide. Following the high court ruling, however, lawsuits filed in more than one jurisdiction could result in contradictory rulings and regulatory requirements — meaning health care policies for patients, providers, or insurers could differ greatly from one area to another.

One circuit may uphold a regulation from the Centers for Disease Control and Prevention, for example, while other circuits may take different views.

“You could have eight or nine of 11 different views of the courts,” said William Buzbee, a professor at Georgetown Law.

A court in one circuit could issue a nationwide injunction to enforce its interpretation while another circuit disagrees, said Maura Monaghan, a partner at Debevoise & Plimpton. Few cases are taken up by the U.S. Supreme Court, which could leave clashing directives in place for many years.

In the immediate future, health policy leaders say agencies should brace for more litigation over controversial initiatives. A requirement that most Affordable Care Act health plans cover preventive services, for example, is already being litigated. Multiple challenges to the mandate could mean different coverage requirements for preventive care depending on where a consumer lives.

Drugmakers have sued to try to stop the Biden administration from implementing a federal law that forces makers of the most expensive drugs to negotiate prices with Medicare — a key cog in President Joe Biden's effort to lower drug prices and control health care costs.

Parts of the health care industry may take on reimbursement rates for doctors that are set by the Centers for Medicare & Medicaid Services because those specific rates aren't written into law. The agency issues rules updating payment rates in Medicare, a health insurance program for people 65 or older and younger people with disabilities. Groups representing doctors and hospitals regularly flock to Washington, D.C., to lobby against trims to their payment rates.

And providers, including those backed by deep-pocketed investors, have sued to block federal surprise-billing legislation. The No Surprises Act, which passed in 2020 and took effect for most people in 2022, aims to protect patients from unexpected, out-of-network medical bills, especially in emergencies. The high court's ruling is expected to spur more litigation over its implementation.

“This really is going to create a tectonic change in the administrative regulatory landscape,” Twinamatsiko said. “The approach since 1984 has created stability. When the FDA or CDC adopt regulations, they know those regulations will be respected. That has been taken back.”

Industry groups, including the American Hospital Association and AHIP, an insurers' trade group, declined to comment.

Agencies such as the FDA that take advantage of their regulatory authority to make specific decisions, such as the granting of exclusive marketing rights upon approval of a drug, will be vulnerable. The reason: Many of their decisions require discretion as opposed to being explicitly defined by federal law, said Joseph Ross, a professor of medicine and public health at Yale School of Medicine.

“The legislation that guides much of the work in the health space, such as FDA and CMS, is not prescriptive,” he said.

In fact, FDA Commissioner Robert Califf said in an episode of the “Healthcare Unfiltered” podcast last year that he was “very worried” about the disruption from judges overruling his agency's scientific decisions.

The high court's ruling will be especially significant for the nation's federal health agencies because their regulations are often complex, creating the opportunity for more pitched legal battles.

Challenges that may not have succeeded in courts because of the deference to agencies could now find more favorable outcomes.

“A whole host of existing regulations could be vulnerable,” said Larry Levitt, executive vice president for health policy at KFF.

Other consequences are possible. Congress may attempt to flesh out more details when drafting legislation to avoid challenges — an approach that may increase partisan standoffs and slow down an already glacial pace in passing legislation, Levitt said.

Agencies are expected to be far more cautious in writing regulations to be sure they don't go beyond the contours of the law.

The Supreme Court's 6-3 decision overturned Chevron U.S.A. v. Natural Resources Defense Council, which held that courts should generally back a federal agency's statutory interpretation as long as it was reasonable. Republicans have largely praised the new ruling as necessary for ensuring agencies don't overstep their authority, while Democrats said in the aftermath of the decision that it amounts to a judicial power grab.

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By: Stephanie Armour
Title: The Supreme Court Just Limited Federal Power. Health Care Is Feeling the Shockwaves.
Sourced From: kffhealthnews.org/news/article/supreme-court-chevron-deference-doctrine-health-care-policy-shockwaves/
Published Date: Mon, 01 Jul 2024 15:30:00 +0000

John Rossheim
Mon, 01 Jul 2024 09:00:00 +0000

“You had to pay the fee, or the doctor wasn't going to see you anymore.”

That was the takeaway for Terri Marroquin of Midland, Texas, when her longtime physician began charging a membership fee in 2019. She found out about the change when someone at the physician's front desk pointed to a posted notice.

At first, she stuck with the practice; in her area, she said, it is now tough to find a primary care doctor who doesn't charge an annual membership fee from $350 to $500.

But last year, Marroquin finally left to join a practice with no membership fee where she sees a physician assistant rather than a doctor. “I had had enough. The concierge fee kept going up, and the doctor's office kept getting nicer and nicer,” she said, referring to the décor.

With the national shortage of primary care physicians reaching 17,637 in 2023 and projected to worsen, more Americans are paying for the privilege of seeing a doctor — on top of insurance premiums that cover most services a doctor might provide or order. Many people seeking a new doctor are calling a long list of primary care practices only to be told they're not taking new patients.

“Concierge medicine potentially leads to disproportionately richer people being able to pay for the scarce resource of physician time and crowding out people who have lower incomes and are sicker,” said Adam Leive, lead author of a 2023 study on concierge medicine and researcher at University of California-Berkeley's Goldman School of Public Policy.

Leive's research showed no decrease in mortality for concierge patients compared with similar patients who saw non-concierge physicians, suggesting concierge care may not notably improve some health outcomes.

A 2005 study showed concierge physicians had smaller proportions of patients with diabetes than their non-concierge counterparts and provided care for fewer Black and Hispanic patients.

There's little reliable data available on the size of the concierge medicine market. But one market research firm projects that concierge medicine revenue will grow about 10.4% annually through 2030. About 5,000 to 7,000 physicians and practices provide concierge care in the United States, most of whom are primary care providers, according to Concierge Medicine Today. (Yes, the burgeoning field already has a trade publication.)

The concierge pitch is simple: More time with your doctor, in-person or remotely, promptly and at your convenience. With many primary care physicians caring for thousands of patients each in appointments of 15 minutes or less, some people who can afford the fee say they feel forced to pay it just to maintain adequate access to their doctor.

As primary care providers convert to concierge medicine, many patients could face the financial and health consequences of a potentially lengthy search for a new provider. With fewer physicians in non-concierge practices, the pool available to people who can't or won't pay is smaller. For them, it is harder to find a doctor.

Concierge care models vary widely, but all involve paying a periodic fee to be a patient of the practice.

These fees are generally not covered by insurance nor payable with a tax-advantaged flexible spending account or health savings account. Annual fees range from $199 for Amazon's One Medical (with a discount available for Prime members) to low four figures for companies like MDVIP and SignatureMD that partner with physicians, to $10,000 or more for top-branded practices like Massachusetts General Hospital's.

Many patients are exasperated with the prospect of pay-to-play primary care. For one thing, under the Affordable Care Act, insurers are required to cover a variety of preventive services without a patient paying out-of-pocket. “Your annual physical should be free,” said Caitlin Donovan, a spokesperson for the National Patient Advocate Foundation. “Why are you paying $2,000 for it?”

Liz Glatzer felt her doctor in Providence, Rhode Island, was competent but didn't have time to absorb her full health history. “I had double mastectomy 25 years ago,” she said. “At my first physical, the doctor ran through my meds and whatever else, and she said, ‘Oh, you haven't had a mammogram.' I said, ‘I don't have breasts to have mammography.'”

In 2023, after repeating that same exchange during her next two physicals, Glatzer signed up to pay $1,900 a year for MDVIP, a concierge staffing service that contracts with her new doctor, who is also a friend's husband. In her first couple of visits, Glatzer's new physician took hours to get to know her, she said.

For the growing numbers of Americans who can't or won't pay when their doctor switches to concierge care, finding new primary care can mean frustration, delayed or missed tests or treatments, and fragmented health care.

“I've met so many patients who couldn't afford the concierge services and needed to look for a new primary care physician,” said Yalda Jabbarpour, director of the Robert Graham Center and a practicing family physician. Separating from a doctor who's transitioning to concierge care “breaks the continuity with the provider that we know is so important for good health outcomes,” she said.

That disruption has consequences. “People don't get the preventive services that they should, and they use more expensive and inefficient avenues for care that could have otherwise been provided by their doctor,” said Abbie Leibowitz, chief medical officer at Health Advocate, a company that helps patients find care and resolve insurance issues.

What happens to patients who find themselves at loose ends when a physician transitions to concierge practice?

Patients who lose their doctors often give up on having an ongoing relationship with a primary care clinician. They may rely solely on a pharmacy-based clinic or urgent care center or even a hospital emergency department for primary care.

Some concierge providers say they are responding to concerns about access and equity by allowing patients to opt out of concierge care but stay with the practice group at a lower tier of service. This might entail longer waits for shorter appointments, fewer visits with a physician, and more visits with midlevel providers, for example.

Deb Gordon of Cambridge, Massachusetts, said she is searching for a new primary care doctor after hers switched to concierge medicine — a challenge that involves finding someone in her network who has admitting privileges at her preferred hospitals and is accepting new patients.

Gordon, who is co-director of the Alliance of Professional Health Advocates, which provides support services to patient advocates, said the practice that her doctor left has not assigned her a new provider, and her health plan said it was OK if she went without one. “I was shocked that they literally said, ‘You can go to urgent care,'” she said.

Some patients find themselves turning to physician assistants and other midlevel providers. But those clinicians have much less training than physicians with board certification in family medicine or internal medicine and so may not be fully qualified to treat patients with complex health problems. “The expertise of physician assistants and nurse practitioners can really vary widely,” said Russell Phillips, director of the Harvard Medical School Center for Primary Care.

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By: John Rossheim
Title: The Concierge Catch: Better Access for a Few Patients Disrupts Care for Many
Sourced From: kffhealthnews.org/news/article/concierge-medicine-primary-care-doctor-pay-to-play/
Published Date: Mon, 01 Jul 2024 09:00:00 +0000

Did you miss our previous article…
https://www.galvestontrendingnews.com/kaiser-health-news/supreme-court-oks-local-crackdowns-on-homelessness-as-advocates-warn-of-chaos/

Angela Hart
Fri, 28 Jun 2024 20:27:00 +0000

The U.S. Supreme Court's watershed decision on homelessness Friday will make it easier for elected officials and law enforcement authorities nationwide to fine and arrest people who live on streets and sidewalks, in broken-down vehicles, or within city parks — which could have far-reaching health consequences for homeless Americans and their communities.

In a 6-to-3 ruling in City of Grants Pass v. Johnson, the justices in the majority said allowing the targeting of homeless people occupying public spaces by enforcing bans on public sleeping or camping with criminal or civil penalties is not cruel and unusual punishment, even if there are no alternative shelter or housing options available for them.

“It's hard to imagine the chaos that is going to ensue. It'll have horrible consequences for mental and physical health,” said Ed Johnson, director of litigation at the Oregon Law Center and lead attorney representing homeless defendants in the case.

“If people aren't allowed to engage in survival while living outside by having things like a blanket and a pillow, or a tarp and a sleeping bag, and they don't have anywhere else to go, they can die,” he said.

The case, the most consequential on homelessness in decades, comes amid widespread public frustration over the proliferation of homeless encampments — especially in Western cities such as Los Angeles, San Francisco, Phoenix, and Portland, Oregon — and the unsafe and unsanitary conditions that often fester around them.

An estimated 653,100 people were homeless in the United States in 2023, according to the most recent federal estimates, the vast majority residing in shanties, broken-down recreational vehicles, and sprawling tent camps scattered across urban and rural communities.

The Oregon city of Grants Pass, at the center of the legal battle, successfully argued that it was not cruel and unusual punishment to fine and arrest homeless people living outdoors or illegally camping on public property.

Mike Zacchino, a spokesperson for Grants Pass, issued a statement Friday that the city was “grateful” to receive the decision and is committed to assisting residents struggling to find stable housing. Theane Evangelis, the city's lead attorney, told the Supreme Court in April that if it couldn't enforce its anticamping laws, “the city's hands will be tied. It will be forced to surrender its public spaces.”

In the majority opinion, Justice Neil Gorsuch argued that the homelessness crisis is complex and has many causes, writing, “With encampments dotting neighborhood sidewalks, adults and children in these communities are sometimes forced to navigate around used needles, human waste, and other hazards to make their way to school, the grocery store, or work.”

However, Gorsuch wrote, the Eighth Amendment does not give the Supreme Court justices primary responsibility “for assessing those causes and devising those responses.” A handful of federal judges cannot “begin to ‘match' the collective wisdom the American people possess in deciding ‘how best to handle' a pressing social question like homelessness,” he wrote.

In a dissenting opinion, Justice Sonia Sotomayor wrote that the decision focuses on the needs of local government and “leaves the most vulnerable in our society with an impossible choice: Either stay awake or be arrested.”

Elected officials, both Republican and Democrat, have increasingly argued that life on the streets is making people sick — and they should be allowed to relocate people for health and safety.

“If government offers people help and they can't or won't accept it, there should be consequences. We have laws that need to be used,” said Sacramento Mayor Darrell Steinberg, who is an adviser to California Gov. Gavin Newsom on homelessness, referencing laws that allow the state to require mental health and addiction treatment, for instance.

The high court decision could further embolden cities to sweep encampments and could force homeless people to be more transient — constantly moving around to evade law enforcement. Sometimes they're offered shelter, but often there is nowhere to go. Steinberg believes many cities will more aggressively sweep encampments and keep homeless people on the move, but he does not believe they should be fined or arrested.

“I'm comfortable telling people that you can't camp in public, but I would not criminalize it,” he said. “Some cities will fine and arrest people.”

Advocates for homeless people say constant relocations will further imperil the health of this population and magnify public health threats, such as the spread of communicable diseases. They fear conservative-leaning communities will criminalize street camping, pushing homeless people to liberal municipalities that provide housing assistance and services.

“Some cities have decided that they want to fine, arrest, and punish people for being homeless, and the majority opinion tells communities that they can go ahead and do that,” said Steve Berg, chief policy officer for the National Alliance to End Homelessness. “If communities really want less homelessness, they need to do what works, which is make sure people have access to housing and supportive services.”

As they disperse and relocate — and possibly get arrested or slapped with fines — they will lose connections to the doctors and nurses who provide primary and specialty care on the streets, some health care experts say.

“It just is going to contribute to more death and higher mortality rates,” said Jim O'Connell, the president of Boston's Health Care for the Homeless Program and an assistant professor of medicine at Harvard Medical School. “It's tough, because there's a public safety versus public health” debate cities are struggling with.

As homeless people become sicker, they will get more expensive to treat, O'Connell said.

“Stop thinking about the emergency room, which is cheap compared to what we actually see, which is homeless people being admitted to the ICU,” he said. “I've got 20-something patients at Mass General today taking a huge amount of money to care for.”

In Los Angeles, which has one of the biggest homeless populations in America, street medicine provider Brett Feldman predicts more patients will need emergency intensive care as chronic conditions like diabetes and heart disease go untreated.

Patients on anti-addiction medication or those undergoing treatment to improve their mental health will also struggle, he said.

“People are already getting moved and camps swept all the time, so we already know what happens,” Feldman said. “People lose their medications; they lose track of us.”

Homeless people die at rates two to six times higher than residents living in stable housing, according to a May report from the Los Angeles County Department of Public Health. Drug overdoses and coronary artery disease were the top two causes of death since 2017.

Feldman said it may become harder to house people or place them into treatment programs.

“We rely on knowing where they are in order to find them,” Feldman said. “And they rely on us knowing where they are to get their health care. And if we can't find them, often they can't complete their housing paperwork and they don't get inside.”

The Biden administration has pushed states to expand the definition of health care to include housing. At least 19 are directing money from Medicaid — the state-federal health insurance program for low-income people — into housing aid.

California is going the biggest, pumping $12 billion into an ambitious Medicaid initiative largely to help homeless patients find housing, pay for it, and avoid eviction. It is also dramatically expanding street medicine services.

The Supreme Court decision could interrupt these programs, said Margot Kushel, a primary care doctor and homelessness researcher at the University of California-San Francisco.

“Now you're going to see disconnections from those case managers and housing navigators and people just losing touch in the chaos and the shuffle,” she said. “What's worse, though, is we are going to lose the trust that is so essential to getting people to take their medications or stop their drug use and, ultimately, getting people into housing.”

Kushel said the ruling would make homelessness worse. “Just having fines and jail time makes it easier for a landlord to reject you for housing,” she said.

At the same time, Americans are increasingly frustrated by encampments spreading into neighborhoods, ringing public parks, and popping up near schools. The spread is marked by more trash, dirty needles, rats, and human excrement on sidewalks.

Local leaders across deep-blue California welcomed the decision from the conservative majority, which will allow them to fine and arrest homeless people, even if there's nowhere for them to go. “The Supreme Court today took decisive action that will ultimately make our communities safer,” said Graham Knaus, CEO of the California State Association of Counties.

Newsom, a Democrat who leads a state with nearly 30% of the nation's homeless population, said the decision gives state and local officials “the definitive authority to implement and enforce policies to clear unsafe encampments from our streets,” ending legal ambiguity that has “tied the hands of local officials for years and limited their ability to deliver on common-sense measures to protect the safety and well-being of communities.”

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. 

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By: Angela Hart
Title: Supreme Court OKs Local Crackdowns on Homelessness, as Advocates Warn of Chaos
Sourced From: kffhealthnews.org/news/article/supreme-court-grants-pass-johnson-homelessness/
Published Date: Fri, 28 Jun 2024 20:27:00 +0000