Affordable Care Act (ACA)’s required coverage of preventive care services in further jeopardy

https://mailchi.mp/f1c5ab8c3811/the-weekly-gist-october-28-2022?e=d1e747d2d8

The plaintiffs in Braidwood v. Becerra filed a motion on Monday asking a US District Court judge in Texas—the same judge who ruled the entire ACA unconstitutional in 2018—to block enforcement of the ACA’s no-cost requirement for preventive care services. This judge already sided with the plaintiffs in September, ruling the government cannot require a company to fully cover preventive HIV drugs, also known as PrEP therapy, for its employees, on the grounds that doing so violates owners’ religious freedom.

In that ruling, the judge also asserted that the government’s system for deciding what preventive care services should be covered under the ACA is unconstitutional. This latest motion now asks him to invalidate all parts of the ACA requiring preventive health services on the grounds that the Preventive Services Task Force was never appointed by Congress, and thus lacks the authority to say which services insurers must cover. The final ruling is expected early next year, after which the case will certainly be appealed, regardless of outcome. 

The Gist: Given the judge’s initial ruling in Braidwood last month, this motion from the plaintiffs was expected. While the US Supreme Court reversed a 2018 ruling by this judge that struck down the entire ACA, it could potentially find the narrow targeting of this case more reasonable, making preventive care coverage optional for employers. 

If that happens, millions of Americans would once again have to pay for some of the most common and highest-value healthcare services, including screening tests for a variety of cancers, sexually transmitted infections, and diabetes. That additional financial burden, along with likely tightening of health plan benefit designs, would create barriers to access and exacerbate health disparities.

HHS Must Restore Full Payment to 340B Hospitals Now, Judge Says

The court ruling comes after the Supreme Court struck down a nearly 30 percent cut to 340B hospital payments from 2018.

October 04, 2022 – A federal judge has ordered HHS to immediately end the almost 30 percent cut in Medicare drug reimbursement to 340B hospitals.

The decision published last week by judge Rudolph Contreras with the US District Court for the District of Columbia rejected HHS’ plan to restore full payment to hospitals participating in the 340B Drug Pricing Program in 2023.

“HHS should not be allowed to continue its unlawful 340B reimbursements for the remainder of the year just because it promises to fix the problem later,” wrote Contreras.

Hospitals participating in the 340B Drug Pricing Program receive outpatient prescription drugs at a discounted price of up to 50 percent since they treat a disproportionate amount of low-income and vulnerable patients. The 340B Program is designed to enable the safety-net providers to stretch their financial resources. Medicare must also reimburse hospitals for administering covered outpatient drugs.

HHS reduced the Medicare drug reimbursement rates for 340B hospitals though in 2018, cutting payments by 28.5 percent in an effort to generate about $1.6 billion in savings. Federal officials reasoned that reimbursing 340B hospitals at the same rate as other hospitals creates an incentive for the hospitals to overprescribe the drugs or prescribe more expensive drugs since they receive covered outpatient drugs at a discounted price.

HHS also argued that 340B hospital reimbursement cuts would lower co-payments for Medicare beneficiaries since the amounts are tied to hospital reimbursement rates.

Hospitals and hospital groups, including the American Hospital Association (AHA) Association of American Medical Colleges (AAMC), and American’s Essential Hospitals, sued the federal government over the reduced reimbursement rates.

The case made it all the way to the Supreme Court where, in a major win for hospitals, judges unanimously ruled that HHS should not have reduced payments to certain hospitals in 2018 and 2019 without surveying hospitals to determine average acquisition costs for drugs. HHS had relied on the average price of the drugs to set lower rates.

However, the Supreme Court did not make judgments on 340B hospital reimbursement cuts for 2020 and later years.  Following the Supreme Court’s ruling, HHS announced it would reimburse hospitals for administering 340B-covered drugs the same as non-340B drugs starting Jan. 1, 2023.

Hospital groups again challenged HHS policy, asking the courts to immediately halt the unlawful cuts in 2022.

“The AHA appreciates Judge Contreras’ ruling that the Department of Health and Human Services must immediately stop unlawful reimbursement cuts for 2022 for hospitals participating in the 340B drug pricing program. Halting these cuts will help 340B hospitals provide comprehensive health services to their patients and communities,” said Melinda Hatton, AHA’s general counsel and secretary, regarding the most recent court ruling.

“We continue to urge the Administration to promptly reimburse all the hospitals that were affected by these unlawful cuts in previous years and to ensure the remainder of the hospital field is not penalized for their prior unlawful policy, especially as hospitals and health systems continue to deal with rising costs for supplies, equipment, drugs and labor,” Hatton continued in the public statement.

340B Health’s president and CEO Maureen Testoni also called the court ruling “an important victory for 340B hospitals that have been fighting these unlawful cuts for nearly six years.” 340B health advocates safety-net hospitals participating in the drug pricing program.

“The Centers for Medicare & Medicaid Services (CMS) has the clear responsibility to restore the appropriate payments for 340B drugs immediately, and now a federal court has ordered it to do so without delay,” Testoni said.

HHS has not announced a repayment plan for 340B hospitals. Notably, the court ruling also did not cover the AHA’s motion to include reimbursement cuts from 2020 through 2022 in the case, nor AHA’s motion to repay hospitals for the cuts since 2018 without penalizing other hospitals.

Court ruling threatens Affordable Care Act’s (ACA) no-cost requirement for preventive care services

https://mailchi.mp/6a3812741768/the-weekly-gist-september-9-2022?e=d1e747d2d8

The same Texas federal judge who ruled the entire ACA unconstitutional in 2018—a decision overturned by the Supreme Court last year—ruled this week that the ACA cannot require a company to fully cover preventive HIV drugs for its employees, on the grounds that doing so violates owners’ religious freedom. He also asserted that the government’s system for deciding what preventive care services should be covered under the ACA is unconstitutional, a broader declaration that potentially jeopardizes a wide swath of no-cost preventive services enshrined in the ACA for millions of Americans, including screening tests for a variety of cancers, sexually transmitted infections, and diabetes. The ruling did not include an injunction and is likely to be appealed. 

The Gist: Fully-covered preventive care services are a cornerstone of the ACA, and have increased access to basic healthcare services for many Americans. While there is still some uncertainty about the scope of this ruling, if it were to stand, millions of Americans would once again have to pay for some of the most common and highest-value healthcare services. That additional financial barrier, along with potential tightening of health plan benefit designs, would create barriers to access that only exacerbate our nation’s already stark healthcare disparities. 

Hospital group wants prompt payment of 340B funds after Supreme Court win

The American Hospital Association wants HHS to act quickly to ensure that affected hospitals receive withheld 340B program funds. 

The organization’s June 28 letter to HHS comes after the Supreme Court recently overturned a $1.6 billion 340B payment cut.

The case centered around whether CMS has the authority to make cuts to the program under its  Medicare Outpatient Prospective Payment System. Under the payment rule, HHS cut the reimbursement rate for covered drugs by 28.5 percent in 2018, but it later lowered the cut to 22.5 percent. The Supreme Court reversed a federal appeals court’s 2020 ruling that HHS had the authority to make the $1.6 billion annual reimbursement cut.  

“Given the vital role that 340B hospitals play in serving vulnerable communities, they should be repaid the funds that have been withheld from them without delay,” the American Hospital Association said in the letter. “They also should be paid for all of the years (2018-2022) in which the Centers for Medicare & Medicaid Services (CMS) illegally cut reimbursement rates.”

The hospital group said it is concerned that despite the Supreme Court’s decision, the resolution of these issues “could be bogged down in needless litigation, and that hospitals will not be appropriately compensated at a time when they are weathering significant financial challenges on many fronts.”

Supreme Court overturns Roe v. Wade, eliminating the constitutional right to an abortion

https://mailchi.mp/3390763e65bb/the-weekly-gist-june-24-2022?e=d1e747d2d8

 The 6-3 decision in Dobbs v. Jackson Women’s Health Organization, challenging a Mississippi law banning most abortions after 15 weeks, overturns the nearly 50-year precedent providing a constitutional right to abortion. The opinion was little changed from a draft that was leaked last month, returning most decision making on abortion to states. At least 13 states have so called ‘trigger laws’ in place that will almost immediately make abortion illegal, and another 13 states are likely to pass similar laws.

The GistIn over half of states, existing or new laws will likely prevent pregnant people from accessing critical and evidence-based reproductive healthcare services, including medically safe abortion, miscarriage care, pregnancy termination for severe fetal anomalies, and endangerment of the childbearing parent’s life.

Patients in Texas, which passed one of the strictest abortion laws last year, have already been facing challenges obtaining prescriptions for medications for miscarriage and abortion care. Many state laws which criminalize providing the procedure put physicians and other medical providers in legal jeopardy.

And as legal experts point out, most malpractice insurance doesn’t protect physicians from damages incurred from criminal charges. 

Moreover, most laws have been written by legislators with little or no medical expertise, leading to lack of clarity about which potentially life-threatening situations, in what circumstances, merit pregnancy termination—forcing physicians to delay lifesaving obstetric care. (Read this NEJM piece to understand what this looks like for doctors and patients in Texas today.) Regardless, today’s decision will lead to increased mortality for pregnant people and those unable to seek safe abortion care. 

Supreme Court reverses 340B Medicare rate cut

https://mailchi.mp/8e26a23da845/the-weekly-gist-june-17th-2022?e=d1e747d2d8

In a unanimous decision, the Justices found that the Department of Health and Human Services (HHS) exceeded its legal authority when it cut Medicare reimbursement rates for outpatient drugs by 28.5 percent at 340B-eligible hospitals in 2018. The justices wrote that the Centers for Medicare and Medicaid Services (CMS) shouldn’t have cut payments to these hospitals without first surveying their average drug acquisition costs, as required by statute.

CMS must now figure out how to repay 340B hospitals the difference in reimbursement for 2018 and 2019, the two years the unlawful cuts were in effect, during which time it redistributed those savings to all hospitals in the form of higher reimbursement for outpatient services. (For an explainer on the mechanics of the 340B program, see our overview here, and for more details on this Supreme Court case, see our summary here.)

The Gist: This decision was a narrow ruling on administrative grounds, and did not touch on the larger policy debates concerning the 340B program. While 340B-eligible health systems can breathe a momentary sigh of relief, they are still facing significant, ongoing revenue disruptions as at least 17 pharmaceutical manufacturers are restricting discounted drug sales to contract pharmacies. 

Scrutiny of the 340B program, which has grown to include over 40 percent of US hospitals, will continue to raise questions about whether there are better ways to subsidize the operations of hospitals serving low-income patients, and to ensure that underserved patients have access to lifesaving treatments.

Businesses face major benefits questions amid Roe uncertainty

Corporate America is facing a flurry of questions about how it provides health benefits in the wake of a leaked U.S. Supreme Court draft that indicates the federal right to abortion could be overturned.

Why it matters: Businesses hoping to use reproductive health benefits as part of efforts to recruit and retain employees would have to be careful not to run afoul of laws should states be allowed to ban abortions.

  • The balancing act over the next several months could get messy, experts warn.

What they’re saying: “It’s a serious issue for employers,” said Candice Sherman, the CEO of the Northeast Business Group on Health. The group represents roughly 80 large companies such as American Express, Colgate, Moderna and Pfizer.

  • Limits on abortion coverage have the potential to impact the physical and mental health of the workforce and could come as many employers are addressing equity and inclusion for women, people of color and LGBTQ employees, Sherman said.
  • That is often communicated by companies through benefit design.

State of play: Some large companies like Amazon, Apple and Lyft have already announced plans to provide workarounds in those states with abortion restrictions.

  • But many others are still on the sidelines as they tease out employees’ priorities on abortion-related benefits, as well as the potential costs and legal risks.
  • Eleven states restrict insurance coverage of abortion in all private insurance plans written in the state, including those offered through Affordable Care Act markets, according to the Guttmacher Institute. Six other states require abortion coverage in private health insurance plans.

Zoom in: One of the most immediate questions is what kind of employer-sponsored abortion coverage — as well as enhanced benefits like travel stipends — might create legal liabilities for companies in states that ban abortion.

  • “There’s a question as to whether providing transportation benefits could be construed, or at least alleged by the states in enforcement, as aiding and abetting,” said Garrett Hohimer, director of policy and advocacy for the Business Group on Health. That group counts corporations like The Walt Disney Co., Walmart and General Motors among its members.
  • Companies like Citigroup that pay for out-of-state abortions have already been threatened with the loss of business.

Yes, but: In the case of a challenge, companies would have a strong argument that federal protections for providing abortion care benefits preempt state laws, Emily Dickens, the head of government affairs for the Society for Human Resource Management, told Axios.

  • Dickens pointed specifically to the Pregnancy Discrimination Act which specifically says an employer is permitted to provide health insurance coverage for abortion, as well as protections under ERISA law.

But, but, but: It’s not a sure thing. For instance: “ERISA is not a get out of jail free card,” Hohimer warned, saying there is some question about how the law would be interpreted.

  • While experts largely believe the Affordable Care Act would provide protections for birth control coverage, it’s unclear how fertility benefits such as egg freezing, surrogacy or in vitro fertilization might be affected, Sherman said.

What to watch: Many large companies already offer health benefits allowing workers to travel to Centers of Excellence for procedures like joint replacements or cancer care.

  • Those kinds of benefits will likely gain more attention because of the attention surrounding reproductive health, Hohimer said.
  • Sherman said this may also raise questions about whether there’s flexibility in the tax code to expand the scope of Flexible Spending Accounts or Health Savings Accounts to cover travel for any health care issues.

The bottom line: “Assuming this discussion comes down the way we think it may, organizations are going to have to work very hard,” Sherman said.

Providers ponder a post-Roe future

https://mailchi.mp/df8b77a765df/the-weekly-gist-may-6-2022?e=d1e747d2d8

If the leaked Supreme Court draft opinion overturning Roe v. Wade—which in 1973 established an individual’s constitutional right to an abortion—is finalized, as many as 26 states are either certain or likely to ban abortion. The resulting patchwork of abortion laws across the country could create confusion for providers and hospitals on multiple fronts, including cases related to the Federal Emergency Medical Treatment and Labor Act (EMTALA), as well as for health systems that operate in multiple states. Medical training on the procedure could become much more limited, as about half of the nation’s obstetrics and gynecology residencies are in states likely to ban abortion.

Recognizing the precarious position that abortion bans will put some providers in, the American Medical Association released a statement on Thursday saying that it is “deeply concerned” with the draft opinion, and that it “would lead to government interference in the patient-physician relationship, dangerous intrusion into the practice of medicine, and potentially criminalizing care.”  

The Gist: Abortion is just one of a raft of issues where the provision of health services increasingly intersects with charged politics in this country. If Roe is overturned, medication abortion—the use of abortion pills—which already accounts for more than half of all abortions, will increase, although multiple states are already seeking to limit access. 

Restricting access to safe abortions will also further exacerbate health disparities, driving up the already distressingly high US maternal mortality rate, especially among Black women. And overturning Roe would have implications far beyond access to abortion, especially for patients experiencing miscarriages, ectopic pregnancies, or other life-threatening medical conditions related to pregnancy.

The Affordable Care Act: Twelve Years and Nine Lives Later

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A new spring brings another anniversary of the Affordable Care Act. Twelve (sometimes tumultuous) years later, this remarkably resilient law is on firmer ground than ever before.

So what are some highlights?

The uninsured rate remained stable even in the face of a global pandemic. Congress leveraged parts of the ACA to quickly cover COVID-19 tests and vaccines without cost sharing.

The American Rescue Plan Act supercharged marketplace subsidies, leading to record-high marketplace enrollment.

And there are currently no existential legal threats to the law working their way through federal courts.

In some ways, this rosy report feels unremarkable. Why expect otherwise with the law now in place for more than a decade and baked into every part of the health care system?

But this outcome was far from inevitable.

Just five years ago, Congress tried to repeal as much of the law as possible. When those broader efforts failed, Congress eliminated the much-maligned individual mandate penalty. We appeared to have reached a stalemate: Democrats could not improve the law while Republicans could not repeal it.

Could this be the moment we moved on from ACA politics?!

Enter the courts. In early 2018, Republican attorneys general sued to invalidate the mandate and, with it, the rest of the law. That lawsuit—California v. Texas—was ultimately heard by a new Supreme Court one week after the 2020 election, and the ACA was upheld just last summer.

This marked the third time that the Supreme Court largely rebuffed what could have been a crippling legal challenge to the law. It feels like ancient history now, but it is worth remembering that we were still playing “will they or won’t they?” with the Supreme Court and ACA only one year ago.

In the meantime, the Trump administration tried to undermine access to coverage under the law—except when it didn’t. I won’t list all the relevant Trump-era policies, but they had an impact: the uninsured rate rose, and marketplace enrollment declined until the 2021 plan year.

Ironically, one policy meant to destabilize the market had the opposite effect: so-called “silver loading” led to more generous marketplace subsidies and likely helped stave off even greater coverage losses.

This is the recent history that is top of mind as I reflect on the year ahead—and the work left to do to achieve universal coverage. Here are just some of the major issues facing policymakers:

     • The clock is ticking to extend the American Rescue Plan Act subsidies. If Congress fails to do so, millions will face premium hikes next year and marketplace enrollment will likely drop.

     • More than 2 million low-income people remain stuck in the Medicaid coverage gap in the 12 states that have not yet expanded their Medicaid program.

     • Up to 15 million people, including nearly 6 million children, could lose Medicaid coverage at the end of the COVID-19 public health emergency.

     • There is increasingly an affordability and underinsurance crisis, including for those with job-based coverage: an estimated 87 million people were underinsured in 2018.

Congress and the White House are working to address these challenges, but much uncertainty remains.
“It feels like ancient history now, but it is worth remembering that we were still playing ‘will they or won’t they?’ with the Supreme Court and Affordable Care Act only one year ago.” – Katie Keith

Looking beyond Congress, 2022 will be an important year for regulatory changes. The Biden administration has proposed, but has not yet finalized, major marketplace changes. Other already-identified priorities include fixing the family glitch, limiting short-term limited duration insurance, and enhancing nondiscrimination protections. We could see movement on at least some of these rules soon.

While the Biden administration may be waiting out Congress before initiating some rulemaking, time is of the essence. New rules take many months to adopt and then take effect—followed by more time to deal with the legal challenges that typically follow.

Follow along as I dive deep on these issues and more in a new Health Affairs’ Health Reform newsletter.

We’ll highlight the latest health policy developments—from legislation to litigation—and explain what these changes mean for patients, payers, providers, and other key health care stakeholders.
It’s Your Birthday, Affordable Care Act!
In March 2020, Health Affairs published a theme issue to celebrate the tenth anniversary of the Affordable Care Act. The issue contains many illuminating research articles on the landmark legislation, from its impact on “the cost curve” to Medicaid expansion.

Above is a datagraphic from the issue showing how the ACA affected insurance coverage.

Biden administration’s vaccine mandate for healthcare workers is a go

https://mailchi.mp/92a96980a92f/the-weekly-gist-january-14-2022?e=d1e747d2d8

Explainer: The legal challenges awaiting Biden's vaccine mandate | Reuters

Biden administration’s vaccine mandate for healthcare workers is a go, but its mandate for large employers and at-home testing plan face roadblocks. The US Supreme Court ruled Thursday that the vaccine mandate for the nation’s healthcare workers at facilities participating in Medicare and Medicaid can go forward while lower courts hear legal challenges. But it said that the Occupational Safety and Health Administration (OSHA) did not have the authority to enforce the broader vaccine-or-test mandate for businesses over 100 employees, which would have covered more than 80 million private sector workers.

Meanwhile, private insurers are required to begin covering eight at-home tests per beneficiary per month starting tomorrow. The roughly half of Americans with private insurance coverage stand to benefit, if they’re lucky enough to get their hands on rapid tests, which have been in increasingly scarce supply.

The Gist: Health systems that were early to issue vaccine mandates will have a leg up on others who paused requirements amid ongoing legal challenges. Lagging facilities now have a little over a month to start enforcement amid troublesome staffing shortages.

Also, the use of the private insurance system to cover at-home tests not only excludes nearly 40 million seniors on traditional Medicare, as well as the uninsured, but means that the cost of tests will ultimately be borne by consumers and employers through higher insurance premiums.