Federal Court Decides ACA “Sabotage” Case

https://www.sheppardhealthlaw.com/

Indian Law won't cover you being photographed secretly but there is still  some hope- Edexlive

On March 4th, the U.S. District Court for the District of Maryland struck down four provisions of the Trump Administration’s Notice of Benefit and Payment Parameters for 2019, 83 Fed. Reg. 16930 (April 17, 2018) (the “Rule”), which governs many aspects of Affordable Care Act (“ACA”) insurance markets beginning in the 2019 plan year.  The decision in City of Columbus, et al. v. Norris Cochran comes two and a half years after the cities of Columbus, Baltimore, Cincinnati, Chicago, and Philadelphia, as well as two individuals who rely on health insurance offered on ACA exchanges, filed suit alleging that the actions of the U.S. Department of Health and Human Services (“HHS”) drove up premiums, made enrollment more difficult, and caused more people to go without affordable, high-quality health insurance.

The plaintiffs originally filed suit against Donald J. Trump (in his official capacity as President of the United States) in August 2018, alleging that the Rule would eliminate protections guaranteed by the ACA, deter Americans from enrolling in quality health insurance plans, and drive up insurance costs. They further alleged that the Executive branch directed agencies to “sabotage” the ACA, committed various actions in an attempt to destabilize the exchanges, strategically worked to decrease enrollment, arbitrarily drove up premiums, and refused to defend the ACA. They claimed that these actions have caused premiums to rise and the number of uninsured to increase, harming the government plaintiffs by forcing them to spend more on uncompensated care. The complaint stated two causes of action, first under the Administrative Procedure Act (alleging that the Rule is arbitrary and capricious) and second under the Take Care Clause of the Constitution (U.S. Const. Art. II, § 3).  The Court dismissed the Take Care claim in 2020.

In vacating four provisions of the Rule, the court held that HHS’s actions were either arbitrary and capricious or contrary to the ACA. The provisions of the Rule that were vacated by the court are:

Federal Review of Network AdequacyThe Rule’s removal of the federal government’s responsibility to ensure that insurance plans offer adequate provider networks was arbitrary and capricious.
Income VerificationThe Rule’s requirement that low-income consumers submit additional documentation to verify their income when it conflicts with government data was arbitrary and capricious.
Standardized OptionsThe Rule’s elimination of “standardized options” — qualified health plans offering different levels of coverage and price, but with a standard cost-sharing structure specified by HHS that makes it easier for consumers to compare plans — was arbitrary and capricious.
Medical Loss RatioThe Rule’s reduced medical loss ratio rebates was contrary to law. Plaintiffs argued that this provision made it easier for insurers to avoid paying legally required rebates to their customers.

The court also held that HHS acted appropriately and in compliance with the law with respect to provisions in the Rule that eliminate direct notices to taxpayers that they are in danger of losing tax credits that allow them to afford health insurance; do away with federal oversight of insurance brokers participating in direct enrollment; revise standards for “navigators” who help people find insurance on exchanges; change aspects of the small business exchange program; and limit review of insurance rate increases.The provisions relating to federal review of network adequacy, income verification and standardized options will now go back to HHS for further action. The MLR provision will not.

The coronavirus vaccines have shattered expectations

https://www.axios.com/coronavirus-vaccines-safe-effective-science-immunity-aaa8b39e-1840-482a-a099-050c31529d1c.html

No matter how hard you squint, or what angle you look at it from, the coronavirus vaccines are a triumph. They are saving lives today; they will help end this pandemic eventually; and they will pay scientific dividends for generations.

The big picture: The pandemic isn’t over. There are still big threats ahead of us and big problems to solve. But for all the things that have gone wrong over the past year, the vaccines themselves have shattered even the most ambitious expectations.

The vaccines represent a “stunning scientific achievement for the world … unprecedented in the history of vaccinology,” said Dan Barouch, an expert on virology and vaccines at Harvard, who worked on the Johnson & Johnson vaccine.

Details: Developing a vaccine takes an average of 10 years — if it works at all. Despite years of well-funded research, there are still no vaccines for HIV or malaria, for example.

  • We now have multiple COVID-19 vaccines, all developed in less than a year.
  • The Pfizer and Moderna vaccines are the world’s first successful mRNA vaccines — which, to oversimplify it, teach our bodies to generate an immune response without relying on weakened or inactivated viruses. It’s a milestone that scientists have been working toward for 30 years.
  • Moderna’s vaccine is the company’s first licensed product of any kind.

Most importantlyall the leading vaccines work extremely well.

  • All four vaccines or vaccine candidates in the U.S. — from Pfizer, Moderna, AstraZeneca and Johnson & Johnson — appear to prevent coronavirus deaths, and to offer total or near-total protection against serious illness.
  • Some of the vaccines are more effective than others at preventing mild or asymptomatic infections, but all of them significantly exceed the FDA’s threshold to be considered effective.

The catch: South Africa on Sunday halted distribution of the AstraZeneca vaccine because it appeared not to work against the dangerous variant discovered there — which is spreading across the world.

  • The other vaccine makers have also said their products aren’t as effective against the South African variant.

But that’s a reason for the rest of the world to lean into the existing vaccines, not to be wary of them.

  • Viruses can mutate when they spread widely. The best defense against widespread variants is to vaccinate as many people as possible and step up social distancing to contain the virus.
  • Drugmakers may need to develop booster shots or new recipes to deal with variants, but waiting for a vaccine that addresses every variant will only leave the door open for more variants.

Our biggest problems are not with the vaccines, but rather the processes that surround them.

  • Supplies need to increase; distribution needs to become far more efficient; we need to ensure that people get their second shots, when applicable; and people need to be willing to get vaccinated once they’re eligible.
  • That’s a long and difficult to-do list, and getting those things wrong could drag the pandemic out for years. But if we can get the process right, the vaccines themselves are powerful enough to do the job.

Once the history of this is written, they are going to be referred to as some of the greatest achievements of science,” Zeynep Tufekci, a University of North Carolina sociologist with a track record of prescience on the coronavirus, told The New York Times’ Ezra Klein.

  • “It’s the kind of thing you would have national celebration and fireworks and church bells ringing and all of that,” she said.

This wasn’t a miracle, and it didn’t happen overnight. “What we’ve seen over the last year is the result and culmination of decades of scientific advances,” Barouch said.

  • Researchers have been building toward mRNA-based vaccines for roughly 30 years, fueled by broader advances in genetic science.
  • Those same advances have also greatly accelerated genetic sequencing — which is why researchers were able to map out COVID-19’s structure within weeks of discovering the virus, and to then begin working on potential vaccines.

What’s next: The vaccine race is one of the few areas of this entire pandemic where the U.S. and the world will be able to learn from our successes, rather than our failures.

  • The breakthrough of successful mRNA vaccines will, scientists hope, pave the way for a new generation of products that are more effective and easier to develop than previous vaccines.
  • Shoveling money at vaccine developers and establishing early, step-by-step communication with regulatory agencies also helped accelerate this process, and can help again in future pandemics.

The bottom line: “Good funding, great science and great collaboration with the regulatory agencies — that’s how they were able to do something that I didn’t think could be done in a year,” said Mark Slifka, an immunology professor at Oregon Health & Science University.

‘Ticking time bomb’ could invalidate thousands of health regulations, lawsuit says

Why Your DIY Social Selling Program Is A Ticking Time Bomb

A coalition of health groups and others sued HHS March 9 over a Trump administration rule that was finalized the day before President Joe Biden’s inauguration. 

The lawsuit, pending in U.S. District Court of the Northern District of California, alleges that thousands of HHS regulations could disappear because of the Securing Updated and Necessary Statutory Evaluations Timely, or SUNSET, rule. The rule requires HHS to review its existing 18,000 regulations within several years. If the review isn’t completed, the rule automatically expires, according to NPR

“The rule does not even specify which of the department’s 18,000 existing regulations are exempted under the limited exceptions. In other words, the outgoing administration planted a ticking time bomb set to go off in five years unless HHS, beginning right now, devotes an enormous amount of resources to an unprecedented and infeasible task,” the complaint states. 

The complaint further alleges that the rule exceeds the authority of HHS and creates uncertainty and instability in the U.S. healthcare system at a time when the public needs clear guidelines because of the pandemic. 

The plaintiffs are asking the court to declare that the rule is arbitrary and capricious and to vacate it. 

The plaintiffs are Santa Clara County, Calif., the National Association of Pediatric Nurse Practitioners, the American Lung Association, the Center for Science in the Public Interest, the California Tribal Families Coalition and the Natural Resources Defense Council. 

Financial incentives for hospitals spur rapid changes to opioid use disorder treatment

https://www.healthcarefinancenews.com/news/financial-incentives-hospitals-spur-rapid-changes-opioid-use-disorder-treatment

Financial incentives for hospitals spur rapid changes to opioid use  disorder treatment | Healthcare Finance News

Strengthening the link between the ED and treatment offers an opportunity to combat the opioid epidemic.

Hospital emergency departments not only care for patients with overdose and other complications from opioid use, but they also serve as vital touch points to encourage patients into longer-term treatment. After an overdose, patients are at risk for repeat overdose and death. 

Pennsylvania is unique in establishing a voluntary incentive program to improve the rate at which patients with opioid use disorder receive follow-up treatment after emergency department care. Evaluations of the program show that financial incentives are effective in producing rapid treatment innovations for opioid use disorder.

In a new study, researchers at the Perelman School of Medicine at the University of Pennsylvania found that Pennsylvania’s financial incentive policy encouraged hospitals to enact rapid system and practice changes to support treatment for opioid use disorder for patients visiting the ED. 

The study, published in Psychiatric Services, evaluates the efficacy of the Opioid Hospital Quality Improvement Program (O-HQIP), which Pennsylvania pioneered in 2019. The program seeks to increase the rate of follow-up treatment for Medicaid patients within seven days of an ED encounter for opioid-related illness by offering financial compensation to hospitals who participate in the program.

WHAT’S THE IMPACT?

Strengthening the link between the ED and treatment offers an opportunity to combat the opioid epidemic, and the financial incentives have shown momentum for the efforts to improve treatment access.

The program identified four distinct treatment pathways: initiation of buprenorphine treatment during the ED encounter, warm handoff to outpatient treatment, referral to treatment for pregnant patients and inpatient initiation of methadone or buprenorphine treatment. 

An initial incentive for participation was paid to hospitals in 2019, contingent on participation in all four pathways, with lesser payments for partial participation. In future years, hospitals can earn additional incentives for improvements in performance.

To evaluate the degree of the program’s success, researchers conducted 20 semistructured interviews with leaders from a diverse sample of hospitals and health systems across Pennsylvania. The interviews revealed that the incentives oriented institutional priorities toward expanding opioid treatment access. 

Hospitals were often on the cusp of change and responded to this nudge to prioritize opioid treatment access. But most hospitals – specifically, smaller or independent hospitals with lower volumes of patients with opioid use disorder – were unable to justify investing in these resources internally. Some hospitals noted resources as a barrier to participation, despite the incentive payments.

While initiating buprenorphine in the ED is proven to improve patients’ health outcomes and retention in treatment, many hospitals found implementing a pathway for buprenorphine difficult and time-consuming, and all partially participating hospitals chose to forgo this pathway.

Future work will focus on overcoming barriers to implementing buprenorphine treatment.

THE LARGER TREND

In 2019, buprenorphine was found by Mayo Clinic Proceedings to be one of three FDA-approved drugs that are underused in helping patients combat opioid addiction. Patient compliance with buprenorphine, that analysis found, is relatively high and associated with improved rates of sobriety and a reduction in accidental overdoses.

The opioid epidemic has long been a challenging issue both for Americans and the healthcare system that treats them, and the mortality statistics are significant. The American Academy of Family Physicians published research in 2019 showing that, if there’s no change in the annual incidence of prescription opioid misuse, annual opioid deaths could hit 82,000 by 2025.

From finding new, more cost-effective care delivery models to establishing outpatient addiction treatment programs, there’s an opportunity for investors to pump some much needed cash into the efforts to curb opioid misuse. If done correctly, the investors can see a healthy ROI, while also helping patients with addiction issues and easing the burden on the healthcare system.

Growth is on the wrong side of the equation

https://mailchi.mp/05e4ff455445/the-weekly-gist-february-26-2021?e=d1e747d2d8

3 health systems' growth strategies, straight from the CEOs

We spend a lot of time talking to health system leaders about growth. It’s almost an article of faith among executives that growth is paramount to success. That’s understandable for investor-owned companies—top-line growth is often the most straightforward way to generate greater earnings, which is what investors demand. But for not-for-profit systems, the answer is a little muddier. 

One unspoken but obvious reason for growth is leverage—the ability to extract higher rates from third party payers.

There are other, more palatable arguments for increasing scale: it yields greater ability to drive efficiencies in purchasing and operations, to invest in talent and technology, to identify and implement best clinical practices, and to ensure financial sustainability. All of those are real and demonstrable benefits of scale, but more often it’s a desire for greater pricing leverage that underlies many “growth strategies”.

Unfortunately, that kind of growth can be downright value-destroying for patients and consumers. The problem is that growth is on the wrong side of the equation, thanks to our dysfunctional, third-party payment system. 

In healthcare, growth is an input to strategy—whereas in other industries, growth is an output, the result of delivering superior services to consumers. Health systems do better by getting bigger, while other firms get bigger because they are better: their growth is earned.

That doesn’t mean that health systems shouldn’t seek to grow, and we certainly spend a lot of our time helping them figure out how to capture growth opportunities. But it’s worth recognizing that it’s the structure of the payment system, not the malevolence of health system executives, that results in leverage-driven growth.

The right focus for policymakers is restructuring incentives to encourage systems to compete on creating value for consumers, rather than punishing health systems for responding rationally to the incentives that currently exist.

21 ‘overpaid’ healthcare CEOs

Final week for Flagler County CARES Act funding applications

The economic effects from the pandemic may place more pressure on investors to reevaluate the pay packages of CEOs in the future. But for the time being, “we are simply getting wealthier CEOs,” according to an annual report from the nonprofit shareholder advocacy group As You Sow.

For its report, As You Sow evaluated the most “overpaid” CEOs of S&P 500 companies. The nonprofit used data to compute what CEO pay would be assuming such pay is related to total shareholder return. In its methodology, a ranking of companies by excess CEO pay and by shareholder votes on CEO pay are weighted at 40 percent. The final ranking based on CEO-to-worker pay ratio is weighted at 20 percent. Find the full methodology here.

As You Sow notes some CEOs may no longer hold the positions listed below, as the rankings were calculated using data made available before June 30, 2020.

Here are 21 healthcare CEOs who made As You Sow’s list:

Larry Merlo (CVS Health)
Pay: $36.5 million
CEO-to-worker pay ratio: 790:1
Excess pay: $24.3 million

Alan Miller (King of Prussia, Pa.-based Universal Health Services)
Pay: $24.5 million
CEO-to-worker pay ratio: 629:1
Excess pay: $12.4 million

Michael Neidorff (Centene)
Pay: $26.4 million
CEO-to-worker pay ratio: 383:1
Excess pay: $13.3 million

Heather Bresch (Mylan)
Pay: $18.5 million
CEO-to-worker pay ratio: 427:1
Excess pay: $7.5 million

John Hammergren (McKesson)
Pay: $17.4 million
CEO-to-worker pay ratio: 458:1
Excess pay: $5.2 million

Samuel Hazen (Nashville, Tenn.-based HCA Healthcare)
Pay: $26.8 million
CEO-to-worker pay ratio: 478:1
Excess pay: $14.1 million 

Stefano Pessina (Walgreens Boots Alliance)
Pay: $19.2 million
CEO-to-worker pay ratio: 562:1
Excess pay: $7.3 million

Ari Bousbib (IQVIA)
Pay: $22.1 million
CEO-to-worker pay ratio: 186:1
Excess pay: $8.7 million 

Miles White (Abbott Laboratories)
Pay: $27.8 million
CEO-to-worker pay ratio: 329:1
Excess pay: $14.2 million

Javier Rodriguez (DaVita)
Pay: $16.9 million 
CEO-to-worker pay ratio: 286:1
Excess pay: $4.3 million

Leonard Schleifer, MD, PhD (Regeneron Pharmaceuticals)
Pay: $21.5 million
CEO-to-worker pay ratio: 154:1
Excess pay: $8.6 million

Daniel O’Day (Gilead Sciences)
Pay: $29.1 million
CEO-to-worker pay ratio: 169:1
Excess pay: $16.9 million

David Cordani (Cigna)
Pay: $19.3 million
CEO-to-worker pay ratio: 306.7:1
Excess pay: $6.5 million

Michael Minogue (Abiomed)
Pay: $19.2 million
CEO-to-worker pay ratio: 166:1
Excess pay: $4.8 million

Joseph Hogan (Align Technology)
Pay: $18.3 million
CEO-to-worker pay ratio: 1,328:1
Excess pay: $3.5 million

Kenneth Frazier (Merck)
Pay: $27.6 million
CEO-to-worker pay ratio: 289:1
Excess pay: $14.5 million

Marc Casper (Thermo Fisher Scientific)
Pay: $19 million
CEO-to-worker pay ratio: 235:1
Excess pay: $5 million

Michel Vounatsos (Biogen)
Pay: $18.2 million
CEO-to-worker pay ratio: 114:1
Excess pay: $6 million

Michael Kaufmann (Cardinal Health)
Pay: $15.6 million 
CEO-to-worker pay ratio: 272:1
Excess pay: $3.4 million

Vincent Forlenza (Becton, Dickinson and Co.)
Pay: $16 million
CEO-to-worker pay ratio: 379:1
Excess pay: $2.6 million

Omar Ishrak (Medtronic)
Pay: $17.8 million 
CEO-to-worker pay ratio: 240:1
Excess pay: $4.8 million 

Access the full list here.

Time to stop the hygiene theater

https://mailchi.mp/41540f595c92/the-weekly-gist-february-12-2021?e=d1e747d2d8

Image result for Time to stop the hygiene theater
The billboards along the interstate near our houses still flash, “Wash your hands and wear a mask to stop the spread of COVID”. As we learn more about the virus, it’s increasingly clear that those two actions are not equivalent. A new piece in the Atlantic makes a strong argument that our obsessive surface cleaning and handwashing is largely “hygiene theater”, doing very little to stop the spread of the disease.

COVID-19 is spread almost exclusively by aerosol transmission, breathing in virus particles emitted from an infected person that remain suspended in the air. Spread by fomites, or virus particles lingering on surfaces, is responsible for little-to-no documented transmission, despite numerous studies (of varying quality) showing the virus can “live” on surfaces for up to a month. The author concedes it’s not impossible, but the attention to surfaces is misdirected: “If somebody with COVID-19 sneezes three times onto a little spot on a cold steel table, and you rub your hand around in the snot for a bit and immediately lick your fingers, that disgusting act may well result in you infecting yourself. But the threat of such unbelievably stupid behavior at a mass level shouldn’t warrant a multibillion-dollar war on fomites.”
 
Our obsession with surface cleaning has harmful consequences. The billions of dollars spent on regimented cleaning could be redirected toward better uses. Schools are still waiting for funding to safely reopen. The money devoted to surface cleaning should instead be spent improving ventilation and making sure all teachers and students have high-quality masks. All of the harsh cleaning chemicals we are inhaling may be harming our health. And most importantly, surface cleaning creates a false sense of security, sending a message that it’s OK to dine maskless, indoors, at a restaurant because they’re lowering risk by thoroughly cleaning the menus and tables. As we navigate our way to the end of the pandemic, we need to reinforce the point that masks, ventilation and vaccines, not Lysol and Clorox, are our best weapons against the virus.