New Guidance on Using High-Efficacy Disease Modifying Therapies in MS

 High-efficacy therapies for multiple sclerosis (MS) have improved disease outcomes for many patients, but physicians are uncertain when to use them. Despite better long-term disease outcomes, there are concerns over long-term safety, and some physicians and patients remain wary of these medications.

High-efficacy therapies were the subject of a session at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Key topics included patient selection, timing of escalation to high-efficacy therapies, and initial use of high-efficacy therapies. The session produced a compelling message, according to moderator Patricia Coyle, MD. "I think [the speakers provided] accumulating data that this is a smart thing to do: Use high-efficacy therapies early to get the maximum bang for the buck," Coyle said in an interview. She is professor of neurology and director of the MS Comprehensive Care Center at Stony Brook (N.Y.) University.

Consider Baseline Characteristics

In the first talk, Xavier Montalban, MD, PhD, noted that a statement from the ECTRIMS/EAN (European Academy of Neurology) guideline update in 2021 said that a high-efficacy disease-modifying therapy (DMT) should be considered early in the disease course. A key question is whether any baseline characteristics can be used to select patients, and studies have shown worse prognosis with older age, male sex, low levels of vitamin D, and smoking status, among various other factors.

He presented subgroup analyses from trials of fingolimod and ozanimod, which showed that the drugs did not work as well in patients with poor prognostic factors such as an Expanded Disability Status Scale (EDSS) score of 4 or above and age over 40 years. Lower doses also tend to have less efficacy in males. "If you have [a patient with] bad baseline prognostic factors, you need high-efficacy medication at the right dose, because a lower dose will not work well. It is the same phenomenon for age," Montalban said in his talk. On the other hand, he showed the results of a study of ofatumumab and ocrelizumab, both of which showed high efficacy even in patients with poor prognostic factors.

Among patients with secondary progressive MS, clinical or MRI evidence of inflammatory activity is the only poor prognostic factor that appears to be a good predictor of treatment response.

Montalban also addressed the timing of intervention with DMTs. A study from his group prospectively followed 1,015 patients treated with DMTs. "Interestingly, what we observed is that patients who were treated with DMTs just after the first attack did better than those who were treated after the second attack, and you have to take into consideration that we treat those patients after the first attack, those who had the worst prognostic factors, so treatment was very effective in that sense," said Montalban, director of the Multiple Sclerosis Centre of Catalonia at Vall d'Hebron University Hospital in Barcelona.

Switching DMTs

In the second presentation, Dalia Rotstein, MD, discussed how to incorporate prognostic factors when switching a patient to high-efficacy therapies as a result of new disease activity while on another therapy.

Patients with favorable prognostic factors at baseline may be started out on immunomodulatory therapy. "Essentially, we want to match the intensity of the therapy to the intensity of the disease of the patient in front of us," Rotstein said in her talk. Nevertheless, the course of MS is unpredictable, and the first year or two of immunomodulatory therapy can give physicians clues about the longer-term course of the disease. "We need to observe closely for disease activity in the first year, but even up to 2 years on therapy to determine a need for early escalation," said Rotstein, assistant professor of medicine at University of Toronto.

For switching to high-efficacy therapies, any relapse, disability progression, or an EDSS change of 1 point or more could be a consideration. MRI indicators are more controversial, but one to three new T2 lesions also could prompt a switch.

Serum neural filament light chain (sNFL) is a useful biomarker for monitoring disease activity as it correlates well with new disease activity within the next year. It can be monitored every 3-4 months and adjusted for clinical factors and monitored for changing levels. A concerning finding can be followed up with an MRI or in-person visit.

When switching to a high-efficacy therapy, it's important to administer any vaccines well in advance to ensure a good immune response.

When it comes to a washout period, physicians need to consider both the risk of immunosuppression and breakthrough disease activity. "But in general, we've observed that we can minimize the duration of the washout when stopping initial immunomodulator therapy to reduce the risk of breakthrough disease activity. We need to pay particular attention to the risk of rebound activity with longer washouts after stopping sphingosine-1 phosphate (S1P) receptor modulators because the rebound activity can be devastating," said Rotstein.

A study of timing of relapses after fingolimod washout, carried out by Rotstein's group, found a stark signal. "We observed that when the washout after fingolimod discontinuation was 30 days or more, there is a very high risk of early relapse," she said.

The Case for Induction Therapy

In the third talk, Gavin Giovannoni, MBBCh, PhD, discussed "flipping the pyramid" – that is, starting patients off immediately with high-efficacy therapies rather than waiting until they progress on other therapies. He likened such a decision to a gambler, because MS patients on less-effective therapy can suffer irreversible, long-term physical consequences, as well as social consequences such as unemployment due to cognitive effects.

"We always tend to put up a graph about the risks and benefits of a specific treatment, and we forget about the risks of untreated or undertreated MS. Keep that in mind when making decisions about high-efficacy therapies," said Giovannoni, professor of neurology at Queen Mary University of London.

About 80% of patients on tier 1, or low-efficacy therapies, will have breakthrough activity on MRI within 4 years. Moving up a tier gets to about a 60% rate of breakthrough activity. High-efficacy therapies attain an efficacy of about 80% at 6 months. "If you have MS, you've got to realize that if you had to roll the dice, which tier would you want to be in? By putting all of them [on high-efficacy therapies], you're going to get the majority responding and a few of them will break through," said Giovannoni.

He presented some real-world evidence to back up the argument: A study comparing outcomes in Sweden and Denmark, which have similar demographics. In Denmark, 7.6% of patients with MS received high-efficacy therapies initially, while in Sweden the proportion was 34.5%. Patients with MS treated in Sweden had a 29% lower probability of progressing to disability (P = .004) and there were 22% fewer discontinuations of DMTs (P < .001). Since that study, the proportion of patients receiving high-efficacy therapies to begin with is closer to 70%. "This is compelling evidence that you want to be on a [high-efficacy therapy] early. If I had MS, I would want to live in Sweden," said Giovannoni.

Historical treatments focused on reducing relapses, and more recently on eliminating evidence of inflammatory disease. He said that physicians are prioritizing brain volume loss to improve long-term outcomes in MS, and some are studying long-term disability. "We know that brain volume loss in MS is a prognostic sign both at baseline and at follow-up. It predicts poor outcome, poor cognition and employment, poor quality of life, et cetera," said Giovannoni.

He cited data from studies of alemtuzumab that showed a significant reduction in brain volume loss. "The rate is about 0.2% per annum, which is kind of getting into the normal range for age-matched controls. Those people who were started off on interferons in the study lost a lot of brain volume in those first 2 years, and that's irreversible," said Giovannoni.

He pointed out that studies of hematopoietic stem cell therapy showed similar brain-volume outcomes. "So flipping the pyramid with the two most highly effective therapies almost normalizes brain volume loss in people with MS," said Giovannoni.

There is also evidence in other autoimmune diseases that early use of high-efficacy therapies improves outcomes. More aggressive therapy in rheumatoid arthritis has reduced joint replacements by 90%.

"I think you really, really need to give your patients the opportunity of flipping the pyramid. You shouldn't decide that for them," said Giovannoni.

Coyle has consulted for nearly all pharmaceutical companies developing drugs in the MS space. Montalban has financial relationships with Biogen Idec, Merck Serono, Genentech, Genzyme, Novartis, Sanofi-Aventis, Teva, Roche, Celgene, Actelion, Mylan, BMS, and Sandoz. Rotstein has financial ties with Roche Canada, Alexion, Biogen, EMD Serono, Novartis, Roche, and Sanofi Aventis. Giovannoni has financial ties with AbbVie, Aslan, Atara Bio, Biogen, BMS-Celgene, GlaxoSmithKline, GW Pharma, Janssen/J&J, Japanese Tobacco, Jazz Pharmaceuticals, LifNano, Merck & Co., Merck KGaA/EMD Serono, Moderna, Novartis, Sanofi, Roche/Genentech, and Teva.

https://www.medscape.com/viewarticle/983200

How Will Lack of Exercise Affect Global Health in the 2020s?

 A report recently published by the World Health Organization (WHO) warns that, as a result of physical inactivity, almost 500 million people will develop heart disease, obesity, diabetes, or other noncommunicable diseases in the decade from 2020 to 2030. Almost half of these new cases (47%) will be the result of high blood pressure, and 43% will be caused by depression. The most affected countries will be those of low or middle income.

The document, which has measured the extent to which governments are implementing recommendations to increase physical activity across all ages and abilities based on data from 194 countries, shows that there is slow progress. According to the international body, states should urgently accelerate the development and implementation of policies to increase levels of exercise with the aim of preventing diseases and reducing the burden on healthcare systems that are already overwhelmed.

One of the most striking figures in the publication warns that currently less than 50% of countries have a national physical activity policy, of which not even 40% have carried it out. And only 30% have national exercise guidelines for all age groups.

On the other hand, although almost all countries have a system for monitoring physical activity in adults, less than 75% of them monitor adolescents and less than 30% monitor children under age 5 years.

Walking and Cycling

The data in the section of the report dedicated to analyzing the policies developed to promote active and sustainable transport are no more encouraging. According to the WHO, just over 40% of countries have road design plans that make walking and cycling safer, figures that the WHO says create a very negative impact on public health.

As determined by a study carried out at the beginning of the year by Colorado State University and the Barcelona Institute for Global Health (ISGlobal), promoting the use of bicycles could prevent as many as 205,000 premature deaths each year. According to this study, which calculated the impact on health of a global shift toward urban cycling in 17 countries in 2050, to increase the use of bicycles, it would be necessary to urgently introduce measures that would encourage it.

This conclusion is in line with recent statements by the WHO Director General, Tedros Adhanom Ghebreyesus, who has expressed the need for "more countries to expand the implementation of policies to help people be more active through walking, cycling, sports, and other physical activities. The benefits are enormous not only for people's physical and mental health, but also for societies, environments, and economies."

Lack of Initiatives

Another of the most relevant points of the report analyzes the economic impact of physical inactivity. The WHO estimates that the cost of treating new cases of preventable noncommunicable diseases will reach almost $30 million by 2030.

The minimal communication carried out about this public health problem is another incomplete task of world governments. Data from the report show that just over 50% of countries have conducted a national communication campaign or organized mass participation physical activity events in the last 2 years.

Furthermore, the COVID-19 pandemic has not only stalled these initiatives, but also has affected the implementation of other policies. It has widened inequalities in access and opportunities to participate in physical activity for many communities and settings such as schools.

With the aim of helping countries increase physical activity, the new WHO Global Action Plan on Physical Activity 2018–2030 sets out 20 policy recommendations that include measures for the creation of safer roads that promote more active transportation, as well as providing more programs and opportunities for physical activity in key settings such as nurseries, schools, primary healthcare, and workplaces.

The report also asks the world's governments to provide some hard-to-determine key numbers. As Dr Fiona Bull, the head of the Physical Activity Unit in the WHO's Department of Health Promotion, commented in a press release: "There is a lack of globally approved indicators to measure access to parks, cycle paths, and pedestrian paths, although we know that there are data in some countries. Consequently, we are unable to report or track the global provision of infrastructure that will facilitate increased physical activity."

With the aim of improving the health of the population and addressing noncommunicable diseases, the document urges countries to prioritize physical activity, integrating it into all relevant policies and developing tools, guidance, and training to improve its implementation.

Finally, as Ruediger Krech, the director of the WHO's Department of Health Promotion, concludes: "Inclusive physical activity programs need to be facilitated for all, ensuring that people have easier access to them. This report makes a clear call to all countries for stronger and accelerated action by all relevant stakeholders to work better together to achieve the global target of a 15% reduction in the prevalence of physical inactivity by 2030."

https://www.medscape.com/viewarticle/983206

SCOTUS takes case on Harvard and University of North Carolina’s use of affirmative action

The Supreme Court will meet Monday to consider whether colleges and universities can continue to take race into consideration as a factor in admissions, a case that could diminish the number of Black and Hispanic students in higher education.

Hanging in the balance is the future of admissions plans at hundreds of schools that have relied on court precedent for decades in order to achieve the educational benefits they say flow from student body diversity on campus.

Challengers in the case are targeting Harvard and the University of North Carolina arguing that their programs violate equal protection principles, dash the promise of a colorblind society, and discriminate against Asian Americans. They are urging the court to overturn precedent and they say that the schools should explore and further develop race-neutral alternatives to achieve diversity.

At least nine states have already chosen to end consideration of race in university admissions, including Arizona, California, Florida, Idaho, Michigan, Nebraska, Oklahoma and Washington, according to the National Conference of State Legislatures. Supreme Court precedent allows the consideration of race, but the court’s new composition of conservative justices did not hesitate last term to overturn decades old precedent in a case that curtailed a federal right to abortion.

A Washington Post poll found that 63% of US adults support the Supreme Court banning colleges and universities from considering a student’s race and ethnicity when making decisions about student admissions. At the same time, 64% also say that in general, programs designed to increase the racial diversity of students on college campuses are a good thing.

A conservative group, Students for Fair Admissions (SFFA) is behind both challenges.

Edward Blum, the President of SFFA, has hired a conservative boutique law firm, Consovoy McCarthy, to challenge the policies at the country’s oldest private university, Harvard and the country’s first public university, University of North Carolina. The firm is composed of several former clerks of Justice Clarence Thomas who has been a critic of affirmative action.

In 2003, Thomas wrote in one opinion: “The Constitution abhors classifications based on race, not only because those classifications can harm favored races or are based on illegitimate motives, but also because every time the government places citizens on racial registers and makes race relevant to the provision of burdens or benefits, it demeans us all.”

SSFA argues that the Harvard policy violates Title VI of the 1964 Civil Rights Act that prohibits schools receiving federal funds from discriminating based on race. He says that the UNC policy is subject to Title VI, as well as 14th Amendment’s guarantee of equal protection under the law, which covers state universities.

Lower US courts have ruled in favor of the schools finding that that the programs used race in a sufficiently limited way to fulfill a compelling interest in diversity.

The two disputes were initially consolidated, but after Justice Ketanji Brown Jackson announced she would recuse herself from the Harvard case because she had served on the school’s board of overseers, they were decoupled, so the nation’s first black justice could weigh in on the issue in at least one case.

North Carolina challenge

The University of North Carolina, established in 1789, was formally segregated for much of its history. The current challenge comes some 70 years after the first Black student was admitted.

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After an eight-day trial in 2020, district Judge Loretta C. Biggs ruled in favor of the school making special mention of its history steeped in racism.

In a footnote, she noted the school’s “comparatively recent embrace of diversity,” citing Southern historian Dr. David Cecelski, who, she said provided the court with credible evidence that UNC has been a “strong and active promoter of white supremacy and racist exclusion for most of its history.” The judge noted that Cecelski put forth considerable findings that while the school has made “important strides to reform the institution’s racial outlook and policies” the efforts have fallen short of “repairing deep-seated strides to reform the institution’s racial outlook and policies.”

“The University continues to face challenges admitting and enrolling underrepresented minorities particularly African American males, Hispanics, and Native Americans,” Biggs said and noted that in 2013 enrollment of African American men in the first-year class fell below 100 students.

Siding with UNC, Biggs said “Ensuring that our public institutions of higher learning are open and available to all segments of our citizenry is not a gift to be sparingly given only to select populations, but rather is an institutional obligation to be broadly and equitably administered.” The Supreme Court stepped in to consider the case before it was heard by a federal appeals court.

The school’s admissions office consists of about 120 employees engaged in a process where in the typical cycle the school receives about 43,500 applications for a freshman class of 4,200. Generally, about half the applicants are North Carolina residents. The requirements for admissions include a common application, an essay, letters of recommendation and standardized test scores. Race is used as a “plus factor” as the school considers criteria that includes a high school’s program criteria, academic performance, testing and engagement in activities outside of the classroom as well as personal attributes such as curiosity, honesty, motivation, and impact on the community. In addition, the school considers race-neutral alternatives that would allow it to achieve diversity.

North Carolina Solicitor General Ryan Park, argued that diversity is a compelling interest at the school and that the admissions office uses a holistic approach that affords an individualized consideration of all aspects of an applicant’s background, never relying upon quotas when it considers race. He also said the school makes a good faith effort to consider race neutral alternatives.

“In UNC’s academic judgement, diversity is central to the education it aims to provide the next generation of leaders in business, science, medicine, government and beyond,” Park said in court papers.

He said that while an applicant’s race may occasionally tip the balance toward admission in an individual case “it almost always does not.” He said the school offers about $159 million in undergraduate scholarships, part of which go to students based on their family’s socio-economic standing. It also recruits from a pool of high achieving community college students.

Park also borrowed from the judicial philosophy favored by several of the current conservative justices who believe that the Constitution should be interpreted according to the original meaning of the founders. Park argued that the 14th Amendment was originally understood to allow “appropriately tailored race-conscious decision making”, an argument that Justice Jackson made in a different case earlier in the term concerning the historic Voting Rights Act. To make the connection, Park referred to historian Andrew Kull, who wrote that the framers considered and rejected proposals that would have made the Constitution explicitly colorblind.

And he cited Brown v. Board of Education, the seminal opinion holding that state laws requiring separate but equal schools violated the Constitution. He argued that UNC’s admissions policy furthers the school’s “unwavering commitment to providing equal educational opportunities to all qualified students, no matter their race.”

SSFA lawyer Patrick Strawbridge responded that the process is not holistic, and in fact the school conceals the improper use of race behind opaque procedures awarding “mammoth racial preferences” to African Americans and Hispanics. He said that the use of race so permeates the process that race becomes a predominant factor at “every stage.”

He told the justices that the lawsuit had revealed the schools “sporadic and unserious efforts” to examine the availability of face-neutral alternatives by providing data through simulations

“A white, out-of -state male who had only a 10% chance of admission would have a 98% chance if UNC treated him as an African American and a 69% chance if UNC treated him as a Hispanic,” he said.

Strawbridge argued that the Brown decision actually supports his position. “Separate but equal has no place in education,” he said but added that the court should overturn a 2003 case called Grutter v. Bollinger that upheld the affirmative action admissions policy at the University of Michigan Law School. “Because Brown is our law, Grutter cannot be,” he said.

Harvard case centers around treatment of Asian American students

Harvard’s program is like that of University of North Carolina, but the challenge at hand focuses particularly on the treatment of Asian American students and a charge that the school intentionally discriminates against them setting higher standards for their admission. While Harvard is a private university, it is still subject to Title VI because it receives public funds.

Its freshman class in 2019 had 1,600 students out of 35,000 applicants. Of the 35,000, 2,700 had perfect verbal SAT scores, 3,400 had perfect math SAT scores and more than 8,000 had perfect GPA’s. After a 15-day bench trial that featured 30 witnesses, the district court ruled in favor of Harvard, finding that the school did not discriminate against Asian Americans in violation of Title VI.

The 1st US Circuit Court of Appeals affirmed the district court, holding that it did “not clearly err in finding that Harvard did not intentionally discriminate against Asian Americans. “

The admissions process at the school takes into consideration several components including pre-application recruitment efforts, applications, a “first read” of application materials, and interviews. The reading procedures include guideline to assign numerical numbers to certain categories to detail the factors admissions officers should consider. Those factors include academic ratings, extracurricular ratings, athletic ratings, and personal ratings.

The personal ratings attempt to measure how an applicant impacts people around them and contributions they might make. Considerations include perceived leadership, maturity, self-confidence, likeability, courage and kindness. After SFFA brought the suit, Harvard modified its instructions to say that an applicant’s race or ethnicity should not be considered in assigning the personal ratings. Harvard has a list of so called “tip” factors including race that are used after the first read process.

Former US Solicitor General Seth Waxman, Harvard’s lead lawyer, pointed out in court papers that court precedent allows a “holistic” review of an application, and that it need not ignore race.

“Seeking the benefits of a diverse student body, universities may consider race as one among many factors,” he said.

“Our Constitution promises ‘equal protection of the laws,’ he said and added “it does not require us to disregard the commonsense reality that race is one among many things that shape life experiences in meaningful ways.”

He roundly rejected charges of any discrimination against Asian American students arguing that while the SFFA “invokes the bogeyman of discrimination” against Asian American applicants the lower courts had found “in no uncertain terms that Harvard does not discriminate.”

And he said that the lower courts had found that none of the asserted race-neutral alternatives put forward by Harvard would allow it to achieve its goals and that if it abandoned consideration of race as one among many factors, representation of African Americans and Hispanic students would decline.

Cameron Norris, the SSFA lawyer charged with arguing the Harvard case, charges the schools with ignoring precedent and the “mistreatment” of Asian American applicants.

“Its admissions process penalizes them for supposedly lacking as much leadership, confidence likability, or kindness as white applicants” he said.

He particularly attacked Harvard’s system based on so called “personal ratings.” By considering race alongside subjective criteria like “self-confidence, likability, and courage” universities invite admissions officers to rely on anti-Asian stereotypes, he said.

“No one is under the illusion that we live in a post-racial society, or that racial discrimination is a thing of the past,” Norris said in court papers. “But when elite universities place high-schoolers on racial registers and tell the world that their skin color affects what they think and know, the universities are hurting, not helping,” he said.

Role of Biden administration

Solicitor General Elizabeth Prelogar supports both Harvard and the University of North Carolina, urging the justices to reject the invitation to ignore court precedent stemming from the Court’s 1978 decision in Regents of the University of California v Bakke where Justice Lewis F. Powell Jr. recognized that the nation’s future “depends upon leaders trained through wide exposure to the ideas and mores of students as diverse as this Nation of many peoples.”

She noted that court precedent has played a vital role in bringing diversity in higher education that has had rippling effect in the work force.

“The Nation’s military leaders, for example, have learned through hard experience that the effectiveness of our military depends on a diverse officer corps that is ready to lead an increasingly diverse fighting force,” she said in court briefs.

She said court precedent has proven “eminently workable, carefully limiting the consideration of race and requiring use of race-netural alternatives to the extent possible.”

And she, too cited, Brown.

“Nothing in Brown’s condemnation of laws segregating the races to perpetuate a caste system calls into question admissions policies adopted to promote greater integration and diversity,” she wrote.

A friend of the court brief filed on behalf of the NAACP Legal Defense Fund also questions the challengers’ suggestion that Brown mandates a result in SSFA’s favor.

“Petitioner would transform Brown from an indictment against racial apartheid into a tool that supports racial exclusion, prevents further advancement in the Nation’s progress towards racial integration, and deepens persistent inequalities in educational opportunities,” the brief said.

The Asian American Legal Defense and Education Fund is also supporting the school, rejecting the charge that race-conscious admissions policies discriminate against Asian Americans or perpetuate harmful stereotypes against them.

“The Asian American community is vast and varied, including first-generation college students and children whose parents’ professions secured their immigration; children of working-class refugees and multigenerational Americans; speakers of over 300 languages; aspiring entrepreneurs, artists, teachers, and more,” they argued. They say that Students for Fair Admission relies on “manipulated date” to attempt to demonstrate that Asian Americans with high test scores are admitted at lower rates than other racial groups.

Two groups, however, the Asian American Coalition for Education and the Asian American Legal Foundation, support SFFA with a particular emphasis on the “personal ratings” used by Harvard that the groups say assigns an “artificially low” rating to Asian American applicants during the admissions process to “counter their otherwise above-average metrics and ‘balance’ the racial makeup of its student body.”

“Through use of the personal rating, Harvard essentially imposes a racial hierarchy, where African Americans are the most desirable, followed by Hispanics, followed by whites, and with Asians at the very bottom as the least favored and the least likely to be admitted,” they said.

David E. Bernstein, a University Professor at George Mason University’s Antonin Scalia Law School also supports SFFA. He calls into question Harvard’s racial categories, deeming them “arbitrary and irrational.”

“Harvard cannot explain why roughly 60% of the world’s population should be grouped together as ‘Asian” despite vast differences in appearance, language, and culture,” he added.

https://www.cnn.com/2022/10/30/politics/harvard-unc-supreme-court-affirmative-action

Insurance Market Requiring Gov't Handouts Is Dysfunctional

 This week marks the beginning of open enrollment on the health insurance exchanges created by the Affordable Care Act. According to one recent analysis of 72 exchange insurers, premiums are likely to increase by an average of 10%. In some cases, rate hikes could exceed 25%.

Most consumers won't feel these price increases, thanks to the generous premium subsidies provided by the recently passed Inflation Reduction Act. But spending billions of dollars to obscure premium hikes indicates that the Affordable Care Act is failing to deliver on its eponymous promise.

Between 2013 — the year before the exchanges opened for business — and 2019, average monthly premiums on the individual insurance market more than doubled, from $244 to $588. So the latest round of rate hikes is not out of the ordinary.

The ever-increasing cost of health insurance is a function of Obamacare's many regulations. For instance, the law requires insurers to sell to all comers, regardless of health status or history.

It prohibits them from charging the old any more than three times what they charge the young, even though older people cost much more to insure. And it required that all health plans cover 10 "essential health benefits," regardless of whether consumers wanted or needed them.

Rules such as these simultaneously eliminated some of the insurance industry's most useful strategies for containing costs while effectively banning minimalist, lower-cost health plans. Their predictable consequence has been a steady increase in premiums that continues to this day.

Democrats are shrewd enough to realize that yearly premium hikes are a recipe for losses at the ballot box. Hence, bigger federal premium subsidies.

The Inflation Reduction Act's enhanced subsidies significantly increase the amount of assistance available to patients earning between 100% and 400% of the poverty level. They also guarantee that no household pays more than 8.5% of their income for exchange coverage — regardless of how much money they earn.

These enhanced subsidies became a political necessity because even middle-class and relatively well-off families are finding health coverage unaffordable under Obamacare's rules. In 2019, for instance, half of households making between four and six times the poverty level faced the prospect of paying at least 11.3% of their income for the least expensive bronze exchange plan.

And picking up an ever greater share of consumers' premiums has understandably boosted enrollment. This year, 14.5 million people signed up for coverage through the exchanges, compared to 8 million in 2014, their first year in operation.

It would be far better for taxpayers — not to mention the inflation outlook — if Democrats took steps to actually make health insurance more affordable, rather than hiding its rising cost with subsidies.

Rolling back Obamacare's insurance market regulations would go a long way to reducing premiums for most Americans. Failing that, expanding access to short-term, limited duration health plans would help.

As their name suggests, short-term health insurance policies were originally intended to fill unexpected gaps in coverage. But since they're exempt from Obamacare's insurance rules, they have emerged as an affordable alternative to exchange coverage.

Federal rules allow insurers to renew short-term plans up to two times. So a person could rely on a short-term policy for up to three years of coverage, unless their state has more stringent rules.

Recognizing short-term plans as a threat to exchange enrollment, Democrats have done their best to condemn these policies as "junk insurance." Earlier this month, Rep. Lloyd Doggett, D-Texas, complained that the "Biden administration’s failure to react swiftly to junk insurance only puts more consumers at risk."

Several states, including California and New York, have banned short-term plans or effectively regulated them out of existence.

But for many consumers — even older ones in less-than-perfect health — short-term plans can provide coverage that is comparable in quality to exchange plans, sometimes at nearly half the price. They're also less likely to feature the narrow provider networks characteristic of marketplace coverage.

The real threat to consumers is the out-of-control growth in the cost of health insurance brought on by Obamacare. More generous exchange subsidies might temporarily take some of the sting out of this affordability crisis. But an insurance market that requires endless government handouts isn't functional.

Sally C. Pipes is president, CEO, and the Thomas W. Smith fellow in healthcare policy at the Pacific Research Institute. Her latest book is "False Premise, False Promise: The Disastrous Reality of Medicare for All," (Encounter Books 2020).

https://www.newsmax.com/sallypipes/health-insurance-government-premiums/2022/10/27/id/1093738/