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Hikal inks 10-year multi-product deal with global pharma co for APIs – ET HealthWorld



Hikal inks 10-year multi-product deal with global pharma co for APIs – ET HealthWorld

Hikal inks 10-year multi-product deal with global pharma co for APIsLife sciences firm Hikal Ltd on Wednesday said it has signed a 10-year deal with a global pharmaceutical company for development and supply of a portfolio of niche Active Pharmaceutical Ingredients (APIs). The company has signed a multi-year contract with a leading global pharmaceutical company.

This contract entails the development and supply of a portfolio of niche APIs over a period of 10 years, Hikal said in a regulatory filing.

The company did not reveal the name of the global pharmaceutical firm and the value of the deal.

Hikal said the company and its customer will partner to set up a manufacturing facility to maintain security of supplies for the next 10 years.

Both the companies will jointly invest at its Panoli site in Gujarat to set up a multi-purpose manufacturing asset for manufacturing of these APIs.

Commercial supplies will commence post successful development and plant commercialisation estimated to be in FY 2024 onwards, the company added.

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Premium increases lead to Medicaid enrollment drop off



Premium increases lead to Medicaid enrollment drop off

Researchers from the University of Michigan analyzed administrative data from the state’s Department of Health and Human Services to determine how premium payments impacted churn among adult Medicaid enrollees from 2014 to 2016. CMS mandated the study—Michigan was one of the first states with a Republican governor and legislature to expand Medicaid under the Affordable Care Act, and received a federal waiver that allowed officials to charge some Medicaid members a premium, with the aim that having individuals pay up to 2% of the amount of their plan would “encourage[sic] enrollees to take responsibility for their health and care costs,” according to the study. This paper represents just one of a series of ongoing analyses by the University of Michigan.

Cliff was unsure how CMS would use the results, which found that imposing a premium increased disenrollment among those with below-average health spending or no chronic disease by 13 percentage points over the time period studied. These individuals left Medicaid even though they could not, technically, be kicked off the program for not paying their premiums, and could reduce their costs by completing certain preventative care appointments, the study said. CMS was unable to respond to an interview request.

“If they won the lottery, they could have those earnings garnished, and the same thing with tax refunds,” Cliff said. “But otherwise, people couldn’t lose their insurance if they didn’t pay the premiums, and they couldn’t be barred from health services. There’s not a lot of enforcement. And yet, still, people dropped their insurance.”

While researchers did not study how a decline in healthy enrollees impacted the managed-care companies that run Michigan’s Medicaid program, she said it could destabilize these insurers, since they were suddenly responsible for a much sicker population than their original risk scores illustrated. Michigan’s managed-care companies receive a set rate per member per month from the state to care for their members. Any care that exceeds that fixed rate represents a cost the insurer must swallow. The study said that healthy people leaving the Medicaid program led to an approximately 1% drop in total expansion program revenue.

“These losses are not trivial; Michigan builds margins of about 2% into their capitation rates across plans,” researchers wrote.

McLaren Health Plan does have a “a lot” of churn among its younger, healthy Medicaid expansion members, said Tasha LaJeanna Oliver, director of the integrated delivery system’s Medicaid programs. Most of its enrollees are between the ages of 18 to 24, do not have chronic conditions and normally do not leave their coverage for more than six months, she said. When they do drop, it’s usually because of a life change, like losing a job, or because they forgot to pay their bill. To help retain these members, McLaren now allows individuals’ premium costs to be drawn directly from their bank accounts and is looking into restructuring its marketing and outreach programs. LaJeanna Oliver said she wasn’t sure about the exact rate of churn among the Grand Blanc-based health insurer’s members.

“Membership is tied directly to financial outcomes and things like that, but that churn for us is somewhat minimal. So, we have not noticed a large financial impact in regards to that,” LaJeanna Oliver said.

She added that, during the COVID-19 pandemic, Medicaid expansion membership has grown 30% year-over-year to approximately 90,000 members. The pandemic has underscored the importance of health insurance for these younger Medicaid members who may have previously lacked the forethought to pay for insurance and figured “I’m healthy, I’m invincible,” , LaJeanna Oliver said.

Their change in perspective could save taxpayers money long-term.

The study found that disenrollment of healthy enrollees leads to an increase in individuals taking advantage of safety-net providers, conditional coverage or enrolling in Medicaid after a health scare. All these moves could increase the long-term costs on taxpayers, said Cliff, the report author.

“The more churn you have, the less likely people are to get preventive care and they have trouble with continuity of care, which we know is important. And you have higher administrative costs, trying to track all these people as they go in and out,” Cliff said. “Even if you say, ‘Well, look, you’re not losing the sick people,’ it doesn’t mean that those people who you’re losing wouldn’t benefit from being covered by health insurance.”

As states consider expanding Medicaid, Cliff said lawmakers should realize that imposing premiums will limit their program’s reach. She said the study also has implications for other insurance markets that target low-income populations, like the ACA exchanges. Because members studied were sensitive to even small premiums charged, Cliff said that subsidies in the individual market would need to cover nearly all premium costs if they wanted to maintain enrollment among healthy beneficiaries. This finding is particularly relevant as lawmakers mull making the enhanced ACA subsidies permanent, she said.

“If you want to make sure that the program reaches the targeted population, there does need to be substantial subsidization of the premium amounts,” Cliff said.

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Congress eyes private equity-owned nursing homes after COVID-19 deaths



Congress eyes private equity-owned nursing homes after COVID-19  deaths

Congress is renewing its scrutiny of the nursing home industry, arguing there is a lack of transparency around the ownership and finances of chains, especially those owned by private equity.

About 40% of COVID-19 deaths in the U.S. occurred in nursing homes, partly due to the nature of congregate settings that make it hard to control the spread of infections. But Democrats want more information about the roles private equity and chain ownership of nursing homes plays in patient outcomes, pointing to studies that show more deaths and worse care in facilities owned by investors.

“We need better information about nursing home ownership and strong enforcement of nursing home quality standards,” Sen. Elizabeth Warren (D-Mass.), a critic of private equity, told Modern Healthcare. “This is why I intend to re-open my investigation of private equity-owned nursing homes so we can make progress on these issues.”

The scrutiny of private equity investment in nursing homes is not new but little has changed since Congress investigated the issue 10 years ago.

A paper published in February by the National Bureau of Economic Research, which hasn’t been peer reviewed, found Medicare patients were 10% more likely to die at private-equity owned nursing homes in the first 90 days, due to lower staffing levels, higher use of antipsychotic drugs and other reasons.

Experts hope the COVID-19 pandemic and its effect on residents will drive Congress to address the issue but they say it’s hard to hold people accountable without more information about who owns nursing homes and how profitable they actually are, two things some experts say private equity owners and chains can hide under the current laws.

A proposal by Ways & Means Committee Chairman Richard Neal (D-Mass.), which will be reintroduced this year, would significantly increase the amount of information investors in the healthcare industry have to report to the IRS.

With nursing homes in particular — an already fragmented section of the healthcare industry — complex ownership structures make it hard for policymakers and families to know which facilities are owned by private equity investors or how profitable they are.

“Examining the role of private equity in the healthcare system remains a top priority for the committee, especially in light of the last year, and we are actively accessing options for action here,” said a Ways & Means Committee aide.

A version of the Neal bill introduced last year would require private equity firms with controlling interests in medical services providers file annual information returns with the IRS detailing real estate and payments to related parties, debts, acquisitions and more, and for that information to be made public.

“I think one of the biggest problems with private equity investment in healthcare is it’s impossible to measure the impact,” said Eileen O’Grady, research and campaign coordinator at the Private Equity Stakeholder Project, which receives funding from unions and other not-for-profits. “All we have are these anecdotal stories. It’s very much the tip of the iceberg. What increased transparency does is allow regulators and lawmakers to have a more accurate picture of the landscape and help design policy that ensures these predatory practices can’t continue.”

While nursing homes have caught the attention of Congress, private equity investments in healthcare have also spread to home health, behavioral health, urgent care and other sectors of the industry.

All would be effected by the Neal bill, which would discourage investment in the health sector, opponents argue.

“This legislation includes burdensome regulations that would chill private sector investment, innovation, and growth in the healthcare space and ultimately threaten access to quality care,” said a spokesperson for the American Investment Council.

There are more than 15,000 nursing homes in the U.S., about 70% of which are for-profit.

About 10% are owned by private equity investors, according to the American Health Care Association, a trade group representing for-profit nursing homes, but other experts say that number doesn’t tell the full story.

Skilled nursing facilities only have to report direct or indirect ownership down to 5% to the Medicare Provider Enrollment, Chain and Ownership System (PECOS) database.

“They could own 4.5% but still have a lot of control over the administration over the home,” said one senior Democratic aide. “It’s kind of staggering how much we don’t know.”

The information that is filed to PECOS is not audited by CMS for accuracy or completeness, or made available to the public, according to a Health Affairs brief published in February.

President Joe Biden on the campaign trail vowed to require HHS Office of Inspector General audit nursing home cost reports and PECOS ownership data. Experts have recommended HHS work with CMS, HHS OIG, the Department of Justice and the CDC to analyze PECOS data for accuracy and completeness.

“The monetary and enforcement authorities are pretty robust at the federal levels between DOJ, HHS and CMS but they don’t tend to work together. They tend work in silos,” said Anne Montgomery, director of eldercare improvement at Altarum and co-author of the Health Affairs article.

The data could then be used to determine the impacts of ownership on patient care and discipline bad actors with a history of problems.

CMS didn’t respond to a request for comment. HHS Secretary Xavier Becerra told Sen. Warren in February, in response to written questions about private equity ownership of nursing homes, “nursing homes’ first obligation should be to their patients, no matter what kind of ownership arrangements they have.”

Organizations that receive Medicare or Medicaid reimbursements are also required to file annual cost reports but those also don’t present a full picture on whether a nursing home or chain is profitable, experts say.

Nursing home operators have to report revenues and expenses during a particular time period, but experts say profits can be “hidden” in related-third parties to make it appear that a facility is losing money.

Experts say for-profit chains — sometimes owned by private-equity firms — can pull out profits from a nursing home by contracting with a related-party it also owns, like a staffing agency. Sometimes those related parties charge the nursing homes inflated rates, “siphoning” profits from the facility, an expert told the Ways & Means Committee last month. While charges to related-parties must be reported on cost reports, those parties don’t have to file reports with CMS.

Lawmakers and experts have questioned private equity’s strategy of buying nursing homes in an apparent attempt to profit off its real estate by selling it to related third-parties and leasing it back to the operators at high rents.

“They’re able to pull so much money out of nursing homes through related party organizations and they don’t have to report on those,” said Charlene Harrington, a professor emerita of nursing and sociology at the University of California at San Francisco who studies nursing homes and co-authored the Health Affairs brief.

The brief recommends cost report requirements be amended to require nursing homes provide consolidated financial reports including data from operating entities, and all organizations and entities related by common ownership or control.

As nursing homes beg Congress for more money, and claim Medicaid and Medicare reimbursement rates are too low to cover the cost of the services they provide, experts say these complex ownership structures make it impossible to know how profitable some of these facilities actually are.

“We really don’t know whether rates are too low because without transparency, we have no idea where the money is going. We just know it’s not going for the care,” Harrington said.

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Meat Production Is Polluting the Air You Breathe



Meat Production Is Polluting the Air You Breathe

By Amy Norton
HealthDay Reporter

TUESDAY, May 11, 2021 (HealthDay News) — Steaks and burgers could be killing thousands of Americans each year, but in a way most people wouldn’t expect — via air pollution.

That’s the conclusion of a new study estimating that airborne particles generated by food production kill nearly 16,000 Americans each year. Pollution related to animal products — most notably beef — accounts for 80% of those deaths.

“What we eat affects not only our own health, but the health of others,” said researcher Jason Hill, a professor of bioproducts and biosystems engineering at the University of Minnesota in St. Paul.

Farming generates pollutants in numerous ways, but Hill’s team focused specifically on its role in fine-particle pollution — tiny substances suspended in the air that can be inhaled deeply into the lungs.

That can be especially dangerous for people with existing heart or lung conditions, and the World Health Organization says exposure to dirty air kills roughly 7 million people worldwide each year.


Farming activities like plowing fields, fertilizing crops and spreading and storing manure all help generate fine-particle pollution.

Growing plant foods creates some pollutants, but not at the level of animal products. There’s not only the livestock themselves — think manure — but the crops grown to feed them, Hill said.

Raising cattle requires the most resources and churns out the most pollution.

Accordingly, the study found, air pollution related to red-meat production caused the most harm: Per serving, its impact on deaths was seven times that of poultry, 10 times that of nuts and seeds, and at least 15 times that of other plant foods.

“Red meat has such a large impact that reducing our intake of that alone could make a big difference,” Hill said.

Gidon Eshel, a researcher not involved in the study, agreed.

Beef production “exerts, by far, the most environmental and health consequences,” said Eshel, a research professor at Bard College in Annandale-on-Hudson, N.Y.

It’s been well known that agriculture contributes to air pollution, Eshel said, and that air pollution contributes to deaths.

But the new findings, he said, show “crisply and numerically” how the nation’s collective diet contributes to deaths in the population.


The study — published May 10 in the Proceedings of the National Academy of Sciences — was partly funded by the U.S. Environmental Protection Agency (EPA) and U.S. Department of Agriculture.

It drew on EPA emissions data to gauge the impact of different farming activities on U.S. counties’ air quality. The researchers then used statistical models to estimate the effects of fine-particle pollution, from various agriculture sources, on annual deaths nationwide.

The verdict: Agriculture generates enough dirty air to kill about 18,000 Americans each year. Specifically, ammonia from livestock waste and fertilizer was a major culprit, the researchers said.

Of those deaths, the vast majority — almost 16,000 — were related to food production, mainly meat, poultry and dairy.

To take a more positive view, Hill’s team also estimated the impact of potential solutions.

They found that certain farming measures — such as improving fertilizer application — could prevent some deaths.

But changes to the American diet would reap far greater benefits: If veganism and vegetarianism swept the nation, most of the described deaths could be avoided, the researchers found.


However, Hill stressed, “you don’t have to become an absolutist.”

His team projected that “flexitarian” eating would prevent a large number of deaths, too. That refers to diets that are largely plant-based but allow some animal products in moderation.

Given the large effects of red meat, Hill noted, even declaring “meatless Mondays” could make a difference.

But would there be ill health effects from eschewing animal protein?

Eshel said there’s “not a shred of evidence” that people need animal protein to be healthy — but a “mountain of evidence” supporting the benefits of plant-based diets.

In a 2019 study, Eshel estimated that if all Americans traded in meat for plant alternatives, it would make a big dent in greenhouse gas emissions, and use of crop lands and nitrogen fertilizers.

And with sources like soy and buckwheat supplying protein, the study found, there would be no skimping on nutrients, either.

But Eshel also acknowledged that a national embracing of veganism is unlikely. He said that “jettisoning” beef, and replacing it with healthy plant foods, would be a good step in itself.


More information

The Academy of Nutrition and Dietetics has advice on building healthy vegetarian diets.

SOURCES: Jason Hill, PhD, professor, bioproducts and biosystems engineering, University of Minnesota, St. Paul; Gidon Eshel, PhD, research professor, environmental and urban studies, Bard College, Annandale-on-Hudson, N.Y.; Proceedings of the National Academy of Sciences, online, May 10, 2021

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